chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles 10 days after 2nd dose; lot of pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number G2J53, expiry date unknown) for prophylaxis.   The patient's past medical history included kidney transplant. Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included immunosuppression.   On 24th January 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd February 2022, 10 days after receiving Shingrix, the patient experienced shingles. The patient was treated with mycophenolic acid (Mycophenolate) and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her second Shingrix dose on her arm and ten days later she developed shingles. The patient was treating the shingles with Valtrex 1 gram daily. The reporter consented to follow up with her physician but doesn't have physician's name or contact information at the time of the call. This case is linked to the case US2022AMR024400, reported by the same reporter (pharma drug Valtrex case).   Follow up information received from consumer on 17th February 2022: No new information found during the follow-up.   Follow up information received from consumer on 22nd March 2022: The batch number of Shingrix was updated. After receiving Shingrix, the patient experienced pain. The patient was still in a lot of pain and still had shingles.  The patient provided NDC number 58160-823-11. The patient would like to know if anyone has been diagnosed with shingles after using this lot. The patient was referred her to healthcare professional.  It was unknown if the reporter considered the pain to be related to Shingrix; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024400:same reporter
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles 10 days after 2nd dose; lot of pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number G2J53, expiry date unknown) for prophylaxis.   The patient's past medical history included kidney transplant. Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included immunosuppression.   On 24th January 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd February 2022, 10 days after receiving Shingrix, the patient experienced shingles. The patient was treated with mycophenolic acid (Mycophenolate) and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her second Shingrix dose on her arm and ten days later she developed shingles. The patient was treating the shingles with Valtrex 1 gram daily. The reporter consented to follow up with her physician but doesn't have physician's name or contact information at the time of the call. This case is linked to the case US2022AMR024400, reported by the same reporter (pharma drug Valtrex case).   Follow up information received from consumer on 17th February 2022: No new information found during the follow-up.   Follow up information received from consumer on 22nd March 2022: The batch number of Shingrix was updated. After receiving Shingrix, the patient experienced pain. The patient was still in a lot of pain and still had shingles.  The patient provided NDC number 58160-823-11. The patient would like to know if anyone has been diagnosed with shingles after using this lot. The patient was referred her to healthcare professional.  It was unknown if the reporter considered the pain to be related to Shingrix; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024400:same reporter
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Surgery
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer sponsored program. The reporter is the patient. A 66-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BILIARY COLIC (hospitalization, medically significant) with onset 19Feb2022, outcome "unknown", described as "had very severe pain and resulted in the removal of gallbladder". Therapeutic measures were taken as a result of biliary colic. Clinical course: The patient had a very severe pain and resulted in the removal of gallbladder. The surgery was not planned prior to taking the vaccine. The patient asked how many other people needed to have their gallbladder removed after getting the Pfizer vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biliary colic
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer sponsored program. The reporter is the patient. A 66-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BILIARY COLIC (hospitalization, medically significant) with onset 19Feb2022, outcome "unknown", described as "had very severe pain and resulted in the removal of gallbladder". Therapeutic measures were taken as a result of biliary colic. Clinical course: The patient had a very severe pain and resulted in the removal of gallbladder. The surgery was not planned prior to taking the vaccine. The patient asked how many other people needed to have their gallbladder removed after getting the Pfizer vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Facial pain, Laboratory test abnormal, Neuritis, Pain of skin
Clinical narrative: Suffered facial neuritis or Bell's palsy; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 58-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09May2021 10:15 (Lot number: EW0168) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Known allergies: none. Concomitant medication(s) included: AMLODIPINE; CANDESARTAN. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: ER8731, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 18Apr2021, when the patient was 58 years old, for Covid-19 immunisation. The following information was reported: BELL'S PALSY (medically significant) with onset 07Dec2021, outcome "unknown", described as "Suffered facial neuritis or Bell's palsy". The event "suffered facial neuritis or bell's palsy" was evaluated at the physician office visit. No Covid prior vaccination and was COVID tested post vaccination. The patient underwent the following laboratory tests and procedures: COVID-19 Test: (20Nov2021) unknown results, notes: Nasal swab; (20Feb2022) unknown results, notes: Blood test. Therapeutic measures were taken as a result of Bell's palsy.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Suffered facial neuritis or Bell's palsy; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 58-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09May2021 10:15 (Lot number: EW0168) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Known allergies: none. Concomitant medication(s) included: AMLODIPINE; CANDESARTAN. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: ER8731, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 18Apr2021, when the patient was 58 years old, for Covid-19 immunisation. The following information was reported: BELL'S PALSY (medically significant) with onset 07Dec2021, outcome "unknown", described as "Suffered facial neuritis or Bell's palsy". The event "suffered facial neuritis or bell's palsy" was evaluated at the physician office visit. No Covid prior vaccination and was COVID tested post vaccination. The patient underwent the following laboratory tests and procedures: COVID-19 Test: (20Nov2021) unknown results, notes: Nasal swab; (20Feb2022) unknown results, notes: Blood test. Therapeutic measures were taken as a result of Bell's palsy.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Heavy pain and numbness on left hand - limp node swelling; Heavy pain and numbness on left hand - limp node swelling; Heavy pain and numbness on left hand - limp node swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Nov2021 (Lot number: 33026bd) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Known allergies: No, Other medical history: No. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0151, Location of injection: Arm Left), administration date: 05Apr2021, when the patient was 36 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ep7534, Location of injection: Arm Right), administration date: 15Mar2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), HYPOAESTHESIA (non-serious), LYMPHADENOPATHY (non-serious) all with onset 31Dec2021, outcome "not recovered" and all described as "Heavy pain and numbness on left hand - limp node swelling". The event "heavy pain and numbness on left hand - limp node swelling", "heavy pain and numbness on left hand - limp node swelling" and "heavy pain and numbness on left hand - limp node swelling" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, hypoaesthesia, lymphadenopathy.  Additional information: AE treatment included pain medicine. Facility type vaccine Pharmacy or Drug Store. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and was covid tested post vaccination was yes.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Pain in extremity
Clinical narrative: Heavy pain and numbness on left hand - limp node swelling; Heavy pain and numbness on left hand - limp node swelling; Heavy pain and numbness on left hand - limp node swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Nov2021 (Lot number: 33026bd) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Known allergies: No, Other medical history: No. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0151, Location of injection: Arm Left), administration date: 05Apr2021, when the patient was 36 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ep7534, Location of injection: Arm Right), administration date: 15Mar2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), HYPOAESTHESIA (non-serious), LYMPHADENOPATHY (non-serious) all with onset 31Dec2021, outcome "not recovered" and all described as "Heavy pain and numbness on left hand - limp node swelling". The event "heavy pain and numbness on left hand - limp node swelling", "heavy pain and numbness on left hand - limp node swelling" and "heavy pain and numbness on left hand - limp node swelling" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, hypoaesthesia, lymphadenopathy.  Additional information: AE treatment included pain medicine. Facility type vaccine Pharmacy or Drug Store. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and was covid tested post vaccination was yes.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: FEVER, HEADACHE, BODY ACHES, CHILLS, SWOLLEN ARMPIT
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Oedema peripheral, Pain, Pyrexia
Clinical narrative: FEVER, HEADACHE, BODY ACHES, CHILLS, SWOLLEN ARMPIT
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, Confusional state, Fatigue, Weight increased
Clinical narrative: Increased thyroid stimulating hormone, fatigue, weight gain, confusion
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart Attack
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Subjective left axillary swelling and soreness, not appreciated on exam.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Malaise, Nasopharyngitis
Clinical narrative: 10 HOURS AFTER I GOT THE BOOSTER  SHOT, i WAS VERY ILL,  A LOT SICKER THAN I WAS WHEN I HAD COVID. I EVEN TOOK A COVID TEST. THE FIRST 3 DAYS I HAD A FEVER 102 ,CHILLS. AFTER THAT I HAD DIARRHEA, FOR 2 DAYS. THEN FOR THE NEXT 7 DAYS I HAD THE WORST COLD EVER,  THEN FOR 5 WEEEKS , I HAD A SERVERE  COUGH, A BARK OF A COUGH, ON AND ON. TO THIS DAY I GET FITS A COUGHING.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 10 HOURS AFTER I GOT THE BOOSTER  SHOT, i WAS VERY ILL,  A LOT SICKER THAN I WAS WHEN I HAD COVID. I EVEN TOOK A COVID TEST. THE FIRST 3 DAYS I HAD A FEVER 102 ,CHILLS. AFTER THAT I HAD DIARRHEA, FOR 2 DAYS. THEN FOR THE NEXT 7 DAYS I HAD THE WORST COLD EVER,  THEN FOR 5 WEEEKS , I HAD A SERVERE  COUGH, A BARK OF A COUGH, ON AND ON. TO THIS DAY I GET FITS A COUGHING.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Shortly after receiving the Covid vaccine, I started having some minor but consistent pain in my right underarm. This is the same arm that the vaccine was given in.  I never had this before the vaccination.  I do not remember if it started after the first or second dose.  But it has remained but has moved from the direct armpit area to approximately 4" down on the inside of the arm.  The best I can describe it is a very sharp sudden pain that eases away.  It is not debilitating in any way but it is there and comes on suddenly.  I have mentioned it to several doctors but there seems to be no concern. I am not certain that it was caused by the vaccine but I never had this before the injection.  I feel it should be reported in case others are also experiencing it.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient informed us that he has had a dull intermittent pain at about 3/10 on the pain scale since his first vaccination 04/16/2021 in his left arm. He denies having any restrictions in mobility, he states that the pain comes intermittently with activity. He denies having any restrictions in mobility or any numbness. He takes no current medications and has no allergies.  Denies having any current medical diagnoses. Patient requested to take the vaccine in his right arm today 3/25/22 and patient was okayed for his Pfizer(comirnaty) booster by MD.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: PATIENT RECEIVED BOOSTER DOSE 2 MONTHS EARLY. PRIMARY SERIES FINISHED DECEMBER, BOOSTER DOSE GIVEN IN MARCH. OBSERVED 15 MINUTES POST VACCINATION. NO SIGNS OF DISTRESS. NO COMPLAINTS. PATIENT INFORMED OF POSSIBLE SIDE EFFECTS AND FOR WORSE SYMPTOMS TO CALL 911 OR GO TO E.R.. PATIENT AGREED TO UNDERSTANDING.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Lump under left arm (armpit); soreness; diameter approximately 2 inches.  Treatment - 2 Aleve tablets, heat.  Outcome - soreness continued (less than 24 hrs since treatment).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal ulceration
Clinical narrative: An open sore developed on the back of my throat 2 days after vaccination. I visited any dentist and she prescribed me dexamethasone. After a week and a half the sore disappeared.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Foetal death
Clinical narrative: Intrauterine fetal death discovered at 24 weeks and 3 days gestation. Infant girl delivered on March 24, 2022.  This is patient's second pregnancy. First pregnancy  was successful.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; VAQTA experienced a temperature excursion on 29-DEC-2021. Patient was administered VAQTA after temperature excursion on 05-JAN-2022.; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided by the reporter.   On 29-NOV-2021, Hepatitis A Vaccine, Inactivated (VAQTA) experienced a temperature excursion. Therefore, on 05-JAN-2022, the patient was vaccinated with a improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) (incorrect product storage) lot number U024094, expiration date 10-MAY-2023 (dose and route of administration were not provided). No additional adverse event reported. Administered dose of vaccine experienced the temperature excursion of 35.9 degrees Fahrenheit (°F) for 0 hours 20 minutes 0 seconds. Data logger was not involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA007167:
Sex: F
Vaccine: FLUX, PPV
Symptoms: Soft tissue necrosis
Clinical narrative: necrosis of arm tissue; This spontaneous report was received from a pharmacy technician referring to a 61-year-old female patient. The patient's concurrent conditions included asthma, fibromyalgia and arthritis. The patient's medical history included depression, lethargy, suicidal ideation, indifference and off label use. She had no known drug allergies. the patient's historical drugs included propranolol. The patient's concomitant therapies included etodolac, pregabalin, escitalopram, tramadol, pantoprazole, atorvastatin, levothyroxine, potassium, furosemide, estradiol, trazodone, montelukast and primidone.  On an unknown date in September 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza vaccine (FLU) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On an unknown date in October 2020, the patient experienced necrosis of arm tissue (soft tissue necrosis). The outcome of soft tissue necrosis was unknown.  The causal relationship between the vaccines and soft tissue necrosis was unknown.   Upon internal review, the event soft tissue necrosis was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Blood immunoglobulin A, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, Giardiasis, Inflammation
Clinical narrative: He had non-protective post-Pneumovax titers; Information has been received from the authors in a published literature article, entitled as stated below, referring to a 12-year-old male who on an unspecified date presented with inflammatory bowel disease (IBD), multiple non-infectious pulmonary nodules, and splenomegaly.   On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).      At presentation, his work up revealed giardia infection decreased IgG (283), IgM (15), and  undetectable IgA. He had non-protective post- Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) titers (vaccination failure), and an absolute lymphocyte count of 640. He was diagnosed with common variable immunodeficiency (CVID) and started on intravenous IgG replacement. At age 25, he developed inflammatory arthritis of the right ankle and left wrist treated with sulfasalazine. Genetic testing revealed a pathogenic heterozygous variant in TNFAIP3.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report:
Sex: M
Vaccine: PPV
Symptoms: Lymphocyte count, Vaccination failure
Clinical narrative: He had non-protective post-Pneumovax titers; Information has been received from the authors in a published literature article, entitled as stated below, referring to a 12-year-old male who on an unspecified date presented with inflammatory bowel disease (IBD), multiple non-infectious pulmonary nodules, and splenomegaly.   On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).      At presentation, his work up revealed giardia infection decreased IgG (283), IgM (15), and  undetectable IgA. He had non-protective post- Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) titers (vaccination failure), and an absolute lymphocyte count of 640. He was diagnosed with common variable immunodeficiency (CVID) and started on intravenous IgG replacement. At age 25, he developed inflammatory arthritis of the right ankle and left wrist treated with sulfasalazine. Genetic testing revealed a pathogenic heterozygous variant in TNFAIP3.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report:
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Cardiovascular disorder, Herpes zoster, Post herpetic neuralgia, Visual impairment
Clinical narrative: postherpetic neuralgia; cardiovascular event; vision problems; balance problems; multiple outbreaks of herpes zoster; Information has been received from a lawyer, regarding a case in litigation, concerning a currently approximately 70 years old patient (pt) of unknown and gender. There was no information provided regarding the pt's concurrent conditions, medical history or concomitant medications. On or about 07-APR-2015, the pt was administered the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location, and route of administration were not reported) by a pharmacist at the pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, reported as subsequently to the zoster vaccine live (ZOSTAVAX) administration, the pt was treated by providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: multiple outbreaks of herpes zoster, postherpetic neuralgia, cardiovascular event, vision problems and balance problems. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: PNC15, PPV
Symptoms: Blood immunoglobulin A decreased, Blood immunoglobulin G normal, Blood immunoglobulin M decreased, Endoscopy abnormal, Immunodeficiency common variable
Clinical narrative: Poor response to pneumococcal vaccine; Literature Report:    This literature marketed report has been received from authors of a published article, regarding a 28-year-old male patient. On an unknown dated, the patient was referred to the Allergy, Asthma, and Immunology clinic with 1.5 years of abdominal pain and severe chronic diarrhea causing malnutrition, dehydration, and hospitalization. Of note, the patient did not have a history of recurrent or frequent infections. An extensive gastrointestinal (GI) workup with endoscopic evaluation showed severe villous blunting and increased intraepithelial lymphocytes suggestive of celiac disease, however, serology testing was negative and he did not respond to gluten avoidance. Stool testing did not reveal an infectious etiology. Notably, he also had tryptase of 12.8, but no evidence of mast cell disease. Labs confirmed Common variable immunodeficiency (CVID) with IgG 566, IgM 34, IgA 46, poor response to pneumococcal vaccine, polyvalent (23-valent)/pneumococcal 15v conj vaccine (crm197) (indication default to prophylaxis; strength, dose, frequency, route, lot # and expiration date were not reported) (suspect product reported as pneumococcal vaccine) (vaccination failure). The outcome of vaccination failure was unknown. The causality of vaccination failure was related to pneumococcal vaccine, polyvalent (23-valent)/pneumococcal 15v conj vaccine (crm197).  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: PNC15, PPV
Symptoms: Intestinal intraepithelial lymphocytes increased, Serology test, Stool analysis normal, Tryptase, Vaccination failure
Clinical narrative: Poor response to pneumococcal vaccine; Literature Report:    This literature marketed report has been received from authors of a published article, regarding a 28-year-old male patient. On an unknown dated, the patient was referred to the Allergy, Asthma, and Immunology clinic with 1.5 years of abdominal pain and severe chronic diarrhea causing malnutrition, dehydration, and hospitalization. Of note, the patient did not have a history of recurrent or frequent infections. An extensive gastrointestinal (GI) workup with endoscopic evaluation showed severe villous blunting and increased intraepithelial lymphocytes suggestive of celiac disease, however, serology testing was negative and he did not respond to gluten avoidance. Stool testing did not reveal an infectious etiology. Notably, he also had tryptase of 12.8, but no evidence of mast cell disease. Labs confirmed Common variable immunodeficiency (CVID) with IgG 566, IgM 34, IgA 46, poor response to pneumococcal vaccine, polyvalent (23-valent)/pneumococcal 15v conj vaccine (crm197) (indication default to prophylaxis; strength, dose, frequency, route, lot # and expiration date were not reported) (suspect product reported as pneumococcal vaccine) (vaccination failure). The outcome of vaccination failure was unknown. The causality of vaccination failure was related to pneumococcal vaccine, polyvalent (23-valent)/pneumococcal 15v conj vaccine (crm197).  A copy of the published article is attached as further documentation of the patient's experience.
Age: 2.0
Sex: F
Vaccine: HPV9
Symptoms: Illness, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: The dose made her very sick; she had redness and pain at the injection site; she had redness and pain at the injection site; 2-year-old was accidentally given dose of GARDASIL 9; 2-year-old was accidentally given dose of GARDASIL 9; This spontaneous report was received from a physician assistance on behalf a consumer reporting a 2-year-old female patient. There was no information regarding the patient's past medical history, previous drug reactions or allergies, concurrent conditions or concomitant medications.  On approximately 21-SEP-2021 (reported as "6 months ago"), the patient was accidentally vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (accidental exposure to product/product use issue) administered as prophylaxis (dose, dosage regimen, route of administration, anatomical injection site, lot number and expiration date were not reported).  It was reported that the dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) made her very sick (illness) and she experienced injection site reactions such as redness and pain at the injection site (vaccination site erythema/vaccination site pain). It was confirmed that the patient was not hospitalized due to the events and she recovered on an unspecified date.  The event illness was considered as related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), since it was reported that the dose made her very sick. The causality between the events vaccination site erythema and vaccination site pain was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired vaccine used; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  On 22-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T031825 (rHA), expiration date 16-MAR-2022 (expired product administered) for prophylaxis (dose, route and anatomical location were not reported). No adverse events reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction
Clinical narrative: Patient had anaphylactic reaction after receiving Kinrix and Proquad; This spontaneous report was received from an epidemiologist and refers to a 4 year old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot #, expiration date, dose, frequency, route of administration, anatomical location not provided) and with diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) both as prophylaxis. After receiving the vaccines, the patient had an anaphylactic reaction; in consequence, she went to the emergency room (ER) where she was treated (unspecified). On an unknown date, the patient recovered from the event.   Causality assessment between anaphylactic reaction and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was not reported.  Upon internal review, anaphylactic reaction was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Dry mouth, Insomnia, Pyrexia
Clinical narrative: I had chills; Fever; Couldn't sleep at all last night; Dry mouth; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17th March 2022, the patient received the 1st dose of Shingles vaccine. In March 2022, less than a day after receiving Shingles vaccine, the patient experienced chills, fever, insomnia and dry mouth. On an unknown date, the outcome of the chills, fever, insomnia and dry mouth were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, insomnia and dry mouth to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported.       The patient received 1st dose of Shingles vaccine one day before reporting and had chills, fever and could not sleep at all last night. Less than a week after vaccination, the patient experienced a dry mouth. The patient stated that hopefully he/she would feel better on 19th March 2022. Follow-up could not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: shots worse than desease itself, kicked my behind; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (received 1st dose on an unknown date, refer link case US2022AMR050261).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   The reporter considered the feeling abnormal to be possibly related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR050261  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient thought his/her Shingles shots were worse than the disease itself. The patient stated that it kicked him/her behind for days. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR050261:Same patient, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: shots worse than desease itself, kicked my behind; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal 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, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the feeling abnormal 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 thought his/her Shingles shot was worse than the disease itself. The patient stated that it kicked him/her behind for days. Follow-up could not be possible as no contact details were available. For tolerance to 2nd dose, refer case US2022AMR050244.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR050244:Same patient, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurts like hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the 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 stated that there's an old vaccine that did not protect anyone but the new one does. The patient said that hurts like hell, but not as much as shingles. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Near death experience, Paraplegia
Clinical narrative: guillain barre syndrome/paralyzed from neck up; paralyzed from waist down and neck up; Getting the vaccine almost killed me; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (serious criteria GSK medically significant), paraplegia (serious criteria GSK medically significant) and near death experience (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome, paraplegia and near death experience were unknown.   It was unknown if the reporter considered the guillain barre syndrome, paraplegia and near death experience to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient self-reported this case. The patient received the Shingles vaccine and ended up with Guillain-Barre syndrome. The patient was paralyzed from the waist down and the neck up. Getting the vaccine almost killed the patient. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: sore injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th March 2022, the patient received the 1st dose of Shingles vaccine. In March 2022, less than a week after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got his/her Shingles vaccine and a very sore arm ( injection site) but not as painful as getting shingles. The patient was thankful to his/her doctor recommended this to him/her yesterday at his/her physical.  The follow up would not possible as no contact details were available.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache; Fever; Scary shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st March 2022, the patient received the 1st dose of Shingrix. In March 2022, less than a week after receiving Shingrix, the patient experienced headache, fever and shivering. On an unknown date, the outcome of the headache, fever and shivering were unknown.   It was unknown if the reporter considered the headache, fever and shivering to be related to Shingrix.  Additional details were reported as follows: The case was self reported by the patient. The patient received first dose of Shingrix vaccine and experienced headache, fever and scary shivering. The patient hoped that his/her fever did not stay too long.  The patient was asking if the second shot could present more severe side effect. The patient was worried about second shot of Shingrix vaccine. The patient did not want to disclose his/her contact information and asked to contact via email.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: it hurts; This case was reported by a consumer via interactive digital media and described the occurrence of injection site 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, unknown after receiving Shingles vaccine, 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 Shingles vaccine.     Linked case(s) involving the same patient: US2022AMR052502  Additional details were reported as follows: The case was self reported by the patient. The age at vaccination was not applicable. The patient just got his/her second shot of Shingles vaccine and mentioned it hurts, but nothing like getting shingles. This case was linked with US2022AMR052502 reported by same reporter for same patient for different dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR052502:same report, other dose
Sex: U
Vaccine: HEPAB
Symptoms: Product supply issue
Clinical narrative: Cannot find a local pharmacy that stocks Twinrix; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date) and Twinrix (received 2nd dsoe 1 month later of 1st dose).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   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 reporter was the patient. The age at vaccination was not applicable for this report. The patient did not receive 3rd dose of Twinrix as patient could not find local pharmacy that stocks Twinrix, which led to product supply issue. The patent asked if he/she could get a separate Hepatitis A and Hepatitis B vaccine to substitute.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: redness at injection site; swelling at injection site; joint aches/pain; fever; feeling wiped out; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema, injection site swelling, joint pain, fever and worn out. On an unknown date, the outcome of the injection site erythema, injection site swelling, joint pain, fever and worn out were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, joint pain, fever and worn out 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 reporter said that no side effects from 1st shot, but was not so lucky with the 2nd one. The patient experienced redness and swelling at injection site along with joint aches/pain, some fever, and basically feeling wiped out for about 3 days. The reporter said all worth it to have both doses of Shingrix as the patient did not want shingles. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles symptoms, around the abdomen without an external rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, 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 Shingrix.  Additional details were reported as follows: The case was self-reported by the patient. The age at vaccination was not applicable. 3 weeks after receiving Shingrix, the patient had symptoms of shingles. The patient was asked regarding whether Shingrix vaccine was live vaccine or not. The patient enquired if there were any patients who after receiving the second dose complained of shingles symptoms, around the abdomen without an external rash.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Herpes zoster, Lymphadenopathy, Rash, Scab
Clinical narrative: 2 doses 3 yrs ago. Was diagnosed with shingles last week/ suspected vaccination failure; shingles; Rash started in hairline crusted over; Lymph nodes were very swollen; ear pain; hairline crusted over; This case was reported by a nurse via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In March 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, enlargement of lymph nodes, ear pain and crust. The patient was treated with amoxicillin + clavulanic acid (Augmentin). On an unknown date, the outcome of the vaccination failure, shingles, enlargement of lymph nodes, ear pain and crust were unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, enlargement of lymph nodes, ear pain and crust to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had 2 doses of Shingrix 3 years ago. The patient was diagnosed with shingles last week. Rash started in hairline, crusted over. Lymph nodes were very swollen, ear pain and had to start on augmentin. The rash was resolved. The reporter did not agree for follow up. This case was considered as suspected vaccination failure since details regarding laboratory confirmation was not provided.