chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling hot, Feeling of body temperature change, Flushing, Hypersomnia
Clinical narrative: Body hot,  face red hot, right after shot.  Next day chills, fever (100), fatigue, aching body. chills and body shaking,, neck lymph nodes enlarged,  could not eat,  heavy pain in lower stomach,  hot and cold and shaking.;  slept long.  Next day (today)  Joints ache, fatigue, lesser chills,  lesser lower stomach pain.  No pain at injection site. Face is flush;   fever down
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia, Tremor
Clinical narrative: Body hot,  face red hot, right after shot.  Next day chills, fever (100), fatigue, aching body. chills and body shaking,, neck lymph nodes enlarged,  could not eat,  heavy pain in lower stomach,  hot and cold and shaking.;  slept long.  Next day (today)  Joints ache, fatigue, lesser chills,  lesser lower stomach pain.  No pain at injection site. Face is flush;   fever down
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears began after vaccination and no relief since.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram abnormal, Electrocardiogram normal, Laboratory test normal, Pericarditis, Pleuritic pain
Clinical narrative: Pleuritic chest pain lasting for months.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Abnormal  (increase in frequency) periods with excessive bleeding
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus bilaterally after covid pfizer booster shot
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Full blood count, Full blood count abnormal, Leukocytosis
Clinical narrative: Since 23 January she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, affects her palms and soles, and resolve without post-inflammatory changes. Symptoms led her to present to the ER on 25 January where she was treated with oral antihistamines. On 26 January she developed swelling affecting the skin around her eyes and her throat which caused difficulty swallowing and breathing; she was treated with oral antihistamine, oral corticosteroid, and IM epinephrine. She denies laryngeal symptoms since this episode. She was again treated with a course of oral corticosteroids in February due to persistent cutaneous symptoms. She denies laryngeal (except as noted above), pulmonary (except as noted above), GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 13 January, 10 days prior to onset of symptoms. She has used oral antihistamines and oral corticosteroids with benefit. She denies constitutional symptoms. UCT score today is 24 (3, 3, 3, 2, 2, 4, 4, 3). No history of adverse reactions to prior vaccines.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocytosis, Metabolic function test, Neutrophilia, Pharyngeal swelling, Pruritus
Clinical narrative: Since 23 January she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, affects her palms and soles, and resolve without post-inflammatory changes. Symptoms led her to present to the ER on 25 January where she was treated with oral antihistamines. On 26 January she developed swelling affecting the skin around her eyes and her throat which caused difficulty swallowing and breathing; she was treated with oral antihistamine, oral corticosteroid, and IM epinephrine. She denies laryngeal symptoms since this episode. She was again treated with a course of oral corticosteroids in February due to persistent cutaneous symptoms. She denies laryngeal (except as noted above), pulmonary (except as noted above), GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 13 January, 10 days prior to onset of symptoms. She has used oral antihistamines and oral corticosteroids with benefit. She denies constitutional symptoms. UCT score today is 24 (3, 3, 3, 2, 2, 4, 4, 3). No history of adverse reactions to prior vaccines.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Skin disorder
Clinical narrative: Since 23 January she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, affects her palms and soles, and resolve without post-inflammatory changes. Symptoms led her to present to the ER on 25 January where she was treated with oral antihistamines. On 26 January she developed swelling affecting the skin around her eyes and her throat which caused difficulty swallowing and breathing; she was treated with oral antihistamine, oral corticosteroid, and IM epinephrine. She denies laryngeal symptoms since this episode. She was again treated with a course of oral corticosteroids in February due to persistent cutaneous symptoms. She denies laryngeal (except as noted above), pulmonary (except as noted above), GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 13 January, 10 days prior to onset of symptoms. She has used oral antihistamines and oral corticosteroids with benefit. She denies constitutional symptoms. UCT score today is 24 (3, 3, 3, 2, 2, 4, 4, 3). No history of adverse reactions to prior vaccines.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion, Swelling face, Urticaria
Clinical narrative: Since 23 January she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, affects her palms and soles, and resolve without post-inflammatory changes. Symptoms led her to present to the ER on 25 January where she was treated with oral antihistamines. On 26 January she developed swelling affecting the skin around her eyes and her throat which caused difficulty swallowing and breathing; she was treated with oral antihistamine, oral corticosteroid, and IM epinephrine. She denies laryngeal symptoms since this episode. She was again treated with a course of oral corticosteroids in February due to persistent cutaneous symptoms. She denies laryngeal (except as noted above), pulmonary (except as noted above), GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 13 January, 10 days prior to onset of symptoms. She has used oral antihistamines and oral corticosteroids with benefit. She denies constitutional symptoms. UCT score today is 24 (3, 3, 3, 2, 2, 4, 4, 3). No history of adverse reactions to prior vaccines.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration of vaccine past published expiry; The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Vaccines were administered to 19 patients on 29-Mar-2022, 30-Mar-2022, 31-Mar-2022, 01-Apr-2022 and 04-Apr-2022. Reportedly, 19 doses or Vials were initially stored in the refrigerator on 01-Apr-2022 and thawed on the day of use. The Vials did not undergo any temperature excursions. The doses were administered after 30-day Use By Date and after manufacturer date of expiry.  Treatment details were not reported by the reporter.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: hypersensitivity reaction; This spontaneous report was received from a physician, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) as prophylaxis (dose, frequency, route of administration, lot # and expiration date were not reported).  On an unknown date, the patient experienced a severe hypersensitivity reaction. The outcome of hypersensitivity was unknown.  The reporter considered hypersensitivity to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown).  This is a non-valid case due to lack of patient identifiers.  Follow-up information has been received on 01-APR-2022 from a physician. The patient was established to be female. The reporter stated that the event was remote and since that time, the patient was boosted again.
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage, Menstruation irregular
Clinical narrative: patient experienced bleeding and a alteration in her menstrual cycle within the same month the vaccine was administered. The caller stated that the mentioned stated that the patient's friend experienced similar reactions to the first dose; patient experienced bleeding and a alteration in her menstrual cycle within the same month the vaccine was administered. The caller stated that the mentioned stated that the patient's friend experienced similar reactions to the first dose; This spontaneous report was received from a consumer, referring to her daughter's friend, a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.      On an unknown date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot/batch # and expiration date were not reported) for prophylaxis.       On an unknown date, the patient experienced bleeding and an alteration in her menstrual cycle within the same month the vaccine was administered. The outcome of the events was unknown.      The causality assessment between the events and the suspect vaccine was not provided.  Upon internal review, the event of bleeding was considered to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA009246:
Age: 0.92
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information reported; A patient was adminstered PEDVAX HIB (expiration date 10/17/2021) on 1/21/2022; This spontaneous report was received from a medical assistant, concerning an 11-month-old patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 21-JAN-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number S000356, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 17-OCT-2021), as prophylaxis (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (expired product administered). No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; Caller reports that seven doses of improperly stored GARDASIL 9; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications past drug reaction or allergies were not reported.  On 07-JAN-2022, the patient was vaccinated with one (1) improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage, vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number T039467 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 20-MAY-2023) for prophylaxis (product storage error).   The vaccine previously underwent a temperature excursion of 33.4 degrees Fahrenheit (F) for 2595 hours. There was no previous temperature excursion. No further information provided.   No other adverse events were reported (no adverse event).  This is one of seven reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA007812: US-009507513-2203USA007915: US-009507513-2203USA008053: US-009507513-2203USA008063: US-009507513-2203USA008097: US-009507513-2203USA007997:
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 25-SEP-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by healthcare providers for herpes zoster. The pt claimed damages as a result of injury to themselves and economic losses. The outcome of shingles was unknown and the causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was considered related.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Patient was administered improperly stored PROQUAD Incorrect product storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On an unknown date, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced temperature excursion with 5.612 Fahrenheit degrees for 30 minutes. There was no previous temperature excursion.    This morning on 28-MAR-2022, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U029320, expiration date 19-MAR-2023; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Age: 0.17
Sex: F
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: No additional information provided; she received a dose of ROT ATEQ after ROTARlX; This spontaneous report as received from a medical assistant, referring to a 6 months old female patient. The patient's concurrent conditions, medical history or concomitant medications were not provided.     On unspecified dates in November in 2021 and January in 2022 (also reported at 2 months old and 4 months old), the patient received two doses of rotavirus vaccine live oral 1v(ROTARIX) (dose regimen details, lot #, expiration date and indication were not provided) separately.  On 22-MAR-2022 (also reported as at 6-months old), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), oral for prophylaxis (interchange of vaccine products).  No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse events reported.; an expired dose of PROQUAD was administered to a patient today; 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, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 31-MAR-2022 (reported as at reporting time), the patient was vaccinated with 1 dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (Expiration Date: 07-MAR-2022, dose, strength, route, lot# were not provided) for prophylaxis (expired product administered). The reporter was unable to provide the lot number but confirmed the expiration date. The reporter also confirmed that dose was properly stored up through time of administration. No further information provided. No other adverse events reported. No product quality complaint.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported; MMR II was administered after a temperature excursion.; This spontaneous report was received from a healthcare professional and refers to a patient of unknown age and gender. The patient's medical history, and concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-MAR-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, at a dose of 0.5 milliliters (lot #T016198, expiration date: 11-MAY-2022) administered for prophylaxis (strength, and route of administration were not provided) after a temperature excursion of 46.4 Fahrenheit (°F) for 1 hour, another one of 48.4F for 2 hours 25 minutes and 49.3F for 2 hours 50 minutes  No additional AE or PQC reported.  No previous temperature excursions were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: additional adverse events reported/no product quality complaints; administration of expired dose of ROTATEQ. Dose expired 25MAR2022.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 04-APR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, by oral route, expiration date: 25-MAR-2022, administered for prophylaxis (second dose) (strength, lot #, and route of administration were not provided) (expired product administered).  Product had no prior temperature excursions. No additional adverse events reported/no product quality complaints.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details or PQC; HCP stating a patient was inadvertently administered an expired dose of ROTATEQ which was expired. No additional AE details or PQC.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 21-MAR-2022, the medical assistant stated that a patient was inadvertently administered an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml orally, lot# T033634, expiration date 16-MAR-2022, for prophlaxis (strength and frequency were not reported)(expired product administered). No additional adverse event or PQC reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further adverse events; administration of expired dose of VAQTA; This spontaneous report was received from  a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 01-APR-2022, the patient started therapy with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dosage form, lot #T017179, expiration date reported as 15-OCT-2021, but upon internal validation was confirmed as  26-OCT-2021, administered for prophylaxis (strength, and route of administration were not provided). No adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2022, the patient received the 2nd dose of Shingrix. On 29th March 2022, 4 days after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's Comments: The patient received the 2nd dose of the Shingrix vaccine last Friday (25th March 2022) from day of reporting and on Tuesday (29th March 2022) tested positive for Covid and wanted to know if covid affects the efficacy of the Shingrix vaccine. Additional Supportive Information: This case has been linked to US2022AMR057946, reported by the same reporter. The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR057946:same reporter - husband´s case
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had Shingrix and booster 4 years ago, I had shingles this year/suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In January 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's Comments:  The case was self-reported by the patient. This case was received from consumer via interactive digital media and described the occurrence of suspected vaccination failure. The patient had Shingrix shot and the booster 4 years ago from the date of reporting and had an outbreak of shingles in January 2022. The patient reported that his/her physician thought that he/she would take another booster and asked what you say. Additional Supportive Information: The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash longer than 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter enquired if it was normal to have a rash longer than 4 days after the shingles vaccine. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Pain in the back right side near kidney; This case was reported by a consumer via interactive digital media and described the occurrence of back pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2022, the patient received Shingrix. On 1st April 2022, less than a week after receiving Shingrix, the patient experienced back pain. On an unknown date, the outcome of the back pain was not recovered/not resolved.   It was unknown if the reporter considered the back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-Apr-2022 Reporter's Comment: This case was reported by consumer via interactive digital media. The patient received Shingrix a week ago and now (at the time of reporting) had pain in the back right side near the kidney and wanted to know if this was normal.  Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: was accidentally given a third dose of Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 02-Apr-2022 Reporter's Comment: This case was reported by consumer via interactive digital media. The case was reported by the patient. The patient physician's advice was to drink fluids.  The patient was still wondering if he/she was at risk for any long term problems. Additional Supportive Information: The patient was accidentally given a third dose of Shingrix, which led to extra dose administered. The follow up would not possible as no contact details were available.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: Swelling; redness; heat; itchiness; Anxiety; sporadic sharp pulsating pain; This case was reported by a other health professional via sales rep and described the occurrence of anxiety in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st March 2022, the patient received the 1st dose of Shingrix. On 31st March 2022, 4 hrs after receiving Shingrix, the patient experienced anxiety and pain. In April 2022, the patient experienced swelling, erythema, feeling of warmth and pruritus. On an unknown date, the outcome of the anxiety, pain, swelling, erythema, feeling of warmth and pruritus were unknown.   It was unknown if the reporter considered the anxiety, pain, swelling, erythema, feeling of warmth and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's Comment: The reporter was office manager. The patient experienced anxiety 4 hours after vaccine administration, sporadic sharp pulsating pain over the course of a day.  The patient had swelling, redness, heat and itchiness reported 4 days after vaccination.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling; redness; heat; itchiness; Anxiety; sporadic sharp pulsating pain; This case was reported by a other health professional via sales rep and described the occurrence of anxiety in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st March 2022, the patient received the 1st dose of Shingrix. On 31st March 2022, 4 hrs after receiving Shingrix, the patient experienced anxiety and pain. In April 2022, the patient experienced swelling, erythema, feeling of warmth and pruritus. On an unknown date, the outcome of the anxiety, pain, swelling, erythema, feeling of warmth and pruritus were unknown.   It was unknown if the reporter considered the anxiety, pain, swelling, erythema, feeling of warmth and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's Comment: The reporter was office manager. The patient experienced anxiety 4 hours after vaccine administration, sporadic sharp pulsating pain over the course of a day.  The patient had swelling, redness, heat and itchiness reported 4 days after vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Discomfort, Feeling hot
Clinical narrative: shoulder inflamed; shoulder hot to touch; very painful/left shoulder still remains inflamed, hot to touch and very painful; discomfort; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder arthritis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th 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 shoulder arthritis, feeling hot, shoulder pain and discomfort. On an unknown date, the outcome of the shoulder arthritis, feeling hot, shoulder pain and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the shoulder arthritis, feeling hot, shoulder pain and discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-MAR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received Shingle vaccine on 30th March in morning. The patient's left shoulder still remained inflamed, hot to touch and very painful. The patients asked for how long  this pain/discomfort last. Additional Supportive Information:  The follow-up would not possible as no contact details were available.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Swelling near injection site; This case was reported by a consumer and described the occurrence of swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2022, the patient received the 2nd dose of Shingrix 50 ug. On 3rd April 2022, 2 days after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was not recovered/not resolved.   It was unknown if the reporter considered the swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-Apr-2022 Reporter's Comments: The patient received a dose of Shingrix and had swelling near injection on 3rd April 2022 and 4th April 2022.  The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the second shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix 5 years ago from reporting).   On an unknown date, the patient receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-Apr-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient reported that he/she never got second shot of Shingrix. Additional Supportive Information:  Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: It's not too late to get my second shot 4 years later; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-Apr-2022 Reporter's comment: This case was reported via interactive digital media. The patient reported that it was not too late to get his/her second shot of Shingrix 4 years later. Additional Supportive Information:  Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Off label use
Clinical narrative: received 2 doses experiencing HZ breakouts or HSV2 breakouts; received 2 doses experiencing HZ breakouts or HSV2 breakouts; This case was reported by a physician via call center representative and described the occurrence of off label use in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised and herpes zoster.   In January 2022, the patient received the 1st dose of Shingrix. In February 2022, the patient received the 2nd dose of Shingrix. In January 2022, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced off label use. In February 2022, the patient experienced off label use. On an unknown date, the outcome of the off label use and off label use were unknown.   Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's comments: Doctor of medicine reported that the patient who had been experiencing ongoing breakouts and was immunocompromised thought they were Herpes Zoster breakouts.  The reporter got diagnosis, did not have information and just took patient's word for it and told the patient to get Shingrix vaccine.  The patient received 2 doses of Shingrix somewhere between January 2022 and end of February 2022 since the MD saw the patient on 27th December.  The patient then brought back lab work from 2018 that showed positive herpes simplex virus type 2 (HSV2). Biopsy from 2019 showed 2 resolving lesions of herpes viral infection but was not specific for herpes zoster (HZ) or herpes simplex virus (HSV).  There was no varicella zoster virus detected in a cell culture from 2017.  The patient's lesions were not in her genital area, rather they are on her back and buttock area.  The reporter was unsure if the patient was experiencing HZ breakouts or HSV2 breakouts. The consent to follow up was given. No lot or expiration dates for vaccine nor dates for administration of vaccines were given since administered by pharmacy. Additional Supportive Information: The patient who had been experiencing ongoing breakouts of herpes zoster received Shingrix, which led to off label use.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Mobility decreased, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: sore arms; Muscle weakness; prevented her from lifting her arms; rash on one side of her waist; developed a rash on one side of her waist that itched; pain from her elbow to her shoulder; fever of 100 degrees; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   Concurrent medical conditions included herpes virus infection.   On an unknown date, the patient received the 1st dose of Shingrix and PNEUMOVAX. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced fever, pain in arm, muscle weakness, mobility decreased, rash, itchy rash and pain in elbow. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)) and naproxen (Aleve). On an unknown date, the outcome of the fever, pain in arm, muscle weakness, mobility decreased and pain in elbow were recovered/resolved and the outcome of the rash was unknown and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the fever, pain in arm, muscle weakness, mobility decreased, rash, itchy rash and pain in elbow to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: The patient received Shingrix in the afternoon along with Pneumovax vaccine in the upper arm on an unknown date either the end of January or beginning of February. The patient took an Aleve at 6pm and in the evening, she developed a fever of 100 degrees, very sore arms and muscle weakness that prevented her from lifting her arms.  She reported severe pain from her elbow to her shoulder.  The fever was resolved by the next morning but the pain and muscle weakness took several days before resolving.  A week after the vaccines, she developed a rash on one side of her waist that itched and she was treated with a 7 day course of unspecified antiviral for herpes infection.  The patient reported that she still sometimes itches in the affected area.  The reporter declined to answer questions required to report the adverse event.  The consent was not given to contact health care professional(HCP).  No further information provided.  The reporter did not consent to follow-up. Additional Supportive Information: It was unknown if the reporter considered the fever, pain in arm, muscle weakness, mobility decreased, itchy rash and rash to be related to PNEUMOVAX.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: sore arms; Muscle weakness; prevented her from lifting her arms; rash on one side of her waist; developed a rash on one side of her waist that itched; pain from her elbow to her shoulder; fever of 100 degrees; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   Concurrent medical conditions included herpes virus infection.   On an unknown date, the patient received the 1st dose of Shingrix and PNEUMOVAX. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced fever, pain in arm, muscle weakness, mobility decreased, rash, itchy rash and pain in elbow. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)) and naproxen (Aleve). On an unknown date, the outcome of the fever, pain in arm, muscle weakness, mobility decreased and pain in elbow were recovered/resolved and the outcome of the rash was unknown and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the fever, pain in arm, muscle weakness, mobility decreased, rash, itchy rash and pain in elbow to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: The patient received Shingrix in the afternoon along with Pneumovax vaccine in the upper arm on an unknown date either the end of January or beginning of February. The patient took an Aleve at 6pm and in the evening, she developed a fever of 100 degrees, very sore arms and muscle weakness that prevented her from lifting her arms.  She reported severe pain from her elbow to her shoulder.  The fever was resolved by the next morning but the pain and muscle weakness took several days before resolving.  A week after the vaccines, she developed a rash on one side of her waist that itched and she was treated with a 7 day course of unspecified antiviral for herpes infection.  The patient reported that she still sometimes itches in the affected area.  The reporter declined to answer questions required to report the adverse event.  The consent was not given to contact health care professional(HCP).  No further information provided.  The reporter did not consent to follow-up. Additional Supportive Information: It was unknown if the reporter considered the fever, pain in arm, muscle weakness, mobility decreased, itchy rash and rash to be related to PNEUMOVAX.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose that had expired on 06Feb2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old male patient who received DTPa (Infanrix) (batch number KG4M7, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comments: Medical Assistant reported that a patient was administered a dose of Infanrix that had expired on 6th February 2022. The reporter consented to follow up. Additional Supportive Information: The patient received Infanrix which was already expired, which led to expired vaccine used.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally received Kinrix instead of Pediarix; 4 months old patient accidentally received Kinrix; 4 months old patient accidentally received Kinrix instead of Pediarix.( 2 dose).; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th March 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 30th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's comments: Nurse reported that 4 months old patient accidentally received Kinrix instead of Pediarix as 2nd dose. The consent to follow up was given. Additional Supportive Information: Four month old patient received Kinrix instead of Pediarix as 2nd dose, which led to wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Vaccines administered after freezing temperature storage; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received HBV (Engerix B) (batch number 77X47, expiry date 22nd December 2023) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's Comments: Vaccine manager reported that, since 18th March 2022, Engerix-B was exposed to a lowest temperature of minus 29.3 degree C for 2 hours and 30 minutes. The reporter stated that, it was possible that some of the affected vaccines had been administered after the freezing temperature exposure, though at this time it was not known for certain. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the ASO1B adjuvant component of the vaccine; administered only the ASO1B adjuvant component of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 75PE7, expiry date 3rd June 2023) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix. On 1st April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's Comments:  The reporter administered only the ASO1B adjuvant component of the Shingrix vaccine to a husband and wife. The reporter was not sure which of them received only the diluent or the full vaccination. The reporter consented to follow up. Additional Supportive Information: The reporter administered only the ASO1B adjuvant component of the Shingrix vaccine to a patient in left arm, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered This case is linked with case US2022058811 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022058811:same reporter