chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 at 09:30 as dose 4 (booster), single (Lot number: FK9895) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Feb2021 as dose 1, single (Lot number: 013A21A), in left arm, on 24Mar2021 as dose 2, single (Lot number: 016B21A), in left arm and on 02Nov2021 as dose 3 (booster), single (Lot number: 039905), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Dose:4 Pfizer/Dose:3, 2, 1 Moderna" (not ongoing), notes: Dose:4 Pfizer/Dose:3, 2, 1 Moderna. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: May2020; CALCIUM, start date: Jan2012; VITAMIN B COMPLEX, start date: Jan2021; VITAMIN B12 [CYANOCOBALAMIN], start date: Jan2018; VITAMIN D [COLECALCIFEROL], start date: Jan2012. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive, notes: Positive rapid antigen test at home; (22May2022) Positive, notes: Covid test was again positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was also reported that patient also received Paxlovid from 11May2022 to 16May2022 of lot number FX8140 for the indication of treatment of Covid-19.  Clinical course: Recurrent Covid symptoms very similar to the previous ones onset 5 days after completing full course of Paxlovid and with a positive home antigen test the next day (6 days from finishing Paxlovid).  Both initial and recurrent symptoms have been mild and persist to the date of this report. They include sore throat, congestion, rhinorrhea, myalgias, headache, fatigue and poor appetite. Initial diagnosis of Covid was on 10May22 with a positive rapid antigen test at home. Initial symptoms prior to first test started on 9May2022.Symptoms had seemingly resolved by about 19May did not repeat antigen test at that time. Symptoms recurred 2 days later and Covid test was again positive the next day on 22May2022.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hemiparesis, Injected limb mobility decreased, Muscular weakness, Myositis
Clinical narrative: Weakness in left arm.  Very limited shoulder mobility on the Left side.  Inflamed  Teres Major/Minor.  Cannot lift even 5lbs above the shoulder level and hold.    Symptoms have persisted since 05/22/2022.  I have tried chiropractic treatment twice a week since with no improvement.  Anti-inflammatory drugs also have not helped.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: I had a breakthrough case, I tested positive for COVID 6 months after I got my 3rd dose.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID 11 days after my 3rd dose.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Headache.  Muscle aches.   Restless legs.  Nausea.   Exhaustion.   Incapacitated for 24 hours.   Headache still persists now.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Restless legs syndrome
Clinical narrative: Headache.  Muscle aches.   Restless legs.  Nausea.   Exhaustion.   Incapacitated for 24 hours.   Headache still persists now.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, MENB, MNQ
Symptoms: Abdominal pain upper, Cataplexy, Dyspnoea, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Seconds after receiving the Gardasil Vaccine patient slumped over with a stiff neck and limbs (both wrists) and was convulsing unconscious for several minutes. After coming to she had serious stomach pain and felt like she couldn?t breath. A couple nurses and her doctor witnessed it along with myself (mother)
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, MENB, MNQ
Symptoms: Seizure
Clinical narrative: Seconds after receiving the Gardasil Vaccine patient slumped over with a stiff neck and limbs (both wrists) and was convulsing unconscious for several minutes. After coming to she had serious stomach pain and felt like she couldn?t breath. A couple nurses and her doctor witnessed it along with myself (mother)
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, MENB, MNQ
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Seconds after receiving the Gardasil Vaccine patient slumped over with a stiff neck and limbs (both wrists) and was convulsing unconscious for several minutes. After coming to she had serious stomach pain and felt like she couldn?t breath. A couple nurses and her doctor witnessed it along with myself (mother)
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse events; Patient completed series on schedule and this was a fourth dose; This spontaneous report was received from a nurse practitioner, referring to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 04-MAY-2022, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), orally (lot #, expiration date and dosage were not provided) for prophylaxis. The patient completed whole series on schedule and this was a fourth dose (Extra dose administered). No additional adverse event was reported (No adverse event).
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional  AE was reported; Pharmacist calling to report that a dose of ROTATEQ with a labeled expiry of 4/20/2022 was administered to a patient on 5/9/2022.; This spontaneous report was received from a pharmacist regarding a patient of 4-month-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 09-MAY-2022, the patient was vaccinated with a labeled expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliters (ml) orally administered as prophylaxis, (lot number 1705097 which has been verified to be valid, expiration date reported and validated as 20-APR-2022) (expired product administered) (strength was not reported). No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: During temperature excursion case, caller reports that improperly stored vaccines were administered to 2 patients; No additional AE reported; This spontaneous report was received from an other type of reporter and refers to currently 4-year-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.   On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (A (recombinant human albumin [rHA]) (M-M-R II) lot # T012807 confirmed to be valid with expiration date 14-APR-2022 (dose, route of administration, and anatomical location were not reported) for prophylaxis. The vaccine underwent a temperature excursion of 67.3 degrees Fahrenheit (F) for 1 hour and 13 minutes on an unknown date before administration (product storage error). There was no previous temperature excursion. No additional adverse event was reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2205USA003201:
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; Caller is office manager who reported temperature excursion for GARDASIL 9. One dose of vaccine had been administered. Product "not supported" per evaluation in TE case 02165317. No other details available. No additional adverse events. No product qu; This spontaneous report was received from an office manger and refers to a 16-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. There was no information regarding the patient's allergies or drug reactions.  On 12-MAY-2022, the patient was vaccinated with one dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #U008900, expiration date: 12-AUG-2023, (strength, exact dose, dose #, route and site of administration were not provided) for prophylaxis (product storage error). The temperature and the time frame for the excursion was not provided. It was unknown if there was a previous excursion. No additional adverse events was provided (no adverse event). On 20-MAY-2022 inbound call was received from the office manager. She stated that additional information would be available via Vaccine Adverse Event Reporting System (VAERS). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Product administered at inappropriate site
Clinical narrative: Caller reports dose of PNEUMOVAX 23 was administered intramuscular in Gluteus Maximus.  No other information provided.  No additional AEs or PQC reported.; No additional AEs or PQC reported; This spontaneous report was received from nurse, referring to a 66-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter (ml), administered intramuscularly (IM) in gluteus maximus, as prophylaxis, (strength and vaccination scheme frequency were not provided; lot number T031820 that was verified to be valid for syringe formulation with an expiration date not reported but upon internal validation established as 10-MAY-2022) (product administered at inappropriate site). No other information provided. No adverse events (AEs) (no adverse event) were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: not additional AE; improperly stored PEDVAX HIB 0.5ml IM was administered on 5/9/2022; This spontaneous report was received from licensed practical nurse, referring to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions.   On 09-MAY-2022, the patient was vaccinated licensed practical nurse haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 mL, administered intramuscularly, lot #U02621, expiration date: 02-NOV-2023,given as prophylaxis.The improperly stored dose underwent a temperature excursion at a temperature of at 42.5 degree Celsius (C) for 13 hours and 42 minutes (Product storage error). There were no previous temperature excursions. No additional adverse event was reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: HBP reported AE for improperly stored administered vaccine.; This spontaneous report was received from an office manager (also reported as HBP) and refers to 8-month-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 17-MAY-2022, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1742431 confirmed to be valid with expiration date 31-JAN-2023 (exact dose was not reported) for prophylaxis. The vaccine underwent a temperature excursion of 28 degrees Fahrenheit (F) for 96 hours on an unknown date before administration (product storage error). There was no previous temperature excursion.  This is one of six reports from the same reporter.; Sender's Comments:  US-009507513-2205USA005815: US-009507513-2205USA005673: US-009507513-2205USA005882: US-009507513-2205USA005914: US-009507513-2205USA005906:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reports vaccine administered after temperature excursion; This spontaneous report was received from a registered nurse and refers to a specified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-MAY-2022, the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 ml, lot # U031560, expiration date: 06-APR-2023, administered subcutaneously (strength was not provided) for prophylaxis. Prior to being administered, the vaccine experienced a temperature excursion of 10 degrees Fahrenheit for 14 minutes (product storage error). There were no previous temperature excursions. No additional adverse event reported (no adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient did not have any adverse effects or symptoms following administration.; one dose of PROQUAD was administered following temperature excursion.; This spontaneous report was received from a practice administrator and refers to a 4-year-old patient of unknown gender. The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT). The patient's concurrent conditions, medical history allergies and drug reactions were not reported.   On 23-MAY-2022, the patient was vaccinated with improperly stored one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), lot #W002784, expiration date: 24-JUL-2023, (strength, exact dose, dose number, route and site of administration were not provided) for prophylaxis (product storage error). The vaccine was stored at - 4.6 degree Celsius (C) for 4 hours 16 minutes and 0.2 C for 7 hours 46 minutes. No previous temperature excursions were reported. The patient did not have any adverse effects or symptoms following administration (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: the patient did not receive the full dose as she noted that some leaked out of the syringe when the patient moved; the patient did not receive the full dose as she noted that some leaked out of the syringe when the patient moved; No additional AE reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W004026, expiration date 02-AUG-2023 (dose, route and frequency were not reported) along with sterile diluent, for prophylaxis.   The reporter mentioned that, on an unknown date, the patient moved when she was administering a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), and stated that the patient did not receive the full dose as she noted that some leaked out of the syringe when the patient moved. No additional adverse event was reported.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Temperature excrusion/TE evaluation states vaccines have been administered to multiple patients; Device or device component malfunction; This spontaneous report was received from a medical assistant and an other non-health care professional referring to a 4year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. No illness at time of vaccination nor vaccine within 4 weeks prior to vaccination date was reported.  On 23-MAR-2022, the temperature excursion occurred of varicella virus vaccine live (oka/merck) (VARIVAX). The storage temperature was -14 degree Celsius up to -10 degree Celsius for 3 hours and -10 degree Celsius up to 8 degree Celsius for 1 hour 30 minutes. There was no previous temperature excursion. The temperature excursion occurred as a result of a reading from a digital data logger. On 28-MAR-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection by a healthcare professional for prophylaxis (subcutaneous, lot #U025790, expiration date: 19-AUG-2023; strength and dose were not provided) (product storage error). No additional adverse event (no adverse event) was reported. After administration, the reporter contacted company and verified the viability of vaccine. The vaccine was not available for return or evaluation because it was given to the patient. Additionally, it was reported device or device component malfunction.   This is one of several reports from the same reporter.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Temperature excrusion/TE evaluation states vaccines have been administered to multiple patients; Device or device component malfunction; This spontaneous report was received from a medical assistant and an other non-health care professional referring to a 5 year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. No illness at time of vaccination nor vaccine within 4 weeks prior to vaccination date was reported.  On 23-MAR-2022, the temperature excursion occurred of varicella virus vaccine live (oka/merck) (VARIVAX). The storage temperature was -14 degree Celsius up to -10 degree Celsius for 3 hours and -10 degree Celsius up to 8 degree Celsius for 1 hour 30 minutes. There was no previous temperature excursion. The temperature excursion occurred as a result of a reading from a digital data logger. On 20-APR-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection by a healthcare professional for prophylaxis (subcutaneous, lot #U025790, expiration date: 19-AUG-2023; strength and dose were not provided) (product storage error). No additional adverse event (no adverse event) was reported. After administration, the reporter contacted company and verified the viability of vaccine. The vaccine was not available for return or evaluation because it was given to the patient. Additionally, it was reported device or device component malfunction.   This is one of several reports from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: uggg. Got sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date:25-May-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient took the shingles vaccine and got sick. Additional Supportive Information:  The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Product administered at inappropriate site, Vaccine positive rechallenge
Clinical narrative: Patient had more localized redness; Patient was concerned that the second shot was given in the wrong spot on arm; Patient complained of body aches; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose in January 2022 and experienced Injection site Erythema, refer case US2022AMR085886).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema, general body pain and vaccine administered at inappropriate site. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema and vaccine administered at inappropriate site were unknown and the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the injection site erythema and general body pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR085886   Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: Patient received first dose of Shingrix back in January, 2022 and went in a month before reporting for second dose. Received both doses at local pharmacy, but when received the second dose, the shot was given lower in the deltoid region, more towards the inner arm. The patient had more localized redness than from the first dose and also complained of body aches for about a day or so after the second dose. Patient was concerned that the second shot was given in the wrong spot on arm due to the localized redness and body aches, especially since patient did not have these symptoms after the first dose. The reporter consented to follow up. Additional supportive information: The patient was concerned that the second shot was given in the wrong spot on arm, which led to vaccine administered at inappropriate site; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085886:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Illness, Pyrexia
Clinical narrative: sick; fever; chills; headache; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, fever, chills and headache. On an unknown date, the outcome of the sickness, fever, chills and headache were unknown.   It was unknown if the reporter considered the sickness, fever, chills and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comments: This case was reported via interactive digital media described the occurrence of sickness in for an unspecified number of patients.  who received Herpes zoster (Shingles vaccine) for prophylaxis.  The case was reported by reporter via interactive digital media. After receiving Shingles vaccine, The reporter mentioned that, the patient's physician warn several patient's got this kind of a reaction (sickness sick with fever, chills and headache. The reporter stated that it seemed better than how people would described their shingles here. The follow-up would not possible as no contact details were available. This case has been linked with case US2022AMR084987 as reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR084987:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure/My mom got the vaccine, still got a really bad case of shingles; Still got a really bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-May-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient was the reporter's mother. The patient got the vaccine and still got really bad case of shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I had my 1st dose about 2 years ago. I have not had my 2nd dose.; 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 about 2 years ago).   On an unknown date, the patient received 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: 26-MAY-2022 Reporter's Comments: This case was reported via interactive digital media. Patient stated that he/she had the first shot of the Shingrix vaccination about 2 years ago from the date of reporting and did not receive his/her second dose. Patient enquired about further course of action. Additional Supportive Information: Till the time of reporting, the patient did not received the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received 1st dose 1 year ago didn´t get the 2nd dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose received about 1 year ago.).   On an unknown date, the patient received 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: 26-May-2022 Reporter comments: The case was reported via interactive digital media. The patient received 1st dose of Shingrix about 1 year ago from the date of reporting but did not receive 2nd dose yet. The reporter enquired if he still get the 2nd dose. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Follow up would not be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Bad headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient had continued bad headache. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node is about the size of half/baseball; It hurts like crazy; This case was reported by a consumer via interactive digital media and described the occurrence of enlargement of lymph nodes in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th May 2022, the patient received the 1st dose of Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced enlargement of lymph nodes and lymph node pain. On an unknown date, the outcome of the enlargement of lymph nodes and lymph node pain were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes and lymph node pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. After receiving Shingles vaccine, lymph node under his/ her same arm in which injection was received was about size of half baseball. The patient stated it was hurt like crazy too. The patient did not see this side effect in the list of side effects. The patient asked what did this mean.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: We got the 1st dose, can't afford to pay for 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of product availability issue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product availability issue. On an unknown date, the outcome of the product availability issue was unknown.       Additional Information: GSK Receipt Date: 27-May-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got 1st dose of shingrix. The patient lost medical insurance and when she went to pharmacy they said it would cost 165 dollar. The patient could not afford for that. The patient asked what was the repercussion as the patient already received 1st dose. Additional Supportive Information: Till the time of reporting the patient received the patient did not received 2nd dose of shingrix which led to product availability issue. The case was linked with the case US2022AMR085716, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085716:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Product availability issue
Clinical narrative: We got the 1st dose, can't afford to pay for 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of product availability issue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product availability issue. On an unknown date, the outcome of the product availability issue was unknown.       Additional Information: GSK Receipt Date: 27-May-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got 1st dose of shingrix. The patient lost medical insurance and when she went to pharmacy they said it would cost 165 dollar. The patient could not afford for that. The patient asked what was the repercussion as the patient already received 1st dose. Additional Supportive Information: Till the time of reporting the patient received the patient did not received 2nd dose of shingrix which led to product availability issue. The case has been linked with the case US2022AMR085711.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085711:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbnes in toes; Tingling in toes and arm; This case was reported by a consumer via interactive digital media and described the occurrence of numbness in toes in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. In May 2022, 8 hrs after receiving Shingrix, the patient experienced numbness in toes and tingling of extremity. On an unknown date, the outcome of the numbness in toes was recovered/resolved and the outcome of the tingling of extremity was not recovered/not resolved.   It was unknown if the reporter considered the numbness in toes and tingling of extremity to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient received 1st dose of Shingrix vaccine one week before date of reporting and 8 hours after developed numbness and tingling in toes. 10 days later, the patient had continued off and on tingling in his/her right arm. The numbness was gone in his/her toes. The patient asked if it was normal.
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Ear pain, Hypoaesthesia oral, Tenderness
Clinical narrative: left side of his mouth was "numb"; painful to touch; Bells Palsy effecting left side of face; bad "outer ear" ache, painful to touch; This case was reported by a other health professional via sales rep and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2022, the patient received the 1st dose of Shingrix. On 18th May 2022, 8 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), ear pain and tenderness. On 26th May 2022, the patient experienced numbness oral. On an unknown date, the outcome of the bell's palsy, ear pain, numbness oral and tenderness were unknown.   The reporter considered the bell's palsy, ear pain, numbness oral and tenderness to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 27-May-2022 Reporter's comments: The patient received Shingrix on 10th May late in the day. The reporter wanted to check the chart again to verify the date being that week and not the following week. On 18th May 2022, the patient complained of a bad outer ear ache. Like all around the left ear lobe. Not tender but painful to even touch. On 26th May 2022, late evening,16 days after receiving Shingrix, he noticed the left side of his mouth was numb. Like he had been to the dentist he said. Early morning on 27th May 2022, symptoms of Bell's Palsy affected the left side of the face. The reporter googled and saw something about if the breve around the ear becomes inflamed then there had been some correlation between the Shingrix vaccine and Bell's palsy.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient got new shingles vaccine and had every symptoms. The patient asked how long this shot made you sick. The patient's sickness was on day 5 at the time of reporting.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: busy due to pandemic 1st Shot in 6/19/2021 2nd in 5/28/2022; This case was reported by a consumer and described the occurrence of social problem 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 19 June 2021).   On 28th May 2022, the patient received the 2nd 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 social problem. On an unknown date, the outcome of the social problem 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-May-2022 Reporter's Comments: The case was reported by patient. The patient stated that he/she was off schedule for getting Twinrix vaccines. The patient was very busy during last year due to pandemic and simply forgot. The patient asked how many more shots and how many weeks the patient should wait to complete my Twinrix series. Additional Supportive Information: The patient received 2nd dose late due to pandemic which led to social problem.
Sex: U
Vaccine: VARZOS
Symptoms: Conjunctivitis, Eye disorder
Clinical narrative: is pink eye a possible side effect; goofy eyes since getting the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of pinkeye 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 pinkeye and eye disorder. On an unknown date, the outcome of the pinkeye was unknown and the outcome of the eye disorder was not recovered/not resolved.   It was unknown if the reporter considered the pinkeye and eye disorder to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-May-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had goofy eye since getting the vaccine. The patient asked if pink eye was a possible side effect. Additional supportive information: Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: feel  sick from shingles shot; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: Additional Information: GSK Receipt Date: 29-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient asked how many days do you feel sick from shingles shot. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: diarrhea two days after Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of diarrhea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-MAY-2022 Reporter's Comments: The case was reported from patient via interactive digital media. The patient experienced diarrhea 2 days after the dose of Shingrix. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose on 20-may-2022 was administered on 24-may-2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   On 24th May 2022, the patient received Havrix. On 24th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-May-2022 Reporter's Comments: Health care professional (HCP) reported that Havrix expired on 20th May 2022 that was administered on 24th May 2022. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received Havrix vaccine that was already expired.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in the injection arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2-3 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient  received Shingrix, 2 to 3 years ago from the date of reporting. The patient received dose of Shingrix vaccine and experienced pain in the injection arm for about 2 days. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Dose given to a patient  was expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAB (Twinrix) (batch number 57E3G, expiry date 20th February 2022) 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.   On 25th May 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 25th May 2022, unknown after receiving Twinrix and Twinrix 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: 25-May-2022 Reporter's comment: The pharmacist reported that an expired dose of Twinrix was given to a patient. The reporter had no more details about patient at the time of call. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 0.5
Sex: U
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: received Hep B vaccine in 4/2/2003, third dose that patient needs; drug dose interval too long; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 6-month-old patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (received 1st dose on 2nd April 2003).   On 4th August 2003, the patient received the 2nd dose of Hepatitis B vaccine. On an unknown date, the patient did not receive the 3rd dose of Hepatitis B vaccine. On 4th August 2003, unknown after receiving Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comments: The patient received 2 doses of a Hepatitis B vaccine (brand name unknown). The pharmacist was looking for information about how to proceed with the third dose that the patient needs for the school. The did not consent to follow up. The permission for a follow-up was not asked to the pharmacist. Additional Supportive Information: The patient received 2nd dose later than recommended interval, which led to lengthening of vaccination schedule and till the time of reporting, the patient did not receive 3rd dose of Hepatitis B vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Headache, Injection site pain, Myalgia
Clinical narrative: Pain on the right side of her face; Earache; Jaw pain; Headache; Linear rash along her jawline; Soreness at the injection site; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th May 2022, the patient received the 1st dose of Shingrix. On 13th May 2022, 1 days after receiving Shingrix, the patient experienced injection site pain and muscle pain. On 23rd May 2022, the patient experienced facial pain, ear pain, jaw pain, headache and rash. On an unknown date, the outcome of the injection site pain, muscle pain, facial pain, ear pain, jaw pain, headache and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, facial pain, ear pain, jaw pain, headache and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-MAY-2022 Reporter's Comments: The reporter was patient who called to report side effects from Shingrix vaccination. She stated she received her first dose of Shingrix and the following day after vaccination, she developed soreness at the injection site and muscle pain (Myalgia). The patient states these symptoms was gotten better but not completely resolved. The patient also stated that early week approximately 23rd May 2022, 11 days after receiving Shingrix she began to develop pain on the right side of her face, an earache, jaw pain, headache and a linear rash along her jawline. These had not yet resolved. The patient was referred to healthcare professional and provided medical advised disclaimer. The reporter was consented to follow up.