chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: U
Vaccine: HPV4, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: the patient received GARDASIL quadrivalent and GARDASIL 9 vaccines outside of recommended intervals/ GARDASIL quadrivalent on 8/28/2013 when she was 15 years, GARDASIL 9 on 3/22/2016 and Gardasil 9 on 2/3/2022; the patient received GARDASIL quadrivalent and GARDASIL 9 vaccines outside of recommended intervals/ GARDASIL quadrivalent on 8/28/2013 when she was 15 years, GARDASIL 9 on 3/22/2016 and Gardasil 9 on 2/3/2022; no adverse event; This spontaneous report has been received from a pharmacist regarding a patient of an unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported.  On 28-AUG-2013 (also reported as when the patient was 15 years old), the patient received quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (Valid lot # H021861, expiration date not reported, but upon internal validation established as 09-OCT-2015) (strength, dose, frequency, route and anatomical location were not provided); on 22-MAR-2016, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, anatomical location lot#, and expiration date were not provided); and on 03-FEB-2022, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (valid lot #: T036444, and valid expiration date: 09-APR-2023) (strength, dose, frequency, route and anatomical location were not provided)for prophylaxis. Therefore, the patient received both vaccines outside the recommended intervals (Inappropriate schedule of product administration and Interchange of vaccine products). No additional adverse events were reported.
Age: 48.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no adverse event; Administration of vaccine outside of Prescribing Information recommendations. Initial dose of vaccine given in 2020 and second dose given 03Feb2022.; This spontaneous report has been received from a nurse via a company representative regarding a 50-year-old patient of an unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported.   On unspecified date in 2020, the patient received the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, anatomical location, lot#, and expiration date were not provided) as prophylaxis.   On 03-FEB-2022 (reported as "today"), the patient received a second dose of polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, and anatomical location were not provided) as prophylaxis (inappropriate schedule of product administration). No further adverse event (AE) information was known.  Follow up information has been received on 10-FEB-2022, from another unspecified reporter.  The reporter asked about if there were any other patient demographic information available, as the only available information was the patient's age, the reporter stated that they would get in contact with the primary reporter to see if they can identify the patient. No further information was available.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no other adverse experiences reported; two doses of improperly stored VARIVAX was administered to two patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 07-FEB-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # U015682, expiration date 18-MAY-2023 (site of administration was not provided) for prophylaxis. Administered dose of suspect vaccine experienced temperature excursion of 9.7 Fahrenheit degrees (F) for 40 minutes (Product storage error). No previous temperature excursions were reported. It was unknown if digital data logger was involved.  No other adverse experiences were reported (No adverse event).  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2202USA002198:
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a Medical Assistant, referring to a 58-week-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 07-DEC-2021, the patient was vaccinated with one improper stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot number reported as U024221 and expiration date reported as 04-OCT-2023; route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported) (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 39.55 degrees Fahrenheit (F) for 10 hours. There was no previous temperature excursion reported. No adverse events were reported.  Lot number U024221 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as 04-OCT-2023 but upon internal validation established as 04-AUG-2023.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient patient received her second dose of GARDASIL 9 2-3 months late; no adverse event; This spontaneous report was received from a pharmacist, and refers to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On an unspecified date, the female patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 2-3 months late and the pharmacist would like to know when to administer the third dose. No adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of M-M-R II was administered to a patient; no additional AE reported; This spontaneous report was received from a registered nurse regarding a patient of an unknown age and unknown gender. The patient's medical history, concurrent conditions were not reported and concomitant therapies included sterile diluent (STERILE DILUENT) (manufacturer unknown).  On 04-FEB-2022, an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # T001214 has been verified to be valid, expiration date: 12-JAN-2022), dose: 0.5 ml (strength, dose number, frequency) for prophylaxis was administered to the patient (expired product administered). There was no temperature excursion. No additional adverse events were reported (no adverse event). This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA003414: US-009507513-2202USA003751: US-009507513-2202USA003543: US-009507513-2202USA003627: US-009507513-2202USA003522: US-009507513-2202USA003651: US-009507513-2202USA003569: US-009507513-2202USA003660: US-009507513-2202USA003658: US-009507513-2202USA003778:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; an expired dose of GARDASIL 9 was administered to a patient on 30-DEC-2021; This spontaneous report was received from a nurse (also reported as registered nurse) regarding a patient of an unknown age and unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-DEC-2021, an expired dose human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot # S010729, expiration date: 01-DEC-2021), dose: 0.5 ml (strength, dose number, frequency) for prophylaxis was administered to the patient (Expired product administered). There was no temperature excursion. Not additional adverse events were reported. This was one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-2202USA003414: US-009507513-2202USA003516: US-009507513-2202USA003778: US-009507513-2202USA003751: US-009507513-2202USA003543: US-009507513-2202USA003627: US-009507513-2202USA003651: US-009507513-2202USA003569: US-009507513-2202USA003660: US-009507513-2202USA003658:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was vaccinated woth PNEUMOVAX 23 and pneumococcal vaccine on 17-DEC-2013 and 01-JAN-2015; This spontaneous report was received from a physician via immunization record from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS# 2110USA004749 ), concerning a 68-year-old male patient. On 17-DEC-2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, intramuscularly, in the right deltoid, as prophylaxis (lot number J009689 has been determined to be valid for pneumococcal vaccine, polyvalent (23-valent), expiration date reported and establish as 29-JAN-2015) (strength was not reported) and on 01-JAN-2015, pt was vaccinated with an unspecified pneumococcal vaccine  (manufacturer unknown) (strength, dose, route of administration, anatomical location, indication, lot number, and expiration date were not reported) (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2110USA004749:
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received MMR II and PROQUAD instead of MMR II and VARIVAX; No adverse event; This spontaneous report was received from a registered nurse regarding a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, concomitant medications, drugs reactions and allergies were provided.  On an unknown date, the patient received measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (albumin status: recombinant human albumin [rHA]) (M-M-R II) 0.5 mL, (lot# U007685, expiration date: 09-MAR-2023) (strength, dose, route, and anatomical location were not provided) and measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (albumin status: rHA) (PROQUAD) 0.5 mL (lot# U028181, expiration date: 08-MAR-2023) (strength, dose, route, and anatomical location were not provided) both of them for prophylaxis, instead of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (Wrong product administered). No additional adverse event (AE) was reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event, Product confusion, Wrong product administered
Clinical narrative: No additional adverse event reported, no further information provided; The patient was vaccinated with PROQUAD instead of M-M-R II; The patient was vaccinated with PROQUAD instead of M-M-R II which was concomitantly given with a dose of VARIVAX; Product confusion; This spontaneous report was received from a registered nurse referring to a 1-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were not reported.   On 15-FEB-2022, the nurse had product confusion on measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, once (Lot# U028179 and expiration date : 08-MAR-2023)  as prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (vaccine not administered)  (Lot# and expiration date, exact dose and frequency were not reported) as prophylaxis which was concomitantly given with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, once (Lot# U024765 and expiration date : 10-AUG-2023)  as prophylaxis (product confusion) (wrong product administered) (accidental overdose). No additional adverse event reported, no further information provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; VAQTA was involved in this possible excursion, and caller stated the VAQTA was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-JAN-2022, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe intramuscular injection, 0.5 milliliter, lot #U004366, expiration date: 01-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided) after a potential temperature excursion occurred. The data logger stopped recording for 24 hours, however, there were no specific temperatures to evaluate. The vaccine did not undergo previous temperature excursion. The patient did not experience any adverse event.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse event reported; The patient was vaccinated with improperly stored one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ); The spontaneous report was received from a nurse practitioner concerning to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were not reported.   On 08-FEB-2022, the patient was vaccinated with improperly stored one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1821791, expiration date: 26-JUL-2022) (dose and vaccination site were not provided) as prophylaxis (product storage error). The vaccine underwent a temperature excursion of above 47 Fahrenheit for 0 hours 20 minutes 0 seconds. There was no previous temperature excursion. No further information provided. No further adverse events reported.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Ill-defined disorder, Rash
Clinical narrative: Rash; Other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On or about 11-MAY-2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Subsequently, on an unknown date, the pt was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: rash, and other zoster related conditions (ill-defined disorder). The outcome of the events was unknown. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE's reported; administration of improperly stored doses of ROTATEQ and PEDVAX HIB; This spontaneous report was received from a licensed practical nurse 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, both vaccines of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion. The temperature excursion was above 47 Fahrenheit degrees (47.5 Fahrenheit degrees) for 0 hours 20 minutes 0 seconds, above 47 Fahrenheit degrees (46.7 Fahrenheit degrees) for 0 hours 10 minutes 0 seconds and above 47 Fahrenheit degrees (47.1 Fahrenheit degrees) for 0 hours 20 minutes and 0 seconds. On 15-FEB-2022, the patient was vaccinated with the improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 ml one time, lot# 1742464, expiration date 20-SEP-2022; strength was not reported) orally and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (0.5 ml one time, lot# U024089, expiration date 27-OCT-2023; strength, route of administration and anatomical location were not reported), both for prophylaxis (product storage error). There was no previous temperature excursion. No further adverse event (AE) was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE's reported; Administration of an improperly stored dose of ROTATEQ; This spontaneous report was received from vaccine coordinator referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 31-JAN-2022, the patient vaccinated with improperly stored  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error)  oral liquid, lot number 1742463, expiration date 20-SEP-2022, administered orally for prophylaxis (vaccination scheme, and anatomical location of vaccination were not reported). The vaccine was stored for the time frame of 9 hours 2 minutes in the temperature of following: above 47 degree F (80.8F) for 6 hours, above 47 degree F(61.9F) for 1 hour 10 minutes, above 47 degree F (53.2F) for 1 hour 15 minutes, above 47 degree F (51.8F) for 37 minutes. There was no previous temperature excursion.  No product quality complaint (PQC) and no further adverse event (AEs) (no adverse event) was reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional information provided; Expired vaccine used; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 17-FEB-2022, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (Lot# T027114 and expiration date 07-FEB-2022) (exact dose and frequency were not reported) as prophylaxis. (expired product administered). The vaccine did not experience temperature excursion. No additional adverse event reported, no further information provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE's reported; administration of an improperly stored dose of ROTATEQ; This spontaneous report was received from vaccine coordinator referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 08-FEB-2022, the patient vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (oral liquid, orally, lot number 1742463, expiration date 20-SEP-2022, vaccination scheme, and anatomical location of vaccination were not reported) for prophylaxis. The vaccine was stored for the time frame of 9 hours 2 minutes in the temperature of following: above 47 degree F (80.8F) for 6 hours, above 47 degree F(61.9F) for 1 hour 10 minutes, above 47 degree F (53.2F) for 1 hour 15 minutes, above 47 degree F (51.8F) for 37 minutes. There was no previous temperature excursion.  No product quality complaint (PQC) and no further adverse event (AEs) (no adverse event) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Varivax underwent a temperature excursion and was then administered to a patient; This spontaneous report has been received from a administrator concerning to a 7-years-old patient of unknown gender.  The patient's concurrent condition, medical history and concomitant medications were not provided.  On 28-JAN-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose number, dose, route of administration and anatomical location were not provided) (lot#: U022732, expiration date: 20-JUL-2023) as prophylaxis, however, the vaccine experienced a temperature excursion (product storage error). of 12.0 Fahrenheit (F) for a total time frame of 9 hours and 38 minutes. There were previous temperature excursions: 9.7 F for 2 hours and 41 minutes, 10.8 F for 2 hours and 45 minutes, 10.6 F for 4 hours and 16 minutes, 11.1 F for 3 hours and 14 minutes, 10.9 F for 4 hours and 43 minutes, 10.8 F for 2 hours and 17 minutes, 18.3 F for 2 hours and 36 minutes, 18.7 F for 3 hours and 4 minutes, 12.4 F for 9 hours and 43 minutes, 17.4 F for 24 hours and 19.9 F for 10 hours and 57 minutes. No further information was provided.
Age: 43.0
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling
Clinical narrative: Both of the patient's hands swelled up; This spontaneous report was received from a physician via company representative concerning to a 43-year-old female patient. The patient's concurrent conditions, pertinent medical history, and concomitant therapies were not provided. She did not have previous history of allergies.  On 01-FEB-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (dosage regiment not provided), lot #U007667, expiration date: 23-MAY-2023, administered intramuscularly in left deltoid as prophylaxis. In the night of that day, she also took 1x dose of clonazepam (KLONOPIN) (strength, lot #, expiry date, route of administration, and indication were not provided).   On 02-FEB-2022, the patient woke up and both of her hands swelled up. She did not administer any additional clonazepam (KLONOPIN) dose following event time. On an unknown date in February 2022, the patient recovered (also reported as "fine now") from peripheral swelling.  The causal relationship between the event of peripheral swelling, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and clonazepam (KLONOPIN) was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: First dose received in January 2020, and she has not received her 2nd dose of Gardasil 9 yet; No adverse event; Information has been received from a female patient of unknown age, reporting on herself. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On an unspecified date, in January 2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), dose 1, (dosage information, lot #, expiration date, route, and anatomical location were not provided) for prophylaxis.  It was reported, that at the time of the report, the patient had not received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) yet (Inappropriate schedule of product administration). No adverse event was reported.; Sender's Comments:  US-009507513-2202USA005968:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No other issues or concerns noted; administered expired dose of VARlVAX; 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 18-FEB-2022, the patient was administered expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T003706, expiration date 30-JAN-2022; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No other issues or concerns were noted. No product quality complaint (PQC) was reported.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; other zoster-related injuries; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route not specified) by a health provider for the long-term prevention of shingles and zoster-related conditions. Subsequently (date unknown), the patient was treated by a physician at a medical center for the following injuries resulting from zoster vaccine live (ZOSTAVAX): shingles and other zoster-related injuries (ill-defined disorder). The outcome of the events was unknown.
Sex: U
Vaccine: ANTH
Symptoms: Poor quality product administered
Clinical narrative: End up getting BioThrax (anthrax vaccine) but it was after the 28 days of the vial being opened; Spontaneous report received on 08FEB2022.  A healthcare professional reported that the patient (patient 2) (unknown age and gender) "end up getting BioThrax (anthrax vaccine) but it was after the 28 days of the vial being opened" (PT: Poor quality product administered). It was reported that over the weekend the patient got BioThrax vaccine (lot number unknown) after the 28 days of the vial being opened. Reportedly, the patient did not experience any side effects after taking the vaccine. Action taken with BioThrax with respect to the reported event was not applicable. Outcome of the reported event was unknown.  No additional information was reported.  Based on the information available in the document two individual case safety reports (patient 1) and (patient 2) were created and cross linked in the database.  Company comment: It was reported that a consumer was administered with BioThrax but it was after the 28 days of the vial being opened (poor quality product administered). BioThrax vial is to be used within 28 days after first opening. Considering the case information, the causality of poor quality product administered is assessed as not related with BioThrax due to the nature of the event.; Sender's Comments: It was reported that a consumer was administered with BioThrax but it was after the 28 days of the vial being opened (poor quality product administered). BioThrax vial is to be used within 28 days after first opening. Considering the case information, the causality of poor quality product administered is assessed as not related with BioThrax due to the nature of the event.
Sex: U
Vaccine: ANTH
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: End up getting BioThrax (anthrax vaccine) but it was after the 28 days of the vial being opened; Spontaneous report received on 08FEB2022.  A healthcare professional reported that the patient (patient 1) (unknown age and gender) "end up getting BioThrax (anthrax vaccine) but it was after the 28 days of the vial being opened" (PT: Poor quality product administered). It was reported that over the weekend the patient got BioThrax vaccine (lot number unknown) after the 28 days of the vial being opened. Reportedly, the patient did not experience any side effects after taking the vaccine. Action taken with BioThrax with respect to the reported event was not applicable. Outcome of the reported event was unknown.  No additional information was reported.  Based on the information available in the document two individual case safety reports (patient 1) and (patient 2) were created and cross linked in the database.  Company comment: It was reported that a consumer was administered with BioThrax but it was after the 28 days of the vial being opened (poor quality product administered). BioThrax vial is to be used within 28 days after first opening. Considering the case information, the causality of poor quality product administered is assessed as not related with BioThrax due to the nature of the event.; Sender's Comments: It was reported that a consumer was administered with BioThrax but it was after the 28 days of the vial being opened (poor quality product administered). BioThrax vial is to be used within 28 days after first opening. Considering the case information, the causality of poor quality product administered is assessed as not related with BioThrax due to the nature of the event.
Sex: M
Vaccine: ANTH
Symptoms: Antiphospholipid antibodies negative, Autoimmune disorder, Grip strength decreased, Hypoaesthesia, Memory impairment
Clinical narrative: Extreme memory problems; Numbness in the hands and feet; problem with the grip in his hands; they hurt very badly; Speech problems; Spontaneous report received on 09FEB2022 from a patient.  A male patient (unknown age) had extreme memory problems (PT: Memory impairment), "numbness in the hands and feet; problem with the grip in his hands; they hurt very badly" (PT: Raynaud's phenomenon), and speech problems (PT: Speech disorder) following immunisation with 2 extra shots of BioThrax (anthrax vaccine adsorbed). It was reported that the patient received 2 extra shots of BioThrax in 2007. It was reported that he was experiencing extreme memory problems, numbness in the hands and feet, problems with the grip in his hands which was hurting very badly. He was diagnosed with Raynaud's disease and prescribed with gabapentin medication for Raynaud's disease. Also, he had speech problems which resolved over the time. It was reported that he had been experiencing autoimmune symptoms. Thus, he underwent tests for autoimmune diseases for lupus and rheumatoid arthritis which were negative.   Additionally, the patient reported that his vision was pixelated and described it as "little squares" and "dots" however his vision test was negative.   He did not have any surgical history.  Concomitant medication included Adderall (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine sulfate) for lack of energy/lethargy.   Action taken with BioThrax with respect to the reported events was not applicable.  Outcome of the reported events "extreme memory problems" and "numbness in the hands and feet; problem with the grip in his hands; they hurt very badly" was unknown while the patient had recovered from the event "speech problems" at the time of report.   No additional information was reported.  Company comment: A consumer was administered BioThrax and developed extreme memory problems (memory impairment), numbness in the hands and feet; problem with the grip in his hands; they hurt very badly (Raynaud's phenomenon), and speech problems (speech disorder). It was reported that the patient received 2 extra shots of BioThrax in 2007. Further information regarding the onset of these events and medical history is limited. Considering the limited information, the causality of memory impairment, Raynaud's phenomenon, and speech disorder is assessed as unclassifiable with BioThrax.; Sender's Comments: A consumer was administered BioThrax and developed extreme memory problems (memory impairment), numbness in the hands and feet; problem with the grip in his hands; they hurt very badly (Raynaud's phenomenon), and speech problems (speech disorder). It was reported that the patient received 2 extra shots of BioThrax in 2007. Further information regarding the onset of these events and medical history is limited. Considering the limited information, the causality of memory impairment, Raynaud's phenomenon, and speech disorder is assessed as unclassifiable with BioThrax.
Sex: M
Vaccine: ANTH
Symptoms: Ophthalmological examination normal, Pain in extremity, Raynaud's phenomenon, Rheumatoid factor negative, Speech disorder
Clinical narrative: Extreme memory problems; Numbness in the hands and feet; problem with the grip in his hands; they hurt very badly; Speech problems; Spontaneous report received on 09FEB2022 from a patient.  A male patient (unknown age) had extreme memory problems (PT: Memory impairment), "numbness in the hands and feet; problem with the grip in his hands; they hurt very badly" (PT: Raynaud's phenomenon), and speech problems (PT: Speech disorder) following immunisation with 2 extra shots of BioThrax (anthrax vaccine adsorbed). It was reported that the patient received 2 extra shots of BioThrax in 2007. It was reported that he was experiencing extreme memory problems, numbness in the hands and feet, problems with the grip in his hands which was hurting very badly. He was diagnosed with Raynaud's disease and prescribed with gabapentin medication for Raynaud's disease. Also, he had speech problems which resolved over the time. It was reported that he had been experiencing autoimmune symptoms. Thus, he underwent tests for autoimmune diseases for lupus and rheumatoid arthritis which were negative.   Additionally, the patient reported that his vision was pixelated and described it as "little squares" and "dots" however his vision test was negative.   He did not have any surgical history.  Concomitant medication included Adderall (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine sulfate) for lack of energy/lethargy.   Action taken with BioThrax with respect to the reported events was not applicable.  Outcome of the reported events "extreme memory problems" and "numbness in the hands and feet; problem with the grip in his hands; they hurt very badly" was unknown while the patient had recovered from the event "speech problems" at the time of report.   No additional information was reported.  Company comment: A consumer was administered BioThrax and developed extreme memory problems (memory impairment), numbness in the hands and feet; problem with the grip in his hands; they hurt very badly (Raynaud's phenomenon), and speech problems (speech disorder). It was reported that the patient received 2 extra shots of BioThrax in 2007. Further information regarding the onset of these events and medical history is limited. Considering the limited information, the causality of memory impairment, Raynaud's phenomenon, and speech disorder is assessed as unclassifiable with BioThrax.; Sender's Comments: A consumer was administered BioThrax and developed extreme memory problems (memory impairment), numbness in the hands and feet; problem with the grip in his hands; they hurt very badly (Raynaud's phenomenon), and speech problems (speech disorder). It was reported that the patient received 2 extra shots of BioThrax in 2007. Further information regarding the onset of these events and medical history is limited. Considering the limited information, the causality of memory impairment, Raynaud's phenomenon, and speech disorder is assessed as unclassifiable with BioThrax.
Sex: M
Vaccine: ANTH
Symptoms: Visual impairment
Clinical narrative: Extreme memory problems; Numbness in the hands and feet; problem with the grip in his hands; they hurt very badly; Speech problems; Spontaneous report received on 09FEB2022 from a patient.  A male patient (unknown age) had extreme memory problems (PT: Memory impairment), "numbness in the hands and feet; problem with the grip in his hands; they hurt very badly" (PT: Raynaud's phenomenon), and speech problems (PT: Speech disorder) following immunisation with 2 extra shots of BioThrax (anthrax vaccine adsorbed). It was reported that the patient received 2 extra shots of BioThrax in 2007. It was reported that he was experiencing extreme memory problems, numbness in the hands and feet, problems with the grip in his hands which was hurting very badly. He was diagnosed with Raynaud's disease and prescribed with gabapentin medication for Raynaud's disease. Also, he had speech problems which resolved over the time. It was reported that he had been experiencing autoimmune symptoms. Thus, he underwent tests for autoimmune diseases for lupus and rheumatoid arthritis which were negative.   Additionally, the patient reported that his vision was pixelated and described it as "little squares" and "dots" however his vision test was negative.   He did not have any surgical history.  Concomitant medication included Adderall (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine sulfate) for lack of energy/lethargy.   Action taken with BioThrax with respect to the reported events was not applicable.  Outcome of the reported events "extreme memory problems" and "numbness in the hands and feet; problem with the grip in his hands; they hurt very badly" was unknown while the patient had recovered from the event "speech problems" at the time of report.   No additional information was reported.  Company comment: A consumer was administered BioThrax and developed extreme memory problems (memory impairment), numbness in the hands and feet; problem with the grip in his hands; they hurt very badly (Raynaud's phenomenon), and speech problems (speech disorder). It was reported that the patient received 2 extra shots of BioThrax in 2007. Further information regarding the onset of these events and medical history is limited. Considering the limited information, the causality of memory impairment, Raynaud's phenomenon, and speech disorder is assessed as unclassifiable with BioThrax.; Sender's Comments: A consumer was administered BioThrax and developed extreme memory problems (memory impairment), numbness in the hands and feet; problem with the grip in his hands; they hurt very badly (Raynaud's phenomenon), and speech problems (speech disorder). It was reported that the patient received 2 extra shots of BioThrax in 2007. Further information regarding the onset of these events and medical history is limited. Considering the limited information, the causality of memory impairment, Raynaud's phenomenon, and speech disorder is assessed as unclassifiable with BioThrax.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: rash on my are arm; itched; This case was reported by a consumer via interactive digital media and described the occurrence of rash over arms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and burning skin (nerve ending under patient's skin would not settle down it sure burned and last for 6 months to year).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash over arms and itchy rash. On an unknown date, the outcome of the rash over arms and itchy rash were recovered/resolved.   It was unknown if the reporter considered the rash over arms and itchy rash to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient just got over shingles, had them for 3 months and now he/she got the after effects of them .  The physician told the nerve ending under his/her skin would not settle down and it sure burned, would a last for 6 months to year. The patient had one shingle shot but problem the shot gave him/her was rash on arm for about 3 weeks, sure itched. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of shingles vaccine and experienced sore arm for a day, no issues at all. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Hyperhidrosis, Peripheral coldness
Clinical narrative: tired; become very cold, especially hands and feet; Hyperhidrosis in feet; This case was reported by a consumer and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th January 2022, the patient received the 2nd dose of Shingles vaccine. On 28th January 2022, 1 days after receiving Shingles vaccine, the patient experienced tiredness, cold hands & feet and hyperhidrosis. On an unknown date, the outcome of the tiredness, cold hands & feet and hyperhidrosis were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, cold hands & feet and hyperhidrosis to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingles vaccine and next day experienced tiredness and cold all day. The patient noted that, his/her feet sweat a small amount in socks which were pretty heavy, it was not noticed that. Fast forward to day of reporting, it appeared to be hyperhidrosis in feet. It had gotten progressively worse since 27th January 2022. Additionally, the patient still had periods when he/she suddenly become very cold, especially hands and feet. The feet were partially because they were now damp most of the time (as of this week). The patient wanted to know if anyone else had reported such a side effect and if so was there any idea how long it lasts. Consent to follow up was requested. Note- there was discrepant information reported for sweating of feet as it is noticed on next day but in narrative it also mentioned that, hyperhidrosis was worsened since vaccination. For now, time to onset (TTO)captured as 1 day based on the narrative.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Peripheral swelling, Product administered to patient of inappropriate age, Rheumatoid arthritis
Clinical narrative: Full Rheumatoid Arthritis flare; Inappropriate age at vaccine administration.; Knuckle on her left index finger felt a little "poofy'' / the joints of the middle finger of her right hand flaring; This case was reported by a consumer via other manufacturer and described the occurrence of rheumatoid arthritis flare up in a 45-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included TOFACITINIB CITRATE (XELJANZ).   On an unknown date, the patient received the 1st dose of Shingrix. In January 2022, less than 6 months after receiving Shingrix, the patient experienced swelling of fingers. On an unknown date, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant) and inappropriate age at vaccine administration. On an unknown date, the outcome of the rheumatoid arthritis flare up and inappropriate age at vaccine administration were unknown and the outcome of the swelling of fingers was recovered/resolved.   It was unknown if the reporter considered the rheumatoid arthritis flare up and swelling of fingers to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR031138  Additional details were provided as follows: The patient self-reported this case. The patient received a dose of Shingrix earlier than recommended age, which led to inappropriate age at vaccine administration. The patient had full rheumatoid arthritis flare up with after 1st Shingrix in the fall. Less than 6 months after receiving Xeljanz, the patient had her middle knuckle on her left index finger felt a little poofy prior to early January when she started school and the joints of the middle finger of her right hand flaring due to increased typing. The patient stated that she missed a week of Xeljanz 5 mg due to forgetting to bring her medication on a trip and she believed this was the week of 28th January 2022. The action taken for Xeljanz was unknown. No additional details were reported. The reporter did not considered event caused by Xeljanz. The reporter did not consented to follow-up. For tolerance of 2nd dose of Shingrix, refer case US2022AMR031138.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR031138:Same Reporter
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Product administered to patient of inappropriate age, Sensitive skin
Clinical narrative: Experience achiness; Sensitive skin; Inappropriate age at vaccine administration; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a 45-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rheumatoid arthritis (had full rheumatoid arthritis flare with after 1st Shingrix in the fall, refer case US2022AMR031120) and Xeljanz with an associated reaction of arthralgia (received Xeljanz 5 mg by mouth twice a day from 19th August 2021 and had her middle knuckle on her left index finger felt a little poofy prior to early January when she started school and the joints of the middle finger of her right hand flaring due to increased typing, refer case US2022AMR031120).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain, sensitive skin and inappropriate age at vaccine administration. On an unknown date, the outcome of the pain, sensitive skin and inappropriate age at vaccine administration were unknown.   The reporter considered the pain and sensitive skin to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR031120  Additional details were provided as follows: The patient self-reported this case. The patient reported that she just had her second dose of Shingrix, earlier than recommended age, which led to inappropriate age at vaccine administration and she just experienced expected side effects from Shingrix such as achiness and sensitive skin. The reporter did not consent to follow-up. No additional details were reported; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR031120:Same Patient
Sex: U
Vaccine: MEN
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Rash at site; Swelling; Stinging; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced injection site rash, swelling and stinging. On an unknown date, the outcome of the injection site rash, swelling and stinging were unknown.   It was unknown if the reporter considered the injection site rash, swelling and stinging to be related to Meningococcal B vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Meningitis B shot and experienced rash at site, swelling, stinging.  The reporter asked what was normal. The follow-up would not possible as no contact details were available.