chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Malaise, Metabolic acidosis, Nausea, Occult blood positive
Clinical narrative: fever; swelling at injection site; This spontaneous report was received from a health care professional concerning a female patient currently 76 years old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered as prophylaxis (formulation, strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with fever and swelling at injection site. The outcome of the events were not reported.   Additionally, the patient experienced acute kidney injury, metabolic acidosis, hypothyroidism, hypokalaemia, gastrointestinal disorder, malaise, pleuritic pain, blood creatinine abnormal, rash, asthenia, dyspnoea, pulmonary mass, insomnia, occult blood positive, anaemia, oesophagitis, candida infection, nausea, hypophagia, constipation, hyponatraemia, hypocalcaemia, hypomagnesaemia and vomiting (captured in MARRS# 2208USA009525).  The causal relationship between the events of fever and swelling at injection site were considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).   This is one of two reports from the same patient.; Sender's Comments:  US-009507513-2209USA008773: US-009507513-2208USA009525:Original Case : 2208USA009525
Sex: F
Vaccine: PPV
Symptoms: Oesophagitis, Pleuritic pain, Pulmonary mass, Pyrexia, Rash
Clinical narrative: fever; swelling at injection site; This spontaneous report was received from a health care professional concerning a female patient currently 76 years old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered as prophylaxis (formulation, strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with fever and swelling at injection site. The outcome of the events were not reported.   Additionally, the patient experienced acute kidney injury, metabolic acidosis, hypothyroidism, hypokalaemia, gastrointestinal disorder, malaise, pleuritic pain, blood creatinine abnormal, rash, asthenia, dyspnoea, pulmonary mass, insomnia, occult blood positive, anaemia, oesophagitis, candida infection, nausea, hypophagia, constipation, hyponatraemia, hypocalcaemia, hypomagnesaemia and vomiting (captured in MARRS# 2208USA009525).  The causal relationship between the events of fever and swelling at injection site were considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).   This is one of two reports from the same patient.; Sender's Comments:  US-009507513-2209USA008773: US-009507513-2208USA009525:Original Case : 2208USA009525
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: fever; swelling at injection site; This spontaneous report was received from a health care professional concerning a female patient currently 76 years old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered as prophylaxis (formulation, strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with fever and swelling at injection site. The outcome of the events were not reported.   Additionally, the patient experienced acute kidney injury, metabolic acidosis, hypothyroidism, hypokalaemia, gastrointestinal disorder, malaise, pleuritic pain, blood creatinine abnormal, rash, asthenia, dyspnoea, pulmonary mass, insomnia, occult blood positive, anaemia, oesophagitis, candida infection, nausea, hypophagia, constipation, hyponatraemia, hypocalcaemia, hypomagnesaemia and vomiting (captured in MARRS# 2208USA009525).  The causal relationship between the events of fever and swelling at injection site were considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).   This is one of two reports from the same patient.; Sender's Comments:  US-009507513-2209USA008773: US-009507513-2208USA009525:Original Case : 2208USA009525
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-SEP-2022, improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status: recombinant human albumin (rHA) subcutaneous injection lot #W019623, expiration date: 19-DEC-2023 (dose, route of administration and anatomical location were not provided) was administered for prophylaxis. The vaccine experienced a temperature excursion of -11.8 degree Celsius for 1 hour and 45 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 05-OCT-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot # W017574, expiration date: 29-NOV-2023, administered for prophylaxis (dose, anatomical location, and route of administration were not provided). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) was stored at 10.8 degrees Fahrenheit for 1 hour and 39 minutes, no previous temperature excursion were reported (product storage error).  There were no adverse events reported (no adverse event).; Sender's Comments:  US-009507513-2210USA002259: US-009507513-2210USA002344:
Sex: U
Vaccine: PPV
Symptoms: Anxiety, Extra dose administered
Clinical narrative: redundant shot; I'm concerned that I might have a future problems; This spontaneous report was received from a consumer referring to herself/himself, a 76-year-old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On an unknown date in 2012 (reported as original date), the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, vaccination scheme frequency, anatomical location, dose, lot #, expiry date, and route of administration were not provided).  On 09-OCT-2022, the patient received a redundant shot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by a pharmacy, administered for prophylaxis (strength, vaccination scheme frequency, anatomical location, dose, lot #, expiry date, and route of administration were not provided) (extra dose administered). The patient concerned that he/she might have a future problems and had doubt that if the redundant dose would cause additional side effects (anxiety). The outcome of anxiety was unknown.  The causal relationship between anxiety and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HBP called in and reported that the improperly stored vaccine was administered.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 13-OCT-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W011622, expiration date: 06-APR-2024, administered for prophylaxis (dose, anatomical location, and route of administration were not provided). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at -14 Celsius degrees up to -10 Celsius degrees (-11.9 Celsius degrees) for 42 minutes, no previous temperature excursion were reported (product storage error).  There were no adverse events reported (no adverse event).; Sender's Comments:  US-009507513-2210USA005958:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; expired dose of VAQTA was administered to the patient; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 14-OCT-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 ml, lot #U004366, expiration date: 01-OCT-2022 (strength, vaccination schedule, site and route of administration were not provided) for prophylaxis (Expired product administered). The reporter stated the vaccine did not experience a temperature excursion. No additional adverse event was reported.
Age: 0.42
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; administration of vaccines that experienced temperature excursion on 10/13/22; This spontaneous report was received from other health professional and refers to a 5-month-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 13-OCT-2022, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #W011278, expiration date: 01-NOV-2023, administered orally for prophylaxis (strength was not provided) and improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, lot #U034522, expiration date: 22-JUN-2024, administered for prophylaxis (strength and route of administration were not provided) (product storage error). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; earlier than the recommended doging interval; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 15-JUL-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) injection, 0.5 ml, lot #W000244, expiration date: 09-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided). The second dose was given on 17-AUG-2022, and the third dose was administered on 20-OCT-2022, administered earlier than the recommended dosing interval (Inappropriate schedule of vaccine administered) at the reporting time, no adverse event was experienced.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE; a patient was inadvertently administered VARIVAX via intramuscular rout rather than subcutaneously; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, and allergies were not reported. Concomitant medications included sterile diluent.    On 17-OCT-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) administered intramuscularly (lot #W012166 had been verified to be a valid number; expiration date 12-APR-2024 and upon internal validation established as the same date) (dose, vaccination scheme, frequency, and anatomical site of injection were not reported) (incorrect route of product administration). No additional adverse events were reported.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE details were provided; she was given her third dose yesterday 24OCT2022. The clinic then learned after the patient was vaccinated that the patient received all 3 doses of GARDASIL 9 in 2015.; This spontaneous report was received from a nurse regarding a 22-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On unknown dates in 2015, the patient was vaccinated with the first, second, and third doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (strength, dosage regimen, lot #, expiry date, and route of administration were not provided) administered as prophylaxis. On 24-OCT-2022, the patient was vaccinated with the fourth dose (in the moment of vaccination the patient stated that before she only received two doses) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (strength, dosage regimen, lot #, expiry date, and route of administration were not provided) administered as prophylaxis (Extra dose administered). No adverse events were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: HAS SORENESS WHERE THEY GAVE THE NEEDLE IN THE LEFT ARM; A LOT OF PAIN; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2022-125012.  This case was received via {BP} Pfizer Inc (Reference number: 7809768) on 20-Oct-2022. Information was received from a Consumer/other non health professional concerning a Male patient, who received Suspect product APIXABAN for Tablet; Suspect product COVID-19 VACCINE. On an unknown date, the patient experienced pain(a lot of pain) which was considered not serious. On an unknown date, the patient experienced pain in extremity(has soreness where they gave the needle in the left arm) which was considered not serious. Concomitant medications were not reported. The reporter did not provide a causal assessment for events pain and pain in extremity to product APIXABAN. The reporter did not provide a causal assessment for events pain and pain in extremity to product COVID-19 VACCINE. Tracking of Changes: 20-Oct-2022: Initial information was received.  Eliquis is under agreement with Company.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash, Vaccination failure
Clinical narrative: was vaccinated then her shingles was mild/ Suspected vaccination failure; shingles was mild; small rash of about 3 dots; This case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash (The rash was so severe that it started on her stomach and wrapped around to her shoulder blade), walking difficulty and nerve pain. Previously administered products included Steroids and Gabapentin.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comments: The reporter stated that patient experienced shingles before she was eligible to receive Shingrix.  The patient had rash and was treated with steroids and gabapentin and had difficulty walking, rash for 3 weeks, and weeks of nerve pain and sensitivity. The patient received her first Shingrix injection on June 20 th on her birthday followed by a second dose 2-4 months later. Four months ago she noticed a small rash of about 3 dots so she contacted her HCP and was prescribed medication. The patient followed up with HCP 2 days later.  The patient shared that due to being vaccinated, the shingles was mild and only lasted a couple of days. The patient was thankful she had received the vaccine.  The HCP did not do a PCR test since she was already on treatment. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shots and have it now / suspected Vaccination failure; Have it now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient both the Shingles shots and had shingles now. The patient believed it easier because of shot though. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had vaccine and got shingles/ suspected vaccination failure; mild shingles on head and forehead; So painful; Felt like sunburn; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (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), shingles, pain and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, pain and burning sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and burning sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comments: Reporter's Comments: This case was received from consumer via interactive digital media. The patient had the vaccine and still got a mild form of shingles a few weeks back on his/her head and forehead. It was so painful and started like had a sunburn which he/she did not but felt that way. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Received shingles vaccine 3 times, have shingles; Have shingles; Received shingles vaccine 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 23-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was currently 63 years old. The patient had received shingles vaccine 3 times and had shingles. The patient asked that he/she could tried the vaccine again. Additional supportive information: The patient received shingles vaccine 3 times, which led to extra dose administered. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 51.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Extra dose administered, Lethargy, Pruritus
Clinical narrative: Lethargic; generalized itching; Unsure if got 2nd dose,  2nd dose Nov2021, 3rd 16oct2022; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose on November 2021) and Shingrix (received 1st dose (0.5 ml) intramuscularly in August 2021).   On 16th October 2022, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml and the 1st dose of FLU VACCINE (NAME UNKNOWN) (intramuscular). On 16th October 2022, unknown after receiving Shingrix and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), the patient experienced extra dose administered. On 17th October 2022, the patient experienced lethargy and generalized pruritus. On an unknown date, the outcome of the lethargy and generalized pruritus were not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the lethargy and generalized pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: The patient self-reported this case. The patient reported that she might had received possible third dose administered in right arm and also received Flu vaccine (non GSK) in left arm on the same day. One day after vaccination, the patient was lethargic and had generalized itching. Patient also reported that she was unsure if got the second Shingrix vaccine prior to yesterday's Shingrix vaccine and pharmacy had no record of patient receiving it. Patient potentially received a third Shingrix vaccine yesterday. Patient had not gotten a second vaccine prior to yesterday, then would have been past the 6 months for getting her second vaccine. It was unknown if the reporter considered the lethargy and pruritus to be related to Flu vaccine (non GSK).    Reporter consented to follow up. Additional supportive information: The patient received possible 3rd dose of Shingrix, which led to extra dose administered. Discrepancy for vaccine information in source document, hence dose and unit, route of administration and anatomical location were conservative capture for 3rd dose instead of 2nd, clarification has been raised.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Bone pain, Illness, Pain
Clinical narrative: Sick for several days; thought I was dying, worried about residual side effects; it hurt to move head, fingers, painful side effects; bones felt like throbbing; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient did not receive Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, impending doom, pain upon movement and bone pain. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the impending doom, pain upon movement and bone pain were unknown.   The reporter considered the sickness, impending doom, pain upon movement and bone pain to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient took the Shingles vaccine and had the worst reaction. The patient experienced painful side effects post vaccine The patient was sick for several days thought she was dying. The patient reported that bones felt like they were throbbing, and it hurt to move head and fingers. The patient was worried about a residual effect down the road. The patient stated do not take this shot. The reporter thought that the event might had been related to the vaccine. The reported did not agreed to contact healthcare professional. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Myalgia, Rash, Swelling
Clinical narrative: Pain in my arm muscles; Rashes; Swelling; Miserable; This case was reported by a consumer via interactive digital media and described the occurrence of myalgia upper extremities 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 myalgia upper extremities, rash, swelling and feeling miserable. On an unknown date, the outcome of the myalgia upper extremities, rash, swelling and feeling miserable were unknown.   It was unknown if the reporter considered the myalgia upper extremities, rash, swelling and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and the vaccine gave him/her pain in his/her arm muscles, rashes, swelling and miserable. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body hurts; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th October 2022, the patient received the 2nd dose of Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just got his/her second shot yesterday (on the day before reporting) and the only side effects he/she had body hurts. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine and experienced rash. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick for a week; 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 the 2nd dose of 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 recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: This case was reported by the patient's friend via interactive digital media. Reporter asked dose anyone had side effects from new Shingles vaccine. Reporter stated that one of his friend that was patient was sick for a week after receiving the second dose. Additional supportive information:  Follow-up would not possible as no contact details were available.
Age: 70.0
Sex: M
Vaccine: MENB
Symptoms: Extra dose administered, Medication error, Product administered to patient of inappropriate age
Clinical narrative: 70 year old patient received Bexsero series; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 70-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included lymphadenectomy.   In January 2020, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In January 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The Bexsero vaccine approved for use in individuals aged 10 through 25 years however 70 year old patient received Bexsero series, which led to inappropriate age at vaccine administration. The patient had a lymphadenectomy and would like data on a booster. The reporter planned on administering the booster dose, which led to extra dose administered and circumstance or information capable of leading to medication error. No reactions were reported. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter.  Follow up information received from physician on12th March 2021: The reporter received follow up letter and had questions about adverse event but had no information to provide.  GSK Receipt Date: 12-MAR-2021 Case update: The event circumstance or information capable of leading to medication error and extra dose administered was deleted from case and narrative updated.
Sex: M
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products, Medication error
Clinical narrative: Trumenba on 8/10/20 but they only have Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th August 2020, the patient received the 1st dose of TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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 was provided as follows: The reporter was an office manager. The age at vaccination was not applicable for this report. The reporter stated that the patient was transferred to them and patient had a 1st dose of Trumenba, but they only had Bexsero on hand, which led to interchange of vaccine products and circumstance or information capable of leading to medication error. The reporter called to inquired about Trumenba and Bexsero series interchange and asked about how could they proceed with Bexsero series. The reporter did not consent to follow up.  GSK Receipt Date: 23-MAR-2021 Case update: The event circumstance or information capable of leading to medication error was deleted from case and narrative updated.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: reaction / rash on lower back; were very itchy; 12 to 15 noticeable welts; This case was reported by a consumer via call center representative and described the occurrence of rash in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2022, the patient received the 1st dose of Shingrix (intramuscular). On 23rd September 2022, 1 days after receiving Shingrix, the patient experienced rash, itchy rash and welts. The patient was treated with loratadine (Claritine) and clarithromycin (Claritin Tablets (Clarithromycin)). On an unknown date, the outcome of the rash, itchy rash and welts were recovered/resolved.   It was unknown if the reporter considered the rash, itchy rash and welts to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: The reporter stated that the patient got the 1st dose of Shingrix Vaccine.  The Reporter stated that he got the vaccine in the left arm.  The reporter mentioned next day in the morning the patient  had a reaction.  The patient  had a breakout rash on my lower back and rash had 12 to 15 noticeable welts that were very itchy. The reporter state that the patient went to a dermatologist that prescribed Claritin tablets and a cream for the rash.  The reporter mentioned that the itching resolved after 8 to 9 days.   The patient reports that after treating the rash with Claritin and the cream, the rash had subsided.  The Patient reports the rash has disappeared and healed. The reporter give consent to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Intercepted product storage error
Clinical narrative: was intended to administer but it was discouraged; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error in a patient who received HAV (Havrix) (batch number H4H53, expiry date 31st January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient did not receive Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error 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: 17-OCT-2022 Reporter's Comment: Pharmacist reported that a Havrix prefilled syringe was activated on the previous day and was stored on refrigerator until the day of reporting.  The pharmacist was intended to administer the vaccine one day after the Prefilled syringe was activated, however practice was discouraged. Additional supportive information: As product was not stored properly and practice was discouraged, which led to intercepted product storage error.
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Eating disorder, Fatigue, Feeling cold, Hyperaesthesia teeth
Clinical narrative: Sensitivity in teeth; Sensitivity in jaw; Intermittent ear pain; Numbness in chin; Nausea; Difficulty eating, can't drink anything hot or cold; Feeling cold; Tired; This case was reported by a other health professional via call center representative and described the occurrence of sensitivity of teeth in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, several days after receiving Shingrix, the patient experienced sensitivity of teeth, jaw pain, ear pain, numbness facial, nausea, eating disorder, feeling cold and tiredness. On an unknown date, the outcome of the sensitivity of teeth, jaw pain, ear pain, numbness facial, nausea, eating disorder, feeling cold and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the sensitivity of teeth, jaw pain, ear pain, numbness facial, nausea, eating disorder, feeling cold and tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comments: The patient reports she received dose of Shingrix in the right arm.  The patient stated few days later had sensitivity in lower right jaw and teeth. The patient stated she also had ear pain, intermittently.  The patient also mentioned numbness in chin, nausea with difficulty eating, had cold and was tired. The patient mentioned she had seen her HCP and dentist and neither could find a diagnosis.  The patient asked about receiving 2nd dose. Information provided.  All symptoms still persisted, not recovered or resolved. The reporter spoke per (package insert) PI and FAQ content.  The patient also states she was an HCP. The phone number and transfer provided.  Medical disclaimer and referred to HCP.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Nausea, Pain in jaw
Clinical narrative: Sensitivity in teeth; Sensitivity in jaw; Intermittent ear pain; Numbness in chin; Nausea; Difficulty eating, can't drink anything hot or cold; Feeling cold; Tired; This case was reported by a other health professional via call center representative and described the occurrence of sensitivity of teeth in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, several days after receiving Shingrix, the patient experienced sensitivity of teeth, jaw pain, ear pain, numbness facial, nausea, eating disorder, feeling cold and tiredness. On an unknown date, the outcome of the sensitivity of teeth, jaw pain, ear pain, numbness facial, nausea, eating disorder, feeling cold and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the sensitivity of teeth, jaw pain, ear pain, numbness facial, nausea, eating disorder, feeling cold and tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comments: The patient reports she received dose of Shingrix in the right arm.  The patient stated few days later had sensitivity in lower right jaw and teeth. The patient stated she also had ear pain, intermittently.  The patient also mentioned numbness in chin, nausea with difficulty eating, had cold and was tired. The patient mentioned she had seen her HCP and dentist and neither could find a diagnosis.  The patient asked about receiving 2nd dose. Information provided.  All symptoms still persisted, not recovered or resolved. The reporter spoke per (package insert) PI and FAQ content.  The patient also states she was an HCP. The phone number and transfer provided.  Medical disclaimer and referred to HCP.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Elevated area, looks like a bug  bite; Red elevated area; Itchyelevated area; This case was reported by a consumer via call center representative and described the occurrence of swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced swelling, erythema and pruritus. On an unknown date, the outcome of the swelling, erythema and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the swelling, erythema and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: The reporter was the patient.  The patient received her Shingrix about 48 hours ago.  The patient was experiencing an itchy, red, and elevated area which she described looks like a bug bite.  The patient did not wish to provide DOB (date of birth). However, provided year of birth. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Forget 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-OCT-2022 Reporter's comment: The pharmacist had inquired about the Shingrix and had asked that for how long before they could start the series over if they had forgotten the second dose. The inquiry came through chat, which was ended by the user before collecting any other details available. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which had led to incomplete course of vaccination.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B virus test, Inappropriate schedule of product administration, Injury associated with device, Therapy non-responder
Clinical narrative: Hep B titers showed no antibodies after a needle stick; 1st dose on 20Nov2001, 3rd on 01Jul2002; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 8-month-old female patient who received HBV (Engerix B 10 mcg) for prophylaxis.   Co-suspect products included HBV (Engerix B 10 mcg) for prophylaxis and HBV (Engerix B 10 mcg) for prophylaxis.   On 1st July 2002, the patient received the 3rd dose of Engerix B 10 mcg. On 20th December 2001, the patient received the 2nd dose of Engerix B 10 mcg. On 20th November 2001, the patient received the 1st dose of Engerix B 10 mcg. On 1st July 2002, unknown after receiving Engerix B 10 mcg, not applicable after receiving Engerix B 10 mcg and Engerix B 10 mcg and not applicable after receiving Engerix B 10 mcg and Engerix B 10 mcg, the patient experienced drug dose administration interval too long. In October 2022, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown.   Additional Information: GSK receipt date: 17-Oct-2022 Reporter's comment: A pharmacist reported that patient completed an Engerix-B series years ago from reporting. The patient recently had a needle stick and went to Urgent Care last week from reporting (unsure of day) for blood work and her Hepatitis B titers showed no antibodies. The reporter consented to follow up. Additional supportive information: The patient received 3rd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: DTAP
Symptoms: Incomplete course of vaccination
Clinical narrative: 7-year-old only had 2DTaP; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a 7-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTaP (received 2 dose of vaccine on an unknown date) and POLIO VACCINE (received 2 doses of vaccine on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, 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: 17-OCT-2022 Reporter's Comment:  The case was received per after hours. The reporter had a 7-year old patient who the school was saying she needed shots. The school said that she needed to get a TDaP and polio, she only had 2DTaP and 2 polios. The reporter gave her the polio but couldn't give her the Boostrix because she's younger than 10 years old. Brand of DTAP and IPV were not provided in request/inquiry. Consented to follow up.  Additional supportive information: Till the time of reporting as patient did not receive DTap vaccine, which led to incomplete course of vaccination.