chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: No additional AE; Patient moved their body while receiving their first dose of GARDASIL 9 and received about "70 percent" of the dose in the syringe; This spontaneous report as received from a medical assistant refers to a 10-year-old patient., gender unknown. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  It was reported that on 13-JUN-2024, the patient moved their body while receiving their first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe for prophylaxis(dose, route of administration, lot number and expiration date were not reported), and received about "70 percent" of the dose in the syringe and the patient did not receive a full dose (underdose).No additional Adverse event or product quality complaint was reported.
Age: 22.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Product confusion, Wrong product administered
Clinical narrative: PROQUAD was inadvertently administered to an adult patient; PROQUAD administered instead of MMR II; Product confusion unspecified; No additional AE; This spontaneous report was received from employee and refers to a 22-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis instead of dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (Wrong product administered, Product administered to patient of inappropriate age). Product confusion unspecified (Product confusion). No symptoms reported. No additional AE/PQC (No adverse event).  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Gait inability, Herpes zoster, Loss of personal independence in daily activities, Pain
Clinical narrative: get sharp pains; Pain travels all the way up my leg to my knee; Pain travels all the way up my leg to my knee.; Suspected vaccination failure; I got it on my right foot, top and bottom; Couldn't walk; Couldn't walk or wear shoes; This serious 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got it on my right foot, top and bottom), unable to walk (Verbatim: Couldn't walk), pain (Verbatim: get sharp pains), leg pain (Verbatim: Pain travels all the way up my leg to my knee), knee pain (Verbatim: Pain travels all the way up my leg to my knee.) and activities of daily living impaired (Verbatim: Couldn't walk or wear shoes). The outcome of the vaccination failure was unknown and the outcome of the shingles, unable to walk and activities of daily living impaired were resolved (duration 3 months) and the outcome of the pain was not resolved and the outcome of the leg pain and knee pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, unable to walk, pain, leg pain, knee pain and activities of daily living impaired to be related to Shingles vaccine and Shingles vaccine.  The company considered the vaccination failure and knee pain to be related to Shingles vaccine and Shingles vaccine. The company considered the shingles, unable to walk, pain, leg pain and activities of daily living impaired to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUN-2024 This case was reported by a patient via (social media) interactive digital media. The patient had both vaccines. The patient got it on his/her right foot, top and bottom. The patient could not walk or wear shoes. Lasted for 3 months. The patient still got sharp pains periodically with no warning. The pain traveled all the way up his/her leg to knee. 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.; Sender's Comments: Vaccination failure and Arthralgia are listed events which are considered related to GSK vaccines Shingles vaccine dose I & Shingles vaccine dose II.  Herpes zoster, Gait inability, Pain, Pain in extremity and Loss of personal independence in daily activities are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine dose I & Shingles vaccine dose II.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Vaccination failure
Clinical narrative: get sharp pains; Pain travels all the way up my leg to my knee; Pain travels all the way up my leg to my knee.; Suspected vaccination failure; I got it on my right foot, top and bottom; Couldn't walk; Couldn't walk or wear shoes; This serious 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got it on my right foot, top and bottom), unable to walk (Verbatim: Couldn't walk), pain (Verbatim: get sharp pains), leg pain (Verbatim: Pain travels all the way up my leg to my knee), knee pain (Verbatim: Pain travels all the way up my leg to my knee.) and activities of daily living impaired (Verbatim: Couldn't walk or wear shoes). The outcome of the vaccination failure was unknown and the outcome of the shingles, unable to walk and activities of daily living impaired were resolved (duration 3 months) and the outcome of the pain was not resolved and the outcome of the leg pain and knee pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, unable to walk, pain, leg pain, knee pain and activities of daily living impaired to be related to Shingles vaccine and Shingles vaccine.  The company considered the vaccination failure and knee pain to be related to Shingles vaccine and Shingles vaccine. The company considered the shingles, unable to walk, pain, leg pain and activities of daily living impaired to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUN-2024 This case was reported by a patient via (social media) interactive digital media. The patient had both vaccines. The patient got it on his/her right foot, top and bottom. The patient could not walk or wear shoes. Lasted for 3 months. The patient still got sharp pains periodically with no warning. The pain traveled all the way up his/her leg to knee. 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.; Sender's Comments: Vaccination failure and Arthralgia are listed events which are considered related to GSK vaccines Shingles vaccine dose I & Shingles vaccine dose II.  Herpes zoster, Gait inability, Pain, Pain in extremity and Loss of personal independence in daily activities are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine dose I & Shingles vaccine dose II.
Sex: U
Vaccine: RVX
Symptoms: Illness
Clinical narrative: it made me very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: it made me very sick). The outcome of the sickness was not reported.   The reporter considered the sickness to be related to RSV vaccine.   The company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 12-JUN-2024 This case was reported by a patient via interactive digital media. The patient had the RSV vaccine and it made him/her very sick.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: improperly stored out of temperature guidelines; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number ya493, expiry date 16-APR-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: improperly stored out of temperature guidelines). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt date: 13-JUN-2024 An HCP reported that Shingrix had been administered to a patient after being improperly stored out of temperature guidelines which led to incorrect storage of drug. No symptoms reported and no further information reported.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Feeling cold, Feeling hot, Headache
Clinical narrative: felt feverish; cold feeling; myalgia; headache; raised rash; rash that is itchy; redness (arm); itchiness (arm); swelling (arm); feverish; swelling (lymph nodes); feeling like "burning from an flat iron" on her arm.; a rash that is swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling hot in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JUN-2024, the patient received the 1st dose of Shingrix (left arm). In JUN-2024, an unknown time after receiving Shingrix, the patient experienced feeling hot (Verbatim: felt feverish), feeling cold (Verbatim: cold feeling), myalgia (Verbatim: myalgia), headache (Verbatim: headache), raised rash (Verbatim: raised rash), itchy rash (Verbatim: rash that is itchy), erythema of extremities (Verbatim: redness (arm)), itchy upper limbs (Verbatim: itchiness (arm)), swelling arm (Verbatim: swelling (arm)), fever (Verbatim: feverish), enlargement of lymph nodes (Verbatim: swelling (lymph nodes)), burning sensation (Verbatim: feeling like "burning from an flat iron" on her arm.) and swelling (Verbatim: a rash that is swelling). The patient was treated with paracetamol (Tylenol) and fexofenadine hydrochloride (Allegra). The outcome of the feeling hot, feeling cold, myalgia, headache, raised rash, itchy rash, erythema of extremities, itchy upper limbs, swelling arm, fever, enlargement of lymph nodes, burning sensation and swelling were not resolved.   It was unknown if the reporter considered the feeling hot, feeling cold, myalgia, headache, raised rash, itchy rash, erythema of extremities, itchy upper limbs, swelling arm, fever, enlargement of lymph nodes, burning sensation and swelling to be related to Shingrix.     It was unknown if the company considered the feeling hot, feeling cold, myalgia, headache, raised rash, itchy rash, erythema of extremities, itchy upper limbs, swelling arm, fever, enlargement of lymph nodes, burning sensation and swelling to be related to Shingrix.   Additional Information: GSK receipt date: 10-JUN-2024 The patient received vaccine last Monday night.  She stated that a few days after the dose she felt feverish, had a cold feeling, myalgia, and headache.  She also developed a rash that was swelling, raised, itchy, and red (left arm).  She described the feeling like burning from an flat iron on her arm.  The rash had gotten bigger and was traveling toward her armpit, that also grown when she itches that.  She also mentioned swelling of her lymph nodes.  She took Allegra for the rash but it did not do anything and took Tylenol for the feverish symptoms.  Symptoms had not resolved. Did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Myalgia, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: felt feverish; cold feeling; myalgia; headache; raised rash; rash that is itchy; redness (arm); itchiness (arm); swelling (arm); feverish; swelling (lymph nodes); feeling like "burning from an flat iron" on her arm.; a rash that is swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling hot in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JUN-2024, the patient received the 1st dose of Shingrix (left arm). In JUN-2024, an unknown time after receiving Shingrix, the patient experienced feeling hot (Verbatim: felt feverish), feeling cold (Verbatim: cold feeling), myalgia (Verbatim: myalgia), headache (Verbatim: headache), raised rash (Verbatim: raised rash), itchy rash (Verbatim: rash that is itchy), erythema of extremities (Verbatim: redness (arm)), itchy upper limbs (Verbatim: itchiness (arm)), swelling arm (Verbatim: swelling (arm)), fever (Verbatim: feverish), enlargement of lymph nodes (Verbatim: swelling (lymph nodes)), burning sensation (Verbatim: feeling like "burning from an flat iron" on her arm.) and swelling (Verbatim: a rash that is swelling). The patient was treated with paracetamol (Tylenol) and fexofenadine hydrochloride (Allegra). The outcome of the feeling hot, feeling cold, myalgia, headache, raised rash, itchy rash, erythema of extremities, itchy upper limbs, swelling arm, fever, enlargement of lymph nodes, burning sensation and swelling were not resolved.   It was unknown if the reporter considered the feeling hot, feeling cold, myalgia, headache, raised rash, itchy rash, erythema of extremities, itchy upper limbs, swelling arm, fever, enlargement of lymph nodes, burning sensation and swelling to be related to Shingrix.     It was unknown if the company considered the feeling hot, feeling cold, myalgia, headache, raised rash, itchy rash, erythema of extremities, itchy upper limbs, swelling arm, fever, enlargement of lymph nodes, burning sensation and swelling to be related to Shingrix.   Additional Information: GSK receipt date: 10-JUN-2024 The patient received vaccine last Monday night.  She stated that a few days after the dose she felt feverish, had a cold feeling, myalgia, and headache.  She also developed a rash that was swelling, raised, itchy, and red (left arm).  She described the feeling like burning from an flat iron on her arm.  The rash had gotten bigger and was traveling toward her armpit, that also grown when she itches that.  She also mentioned swelling of her lymph nodes.  She took Allegra for the rash but it did not do anything and took Tylenol for the feverish symptoms.  Symptoms had not resolved. Did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: felt feverish; cold feeling; myalgia; headache; raised rash; rash that is itchy; redness (arm); itchiness (arm); swelling (arm); feverish; swelling (lymph nodes); feeling like "burning from an flat iron" on her arm.; a rash that is swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling hot in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JUN-2024, the patient received the 1st dose of Shingrix (left arm). In JUN-2024, an unknown time after receiving Shingrix, the patient experienced feeling hot (Verbatim: felt feverish), feeling cold (Verbatim: cold feeling), myalgia (Verbatim: myalgia), headache (Verbatim: headache), raised rash (Verbatim: raised rash), itchy rash (Verbatim: rash that is itchy), erythema of extremities (Verbatim: redness (arm)), itchy upper limbs (Verbatim: itchiness (arm)), swelling arm (Verbatim: swelling (arm)), fever (Verbatim: feverish), enlargement of lymph nodes (Verbatim: swelling (lymph nodes)), burning sensation (Verbatim: feeling like "burning from an flat iron" on her arm.) and swelling (Verbatim: a rash that is swelling). The patient was treated with paracetamol (Tylenol) and fexofenadine hydrochloride (Allegra). The outcome of the feeling hot, feeling cold, myalgia, headache, raised rash, itchy rash, erythema of extremities, itchy upper limbs, swelling arm, fever, enlargement of lymph nodes, burning sensation and swelling were not resolved.   It was unknown if the reporter considered the feeling hot, feeling cold, myalgia, headache, raised rash, itchy rash, erythema of extremities, itchy upper limbs, swelling arm, fever, enlargement of lymph nodes, burning sensation and swelling to be related to Shingrix.     It was unknown if the company considered the feeling hot, feeling cold, myalgia, headache, raised rash, itchy rash, erythema of extremities, itchy upper limbs, swelling arm, fever, enlargement of lymph nodes, burning sensation and swelling to be related to Shingrix.   Additional Information: GSK receipt date: 10-JUN-2024 The patient received vaccine last Monday night.  She stated that a few days after the dose she felt feverish, had a cold feeling, myalgia, and headache.  She also developed a rash that was swelling, raised, itchy, and red (left arm).  She described the feeling like burning from an flat iron on her arm.  The rash had gotten bigger and was traveling toward her armpit, that also grown when she itches that.  She also mentioned swelling of her lymph nodes.  She took Allegra for the rash but it did not do anything and took Tylenol for the feverish symptoms.  Symptoms had not resolved. Did not consent to follow-up.
Age: 10.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero dose given instead of Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 10-year-old female patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis.   On 05-JUN-2024, the patient received Bexsero. On 05-JUN-2024, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero dose given instead of Boostrix). The outcome of the wrong vaccine administered 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: 10-JUN-2024 The reporter stated of administration of a vaccine in error and the doctor wanted me to call to discuss. It was further clarified with the nurse that a Bexsero dose was accidentally given to a patient instead of Boostrix, which led to wrong vaccine administered.  Consented to follow up.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: got second dose by mistake; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   On 15-MAY-2024, the patient received the 2nd dose of Arexvy. On 15-MAY-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: got second dose by mistake). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date:10-JUN-2024 On 21-FEB-2024, the patient received first dose of Arexvy. The patient received a second dose by mistake, which led to extra dose administered. The pharmacist calls wanting to know if there was information on giving a second Arexvy dose to a patient. The reporter consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: Plunger came off needle stayed in the baby; reporter was not sure if the baby got all of the vaccine or a partial dose; Syringe connection issue; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental needle stick in a child patient who received Hib (Hiberix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: Plunger came off needle stayed in the baby), incomplete dose administered (Verbatim: reporter was not sure if the baby got all of the vaccine or a partial dose), syringe connection issue (Verbatim: Syringe connection issue) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental needle stick was not reported and the outcome of the incomplete dose administered, syringe connection issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the accidental needle stick to be related to Hiberix.     It was unknown if the company considered the accidental needle stick to be related to Hiberix.   Additional Information: GSK Receipt date: 11-JAN-2024 A nurse reported that an administrator in the practice was administering a dose of Hiberix to a baby and the needle fell off the end of the syringe and stayed in the baby's leg.  The reporter was not sure if the baby got all of the vaccine or a partial dose which led to Incomplete dose administered.  The reporter was not sure if when the Hiberix vaccines spilled out of the 2 doses where the plunger fell out of the pre filled syringes, if the administrators had gloves on or if skin contact was made.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; She contracted shingles three days ago; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 03-JUN-2024, 1 year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: She contracted shingles three days ago). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 13-JUN-2024 The patient self-reported this case. She received both Shingrix doses last year and she contracted shingles three days ago. The exact vaccine date was unknown.   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.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix.
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: "Heard" GARDASIL 9 can delay menarche; This spontaneous report has been received from a Physician referring a non-pregnant female patient of an unknown age.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  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) injection, administered for prophylaxis (strength, dose administered, route and anatomical location of administration, lot # and expiration date were not provided).  On an unknown date, it was "heard" that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) can delay menarche. At the time of this report, the outcome of the event was unknown.    The causal relationship between delayed menarche and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) has been determined to be related.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles outbreak in 2021. According to patient she received both Shingrix shots in 2017, over 6 months apart; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles outbreak in 2021. According to patient she received both Shingrix shots in 2017, over 6 months apart). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. The company considered the shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 11-JUN-2024 This case was self-reported by patient. The patient received the both doses of Shingrix shots in 2017, over 6 months apart (dates unknown). 2nd shot was received several month later than directed. The patient reported that she had developed a shingles outbreak in 2021. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: longer than recommended interval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced drug dose administration interval too long (Verbatim: longer than recommended interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 13-JUN-2024 The patient received 2nd dose at longer interval, which led to lengthening of vaccination schedule. The reporter asked question, what if it's been a year or more than they got their Shingrix second dose. Did just give them the 2nd dose or restart the series? The reporter reported, this has been happening with some of patients, probably hundreds of them but did not have that information of them and we would take care of it here, no follow up needed. The reporter did not consent to follow-up.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Injury associated with device, Product complaint
Clinical narrative: the needle actually stayed within the patient's thigh; Dose was partially administered to the patient; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental needle stick in a 4-month-old male patient who received Hib (Hiberix) (batch number M7422) and (batch number y24t9, expiry date 14-MAR-2026) for prophylaxis. This case was associated with a product complaint.   On 12-JUN-2024, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: the needle actually stayed within the patient's thigh), incomplete dose administered (Verbatim: Dose was partially administered to the patient) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental needle stick was not reported and the outcome of the incomplete dose administered and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the accidental needle stick to be related to Hiberix.     It was unknown if the company considered the accidental needle stick to be related to Hiberix.   Additional Information: GSK Receipt date: 13-JAN-2024 A nurse Practitioner reported that yesterday afternoon she had a patient came in for a regular child exam and required the HIB injection and, this medication comes with a vial that needs to have reconstitution with syringe and then drawn back into the same syringe for administration. So, upon administering the vaccine to the patient there was a pop heard and, when she removed the syringe after administering the vaccine, the needle stayed within the patient's thigh. Dose was partially administered to the patient (about 3/4 of the medication) which led to incomplete dose administered.  Defect was noticed during administration and after partial use of the pack.  Luer lok needle was used, reviewed product instructions for use step by step.  She had no issues with the attachment of the initial needle used in reconstitution.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: LACK OF EFFICACY; REBOUND COVID; This spontaneous report received from a consumer by a Business partner (Pfizer Inc.) on 10-JUN-2024 was received on 10-JUN-2024 and concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: allergy, and concurrent conditions included: obesity. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 07-MAY-2021 to Left Arm for covid-19 prophylaxis. Non-company suspect vaccine included: elasomeran (dose series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 01-MAR-2022 to Left Arm for an unspecified indication. ; and tozinameran (dose series 3) (batch number: HG4628, form of admin, route of admin, and were not reported) dose was not reported, administered on 01-OCT-2022 to Left Arm, and dose was not reported, administered on 25-SEP-2023 to Left Arm for an unspecified indication. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. Concomitant medications included ascorbic acid/iron pentacarbonyl, bupropion, buspirone, cetirizine hydrochloride, dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, diclofenac, guaifenesin, montelukast, paracetamol, pseudoephedrine hydrochloride, and vitamins nos. On 28-MAY-2024, treatment medications included: nirmatrelvir/ritonavir. On an unspecified date, the patient experienced lack of efficacy, and rebound covid (dose series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rebound covid, and the outcome of lack of efficacy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Drug ineffective; The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: NATURE OF EVENT. Therefore, this event is considered inconsistent with vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain
Clinical narrative: Bones hurt; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bones hurt) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous use) 40 milligram once a day. On an unknown date, the patient experienced BONE PAIN (Bones hurt). At the time of the report, BONE PAIN (Bones hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       Concomitant medication use information was not provided by reporter.  The suspect product Moderna COVID-19 vaccine was reported.  The suspect product Moderna COVID-19 vaccine dosage text was reported as frequency: 1 in once, total.  The reporter's causality for the event(s) of bones hurt with adalimumab solution for injection was not provided.  Treatment medication use information was not provided by reporter.
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling
Clinical narrative: Local swelling of upper arm leading to potential cellulitis; Local swelling of upper arm leading to potential cellulitis; This is a spontaneous report received from an Other HCP from a sales representative.  A female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), CELLULITIS (non-serious), outcome "unknown" and all described as "Local swelling of upper arm leading to potential cellulitis". Therapeutic measures were taken as a result of peripheral swelling, cellulitis.  Additional information: Local swelling of upper arm leading to potential cellulitis. It was unknown if the patient received any other vaccines on the same date as the vaccine for which you are reporting. It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccine for which you are reporting. It was unknown if the patient taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid-19 yesterday, Symptoms started 09Jun2024; tested positive for Covid-19 yesterday, Symptoms started 09Jun2024; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series done, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jun2024, outcome "recovering" and all described as "tested positive for Covid-19 yesterday, Symptoms started 09Jun2024". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jun2024) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Patient reported that she tested positive for Covid-19 yesterday. Symptoms started 09Jun2024, but did not test positive until yesterday. Was not sure If she had to report this as last dose of Pfizer shot was 23Sep. No COVID prior vaccination. No known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid as treatment from 11Jun2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10May2024 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: Hypertension; "mild hyperlipidemia" (unspecified if ongoing), notes: mild Hyperlipidemia; "borderline pre-diabetes" (unspecified if ongoing), notes: Borderline pre-diabetes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 5, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of covid-19 and included treatment with Paxlovid from 04Jun2024 to 09Jun2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: bilateral pulmonary embolism; This is a spontaneous report received from a Pharmacist from medical information team.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary immunization complete), for COVID-19 Immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "bilateral pulmonary embolism".  Clinical course: The pharmacist reported that her father is a healthy 77 year old man, that has been administered regularly with the Comirnaty vaccine and the last dose was on 2023 fall, maybe September or October. Her father has been recently diagnosed with bilateral pulmonary embolism. She was asking if there are safety reports for the administration of the Comirnaty vaccine and cases of clotting.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pulmonary embolism and the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest X-ray abnormal, Computerised tomogram, Dyspnoea, Laboratory test abnormal
Clinical narrative: bilateral pulmonary embolism; This is a spontaneous report received from a Pharmacist from medical information team.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary immunization complete), for COVID-19 Immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "bilateral pulmonary embolism".  Clinical course: The pharmacist reported that her father is a healthy 77 year old man, that has been administered regularly with the Comirnaty vaccine and the last dose was on 2023 fall, maybe September or October. Her father has been recently diagnosed with bilateral pulmonary embolism. She was asking if there are safety reports for the administration of the Comirnaty vaccine and cases of clotting.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pulmonary embolism and the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle strain, Pneumothorax, Pulmonary embolism
Clinical narrative: bilateral pulmonary embolism; This is a spontaneous report received from a Pharmacist from medical information team.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary immunization complete), for COVID-19 Immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "bilateral pulmonary embolism".  Clinical course: The pharmacist reported that her father is a healthy 77 year old man, that has been administered regularly with the Comirnaty vaccine and the last dose was on 2023 fall, maybe September or October. Her father has been recently diagnosed with bilateral pulmonary embolism. She was asking if there are safety reports for the administration of the Comirnaty vaccine and cases of clotting.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pulmonary embolism and the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 79-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing), notes: He has a history of a penicillin allergy. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 5, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 6, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with COVID".  Clinical course: Patient was diagnosed with COVID on Sunday. He said that he's been vaccinated against COVID 7 times and he doesn't know why he got sick (unknown manufacturer of the COVID vaccine that he received). He has a history of a penicillin allergy.  Batch/lot number is not provided, and it cannot be obtained.