chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administered a hepatitis -b vaccine that had expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received HBV (Engerix B) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   On 03-JUN-2024, the patient received Engerix B. On 03-JUN-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Administered a hepatitis -b vaccine that had expired). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 06-JUN-2024 The reporter administered a hepatitis b vaccine that had expired Consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: only the adjuvant portion of the shingrix vaccine was administered to a patient without mixing with the lyophilized vial; only adjuvant administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number Nj9yd, expiry date 13-APR-2026) for prophylaxis.   On 11-JUN-2024, the patient received Shingrix. On 11-JUN-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: only the adjuvant portion of the shingrix vaccine was administered to a patient without mixing with the lyophilized vial) and inappropriate dose of vaccine administered (Verbatim: only adjuvant administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-JUN-2024 The nurse calls to report only the adjuvant portion of the shingrix vaccine was administered to a patient without mixing with the lyophilized vial, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinitus increased to the point where I contacted my cardiologist and asked if the new medication might be the cause. When I saw the article in the newspaper about the vaccine causing tinitus in some, I thought I should report it.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Immunisation reaction, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: HPI Pt presents for evaluation of mildly itchy and painful red skin eruption to left arm. Pt has h/o HTN, ventricular tachycardia, afib (on xarelto), hypothyroidism. Pt had first shingrix vaccine to left arm 6/6. Pt had chicken pox when she was 27. Pt noted slightly itchy/painful bumps (two of them) above the injection site Monday; Pt had bruising at injection site within a day of vaccine. Since Monday Pt has developed flat red itchy/painful skin eruption to mid portion of left arm since Monday with continued spreading of this eruption as of last night. No other changes skin. Pt notes having possible insect bite to posterior right ankle a couple weeks ago; that is resolving. Pt notes feeling warm overall since vaccine. No lip, tongue, throat swelling/itching, coughing, dyspnea, chest pain, palpitations. Pt notes she planted some plants, but no known exposure to poison ivy. Pt has allergies/intolerances as per Epic. Pt did not apply anything to skin. Plan    Assess: No evidence of anaphylaxis or SJS/TENS. Skin eruption could be some adverse reaction to vaccine. I do no think this is bacterial cellulitis or fungal infection. Possibly, it is some contact dermatitis. I doubt insect bite reaction. Affected skin mostly within C-5 dermatome. I am concerned this could be, ironically, reactivation of zoster (see pubmed case report abstract below).   Plan: Discuss with derm and pharmacy VZV swab   I spoke with Derm RN; she said Dr reviewed my photos and history and noted it was probably skin reaction to vaccine; he recommended cold compresses.   I spoke with pharmacist, and he asked that I route this chart to their pool so this can be reported.   I d/w Pt this could be adverse reaction to vaccine; it could be zoster, though less likely. Given her age and appearance of eruption I recommended Valtrex. I d/w her benefits and risks. I asked that she cover eruption.   I recommended she see her dermatologist this week, and she will need to d/w them and her PCP if she can have subsequent Shingrix vaccine.   Re BP I asked that she f/u with her cardiologist, Dr.   D/c plan as per AVS I d/w Pt reasons to call EMS   I dispensed gauze pads and tape.       2023 Jan; 15(1):. Published online 2023 Jan 31. PMID:  Monitoring Editor:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site vesicles, Pain of skin, Pallor
Clinical narrative: HPI Pt presents for evaluation of mildly itchy and painful red skin eruption to left arm. Pt has h/o HTN, ventricular tachycardia, afib (on xarelto), hypothyroidism. Pt had first shingrix vaccine to left arm 6/6. Pt had chicken pox when she was 27. Pt noted slightly itchy/painful bumps (two of them) above the injection site Monday; Pt had bruising at injection site within a day of vaccine. Since Monday Pt has developed flat red itchy/painful skin eruption to mid portion of left arm since Monday with continued spreading of this eruption as of last night. No other changes skin. Pt notes having possible insect bite to posterior right ankle a couple weeks ago; that is resolving. Pt notes feeling warm overall since vaccine. No lip, tongue, throat swelling/itching, coughing, dyspnea, chest pain, palpitations. Pt notes she planted some plants, but no known exposure to poison ivy. Pt has allergies/intolerances as per Epic. Pt did not apply anything to skin. Plan    Assess: No evidence of anaphylaxis or SJS/TENS. Skin eruption could be some adverse reaction to vaccine. I do no think this is bacterial cellulitis or fungal infection. Possibly, it is some contact dermatitis. I doubt insect bite reaction. Affected skin mostly within C-5 dermatome. I am concerned this could be, ironically, reactivation of zoster (see pubmed case report abstract below).   Plan: Discuss with derm and pharmacy VZV swab   I spoke with Derm RN; she said Dr reviewed my photos and history and noted it was probably skin reaction to vaccine; he recommended cold compresses.   I spoke with pharmacist, and he asked that I route this chart to their pool so this can be reported.   I d/w Pt this could be adverse reaction to vaccine; it could be zoster, though less likely. Given her age and appearance of eruption I recommended Valtrex. I d/w her benefits and risks. I asked that she cover eruption.   I recommended she see her dermatologist this week, and she will need to d/w them and her PCP if she can have subsequent Shingrix vaccine.   Re BP I asked that she f/u with her cardiologist, Dr.   D/c plan as per AVS I d/w Pt reasons to call EMS   I dispensed gauze pads and tape.       2023 Jan; 15(1):. Published online 2023 Jan 31. PMID:  Monitoring Editor:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Papule, Rash, Rash erythematous, Rash pruritic, Skin reaction
Clinical narrative: HPI Pt presents for evaluation of mildly itchy and painful red skin eruption to left arm. Pt has h/o HTN, ventricular tachycardia, afib (on xarelto), hypothyroidism. Pt had first shingrix vaccine to left arm 6/6. Pt had chicken pox when she was 27. Pt noted slightly itchy/painful bumps (two of them) above the injection site Monday; Pt had bruising at injection site within a day of vaccine. Since Monday Pt has developed flat red itchy/painful skin eruption to mid portion of left arm since Monday with continued spreading of this eruption as of last night. No other changes skin. Pt notes having possible insect bite to posterior right ankle a couple weeks ago; that is resolving. Pt notes feeling warm overall since vaccine. No lip, tongue, throat swelling/itching, coughing, dyspnea, chest pain, palpitations. Pt notes she planted some plants, but no known exposure to poison ivy. Pt has allergies/intolerances as per Epic. Pt did not apply anything to skin. Plan    Assess: No evidence of anaphylaxis or SJS/TENS. Skin eruption could be some adverse reaction to vaccine. I do no think this is bacterial cellulitis or fungal infection. Possibly, it is some contact dermatitis. I doubt insect bite reaction. Affected skin mostly within C-5 dermatome. I am concerned this could be, ironically, reactivation of zoster (see pubmed case report abstract below).   Plan: Discuss with derm and pharmacy VZV swab   I spoke with Derm RN; she said Dr reviewed my photos and history and noted it was probably skin reaction to vaccine; he recommended cold compresses.   I spoke with pharmacist, and he asked that I route this chart to their pool so this can be reported.   I d/w Pt this could be adverse reaction to vaccine; it could be zoster, though less likely. Given her age and appearance of eruption I recommended Valtrex. I d/w her benefits and risks. I asked that she cover eruption.   I recommended she see her dermatologist this week, and she will need to d/w them and her PCP if she can have subsequent Shingrix vaccine.   Re BP I asked that she f/u with her cardiologist, Dr.   D/c plan as per AVS I d/w Pt reasons to call EMS   I dispensed gauze pads and tape.       2023 Jan; 15(1):. Published online 2023 Jan 31. PMID:  Monitoring Editor:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient received MMRV & DTAP/IPV on 6/11/2024. Mother of patient reports on 6/11/2024 after receiving the vaccines the patient's arm was red.  Mother reported patient with elevated temp on 6/12/2024 and "more redness" to left arm (area of vaccination). On 6/13/2024 patient noted with left arm redness, area warm to touch, indurated from shoulder to 2CM above elbow. Diagnosed with left arm cellulitis. Prescribed cefdinir.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong patient received product, Wrong product administered
Clinical narrative: Patient was here with sibling for immunizations, immunizations were ready for both siblings in separate trays. Upon calling them in older sister sat on the table first. I gave her the shots that were for younger sibling. Patient was due for Pcv 20. Proquad, Hib, Hep A, Dtap. Patient received KINRIX and Proquad.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Aphasia, Dyspnoea, General physical condition abnormal, Heart rate decreased
Clinical narrative: Following completion of examination, within minutes of receiving Shingrix vaccination, patient had anaphylactic reaction.  She could not speak, had significant difficulty breathing, tripod position, became very pale, and diaphoretic.  When auscultated, minimal air movement was noted bilaterally, continued to not be able to speak, small gasps for breathing.  When saturation probe was applied, saturations were upper 80s and dropping, as well as heart rate.  She became very pale, heart rate dropped from 70s to 43, saturations to low 80s, she was laid supine as she appeared she was going to lose consciousness.  After laying her supine, breathing improved, saturations and heart rate came back up to an appropriate level.  Epinephrine was at the bedside at this time, given to patient at 0920.  Within minutes of receiving epinephrine, patient was able to speak, breathe more easily without wheezing noted via auscultation.  Continue to have complaint of some throat swelling.  Vitals remained stable until EMS was able to arrive to take her to the emergency room for monitoring.  EMS inquired if she wanted to go to the hospital, patient was still recovering from altered mental status post near syncope. They again asked 2 more times. My recommendations were for her to attend for monitoring after such a severe reaction and receiving epinephrine. She may also have continued reaction or throat swelling, so highly advised attending ER by EMS.   After sitting up at the bedside, she had difficulty breathing and speaking again, pointing to her throat, became very tearful.  EMS at this time inquired history of anxiety, she shook her head no.  Did require laying supine to improve symptoms.  Was transferred to the cot without issue, report and documentation provided for EMS.  Report was also called to emergency room.  Her family was notified and planned to meet her at the emergency room.   APRN  6/12/2024
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Mental status changes, Oxygen saturation decreased, Pallor, Pharyngeal swelling
Clinical narrative: Following completion of examination, within minutes of receiving Shingrix vaccination, patient had anaphylactic reaction.  She could not speak, had significant difficulty breathing, tripod position, became very pale, and diaphoretic.  When auscultated, minimal air movement was noted bilaterally, continued to not be able to speak, small gasps for breathing.  When saturation probe was applied, saturations were upper 80s and dropping, as well as heart rate.  She became very pale, heart rate dropped from 70s to 43, saturations to low 80s, she was laid supine as she appeared she was going to lose consciousness.  After laying her supine, breathing improved, saturations and heart rate came back up to an appropriate level.  Epinephrine was at the bedside at this time, given to patient at 0920.  Within minutes of receiving epinephrine, patient was able to speak, breathe more easily without wheezing noted via auscultation.  Continue to have complaint of some throat swelling.  Vitals remained stable until EMS was able to arrive to take her to the emergency room for monitoring.  EMS inquired if she wanted to go to the hospital, patient was still recovering from altered mental status post near syncope. They again asked 2 more times. My recommendations were for her to attend for monitoring after such a severe reaction and receiving epinephrine. She may also have continued reaction or throat swelling, so highly advised attending ER by EMS.   After sitting up at the bedside, she had difficulty breathing and speaking again, pointing to her throat, became very tearful.  EMS at this time inquired history of anxiety, she shook her head no.  Did require laying supine to improve symptoms.  Was transferred to the cot without issue, report and documentation provided for EMS.  Report was also called to emergency room.  Her family was notified and planned to meet her at the emergency room.   APRN  6/12/2024
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Presyncope, Speech disorder, Tearfulness, Wheezing
Clinical narrative: Following completion of examination, within minutes of receiving Shingrix vaccination, patient had anaphylactic reaction.  She could not speak, had significant difficulty breathing, tripod position, became very pale, and diaphoretic.  When auscultated, minimal air movement was noted bilaterally, continued to not be able to speak, small gasps for breathing.  When saturation probe was applied, saturations were upper 80s and dropping, as well as heart rate.  She became very pale, heart rate dropped from 70s to 43, saturations to low 80s, she was laid supine as she appeared she was going to lose consciousness.  After laying her supine, breathing improved, saturations and heart rate came back up to an appropriate level.  Epinephrine was at the bedside at this time, given to patient at 0920.  Within minutes of receiving epinephrine, patient was able to speak, breathe more easily without wheezing noted via auscultation.  Continue to have complaint of some throat swelling.  Vitals remained stable until EMS was able to arrive to take her to the emergency room for monitoring.  EMS inquired if she wanted to go to the hospital, patient was still recovering from altered mental status post near syncope. They again asked 2 more times. My recommendations were for her to attend for monitoring after such a severe reaction and receiving epinephrine. She may also have continued reaction or throat swelling, so highly advised attending ER by EMS.   After sitting up at the bedside, she had difficulty breathing and speaking again, pointing to her throat, became very tearful.  EMS at this time inquired history of anxiety, she shook her head no.  Did require laying supine to improve symptoms.  Was transferred to the cot without issue, report and documentation provided for EMS.  Report was also called to emergency room.  Her family was notified and planned to meet her at the emergency room.   APRN  6/12/2024
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC20
Symptoms: Wrong patient received product, Wrong product administered
Clinical narrative: Patient was here with sibling for immunizations, immunizations were ready for both siblings in separate trays.  I gave her the shots that were for younger sibling. Patient was due for only Kinrix, Proquad. She received Pcv 20. Proquad, Hib, Hep A, Dtap.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt mistakenly received a second dose of  Private Moderna 12 years+ Additional 2023-2024 COVID Season, Lot: 3033277 when she had already received the COVID seasonal vaccine on 11/16/23 and she is not immunocompromised.  Nurses observed the patient for 30 minutes for any abnormal reactions to the vaccine and none were found.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: INFO PER PT
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction at this time but 2nd dose of Vaqta (Hep A) was given in error too early. 2nd dose  was not due until December 2024 and was given 3 months after the 1st dose. Parent is aware.
Age: 64.0
Sex: F
Vaccine: COVID19-2, HEP, RSV
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever, headache, fatigue, nausea. Treated with extra rest, massage, 800mg ibuprofen, drinking ice water
Age: 1.58
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received both MMRV and Varicella at the same time.  Pt did not have any reactions.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood test, Computerised tomogram, Disorientation, Fall, Head injury
Clinical narrative: Patient faints, falls to the floor and hits his head. She quickly wakes up disoriented and pale, asking what happened to her. She was instructed to sit down to take vital signs and were within normal parameters. Mother reports that the minor had not eaten since 9:00 A.M., which was an egg, hot dog and a juice. Mother indicates that she will take her to the Emergency Room for radiological studies. I contacted the next day to follow-up, but the mother of the minor refuses to provide information.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Patient faints, falls to the floor and hits his head. She quickly wakes up disoriented and pale, asking what happened to her. She was instructed to sit down to take vital signs and were within normal parameters. Mother reports that the minor had not eaten since 9:00 A.M., which was an egg, hot dog and a juice. Mother indicates that she will take her to the Emergency Room for radiological studies. I contacted the next day to follow-up, but the mother of the minor refuses to provide information.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Tdap vaccination administered in error at in appropriate interval.  Previous dose was administered on 11/24/2020
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Dizziness, Dyspnoea, Paraesthesia, Presyncope
Clinical narrative: EE (employee) stated that she was feeling dizzy after receiving the TDAP and Hep B #1 vaccines. Vasovagal response was suspected. EE was told to lay on the floor while having legs elevated on the chair. While in this position ee felt that her legs were tingling. EE stated that she was having a hard time breathing. She said that she felt like her throat was tight and her "tongue felt thick." Vitals were taken twice, and were within normal range. EE sat in chair. She wanted to walk around. Epi pen was offered but she refused it. She stated that she had the epi pen before and preferred to wait. 911 was called with ee's consent. EMS responded. After being evaluated by EMS, ee was released and she returned back to complete her work. She was not transported to the ER. Per ee, they stated that it was not an allergic rxn. It was believed to be anxiety.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness, Tongue disorder
Clinical narrative: EE (employee) stated that she was feeling dizzy after receiving the TDAP and Hep B #1 vaccines. Vasovagal response was suspected. EE was told to lay on the floor while having legs elevated on the chair. While in this position ee felt that her legs were tingling. EE stated that she was having a hard time breathing. She said that she felt like her throat was tight and her "tongue felt thick." Vitals were taken twice, and were within normal range. EE sat in chair. She wanted to walk around. Epi pen was offered but she refused it. She stated that she had the epi pen before and preferred to wait. 911 was called with ee's consent. EMS responded. After being evaluated by EMS, ee was released and she returned back to complete her work. She was not transported to the ER. Per ee, they stated that it was not an allergic rxn. It was believed to be anxiety.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Hyperhidrosis, Peripheral swelling
Clinical narrative: Patient reported "stomach cramping, chills, swelling in arm, and sweating" for "12 hours" following injection.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dyskinesia, Eye movement disorder, Pallor, Seizure like phenomena, Syncope
Clinical narrative: After vaccine patient became pale, her eyes rolled over. Pt had seizure like body movements while she fainted.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site macule
Clinical narrative: R thigh with blotchy redness approx 2 cm with central ecchymosis
Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Patient was scheduled to be administered the Bexsero booster dose on 6/13 but visit was cancelled due to hospitalization.
Age: 69.0
Sex: F
Vaccine: DTAP
Symptoms: Incorrect product formulation administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effect noted at the time of administration [06/03/2024] or on a regularly scheduled follow-up visit on 06/12/2024.  The patient, an adult, received  DTaP vaccine PRIMARY vaccine, INSTEAD OF the adult BOOSTER vaccine.  The vaccine given was supplied by the Vaccine Program.
Age: 72.0
Sex: M
Vaccine: DTAP
Symptoms: Incorrect product formulation administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effect noted at the time of administration [06/03/2024] or on a regularly scheduled follow-up visit on 06/12/2024.  The patient, an adult, received  DTaP vaccine PRIMARY vaccine, INSTEAD OF the adult BOOSTER vaccine.  The vaccine given was supplied by the Child Vaccine Program.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Pityriasis rosea, Rash, Rash erythematous
Clinical narrative: Noticed a red rash on neck and slowly spread over body, denied itching, no other symptoms reported. Pt was seen with local provider APRN on 6/4/24 patient was referred to Dr-Dermatology with appt 6/5/2024. Per Mother and Father was told rash was Pityriasis Rosea most likely viral and could last up to 3 months. No treatment given.
Age: 47.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: No adverse event, Vaccination error, Wrong product administered
Clinical narrative: NO adverse Reaction. This is a report for a vaccine error. Patient was given HPV vaccine instead of Prevnar20
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Headache
Clinical narrative: Patient reports waking up the morning after the vaccine with a moderately severe headache (not at the level of migraine) which continued for 60 consecutive days. The headache then tapered on and off for 3 months. Only this week did it subside. Patient has a history of headaches triggered by barometric pressure changes, but has never experienced anything like this.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Eye irritation, Injection site rash, Poor quality sleep, Rash
Clinical narrative: Patient received PCV15 (not an option above). Received vaccine at 1030 on 6/13/2024. Was rubbing at eyes and did not sleep well that night. In the morning on 6/14/2024 was noted by mother to have redness and swelling and rash of cheeks and left leg. This then spread to other leg and abdomen. Urticarial appearing on exam. Denies other symptoms, does have concurrent URI symptoms of rhinorrhea and cough. Referred to Allergist.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Swelling, Urticaria
Clinical narrative: Patient received PCV15 (not an option above). Received vaccine at 1030 on 6/13/2024. Was rubbing at eyes and did not sleep well that night. In the morning on 6/14/2024 was noted by mother to have redness and swelling and rash of cheeks and left leg. This then spread to other leg and abdomen. Urticarial appearing on exam. Denies other symptoms, does have concurrent URI symptoms of rhinorrhea and cough. Referred to Allergist.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: COVID vaccine received 4/5/24 was to be used by 6/13/24, vaccine was administered today. Per vial expiration date is July 2024.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Guillain-Barre syndrome
Clinical narrative: Patient presented to ED with weakness that neurologist diagnosed as Guillan Barre syndrome
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Computerised tomogram, Magnetic resonance imaging, Positron emission tomogram, Pruritus
Clinical narrative: Since December 2022, patient has been experiencing constant and intense under skin itching without a rash throughout her entire body.  When she exerts herself, the itching intensifies.  She has seen numerous specialists (ENT, endocrinologist), infectious disease, rheumatologist, dermatologist, immunologist/allergist, neurologist, None have been able to determine the root cause of the illness.
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ultrasound abdomen
Clinical narrative: Since December 2022, patient has been experiencing constant and intense under skin itching without a rash throughout her entire body.  When she exerts herself, the itching intensifies.  She has seen numerous specialists (ENT, endocrinologist), infectious disease, rheumatologist, dermatologist, immunologist/allergist, neurologist, None have been able to determine the root cause of the illness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash erythematous
Clinical narrative: Pt developed a large red rash after his vaccine, it spread overnight.
Age: 58.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event. Given at age 58 instead of age 60 in pt with HIV/immunocompromised
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Nurse administered second dose of meningococcal vaccine before recommended due date. No adverse effects observed during or after administration.
Age: 0.5
Sex: M
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: Varicella vaccination administered instead of Vaxelis (DTaP, IPV, Hepatitis B, Hib combination)
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Inadvertently given expired vaccine. Expiration 06/02/2024.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer vaccine was stored incorrectly. Vaccine was stored in the freezer instead of the refigerator.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored incorrectly. Freezer instead of the refigerator.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored incorrectly in freezer instead of refigerator.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bile duct cancer, Biliary obstruction, Jaundice, Metastases to liver, Surgery
Clinical narrative: Pt with treated colon cancer in 2018. Suddenly mets to liver 7/2023. Now with cholangeal tumor and jaundice and biliary obstruction after most recent Astazeneca shot 12/2023 needing mult hospitals and surgeries since 1/2024
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: No additional AE/no PQC.; HBP calling to report a child received only half of a dose of VAQTA, because "they were moving" during vaccination; a child received only half of a dose of VAQTA, because "they were moving" during vaccination.; This spontaneous report has been received from an office manager, referring to a 2-year-old patient of unknown gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 06-JUN-2024, the patient was vaccinated with 2nd dose of hepatitis a vaccine, inactivated (VAQTA), administered for prophylaxis (exact dose, route of administration, anatomical location, lot# and expiry date were not reported). The child received only half of a dose of hepatitis a vaccine, inactivated (VAQTA), because "they were moving" during vaccination (accidental underdose, product administration interrupted). No additional adverse events reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/No PQC.; expired MMR II vaccine that was given to a child; This spontaneous report was received from a medical assistant referring to a child patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 07-JUN-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # W035197, expiration date: 24-MAY-2024 (strength, dose, dose number, route and anatomical location were not provided (expired product administered) for prophylaxis.  No adverse side effects were reported.  Product was supported by post expiry memo. No adverse side effects were reported.
Age: 0.5
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; HBP reporting that 6 month old patient received VAQTA on 5/30/2024.  No adverse effects reported.  AE was identified during routine chart review.  Confirmed no PQC, per reporter it was human error.  No other information provided. No additional AE. No; This spontaneous report was received from an administrator referring to a 6-month-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 30-MAY-2024, due to a human error, the 6-year-old patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) single dose, lot # X021007 with expiration date 26-DEC-2024, for prophylaxis (strength, dose, route of administration and anatomical location were not reported) (Product administered to patient of inappropriate age). No adverse effects reported. No additional adverse event (AE) was reported.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported.; HCP called to report TE where patient received the PEDVAX HIB; This spontaneous report has been received from a nurse practitioner, referring to a 9-week-old male patient. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 11-JUN-2024, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) at a dose of 0.5 mL, lot# W006595, expiry date 10-OCT-2024, administered for prophylaxis (route of administration and anatomical location were not reported). The vaccine underwent temperature excursion prior to administration (39.4 F for 1 hour 50 minutes) (product storage error). No previous excursions were reported. No symptoms reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure / had the shot still got it; Had the shot still got it; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure / had the shot still got it) (serious criteria GSK medically significant) and shingles (Verbatim: Had the shot still got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   The company considered the vaccination failure to be related to Shingles vaccine. The company considered the shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-JUN-2024 This case was reported by a patient via interactive digital media. The patient had the shingles vaccine and still got it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: muscle ache; joints ache like I never had before; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced muscle pain (Verbatim: muscle ache) and joint pain (Verbatim: joints ache like I never had before). The outcome of the muscle pain and joint pain were not reported.   The reporter considered the muscle pain and joint pain to be related to Shingles vaccine.   The company considered the muscle pain and joint pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-JUN-2024 This case was reported by a patient via interactive digital media. The patient reported that shingles vaccine was the worst thing he/she ever did. The patient reported his/her muscles ache and joints ache like he/she never had before because of that stupid vaccine. Never again.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Above temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a specified number of patient who received DTPa (Reduced antigen) (Boostrix) (batch number Z7L7H, expiry date 09-AUG-2026) for prophylaxis.   On 04-JUN-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Above temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 04-JUN-2024 The reporter reported that the caller mentioned that they left out of the Boostrix vaccine, this was for all night, and they get warm, they need assistance to get a replacement of the vaccine because they already administered it to 4 patients. The reporter asked she knows the storage condition. The vaccine was at room temperature, like 72 degree Fahrenheit, with no prior excursion. The reporter did not have the information from the patients or vaccination date, on the format we set the date 4th June 2024 due there was no option to left in blank. The reporter reported that these vaccine were administered last week. The vaccine administration facility was the same as primary reporter.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: patient received a dose of Priorix on June 4th 2024 which had expired on June 1st 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 30-year-old female patient who received MMR (Priorix) (batch number M79YM, expiry date 01-JUN-2024) for prophylaxis.   On 04-JUN-2024, the patient received the 1st dose of Priorix. On 04-JUN-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: patient received a dose of Pyrex on June 4th 2024 which had expired on June 1st 2024). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JUN-2024 The nurse reported that, the patient received a dose of Priorix on 4th June 2024 which was expired on 1st June 2024, which led to expired vaccine used. The patient received the vaccine at the same site.  The reporter requested information about how to proceed with the event and safety data.  The reporter was told that there was no safety data and the medical information letter was read and she accepted the information to contact the center for disease control.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did not recived 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 13-JUL-2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient did not recived 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 06-JUN-2024 The reporter was the patient. The patient believed he had received first dose of Shingrix and he believed he had received the second dose, but the pharmacy tells him he had not yet received the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented the follow up.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Product preparation error
Clinical narrative: did not use the Rotarix diluent used one of Merck's sterile water diluents; did not use the Rotarix diluent used one of Merck's sterile water diluents; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old female patient who received Rota (Rotarix liquid formulation) (batch number 7533D, expiry date 17-FEB-2025) for prophylaxis.   On 22-MAY-2024, the patient received Rotarix liquid formulation. On 22-MAY-2024, an unknown time after receiving Rotarix liquid formulation, the patient experienced wrong solution used in drug reconstitution (Verbatim: did not use the Rotarix diluent used one of Merck's sterile water diluents) and inappropriate dose of vaccine administered (Verbatim: did not use the Rotarix diluent used one of Merck's sterile water diluents). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JUN-2024 The site supervisor stated Certified Medical Assistant (CMA) did not use the Rotarix diluent that came with it, she used one of Merck's sterile water diluents which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (expiry date 31-MAR-2024) for prophylaxis.   On 23-MAY-2024, the patient received Menveo. On 23-MAY-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-JUN-2024 The clinic inadvertently administered a dose of Menveo (2-vial presentation) that was expired and was administered which led to expired vaccine used. The diluent was not expired. The reporter questioned was it recommended to repeat the dose based on the expiration date. No other information was provided.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: inadvertently pediatric dose to an adult patient; inadvertently pediatric dose to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 54-year-old female patient who received HBV (Engerix B) (batch number Y5AJ9, expiry date 03-MAR-2025) for prophylaxis.   On 10-JUN-2024, the patient received Engerix B. On 10-JUN-2024, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: inadvertently pediatric dose to an adult patient) and accidental underdose (Verbatim: inadvertently pediatric dose to an adult patient). The outcome of the adult use of a child product and accidental underdose were unknown.   Additional Information: GSK Receipt Date: 11-JUN-2024 The customer wants to know how to complete the hepatitis b schedule for an adult who was inadvertently given one pediatric hepatitis b dose, which led to accidental underdose and adult use of a child product. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pruritus
Clinical narrative: experiencing itching/itchy arms, legs under skin itching; has been incapacitated for a year and a half she cannot work/completely incapacitated she cannot perform a normal life; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 23-year-old female patient received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose number unknown, 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: PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "experiencing itching/itchy arms, legs under skin itching"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "has been incapacitated for a year and a half she cannot work/completely incapacitated she cannot perform a normal life". The events "experiencing itching/itchy arms, legs under skin itching" and "has been incapacitated for a year and a half she cannot work/completely incapacitated she cannot perform a normal life" required emergency room visit. Therapeutic measures were taken as a result of pruritus, loss of personal independence in daily activities. Additional information: Reporter's daughter was having under skin itching after receiving Pfizer COVID-19 vaccine wanted to know if that was a side effect of the vaccine. Received a Pfizer COVID-19 vaccine in September of 2022, reported under skin itching since late 2022, itchy arms, legs under skin itching. She does not have a rash or anything else - nothing topical helps, steroids don't help nothing helps and stated they need to know what they can do. This has been going on for a year and a half. Reporter stated they have been through countless doctors through the last year and a half, they have been through emergency room over 10 times, they cannot find anybody to treat it they don't know what to do. Patient has been incapacitated for a year and a half she cannot work, she cannot go to school, she cannot do anything, she is completely incapacitated she cannot perform a normal life.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: had fainted; This is a spontaneous report received from a Consumer or other non HCP.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), in Jun2024 as dose number unknown, single (Lot number: HJ1516) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (hospitalization, medically significant) with onset Jun2024, outcome "unknown", described as "had fainted".  The reporter informed that it was three girls that were getting the Trumenba vaccine, may be vaccination all three of them had fainted, two of them went to the hospital and one of them was had a seizure. The reason for hospitalization was because they had a reaction to the vaccine so, they were sent to the hospital. The reporter when probed informed that they the (redacted) Children in the Hospital they purchased that and they administered it to those patients.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400191908 same reporter, same vaccine, different patients, similar event.;US-PFIZER INC-202400191910 same reporter, same vaccine, different patients, similar event.;
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: fainted; This is a spontaneous report received from a Consumer or other non HCP.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), in Jun2024 as dose number unknown, single (Lot number: HJ1516) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (hospitalization) with onset Jun2024, outcome "unknown", described as "fainted". Clinical course: The reporter informed that it was three girls that were getting the Trumenba vaccine, may be vaccination all three of them had fainted, two of them went to the hospital and one of them was had a seizure. The reason for hospitalization was because they had a reaction to the vaccine so, they were sent to the hospital. The reporter when probed informed that they the (redacted) ID in the Hospital they purchased that and they administered it to those patients.; Sender's Comments: Linked Report(s): US-PFIZER INC-202400191907 same reporter, same vaccine, different patients, similar event;US-PFIZER INC-202400191910 same reporter, same vaccine, different patients, similar event;