chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: child was given 3 doses of Rotarix/Extra Dose; This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 7LX33, expiry date 14-FEB-2024) for prophylaxis.   On 27-FEB-2023, the patient received the 3rd dose of Rotarix lyophilized formulation. On 27-FEB-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix/Extra Dose). The outcome of the extra dose 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: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142498:different patient same reporter US-GSK-US2023AMR142497:different patient same reporter US-GSK-US2023AMR142499:different patient same reporter US-GSK-US2023AMR142500:different patient same reporter US-GSK-US2023AMR142501:different patient same reporter US-GSK-US2023AMR142502:different patient same reporter US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142512:different patient same reporter
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: child was given 3 doses of Rotarix /Extra Dose; This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number NK245, expiry date 27-JUN-2023) for prophylaxis.   On 21-OCT-2022, the patient received the 3rd dose of Rotarix lyophilized formulation. On 21-OCT-2022, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix /Extra Dose). The outcome of the extra dose 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: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient, same reporter US-GSK-US2023AMR142498:different patient, same reporter US-GSK-US2023AMR142502:different patient, same reporter US-GSK-US2023AMR142500:different patient, same reporter US-GSK-US2023AMR142501:different patient, same reporter US-GSK-US2023AMR142496:different patient, same reporter US-GSK-US2023AMR142499:different patient, same reporter US-GSK-US2023AMR142512:different patient, same reporter US-GSK-US2023130319:same reprter, different patient
Age: 0.5
Sex: M
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: child was given 3 doses of Rotarix/extra Dose; This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number NK245, expiry date 27-JUN-2023) for prophylaxis.   On 20-MAY-2022, the patient received the 3rd dose of Rotarix lyophilized formulation. On 20-MAY-2022, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix/extra Dose).The outcome of the extra dose 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: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142496:different patient same reporter US-GSK-US2023AMR142497:different patient same reporter US-GSK-US2023AMR142499:different patient same reporter US-GSK-US2023AMR142500:different patient same reporter US-GSK-US2023AMR142501:different patient same reporter US-GSK-US2023AMR142502:different patient same reporter US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142512:different patient same reporter
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: child was given 3 doses of Rotarix /Extra Dose; This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L4749, expiry date 19-SEP-2024) for prophylaxis.   On 20-JUN-2023, the patient received the 3rd dose of Rotarix lyophilized formulation. On 20-JUN-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix /Extra Dose). The outcome of the extra dose 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: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142498:different patient same reporter US-GSK-US2023AMR142497:different patient same reporter US-GSK-US2023AMR142496:different patient same reporter US-GSK-US2023AMR142500:different patient same reporter US-GSK-US2023AMR142501:different patient same reporter US-GSK-US2023AMR142502:different patient same reporter US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142512:different patient same reporter
Age: 67.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a 3rd dose of Shingles. She requested the vaccine at an off site clinic and did not realize that she already completed the series.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: After receiving Quadracel and Varivax, this patient had an adverse reaction - rash and blistering skin - at the injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Blister, Erythema, Peripheral swelling
Clinical narrative: After receiving Quadracel and Varivax, this patient had an adverse reaction - rash and blistering skin - at the injection site.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: The Pentacel powder was mixed with sodium chloride instead of the normal diluent
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test, Pain in extremity, Peripheral swelling, Scan
Clinical narrative: swelling and pain in arm and legs
Age: 1.0
Sex: F
Vaccine: COVID19, HEPA, MMR, VARCEL, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Patient was given 0.2 mL of undiluted Pfizer COVID-19 2023-2024 vaccine for 6m to <5y. CDC contacted and clinic notified to monitor patient, do not repeat dose, and given next dose as scheduled. Patient without symptoms of adverse reaction when leaving clinic. Lot: HH3252 EXP: 7/2024.
Age: 1.0
Sex: F
Vaccine: COVID19, HEPA, MMR, VARCEL, COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient was given 0.2 mL of undiluted Pfizer COVID-19 2023-2024 vaccine for 6m to <5y. CDC contacted and clinic notified to monitor patient, do not repeat dose, and given next dose as scheduled. Patient without symptoms of adverse reaction when leaving clinic. Lot: HH3252 EXP: 7/2024.
Age: 1.0
Sex: F
Vaccine: COVID19, HEPA, MMR, VARCEL, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: she was given 0.3mL of the vaccine but the vaccine was not diluted at all. one nurse said ?she basically got 2 doses? and another said she did not. this occurred around 2:30pm 10/20/2023
Age: 1.0
Sex: F
Vaccine: COVID19, HEPA, MMR, VARCEL, COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: she was given 0.3mL of the vaccine but the vaccine was not diluted at all. one nurse said ?she basically got 2 doses? and another said she did not. this occurred around 2:30pm 10/20/2023
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram, Full blood count, Hypersensitivity, Hypotension, Injection site pain
Clinical narrative: 2-3 hours after vaccination, pain in left arm injection site, swelling, pain radiating  to shoulder. Patient seen in ED at Medical Center. Patient said that he had blood work done and EKG, also had hypotension probably due to allergic reaction.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Metabolic function test, Pain
Clinical narrative: 2-3 hours after vaccination, pain in left arm injection site, swelling, pain radiating  to shoulder. Patient seen in ED at Medical Center. Patient said that he had blood work done and EKG, also had hypotension probably due to allergic reaction.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Blood pressure increased, Chest pain, Erythema, Fatigue
Clinical narrative: Both vaccines were given between 8:30 a.m. and 8:40 a.m. and felt nothing out of the ordinary.  At 6:00 p.m., I suddenly started feeling exhausted/fatigued, and sleepy, with body aches, back pain, and soreness at both injection sites. I took 2-220mg of ibuprofen and took a nap. At 8:30 p.m. I started experiencing a fast heartbeat, jabbing chest pains on the right & left sides of the sternum, elevated blood pressure, red skin rash on the upper back, exhaustion/fatigue, body aches, back pain, injection site soreness, and overall I felt unwell. I took a naproxen 200mg and took another nap. I have since gotten better but The first 48 hours I just slept.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Heart rate increased, Injection site pain, Malaise, Pain, Rash
Clinical narrative: Both vaccines were given between 8:30 a.m. and 8:40 a.m. and felt nothing out of the ordinary.  At 6:00 p.m., I suddenly started feeling exhausted/fatigued, and sleepy, with body aches, back pain, and soreness at both injection sites. I took 2-220mg of ibuprofen and took a nap. At 8:30 p.m. I started experiencing a fast heartbeat, jabbing chest pains on the right & left sides of the sternum, elevated blood pressure, red skin rash on the upper back, exhaustion/fatigue, body aches, back pain, injection site soreness, and overall I felt unwell. I took a naproxen 200mg and took another nap. I have since gotten better but The first 48 hours I just slept.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Somnolence
Clinical narrative: Both vaccines were given between 8:30 a.m. and 8:40 a.m. and felt nothing out of the ordinary.  At 6:00 p.m., I suddenly started feeling exhausted/fatigued, and sleepy, with body aches, back pain, and soreness at both injection sites. I took 2-220mg of ibuprofen and took a nap. At 8:30 p.m. I started experiencing a fast heartbeat, jabbing chest pains on the right & left sides of the sternum, elevated blood pressure, red skin rash on the upper back, exhaustion/fatigue, body aches, back pain, injection site soreness, and overall I felt unwell. I took a naproxen 200mg and took another nap. I have since gotten better but The first 48 hours I just slept.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: child was given 3 doses of Rotarix (Extra Dose); This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 7L2D7, expiry date 24-FEB-2024) for prophylaxis.   On 28-OCT-2022, the patient received the 3rd dose of Rotarix lyophilized formulation. On 28-OCT-2022, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix (Extra Dose)).  The outcome of the extra dose 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: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142498:different patient same reporter US-GSK-US2023AMR142497:different patient same reporter US-GSK-US2023AMR142499:different patient same reporter US-GSK-US2023AMR142496:different patient same reporter US-GSK-US2023AMR142501:different patient same reporter US-GSK-US2023AMR142502:different patient same reporter US-GSK-US2023AMR142512:different patient same reporter
Age: 0.5
Sex: M
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: child was given 3 doses of Rotarix (Extra Dose); This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 7LX33, expiry date 14-FEB-2024) for prophylaxis.   On 02-DEC-2022, the patient received the 3rd dose of Rotarix lyophilized formulation. On 02-DEC-2022, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix (Extra Dose)).  The outcome of the extra dose 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: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142498:different patient same reporter US-GSK-US2023AMR142497:different patient same reporter US-GSK-US2023AMR142499:different patient same reporter US-GSK-US2023AMR142500:different patient same reporter US-GSK-US2023AMR142496:different patient same reporter US-GSK-US2023AMR142502:different patient same reporter US-GSK-US2023AMR142512:different patient same reporter
Age: 0.5
Sex: M
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: child was given 3 doses of Rotarix (Extra Dose); This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number NK245, expiry date 27-JUN-2023) for prophylaxis.   On 29-SEP-2022, the patient received the 3rd dose of Rotarix lyophilized formulation. On 29-SEP-2022, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix (Extra Dose)).  The outcome of the extra dose 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: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142498:different patient same reporter US-GSK-US2023AMR142497:different patient same reporter US-GSK-US2023AMR142499:different patient same reporter US-GSK-US2023AMR142500:different patient same reporter US-GSK-US2023AMR142501:different patient same reporter US-GSK-US2023AMR142496:different patient same reporter US-GSK-US2023AMR142512:different patient same reporter
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: child was given 3 doses of Rotarix (Extra Dose); This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L4749, expiry date 19-SEP-2024) for prophylaxis.   On 22-JUN-2023, the patient received the 3rd dose of Rotarix lyophilized formulation. On 22-JUN-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix (Extra Dose)).  The outcome of the extra dose 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: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient, same reporter US-GSK-US2023AMR142498:different patient, same reporter US-GSK-US2023AMR142502:different patient, same reporter US-GSK-US2023AMR142500:different patient, same reporter US-GSK-US2023AMR142501:different patient, same reporter US-GSK-US2023AMR142496:different patient, same reporter US-GSK-US2023AMR142499:different patient, same reporter US-GSK-US2023AMR142497:different patient, same reporter
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Product packaging confusion
Clinical narrative: was accidentally administered last year's Fluarix influenza vaccine (Fluarix, 2022-23 season vaccine, expiration date earlier this year 2023; packaging looks very similar for last season's Fluarix versus this season's Fluarix; This non-serious case was reported by a nurse and described the occurrence of expired vaccine used in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   In OCT-2023, the patient received Fluarix Quadrivalent 2022-2023 season. In OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: was accidentally administered last year's Fluarix influenza vaccine (Fluarix, 2022-23 season vaccine, expiration date earlier this year 2023) and product packaging confusion (Verbatim: packaging looks very similar for last season's Fluarix versus this season's Fluarix).  The outcome of the expired vaccine used and product packaging confusion 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 10 Oct 2023: The nurse reported that they were administering influenza vaccines for the 2023-24 influenza season to their advanced home care staff. Earlier this month in October, 2023, a female staff member, age unknown, was accidentally administered last year's Fluarix influenza vaccine (Fluarix, 2022-23 season vaccine, expiration date earlier this year 2023, lot number unknown). There was some of the previous season's Fluarix still left in the refrigerator and it was mistakenly given to the patient, citing that the packaging looks very similar for last season's Fluarix versus this season's Fluarix., which led to expired vaccine used and product packaging confusion. They plan to administer this season's Fluarix to the patient in the next few days. The outcome of the maladministered Fluarix was unknown. The permission to follow up was not requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles on the upper part of face; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: shingles on the upper part of face).  The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt date: 13-OCT-2023 A physician reported that in the past few weeks she had a case of shingles on the upper part of her face.  This patient are over 65 years old, according to the doctor, this occurred about one or two weeks after this patient are administered, according to the doctor, the first dose of shingrix.  For this reason and had knowledge of this claim by the doctor, he/she proceed to report it. The reporter agrees to follow up from GSK. This case was linked with case US2023AMR143598 with same reporter.; Sender's Comments:  US-GSK-US2023AMR143598:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles on the upper part of face; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, between 1 and 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: shingles on the upper part of face).  The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt date: 13-OCT-2023 A physician reported that in the past few weeks she had a case of shingles on the upper part of her face.  This patient are over 65 years old, according to the doctor, this occurred about one or two weeks after this patient are administered, according to the physician, the first dose of shingrix.  For this reason and had knowledge of this claim by the physician, he/she proceed to report it. The reporter agreed to follow up from GlaxoSmithKline. This case was linked with case US2023AMR14359, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR143597:Same reporter.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Inappropriate age at vaccine administration; Pregnant women was accidently administered Arexvy; This non-serious prospective pregnancy case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration) and vaccine exposure during pregnancy (Verbatim: Pregnant women was accidently administered Arexvy).  The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 32 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 12-OCT-2023 It was reported that a pregnant woman at 32 weeks gestation was accidentally administered one dose of Arexvy. The patient had not reported any adverse events to date. The patient who was pregnant was prescribed and received Arexvy vaccine, which led to vaccine exposure during pregnancy and inappropriate age at vaccination administration.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: redness  of left upper arm
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient pulled away and didnt receive full dose
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Headache, Hyperhidrosis, Mobility decreased, Paralysis
Clinical narrative: MONDAY AT 1AM, PT WAS PARALYZED AND COULDN'T MOVE, SOME JOINT PAIN, HEADACHE, FEVER, SWEATING AND SHAKING. PT TOOK MOTRIN AND DRANK LOTSO FLUIDS. SYMPTOMS CONTINUED UNTIL THURSDAY 10/19
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia, Tremor
Clinical narrative: MONDAY AT 1AM, PT WAS PARALYZED AND COULDN'T MOVE, SOME JOINT PAIN, HEADACHE, FEVER, SWEATING AND SHAKING. PT TOOK MOTRIN AND DRANK LOTSO FLUIDS. SYMPTOMS CONTINUED UNTIL THURSDAY 10/19
Age: 82.0
Sex: M
Vaccine: FLUA4, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a 3rd dose of Shingrix.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling noted to L arm, tender area in L arm above L elbow on anterior aspect. Area not adjacent to where she had flu shot. Slightly uncomfortable. No fever or chills. Diagnosed with cellulitis. Prescribed Doxycycline.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.5ml dose instead of the 0.25ml dose of the 6 moths through 11 years moderna covid vaccine
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Illness, Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT EXPEREINCED SWOLLEN, RED, HOT, AND IRRITATED AREA ON LEFT DELTOID 1 DAY POST INJECTION.  CLAIMS SHE ALSO EXPEREINCED HIGH FEVER AND HAS BEEN SICK FOR APPROX. 5 WEEKS WITHOUT RESOLUTION.  CAME TO PHARAMCY AND I DIRECTED HER TO GO TO MD AND BE ASSESSED.  SHE RETURNED TO THE PHARMACY WITH AN RX FOR CEFDINIR FOR POSSIBLE CELLULITIS  AND COLD LIKE SXS.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: PATIENT EXPEREINCED SWOLLEN, RED, HOT, AND IRRITATED AREA ON LEFT DELTOID 1 DAY POST INJECTION.  CLAIMS SHE ALSO EXPEREINCED HIGH FEVER AND HAS BEEN SICK FOR APPROX. 5 WEEKS WITHOUT RESOLUTION.  CAME TO PHARAMCY AND I DIRECTED HER TO GO TO MD AND BE ASSESSED.  SHE RETURNED TO THE PHARMACY WITH AN RX FOR CEFDINIR FOR POSSIBLE CELLULITIS  AND COLD LIKE SXS.
Age: 53.0
Sex: M
Vaccine: VARCEL
Symptoms: Product administration error
Clinical narrative: Client given varicella vaccine in error
Age: 79.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: Around 2:00pm day of vaccinations, I started to experience chills, fatigue, and body aches. I took Tylenol before retiring for the night around 10:00pm.  By 3:00am, the RSV site of injection was sore enough to awaken me when I rolled over on it, and I was experiencing an unusual headache ( I rarely get headaches), as well joint and body aches.  Once again I took Tylenol.  This morning (20th of October) I had mild symptoms, but by 2;00pm, I was very achey and cold so took a nap with blankets on me (the house temp was 71 degrees).  I awakened at 3:45pm still having the body aches and chills and am takin Tylenol again. I am trying to drink lots of liquids and forcing myself to eat healthy foods.  Hope this dissipates today .
Age: 79.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Around 2:00pm day of vaccinations, I started to experience chills, fatigue, and body aches. I took Tylenol before retiring for the night around 10:00pm.  By 3:00am, the RSV site of injection was sore enough to awaken me when I rolled over on it, and I was experiencing an unusual headache ( I rarely get headaches), as well joint and body aches.  Once again I took Tylenol.  This morning (20th of October) I had mild symptoms, but by 2;00pm, I was very achey and cold so took a nap with blankets on me (the house temp was 71 degrees).  I awakened at 3:45pm still having the body aches and chills and am takin Tylenol again. I am trying to drink lots of liquids and forcing myself to eat healthy foods.  Hope this dissipates today .
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the 6 months through 11 years moderna covid vaccine
Age: 65.0
Sex: M
Vaccine: COVID19, FLU4, RSV
Symptoms: Gait disturbance, Muscle spasms, Pain
Clinical narrative: Patient received the three vaccines and within 5 minutes developed fairly severe cramping in lower extremities only while shopping in the store for the monitoring period.  Specifically in the glutes to the point where it was painful to walk and cramping continued after sitting.  Had patient drink an electrolyte drink and sit in our waiting area.  After about 8 to 16 ounces of Gatorade and some rest, around 5 minutes, cramping subsided significantly and he was able to walk normally.  Continued to monitor for another 20 minutes and cramps did not return and no other symptoms developed.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: One dose of Novavax was drawn from a vial that was punctured after 12 hours.  Dose was expired around 9 hours. Patient was informed immediately after discovery and advised to come to pharmacy for another dose according to CDC recommendation. Patient understood and will come in for another dose. No harm was done in this incident.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: I noticed it when I was getting dressed around 10am.  Where I had the shot looks like a big bug bite.  About 3? in diameter, a red welt.  It itches and is sore.   I took Tylenol, wiped it with alcohol, and put some ice on it.     It?s still red and welted right now.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: vaccine was not diluted properly therefore pt got hight dose than recommended. no adverse advent reported
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of0.25ml of the 6 months through 11 year moderna covid vaccine
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Electrocardiogram, Gait disturbance, Neurological symptom, Tremor
Clinical narrative: Patient got her Spikevax vaccination on 10/17/2023 at our facility. I administered it to her in the right arm, and at the time and for 15 minutes later everything was fine. Her daughter was with her and took her home and all was fine. 12 hours later she felt as if she were having a stroke and could not see, was shaky, and couldn't walk. Her daughter called the paramedics and she was hospitalized. Her condition resolved and she was released from the hospital and steadily improved after that. She is fine now.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml instead of 0.25ml of the Moderna 6m-11yrs covid vaccine.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A dose was drawn from a vial that was punctured after 12 hours, which dose was expired around 9 hours. Patient was contacted immediately upon discovery and was advised to come to pharmacy for another dose according to CDC recommendations. No harm was done in this accident.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml instead of 0.25ml Moderna 6M - 11yrs covid vaccine.
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Age: 23.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Blood pressure decreased, Confusional state, Disorientation, Dizziness, Hyperhidrosis
Clinical narrative: At 0902 am, pt received Afluria in his left deltoid and typhoid in his right. Very shortly after that the patient c/o "not feeling well". Pt lost consciousness for no more than 30seconds and came back very confused and disoriented. At 0904, rapid response was called. Pt was placed in Trendelenburg position and was assessed to be very pale and diaphoretic. BP dropped to 78/88 HR 45. Around 0905, pt was more oriented but stated that he still felt very light headed. Patient had not eaten food prior to the event. He denies any sickness or any issues with vaccines prior to this event. Pt drank a Gatorade and ate a nutrigrain bar. Repeat vitals at 108/54. Continued to monitor pt as he became more engaged and aroused. He slowly adjusted to standing without feelings of syncope and was discharge by medical doctor on call in stable condition.
Age: 23.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Loss of consciousness, Malaise, Pallor
Clinical narrative: At 0902 am, pt received Afluria in his left deltoid and typhoid in his right. Very shortly after that the patient c/o "not feeling well". Pt lost consciousness for no more than 30seconds and came back very confused and disoriented. At 0904, rapid response was called. Pt was placed in Trendelenburg position and was assessed to be very pale and diaphoretic. BP dropped to 78/88 HR 45. Around 0905, pt was more oriented but stated that he still felt very light headed. Patient had not eaten food prior to the event. He denies any sickness or any issues with vaccines prior to this event. Pt drank a Gatorade and ate a nutrigrain bar. Repeat vitals at 108/54. Continued to monitor pt as he became more engaged and aroused. He slowly adjusted to standing without feelings of syncope and was discharge by medical doctor on call in stable condition.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml instead of 0.25ml of Moderna 6m - 11yrs covid vaccine
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Rash started at site of injection that evening. No other sx reported.
Age: 74.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Dysstasia, Gait disturbance
Clinical narrative: Patient received an RSV and COVID-vaccine last week Wednesday (10/11/23), and on Wednesday 2 days ago a flu vaccine (10/18/23).  Wife states that on Thursday he was having difficulty walking, and essentially unable to stand by himself, bring him to the ED
Age: 74.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Asthenia, Fall, Guillain-Barre syndrome, Intensive care, Loss of personal independence in daily activities
Clinical narrative: Patient received an RSV and COVID-vaccine last week Wednesday (10/11/23), and on Wednesday 2 days ago a flu vaccine (10/18/23).  Wife states that on Thursday he was having difficulty walking, and essentially unable to stand by himself, bring him to the ED
Age: 74.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Middle insomnia, Walking aid user, Wheelchair user
Clinical narrative: Patient received an RSV and COVID-vaccine last week Wednesday (10/11/23), and on Wednesday 2 days ago a flu vaccine (10/18/23).  Wife states that on Thursday he was having difficulty walking, and essentially unable to stand by himself, bring him to the ED
Age: 1.42
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml instead of 0.25ml Moderna 6m- 11yrs covid vaccine.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient's mother reported child got a big red rash on left arm after flu shot. No pain or itchiness.
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix administration of an expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 32-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30-SEP-2022) for prophylaxis.   On 09-OCT-2023, the patient received Havrix. On 09-OCT-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix administration of an expired dose).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter called to asked for information about the administration of an expired dose of Havrix to a patient, which led to expired vaccine used. The reporter asked for guidance on this situation. The reporter consented to follow up.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Nausea, Urticaria
Clinical narrative: Headache, nausea, chills/rigors, hives. Symptoms developed 11 hours after vaccine. Lasting today 10/20/2022 2 days later , continued headache.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Chest discomfort, Musculoskeletal stiffness
Clinical narrative: Patient called today 10/20/23 stating that last night when sleeping she experienced chest tightness and muscle stiffness. Called urgent care then pharmacy. No symptoms since last night.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Therapeutic product ineffective
Clinical narrative: Rash like appearance on torso-breasts areas and up to neckline, inside of both arms at elbows, insides of both leg thighs, and around knee areas. Continuing as of today. Patient took one  OTC benadryl on the evening of 10/19/2023, but negative results from that treatment.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Brain fog, Chest discomfort, Chest pain, Chills
Clinical narrative: Flushing, headache, nausea, diarrhea, muscle and joint pain, on/off chestpain/discomfort, discomfort/pain in lungs, sleep difficulty, chills/shivering, brain fog
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Flushing, Headache, Insomnia, Myalgia
Clinical narrative: Flushing, headache, nausea, diarrhea, muscle and joint pain, on/off chestpain/discomfort, discomfort/pain in lungs, sleep difficulty, chills/shivering, brain fog
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Pulmonary pain
Clinical narrative: Flushing, headache, nausea, diarrhea, muscle and joint pain, on/off chestpain/discomfort, discomfort/pain in lungs, sleep difficulty, chills/shivering, brain fog
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml instead of 0.25ml Moderna 6m-11yr covid vaccine.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: A dose was drawn from a vial that was punctured after 12 hours, which dose was expired around 9 hours. Patient was contacted immediately upon discovery and was advised to come to pharmacy for another dose according to CDC recommendations. No harm was done in this accident.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure decreased, Central venous catheterisation, Chills, Complication associated with device
Clinical narrative: Vaccinated 10-11-23 at 12:00 Noon, at 12:00 Midnight 10-12-23 experienced fever, chills, temp 100. Given Tylenol. 5:30 AM fever, chills, extreme stomach ache. 7:00 AM received 2 hours of dialysis BP dropped to 80/40, HR 110. 4:00 PM Disorientation, taken to Hospital with what appeared to be septic shock. Given broad spectrum antibiotics. 10-13-23 Infectious disease pulled central port, loss of hemodialysis site in the left arm. 10-14-23 temporary line for dialysis, central line and continued broad spectrum ABX. 10-16-23 Permanent central line placed. Unable to establish line for dialysis. 10-17-23 D/C from hospital.  Consult to Hospital for new dialysis site.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dialysis, Disorientation, Pyrexia, Septic shock
Clinical narrative: Vaccinated 10-11-23 at 12:00 Noon, at 12:00 Midnight 10-12-23 experienced fever, chills, temp 100. Given Tylenol. 5:30 AM fever, chills, extreme stomach ache. 7:00 AM received 2 hours of dialysis BP dropped to 80/40, HR 110. 4:00 PM Disorientation, taken to Hospital with what appeared to be septic shock. Given broad spectrum antibiotics. 10-13-23 Infectious disease pulled central port, loss of hemodialysis site in the left arm. 10-14-23 temporary line for dialysis, central line and continued broad spectrum ABX. 10-16-23 Permanent central line placed. Unable to establish line for dialysis. 10-17-23 D/C from hospital.  Consult to Hospital for new dialysis site.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml instead of 0.25ml Moderna 6m-11yr covid vaccine.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: arm pain
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: the vaccine was not diluted properly causing the patient to get a higher dose of vaccine than recommended. no adverse advents to patien
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza, Nasopharyngitis
Clinical narrative: Extreme cold/flu symptoms but also a blinding headache for approximately 10 hours despite taking 1300mg of Tylenol.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 10-20-2023 1200, Employee reported of having severe headaches and fatigue 2 days following Covid-19 Comirnaty (PFR) 2023-2024 vaccine.  Experienced also fever and chills.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: the administration of an expired Twinrix dose to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 96-year-old female patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 09-OCT-2023, the patient received Twinrix. On 09-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: the administration of an expired Twinrix dose to a patient).  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: 10-OCT-2023 The pharmacist called to ask for information regarding the administration of an expired Twinrix dose to a patient. The health care professional (HCP) asked for any expected adverse reaction and if the patient had to be re-vaccinated. The patient received vaccine on 10th October 2023 which was expired on 22nd September 2023, which led to expired vaccine use. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: There was a patient that received a 5th dose of Hiberix; inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 1-year-old female patient who received Hib (Hiberix) (batch number 242A7, expiry date 10-DEC-2023) for prophylaxis.   Co-suspect products included Hib (Hiberix) for prophylaxis.   On 22-AUG-2023, the patient received the 5th dose of Hiberix. On 07-AUG-2023, the patient received the 4th dose of Hiberix. On 07-AUG-2023, not applicable after receiving Hiberix and an unknown time after receiving Hiberix, the patient experienced inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration). On 22-AUG-2023, the patient experienced extra dose administered (Verbatim: There was a patient that received a 5th dose of Hiberix).  The outcome of the extra dose administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 The registered nurse reported via chat that patient received 5th dose of Hiberix which led to Extra dose administered. The patient received 4th dose on 07 August 2023 at inappropriate age which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.