chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging joint, Magnetic resonance imaging neck, Pain, Pain in extremity
Clinical narrative: I had zero reaction to the first two shots, also Pfizer.  From the moment I had the third shot, I immediately experienced pain down the entire left side of my body.  From behind my left ear all the way to my left foot.  My left pinky and ring finger also have numbness.  And on the same two toes. The pain is especially concentrated in my left shoulder and hip, but generally down the whole left side. I have seen a multitude of doctors, and have had no relief - over two years later. Doctors I have seen include: Dr. (Sports Medicine), (Pain Management), (PT), Dr. (Rheumatologist), Dr. (Neurologist), (Acupuncturist), Dr. (OMM/DO), (PT, Cellular Health Specialist), Dr. (Neurologist), Dr. (Pain Management). No matter what, nothing has worked, and overall my tests are all "normal".  I have tried many many things and spent thousands of dollars trying to find relief.  I know the pain started as soon as the third shot occurred. I am NOT an anti-vaxxer by any means! My life has changed drastically in the last two years as I physically cannot do the things that I used to be able to do - from working out to general lifting of basic objects. I have basically given up trying to fix it because I simply cannot afford to anymore - treatment at this point is generally out of pocket. I'm beyond frustrated. I'm basically told nothing is wrong with me, and I'm tired of it. It's been almost two and a half years and I still have extreme pain and nothing I've tried has given me relief. I have refused any further covid or even flu vaccines.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid factor negative
Clinical narrative: I had zero reaction to the first two shots, also Pfizer.  From the moment I had the third shot, I immediately experienced pain down the entire left side of my body.  From behind my left ear all the way to my left foot.  My left pinky and ring finger also have numbness.  And on the same two toes. The pain is especially concentrated in my left shoulder and hip, but generally down the whole left side. I have seen a multitude of doctors, and have had no relief - over two years later. Doctors I have seen include: Dr. (Sports Medicine), (Pain Management), (PT), Dr. (Rheumatologist), Dr. (Neurologist), (Acupuncturist), Dr. (OMM/DO), (PT, Cellular Health Specialist), Dr. (Neurologist), Dr. (Pain Management). No matter what, nothing has worked, and overall my tests are all "normal".  I have tried many many things and spent thousands of dollars trying to find relief.  I know the pain started as soon as the third shot occurred. I am NOT an anti-vaxxer by any means! My life has changed drastically in the last two years as I physically cannot do the things that I used to be able to do - from working out to general lifting of basic objects. I have basically given up trying to fix it because I simply cannot afford to anymore - treatment at this point is generally out of pocket. I'm beyond frustrated. I'm basically told nothing is wrong with me, and I'm tired of it. It's been almost two and a half years and I still have extreme pain and nothing I've tried has given me relief. I have refused any further covid or even flu vaccines.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Wrong patient received product
Clinical narrative: On 2.8.24, patient was given vaccines that were meant to be for her sister. The administering nurse did not take patients back and the two patients were in the same room. Nurse drew up vaccines for sister., went into the room, had Mom sign immunization sheet then proceeded to patient sitting on the table to give MenACWY, Tdap, HPV, and Flu. Upon leaving the room, the nurse said she will be back to give other her immunizations. Patient on table questioned this and it was found that patient was given her sister?s vaccines. No name or DOB was asked before giving vaccines. The nurse went in and explained the situation to Mom who was very understanding. Sister. was supposed to be getting HPV, Flu ad Covid vaccines, so she was given unnecessary MenACWY & Tdap. Correct vaccines were then drawn up for patient and given.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Per CDC guidelines, recommends revaccinating, no adverse events mentions.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain fog, COVID-19, Cardiac monitoring, Echocardiogram, Electrocardiogram
Clinical narrative: PFIZER #1 8/6/2021 PFIZER #2 9/6/2021 HAD ACUTE INJECTION SITE REACTIONS FEVER AND MALAISE FOR DAYS AFTER EACH INJECTION AND THEN DEVELOPED HEADACHES BRAIN FOG RECURRENT SINUS INFECTIONS POTS AND WITH VACCINE FAILURE SHE HAS HAD COVID-19 ILLNESS FOUR TIMES.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site reaction, Laboratory test, Malaise, Pericarditis
Clinical narrative: PFIZER #1 8/6/2021 PFIZER #2 9/6/2021 HAD ACUTE INJECTION SITE REACTIONS FEVER AND MALAISE FOR DAYS AFTER EACH INJECTION AND THEN DEVELOPED HEADACHES BRAIN FOG RECURRENT SINUS INFECTIONS POTS AND WITH VACCINE FAILURE SHE HAS HAD COVID-19 ILLNESS FOUR TIMES.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome, Pyrexia, Sinusitis, Vaccination failure
Clinical narrative: PFIZER #1 8/6/2021 PFIZER #2 9/6/2021 HAD ACUTE INJECTION SITE REACTIONS FEVER AND MALAISE FOR DAYS AFTER EACH INJECTION AND THEN DEVELOPED HEADACHES BRAIN FOG RECURRENT SINUS INFECTIONS POTS AND WITH VACCINE FAILURE SHE HAS HAD COVID-19 ILLNESS FOUR TIMES.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUA4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Kinrix and Proquad were administered in the left arm. Patient was brought in today 2/15/204 because of "reaction to vaccines." Left arm was significantly swollen, hard and hot to touch. A line was drawn on the child by parent previously and the redness did spread. Dr. evaluated and sent patient to the emergency room.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Persistent pain at injection site, left upper arm up to present.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy, Pain
Clinical narrative: Dull ache in Left arm extending from injection site, lethargy, body ache. All lasting at least 2 days. Treatment included taking Tylenol and resting. No other adverse effects.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site erythema, Injection site pruritus
Clinical narrative: Patient developed a rapid heartbeat about 8 to 10 hours after the vaccine and redness and itchiness below the site of injection
Age: 59.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received the vaccine at the age of 59, instead of the indicated age of 60 years or older. Patient denied any adverse events from the vaccine.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Guillian Barre Syndrome currently hospitalized for it .   Onset Jan 30, 2024, numbness in hands and feet
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chills, Emotional distress, Guillain-Barre syndrome, Headache
Clinical narrative: Guillian Barre Syndrome currently hospitalized for it .   Onset Jan 30, 2024, numbness in hands and feet
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypertension, Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy, Impaired work ability
Clinical narrative: Guillian Barre Syndrome currently hospitalized for it .   Onset Jan 30, 2024, numbness in hands and feet
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Intensive care, Neck pain, Pain
Clinical narrative: Guillian Barre Syndrome currently hospitalized for it .   Onset Jan 30, 2024, numbness in hands and feet
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Plasmapheresis
Clinical narrative: Guillian Barre Syndrome currently hospitalized for it .   Onset Jan 30, 2024, numbness in hands and feet
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received expired Pfizer Covid 5-11 years old on  2/6/24, mom states no adverse effects but asked to monitor. Per CDC guidelines recommended to revaccinate immediate but can do 8 weeks later for non moderate to severe immunosuppressed.  Per mom will bring in child in 8 weeks.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT HAS BEEN GIVEN 2 EXTRA SETS OF 6 MONTH VACCINES DUE TO PATIENT BEING LISTED IN THE REGISTRY UNDER 3 DIFFERENT NAMES. PATIENT HAS HAD A TOTAL OF 5 VACCINATION SETS INSTEAD OF THE ROUTINE 3 SETS BY THE AGE OF 6 MONTHS.  PATIENT WAS BROUGHT BACK IN TO DISCUSS THIS IN OFFICE AND A REQUEST TO MERGE THESE CHARTS IN SYSTEM WAS SUBMITTED. PATIENT NOT ILL OR DID NOT SHOW ANY SIGNS OF ADVERSE EFFECTS.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Haemoptysis, Productive cough
Clinical narrative: Patient reports SOB on Wednesday 2/14/24 and productive coughing with blood x2 on 2/15/24 in AM
Age: 1.17
Sex: M
Vaccine: HIBV, MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to receive MMR , VARICELLA , and HIB.   Patient was corectly given varicella and HIB vaccine. Patient incorrectly given Proquad. (MMR+Varicella).      Patient mother was contacted and made aware of events. Patient mother let me know patient is doing fine and to call our office if any questions arise.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Approximately 10 minutes after administering these vaccines the patient broke out in hives covering most of her left leg. Hep A and Varicella given in that leg. Right leg unaffected. After about 20-30 minutes the issue resolved on its own.
Age: 11.0
Sex: M
Vaccine: COVID19, HPV9, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: LPN,  ordered the 6mo COVID on an 11yr old but grabbed the 12yr COVID and gave it. It didn?t flag in the computer because the lot number was mismatched with the age information in lot manager. She noticed after and told me. The Immunization name was correct (12yr) but the Product type was a mismatch (6mo). I corrected the mismatch in the system. We discussed with Dr., she?s not concerned at all. The patient will be 12 in a few months and he?s 90lb. He received 4 vaccines that day.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Diarrhoea, Dysphonia, Injection site haemorrhage, Injection site swelling
Clinical narrative: It was a flu vaccine.  I?ve been having horseness, and stomach cramping and diarrhea also a lot of swelling and bleeding at injection site
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Chest pain, Erythema, Pain
Clinical narrative: red, painful, burning, chest pain.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient presented to clinic requesting vaccination. Patient denied receiving the vaccine at the time of filling out paperwork. This site is a high volume site and data entry is completed at the end of the clinic. When entering data for the clients vaccinated, it was identified that the patient had received his influenza vaccine at an earlier clinic with this being his 2nd dose of flu vaccine for the year.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: toes went numb
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Burning sensation, Erythema, Headache, Migraine, Pain
Clinical narrative: 1st shot was influenza. Within 10 minutes I started with  headache that went into a migraine. My arm was swollen 3 times it's size. Fire red and itchy. Itching turned to burning. I felt like I had a blistered sunburn on my arm. I also have throbbing in my arm. 2/13/24  I wake up with shooting pains in my arm. Like someone heated a knife stabbing and twisting it into my arm. That's when I went to the Dr.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: 1st shot was influenza. Within 10 minutes I started with  headache that went into a migraine. My arm was swollen 3 times it's size. Fire red and itchy. Itching turned to burning. I felt like I had a blistered sunburn on my arm. I also have throbbing in my arm. 2/13/24  I wake up with shooting pains in my arm. Like someone heated a knife stabbing and twisting it into my arm. That's when I went to the Dr.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oral discomfort, Oral disorder, Swollen tongue
Clinical narrative: mouth was burning, tongue swelling, dental issues
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Injection site coldness, Injection site erythema, Injection site induration
Clinical narrative: Approximately 24 hrs about injection I became very cold, increasing to having shivers. This lasted intensely for about 4 hours but lingered for about 12 hours off and on.  During the intense period I had a temperature up to 99.4 and my heart rate was 80-90 while resting, 100-105 slow walking.  The day after the injection I had upper body aches all day and was fatigued without doing any strenuous activity.  On 02/14/2024, 2 days after injection, my injection site and 3? surrounding area was warm, red, hard, swollen and itchy.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Approximately 24 hrs about injection I became very cold, increasing to having shivers. This lasted intensely for about 4 hours but lingered for about 12 hours off and on.  During the intense period I had a temperature up to 99.4 and my heart rate was 80-90 while resting, 100-105 slow walking.  The day after the injection I had upper body aches all day and was fatigued without doing any strenuous activity.  On 02/14/2024, 2 days after injection, my injection site and 3? surrounding area was warm, red, hard, swollen and itchy.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PPV, RV5
Symptoms: Body temperature increased, Crying, Injection site erythema
Clinical narrative: Parents were concerned because crying a lot and temperature this AM.. After Tylenol acting like himself.  Breast feeding well.  3 pm T max 100.7 Tylenol again.  Right thigh two pinpoint red spots where injection occurred.  No erythema or warmth.  Considered normal localized reaction.  VAERs filled out due to parental concern.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Pediarix inadvertently given as dose #4 for Dtap
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event. Administration error.   Patient received the adult Hep A vaccine instead of the pediatric dose.  Patient did not experience any adverse event
Age: 58.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received vaccine without being indicated for it. Patient experinced no side effects to receiving vaccine or had any complaints.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Found dead 2 days later at home, natural causes, likely an MI.
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Medication Error occurred when I administered dose without diluting the solution before administering .
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient (11 year old at the time of vaccine) and pharmacist gave Comirnaty 12+ for covid 19 on 12/23/2023
Age: 5.0
Sex: F
Vaccine: EBZR
Symptoms: Expired product administered
Clinical narrative: An expired vaccine was given. Expiration date 11/9/23
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient symptoms have been reported/No additional AE; Nurse called and reported VAQTA involved in a temperature excursion has been administered to a patient since the excursion; This spontaneous report has been received from a nurse and refers to a 2-year-old female patient. Her pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.  On 13-DEC-2023, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, as prophylaxis (route of administration and anatomical location of vaccination were not provided; lot number X010373 has been verified to be valid, expiration date 13-NOV-2024); which was involved in a temperature excursion of 59.45 Fahrenheit (F) for 18 hours and 30 minutes. Previous temperature excursions were also reported (53.29 F for 1 hour and 45 minutes; and 49.73 F for 1 hour) (product storage error). No symptoms have been reported.  This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-2401USA006342:MSD US-009507513-2401USA005789:MSD US-009507513-2401USA006339:MSD US-009507513-2401USA006039:MSD US-009507513-2401USA005828:MSD US-009507513-2401USA005851:MSD US-009507513-2401USA005923:MSD US-009507513-2401USA006004:MSD US-009507513-2401USA005823:MSD US-009507513-2401USA006082:MSD US-009507513-2401USA005734:MSD
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient symptoms have been reported/No additional AE; VAQTA involved in a temperature excursion was administered to a patient; This spontaneous report was received from a physician referred to a patient of unknown age and gender. The patient's medical history, historical conditions, concurrent conditions and concomitant therapies were not reported.  On an unknown date, hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #X021007, expiration date: 26-DEC-2024, strength was not reported) experienced temperature excursion at 61.2 degree Fahrenheit (F) for 7 hours 45 minutes 0 seconds. There was no previous temperature excursion. On 15-JAN-2024, the patient was vaccinated with 1 dose of improper stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #X021007, expiration date: 26-DEC-2024, strength, dose, anatomical site of administration and route of administration were not provided) administered for prophylaxis. No patient's symptoms had been reported, no additional adverse event (AE) (no AE).  This is one of 5 reports received from the same reporter. ; Sender's Comments:  US-009507513-2401USA008381: US-009507513-2401USA008919: US-009507513-2401USA008754: US-009507513-2401USA009432:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 26-year-old employee received a dose of PROQUAD; No additional AE reported; Nurse reported that a  26-year-old employee received a dose of PROQUAD instead of separate varicella and MMR vaccines as part of her immunization series. Nurse confirmed that employee has not reported any other AEs. VARIVAX and MMR II added as potent; This spontaneous report was received from a nurse and refers to a 26-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-FEB-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot #X023401, expiration date: 20-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided) instead of and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Wrong product administered and Product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: No additional AE reported; The patient received little to none of MMR II; the medication squirted all out; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's medical history was not reported. Concomitant therapies were not reported.  Office manager reported that on 05-FEB-2024, when the provider when to administer measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, lot #, expiry date, and route of administration were not provided), there was a needle defect (Needle issue) and the medication squirted all out. The patient received little to none of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (underdose).   Office manager explained that sterile diluent pre-filled syringe was used to reconstitute the vaccine and then a needle was attached. The needle was screwed on properly, but the medication still squirted out everywhere whenever the provider went to administer it. Office manager stated nothing was wrong with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) the vial or sterile diluent and she believed it is a needle issue. The needle is not manufactured by Merck, and office manager did not have any further information about needle.  No adverse event reported.   Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller reported AE on behalf of a patient who was inadvertently administered an expired dose of ROTATEQ on 2/6/2024 (w/ no TEs)-- SUPPORTED via post-expiry memo. No symptoms reported. Obtained consent to contact HCP. MIR Filed (Case #02551479). No ad; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-FEB-2024, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #W026137, expiration date: 05-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered).
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient has not experienced any adverse events / No additional AE reported; Nurse reported VARIVAX was administered after a temperature excursion to one patient on Feb 9, 2024; This spontaneous report has been received from a Registered Nurse, concerning a 13-month-old male patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 09-FEB-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, once (lot number X021283 was verified to be valid, expiration date reported and confirmed as 20-AUG-2025), administered as prophylaxis by a Health Professional (exact dose, route of administration, and anatomical location were not provided). The vaccine was administered after a temperature excursion of 6.8 degrees Celsius during a time frame of 10 Minutes, there were no previous temperature excursion (Product storage error).  The patient had not experienced any adverse events.   No additional adverse event (AE) nor further information was reported.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Received A Pediatric Dose of Engerix; Initial report received on 12-Dec-2023  An immunization program manager in the reported that patient (age, gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unknown date, the patient received a pediatric dose of ENGERIX by mistake.  The patient was called back to the office where the dose was given and was given a dose of HEPLISAV-B (lot number, expiration date, NDC number, route, and site not reported).  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Economic problem, Guillain-Barre syndrome, Impaired work ability
Clinical narrative: GBS; have not been able to work for 14 months; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: GBS) (serious criteria GSK medically significant) and inability to work (Verbatim: have not been able to work for 14 months). The outcome of the guillain barre syndrome was not reported and the outcome of the inability to work was resolved (duration 14 months).   The reporter considered the guillain barre syndrome and inability to work to be related to Shingles vaccine.     The company considered the guillain barre syndrome and inability to work to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:09-FEB-2024 This case was reported by a patient via (social media) interactive digital media. The patient got Guillain-Barre syndrome from the Shingles vaccine.  The patient had not been able to work for 14 months and had a lot of bills to pay.
Age: 63.0
Sex: F
Vaccine: RVX
Symptoms: Chills, Fatigue
Clinical narrative: Chills; still tired today; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 63-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 06-FEB-2024 22:00, the patient received RSV vaccine. On 07-FEB-2024, 1 days after receiving RSV vaccine, the patient experienced chills (Verbatim: Chills). In FEB-2024, the patient experienced tiredness (Verbatim: still tired today). The outcome of the tiredness was not resolved and the outcome of the chills was not reported.   It was unknown if the reporter considered the tiredness and chills to be related to RSV vaccine.     It was unknown if the company considered the tiredness and chills to be related to RSV vaccine.   Additional Information: GSK Receipt date: 08-FEB-2024 The patient was self-reported. She received vaccine at 10 pm Tuesday and she had chills all day Wednesday, skipped dinner for sleep and she still tired on reporting day. The reporter wanted to know was this a reaction to the shot and how long the tiredness occurs. This is 1 of 2 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR018465:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine was given 11 days to early (prior to 2m separation); This non-serious case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: vaccine was given 11 days to early (prior to 2m separation)). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 09-FEB-2024 According to reporter, the Shingrix vaccine was given 11 days to early (prior to 2-month separation).  She agreed to call into the service center line and discuss with Medical to receive guidance. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: a child administered expired vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a child patient who received Hib (Hiberix) (batch number 7FZ57, expiry date 30-DEC-2023) for prophylaxis.   On 06-FEB-2024, the patient received the 4th dose of Hiberix. On 06-FEB-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: a child administered expired vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2024 The nurse reported that a child was administered a dose of Hiberix vaccine, which had an expiration date of 30December 2023, which led to expired vaccine used. The patient has fourth dose of Hiberix. The reporter stated that the patient was a child, but she did not have the patient's age or date of birth, gender, or initials. The reporter consented to follow up.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Dtap (Infanrix) but Kinrix was administered instead; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old male patient who received DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   On 31-JAN-2024, the patient received Kinrix. On 31-JAN-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Dtap (Infanrix) but Kinrix was administered instead). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-FEB-2024 The Certified medical assistant stated that a patient was supposed to get Dtap (Infanrix) but Kinrix was administered instead which led to wrong vaccine administered. The reporter stated that the patient was supposed to get Kinrix next month but now it was a month early. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose Sept 2020 and second Feb 2022; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received first dose of Shingrix on September 2022).   In FEB-2022, the patient received the 2nd dose of Shingrix. In FEB-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose Sept 2020 and second Feb 2022). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2024 The Nurse reported that if someone is eligible for Shingrix if they have had the 2 doses but were 2 years apart. The reported stated that should they start the series over again. The reported that first dose received in September 2020 and second dose received February 2022, which led to which led to lengthening of vaccination schedule. The reporter consented to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received a third dose of Shingrix in error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a elderly male patient who received Herpes zoster (Shingrix) (batch number YA493, expiry date 13-APR-2026) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient received a third dose of Shingrix in error). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 08-FEB-2024 The patient received a third dose of Shingrix in error which led to extra dose administered. The vaccine administration facility was the same as primary reporter. The reporter granted the permission for consent to follow up.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired dose of Menveo administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA771A, expiry date 31-JAN-2024) for prophylaxis.   On 07-FEB-2024, the patient received Menveo. On 07-FEB-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired dose of Menveo administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-Feb-2024 The reporter was a office manager. The reporter reported that the patient received an expired dose of Menveo, which led to expired vaccine used. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Migraine
Clinical narrative: Migraine headaches; This non-serious case was reported by a consumer via call center representative and described the occurrence of migraine headache in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included heart attack and concussion (Severe Concussion). Previously administered products included Flu Vaccine and COVID Vaccines. Additional patient notes included patient received pneumonia vaccine.   On 12-JAN-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced migraine headache (Verbatim: Migraine headaches). The patient was treated with paracetamol (Tylenol) and meloxicam. The outcome of the migraine headache was not resolved.   It was unknown if the reporter considered the migraine headache to be related to Arexvy.     It was unknown if the company considered the migraine headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-Feb-2024 The patient was self-reported this case. The reporter reported that the patient received Arexvy vaccine and since then, she had been experiencing migraine headaches every day.   The patient goes to the bed with a migraine and wakes up with one.   The patient received extra strength Tylenol, Meloxicam, and Nurtec to alleviate the migraine.   The patient stated that when she received Nurtec, the headache was goes away for 4 hours then comes back.   The patient also had gone to physical therapy for treatment of the headaches. The patient reported that her physical therapist told her that they had seen several patients suffering with headaches after receiving the RSV vaccine but the manufacturer was not specified.  The patient had never experienced headaches like she had been experiencing since receiving Arexvy vaccine. This US2024017871 case has been linked to the case reported by the same reporter.; Sender's Comments:  US-GSK-US2024017871:2 of 2 report
Age: 4.0
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Incorrect dose administered
Clinical narrative: Kinrix and a Poleo vaccine administered on the same clinic day; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Co-suspect products included Polio vaccine inact (Ipv) for prophylaxis.   On 21-NOV-2023, the patient received Kinrix and Ipv. On 21-NOV-2023, an unknown time after receiving Kinrix, the patient experienced overdose (Verbatim: Kinrix and a Poleo vaccine administered on the same clinic day). The outcome of the overdose 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: 08-FEB-2024 Nurse practitioner reported that patient administered Kinrix vaccine with an IPV non-GSK vaccine on the same clinic day, which led to overdose. Patient had now 2 diphtheria, tetanus, and pertussis doses in total in total and 3 inactivated polio vaccine doses in total. On 21st November 2023, an unknown time after receiving IPV vaccine, the patient experienced overdose. The reporter consented to follow-up.
Sex: F
Vaccine: FLUX, RSV
Symptoms: Cough
Clinical narrative: Cough; This non-serious case was reported by a consumer via call center representative and described the occurrence of cough in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On 05-FEB-2024, the patient received the 1st dose of Arexvy (intramuscular, right deltoid). On 08-FEB-2024, the patient received Influenza vaccine. On 08-FEB-2024, 3 days after receiving Arexvy, the patient experienced cough (Verbatim: Cough). The outcome of the cough was not resolved.   It was unknown if the reporter considered the cough to be related to Arexvy.     It was unknown if the company considered the cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-Feb-2024 The reporter was the patient who received her Arexvy vaccine on Monday, on 5th February 2024.  The reporter stated that there was no sudden symptoms of adverse event, however on the 4th day after getting the vaccine, on 8th February 2024 the patient started having a slight cough.  The patient stated that she received her Flu vaccine the same day at her healthcare professional office.  The patient stated that she did not felt comfortable giving this agent anymore information. On 8th February 2024 less than a day after received Influenza vaccine patient experienced cough. It was unknown if the reporter considered the cough to be related to Influenza vaccine. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: inadvertently gave a patient a 2nd dose of Arexvy; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 06-FEB-2024, the patient received the 2nd dose of Arexvy (left arm). On 06-FEB-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: inadvertently gave a patient a 2nd dose of Arexvy). The outcome of the extra dose administered was unknown.  Additional Information: GSK Receipt Date: 09-FEB-2024 The RPH (registered pharmacist) called to report he inadvertently gave a patient a 2nd dose of Arexvy.  The reporter stated that the patient only wanted 1st dose of Shingrix. The patient received Arexvy and Shingrix on the same day. No additional information reported.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient who is late for her Shingrix second dose 2 to 6 months windows; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient who is late for her Shingrix second dose 2 to 6 months windows). The outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 09-FEB-2024 The pharmacist reported that there was a immunocompetent patient who was late for her Shingrix second dose 2 to 6 months windows, but they were less than a year apart from the first dose. The reporter did not consent to follow-up. The healthcare professional (HCP) was in a rush and no further information was provided.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 46-year-old female patient who received HAB (Twinrix) (batch number 797f9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose was administered on 22-Sep-2023).   On 09-FEB-2024, the patient received the 2nd dose of Twinrix. On 09-FEB-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long 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: 09-FEB-2024 The reporter was pharmacy technician. The reporter reported that patient received a late second dose of Twinrix at the time of reporting..  The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule The reporter consented to follow up.
Age: 0.33
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administration of Boostrix as the second dose of the DTaP series; administration of Boostrix as the second dose of the DTaP series; administration of Boostrix as the second dose of the DTaP series; This non-serious case was reported by a physician via call center representative and described the occurrence of underdose in a 4-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 25A2F, expiry date 02-SEP-2024) for prophylaxis.   On 09-FEB-2024, the patient received the 1st dose of Boostrix. On 09-FEB-2024, an unknown time after receiving Boostrix, the patient experienced underdose (Verbatim: administration of Boostrix as the second dose of the DTaP series), wrong vaccine administered (Verbatim: administration of Boostrix as the second dose of the DTaP series) and inappropriate age at vaccine administration (Verbatim: administration of Boostrix as the second dose of the DTaP series). The outcome of the underdose, wrong vaccine administered and inappropriate age at vaccine administration 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: 09-FEB-2024 A physician called in to request information about the administration of Boostrix as the second dose of the DTaP series, which led to underdose, wrong vaccine administered and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Needle issue, Underdose
Clinical narrative: Shingrix was administered to a patient and the needle leaked so an incomplete dose was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Shingrix was administered to a patient and the needle leaked so an incomplete dose was administered). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 09-FEB-2024 The pharmacist reported that a dose of Shingrix was administered to a patient and the needle leaked so an incomplete dose was administered. No exact vaccination date reported, only that it was a first dose during June 2023 and the patient received a complete second dose during October 2023. No lot number provided. The HCP (health care professional) unsure of the volume administered to the patient, skin contact not reported. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: has not received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2019 ).   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: has not received a second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-FEB-2024 The pharmacist reported that a patient received first dose of Shingrix and has not received a second dose yet. Healthcare professional had no information about the patient at time of chat. Till the time of reporting, the patient did not receive 2nd dose of Hepatitis A vaccine, which led to incomplete course of vaccination. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose given to pediatric patient; Adult dose given to pediatric patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 2-year-old female patient who received HAV (Havrix 1440 adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 01-FEB-2023, the patient received Havrix 1440 adult. On 01-FEB-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: Adult dose given to pediatric patient) and overdose (Verbatim: Adult dose given to pediatric patient). The outcome of the adult product administered to child and overdose 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: 12-FEB-2024 A Pharmacist contacted GlaxoSmithKline via phone inquiring about Havrix and what information was available about the administration of an adult dose to a 2 year old female which led to adult product administered to child and overdose. They provided data about the vaccine, patient, event. The reporter consented to receive follow up. The vaccine administration facility is the same as primary reporter. This case is linked with US2024018942, same reporter.; Sender's Comments:  US-GSK-US2024018942:same reporter