chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: 3/5/24 headache, ear pain bilateral- resulting in bilateral ear infections, bad swelling- generalized resulting in leg and foot swelling, head pressure causing eye discomfort.  Sore throat intermittently, low grade fevers daily.  Hidradenitis suppurativa has flared.  Severe fatigue. No treatment currently.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Injection site bruising, Injection site warmth, Mobility decreased
Clinical narrative: The day following the vaccine, in the evening - the injection site was hot, there was some bruising near the injection site.  Patient experiences pain in upper right chest about 5 inches below her shoulder.  Patient had difficulty raising her right arm.  Patient took APAP 500mg for pain and rubbed Bengay on aching muscles.  Pain and discomfort resolved in 48 hours from the vaccine event.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: The day following the vaccine, in the evening - the injection site was hot, there was some bruising near the injection site.  Patient experiences pain in upper right chest about 5 inches below her shoulder.  Patient had difficulty raising her right arm.  Patient took APAP 500mg for pain and rubbed Bengay on aching muscles.  Pain and discomfort resolved in 48 hours from the vaccine event.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Decreased appetite, Diarrhoea, Faeces discoloured, Irritability, Pyrexia
Clinical narrative: Received vaccines yesterday Through the night spiked a fever as high as 103.5 Last night very fussy and increased respirations This morning fever around 100 and respirations are normal Continues with fussiness today has a decreased appetite Is wetting diapers 1 episode of loose stool through the night decreased drinking last night still with wet diapers looser stool, dark green liquid "
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Respiratory rate increased
Clinical narrative: Received vaccines yesterday Through the night spiked a fever as high as 103.5 Last night very fussy and increased respirations This morning fever around 100 and respirations are normal Continues with fussiness today has a decreased appetite Is wetting diapers 1 episode of loose stool through the night decreased drinking last night still with wet diapers looser stool, dark green liquid "
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Bone pain, Cough, Headache, Influenza
Clinical narrative: In the area where the vaccine was given, it became red, swollen, hot, painful all over the arm. Symptoms: headache, fever, vomiting, bone pain, nausea, flu, cough, weakness.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain in extremity, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: In the area where the vaccine was given, it became red, swollen, hot, painful all over the arm. Symptoms: headache, fever, vomiting, bone pain, nausea, flu, cough, weakness.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site warmth, Vomiting
Clinical narrative: In the area where the vaccine was given, it became red, swollen, hot, painful all over the arm. Symptoms: headache, fever, vomiting, bone pain, nausea, flu, cough, weakness.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Left arm pain
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: patient reported swollen, itchy eyes L > R itching under orbits of eyes/eyelids
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: C-reactive protein increased, Chest pain, Electrocardiogram ST segment elevation, Full blood count, Metabolic function test
Clinical narrative: Chest pain, pericarditis, diffuse ST elevation on EKG, Elevated Trop 10.7  CRP 33.15.  US echo pending at time of this report
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Pericarditis, Troponin increased
Clinical narrative: Chest pain, pericarditis, diffuse ST elevation on EKG, Elevated Trop 10.7  CRP 33.15.  US echo pending at time of this report
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Shortly after Gardasil was injected, patient reported soreness and noticed some tingling down the arm. It began to subside during appointment and called pt back an hour and a half later. Pt reports soreness is gone and tingling is mostly gone with some residual on the finger tip. I believe I correctly located and injected the appropriate target area of the left deltoid, however, the most likely explanation is that the needle hit a nerve. Counseled patient to keep moving and let me know if it does not subside or worsens.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Patient called back clinic stating felt warm and has rash on chest that occur one hour after receiving vaccine.  MD consult made via telephone call, Per MD advise patient to take Tylenol and Benadryl and to monitor rash. Per MD if symptoms worsen to seek medical attention. Patient verbalized understanding.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Inflammation, Injection site bruising, Pain in extremity
Clinical narrative: WHOLE-BODY INFLAMMATION (ONE DAY POST); EXTREME LEFT THIGH PAIN (2 DAYS POST SHOT); EXTREME PAIN IN LEFT ARMPIT (ONGOING); BRUISING ON LEFT DELTOID (ONGOING)
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Fatigue, Haematochezia
Clinical narrative: per mom pt had to be hospitalized, fatigue, blood in stool
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Pain in extremity
Clinical narrative: No adverse events. Just common reaction to vaccines. Pt had leg pain at the site of injection. Advised mom to give Tylenol or Motrin for pain and to try a warm moist compress.
Age: 70.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Blood test, Chest X-ray, Cough, Dyspnoea, Immunisation reaction
Clinical narrative: She got her vaccines, she started having breathign complications, could not breath at all and called the ambulance, they took her to Hospital.  She had had them that she had a reaction to both of her shots, but did not know which one.  She has gone to the ER 4 times, every month and they give her Prednisone, breathing treatments and oxygen while she is there.  She does have a nebulizer at home now.  They told her that they know it was from the vaccine.   She is also to take Robitussin to help with the cough.   She was hospitalized on Friday was hospital, and was discharged from there on Monday.  She saw her PCP on Tuesday and he said that he did not know what happened that ever since she had the vaccine she has been sick.  He is going to try to get her situation resolved.  She has not picked them up and changing all her medicines up.  She atenolol, thalidon, as well as another BP medicine. He wants to get her off of Prednisone.   She did not have any breathing problems or any lung issues prior to getting the vaccines.   She had 3 COVID vaccines and has not had any reactions to those.
Age: 70.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Malaise
Clinical narrative: She got her vaccines, she started having breathign complications, could not breath at all and called the ambulance, they took her to Hospital.  She had had them that she had a reaction to both of her shots, but did not know which one.  She has gone to the ER 4 times, every month and they give her Prednisone, breathing treatments and oxygen while she is there.  She does have a nebulizer at home now.  They told her that they know it was from the vaccine.   She is also to take Robitussin to help with the cough.   She was hospitalized on Friday was hospital, and was discharged from there on Monday.  She saw her PCP on Tuesday and he said that he did not know what happened that ever since she had the vaccine she has been sick.  He is going to try to get her situation resolved.  She has not picked them up and changing all her medicines up.  She atenolol, thalidon, as well as another BP medicine. He wants to get her off of Prednisone.   She did not have any breathing problems or any lung issues prior to getting the vaccines.   She had 3 COVID vaccines and has not had any reactions to those.
Age: 4.0
Sex: M
Vaccine: MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: Give MMR and Proquad both. No signs or symptoms.
Age: 61.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Condition aggravated, Headache, Impaired work ability, Migraine, Respiratory tract congestion
Clinical narrative: I received the Pfizer covid Vaccine Lot#HG4628 on 9/21/2024 at pharmacy. About a week later and for three continuous months afterward, I had major headaches, migraines, head congestion, severe sinus pain and was hard to work. First, I went to Urgent care on two separate times in two weeks and was prescribed antibiotics, treated as a sinus infection. These did not work. Afterward, I was prescribed prednisone which helped a little for a bit, but symptoms returned. Next, I received methylpredisone which helped.   I saw an ENT, had a nasal endoscopy which ruled out any sinus issues. I also had a facial CT Scan with them to which was normal. After three months I returned to normal. I saw the Neurologist March 21 2024 who said I had a response to the Pfizer Covid 19 Vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Sinus pain
Clinical narrative: I received the Pfizer covid Vaccine Lot#HG4628 on 9/21/2024 at pharmacy. About a week later and for three continuous months afterward, I had major headaches, migraines, head congestion, severe sinus pain and was hard to work. First, I went to Urgent care on two separate times in two weeks and was prescribed antibiotics, treated as a sinus infection. These did not work. Afterward, I was prescribed prednisone which helped a little for a bit, but symptoms returned. Next, I received methylpredisone which helped.   I saw an ENT, had a nasal endoscopy which ruled out any sinus issues. I also had a facial CT Scan with them to which was normal. After three months I returned to normal. I saw the Neurologist March 21 2024 who said I had a response to the Pfizer Covid 19 Vaccine.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Malaise
Clinical narrative: Headache starting in evening of shot, through the night into the next day until about 6pm. Mild malaise on the 2nd day after shot and very brief episode of light-headedness for about 5-10 seconds at 4pm while riding stationary bike, which had never occurred before.  Abnormal fatigue on the 18th.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Eye irritation, Fatigue, Feeling hot
Clinical narrative: Migraines, swollen arm, throbbing heat, injection site skin harden like a rock, burning, itching, fatigued, eyes burned, sore muscles and joints. Redness and tenderness lasted for  more than 9 days
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Migraine, Myalgia
Clinical narrative: Migraines, swollen arm, throbbing heat, injection site skin harden like a rock, burning, itching, fatigued, eyes burned, sore muscles and joints. Redness and tenderness lasted for  more than 9 days
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Tenderness
Clinical narrative: Migraines, swollen arm, throbbing heat, injection site skin harden like a rock, burning, itching, fatigued, eyes burned, sore muscles and joints. Redness and tenderness lasted for  more than 9 days
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy liver, Computerised tomogram, Detoxification, Electrocardiogram, Imaging procedure
Clinical narrative: PATIENT DEVELOPED CHOLESTASIS, WEIGHT LOSS, HAD MUTIPLE LAB AND IMAGING STUDIES WITH LIVER BIOPSY AND HAS A WORKING DIAGNOSIS OF Primary biliary cholangitis (PBC)
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulins abnormal, Laboratory test, Liver function test abnormal, Primary biliary cholangitis, Ultrasound scan
Clinical narrative: PATIENT DEVELOPED CHOLESTASIS, WEIGHT LOSS, HAD MUTIPLE LAB AND IMAGING STUDIES WITH LIVER BIOPSY AND HAS A WORKING DIAGNOSIS OF Primary biliary cholangitis (PBC)
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: PATIENT DEVELOPED CHOLESTASIS, WEIGHT LOSS, HAD MUTIPLE LAB AND IMAGING STUDIES WITH LIVER BIOPSY AND HAS A WORKING DIAGNOSIS OF Primary biliary cholangitis (PBC)
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient inadvertently was administered a Moderna COVID 6 m-11 y/o vaccine that was past beyond use date (BUD). The BUD was 4/6/2024 and the administration date was 4/16/2024. However, the manufacturer expiration date was 5/30/2024. There have been no identified reactions or adverse events, however, this reporter was encouraged to complete a VAERS report for documentation.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: the patient came in and said after imz she started to get rash on face and under the neck and itching on forehead and scalp
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: The vaccine administered expired on 4/6/2024 but was given on 4/9/2024. No adverse reaction.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Cancer screening, Computerised tomogram neck, Encephalitis, Facial paralysis
Clinical narrative: Immediately after vaccine fatigue, drowsiness and sleepiness. Slept  for 2 1/2 days.  Subsequent flare up of intermittent swelling of ankles, hands, feet , face.  More on right side.  Recurrent  generalized large muscle weakness, memory problems.   FOurs later presented with facial nerve palsy and encephalitis.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Immediate post-injection reaction, Joint swelling, Laboratory test
Clinical narrative: Immediately after vaccine fatigue, drowsiness and sleepiness. Slept  for 2 1/2 days.  Subsequent flare up of intermittent swelling of ankles, hands, feet , face.  More on right side.  Recurrent  generalized large muscle weakness, memory problems.   FOurs later presented with facial nerve palsy and encephalitis.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging head, Memory impairment, Muscular weakness, Peripheral swelling
Clinical narrative: Immediately after vaccine fatigue, drowsiness and sleepiness. Slept  for 2 1/2 days.  Subsequent flare up of intermittent swelling of ankles, hands, feet , face.  More on right side.  Recurrent  generalized large muscle weakness, memory problems.   FOurs later presented with facial nerve palsy and encephalitis.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Swelling face
Clinical narrative: Immediately after vaccine fatigue, drowsiness and sleepiness. Slept  for 2 1/2 days.  Subsequent flare up of intermittent swelling of ankles, hands, feet , face.  More on right side.  Recurrent  generalized large muscle weakness, memory problems.   FOurs later presented with facial nerve palsy and encephalitis.
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: itching, pain, warmth and a lump at injection site; itching, pain, warmth and a lump at injection site; itching, pain, warmth and a lump at injection site; itching, pain, warmth and a lump at injection site; This spontaneous report was received from a female patient of unknown age referring to herself. The patient's medical history, concurrent conditions and concomitant therapies were unknown.  On 11-MAR-2024, the patient started therapy with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly (IM) for prophylaxis (strength, lot #, and expiry date were unknown).  On 18-MAR-2024 (reported as 1 week out), the patient experienced itching, pain, warmth and a lump at injection site (vaccination site pruritus, vaccination site pain, vaccination site warmth, vaccination site mass). The patient was instructed to try ibuprofen and benadryl and to check back if symptoms do not resolve. At the time of reporting, the patient was recovering from the events of vaccination site pruritus, vaccination site pain, vaccination site warmth, vaccination site mass. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable.   The causal relationship between all events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   Lot # is being requested and will be submitted if received.
Age: 1.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Contraindication to vaccination
Clinical narrative: manufacturer recommends to avoid the use of live vaccines during treatment with dupixent, unknown if any adverse event; This spontaneous report was received from physician and refers to a 14-month-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-FEB-2024, the patient was vaccinated with 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). The patients mother that after speaking with dermatologist and pediatrician patient received vaccines, manufacturer recommends to avoid the use of live vaccines during tratment with dupixent (Contraindicated product administered).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reporting temperature excursion. Dose administered to patient was considered "not supported" after temperature excursion evaluation.; This spontaneous report has been received from an office manager, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 17-MAY-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliters Routine childhood immunization (lot number: W018824, which was determined to be valid, with an expiration date on: 14-JUN-2024) (strength, scheme, route and anatomical location of administration were not reported).  The administered dose underwent a temperature excursion of -10 degrees Celsius (C) up to 8 C (-6 C) for 336 hours. No previous temperature excursion was reported.   Dose administered to patient was considered "not supported" after temperature excursion evaluation.  No additional adverse event was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Dose administered to patient was considered as "not supported" after temperature excursion evaluation/ Time frame: -10°C up to 8°C (-6 C) for > 999 hours; Dose administered to patient was considered as "not supported" after temperature excursion evaluation/ Time frame: -10°C up to 8°C (-6 C) for > 999 hours; This spontaneous report was received from a office manager regarding a unspecified age and gender patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.  On 12-DEC-2023 and 16-JAN-2024, the patient was vaccinated with improper storage doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliter, lot #W018824, expiration date: 14-JUN-2024 who had been verified to be a valid number; same lot number reported for both vaccines, administered for prophylaxis (strength, and route of administration were not provided). Vaccines were considered as "not supported" after temperature excursion which were reported with a time frame of -10°C up to 8°C (-6 C) for > 999 hours (product storage error). There was no information about previous temperature excursion.   No additional adverse event.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Syringe issue
Clinical narrative: No additional AE; syringe broke completely off after administration of the vaccine.; BROKEN SYRINGE TIP IN LUER LOCK AREA; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical conditions, concurrent conditions and concomitant therapies were not reported.  On 12-APR-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection 0.5 ml, 1 dose, lot #X021478, expiration date: 18-MAY-2026, administered for prophylaxis (strength, and route of administration were not provided). There was no difficulty while attaching the syringe needle to the syringe and no issue occurred during the syringe needle being attached to the syringe tip. The syringe tip cap attached properly prior to use.Syringe tray intact and undamaged on receipt. Cellophane covering the syringe tray intact and completely sealed. The syringe carton was not damaged prior to use.  After the needle was pulled out of the patient, syringe tip broke immediately in luer lock area, the entire syringe hub broke off along with the luer lock and luer lock area completely separated from syringe (syringe issue, poor quality device used). No one was injured as a result of the breakage. No additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; Caller reported AE on behalf of a patient who was inadvertently administered an expired dose of MMR-II on 4/11/2024--SUPPORTED via post-expiry memo.; This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-APR-2024, the patient was inadvertently vaccinated with an expired dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) injection, 0.5 milliliter, lot #W023071, expiration date: 05-APR-2024, administered for prophylaxis (dose number, route of administration and anatomical location were not provided) (expired product administered). It was supported via post-expiry memo. No symptoms were reported. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Both vaccines were administered to an 8 day old infant today; This spontaneous report was received from an other, health business partner (HBP), and refers to a 8-days-old patient of unknown gender. The patient's medical history,concurrent conditions, concomitant therapies, drug reactions and allergies  were not reported.  On 15-APR-2024 (reported as today), the patient was vaccinated with the first dose of a rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral liquid, orally (strength, exact dose,  lot #, and expiry date were not provided) for prophylaxis (product administered to patient of inappropriate age); and  with the first dose of a diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection (reported as VAXELIS) (strength, exact dose, lot #, expiry date, route of administration, anatomical site of vaccination, ad indication were not provided). No additional adverse event (AE) was reported (no adverse event).
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP called to report a patient who missed doses of GARDASIL 9. Patient received their first dose of GARDASIL 9 at the age of 17 years old in the year of 2014, and never received any subsequent doses. Confirmed patient received GARDASIL 9, not GARDASI; No additional AE; This spontaneous report was received from an other (medical student) and refers to a patient of an unknown age and gender, approximately 27 years old at the time of reporting.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2014 (at the age of 17 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (exact dose, lot #, expiry date, anatomical location, and route of administration were not provided).   The patient missed doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as he/she never received any subsequent doses (inappropriate schedule of product administration). It was confirmed, that the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), not quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). No additional adverse event (AE) was reported (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: RSV
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pneumonia (Verbatim: Pneumonia) (serious criteria GSK medically significant). The outcome of the pneumonia was not reported.   It was unknown if the reporter considered the pneumonia to be related to Arexvy.     It was unknown if the company considered the pneumonia to be related to Arexvy.   Additional Information: GSK Receipt date: 09-APR-2024 This case was reported by consumer via (Open field AE monitoring) interactive digital media. A reporter reported that the patient was first diagnosed with pneumonia. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever; Arm still sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: Fever ) and pain in arm (Verbatim: Arm still sore). The outcome of the fever was not reported and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the fever and pain in arm to be related to Arexvy.     It was unknown if the company considered the fever and pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-APR-2024 This case was reported via (Open field AE monitoring) interactive digital media. The patient experienced fever maximum of 101.8 degree F and his/her arm was still sore. The reporter asked, what needs to be done for pain in arm.
Sex: U
Vaccine: RSV
Symptoms: Malaise
Clinical narrative: sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was resolved (duration 3 days).   It was unknown if the reporter considered the sickness to be related to Arexvy.     It was unknown if the company considered the sickness to be related to Arexvy.   Additional Information: GSK receipt date: 08-APR-2024 The case was received from the patient via interactive digital media. The reporter was the patient he/she reported that he/she was sick for the 3 days following his/her vaccination, but that was his/her biggest complaint. However, he/she frustration grew when he/she received insurance statement. Follow-up would not possible as no contact details were available
Sex: M
Vaccine: RSV
Symptoms: Chills, Hyperhidrosis, Middle insomnia, Myalgia
Clinical narrative: chills; sweats; severe muscle pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced chills (Verbatim: chills), sweating (Verbatim: sweats) and muscle pain (Verbatim: severe muscle pain). The outcome of the chills, sweating and muscle pain were not reported.   It was unknown if the reporter considered the chills, sweating and muscle pain to be related to Arexvy.     It was unknown if the company considered the chills, sweating and muscle pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-APR-2024 This case was received by the wife of the patient via (Open field AE monitoring) interactive digital media. The reporter's husband (patient) had the RSV (Arexvy) vaccine yesterday (day before reporting), and woke in the middle of the night with chills and sweats and severe muscle pain.
Sex: F
Vaccine: RSV
Symptoms: Chills, Local reaction, Myalgia, Skin warm
Clinical narrative: muscle aches; chills; warm to the touch; Local reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced muscle pain (Verbatim: muscle aches), chills (Verbatim: chills), skin warm (Verbatim: warm to the touch) and local reaction (Verbatim: Local reaction). The outcome of the muscle pain, chills, skin warm and local reaction were not reported.   It was unknown if the reporter considered the muscle pain, chills, skin warm and local reaction to be related to Arexvy.     It was unknown if the company considered the muscle pain, chills, skin warm and local reaction to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-APR-2024 This case was reported via (Open field AE monitoring) interactive digital media. The patient was reporter's mother. The patient was very ill with muscle aches, chills, local reaction and warm to the touch.
Sex: U
Vaccine: RSV
Symptoms: Feeling abnormal
Clinical narrative: Just felt off; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced feeling abnormal (Verbatim: Just felt off). The outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the feeling abnormal to be related to Arexvy.     It was unknown if the company considered the feeling abnormal to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-APR-2024 This case was reported via (Open field AE monitoring) interactive digital media. The patient just felt off.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Pain, Pyrexia, Swelling
Clinical narrative: fever; Fatigue; pain; swelling; headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: fever), fatigue (Verbatim: Fatigue), pain (Verbatim: pain), swelling (Verbatim: swelling) and headache (Verbatim: headache). The outcome of the fever, fatigue, pain, swelling and headache were not reported.   It was unknown if the reporter considered the fever, fatigue, pain, swelling and headache to be related to Arexvy.     It was unknown if the company considered the fever, fatigue, pain, swelling and headache to be related to Arexvy.   Additional Information: GSK Receipt date: 08-APR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had fever, fatigue, pain, swelling and headache badly.
Sex: U
Vaccine: RSV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: my arm is in a lot of pain swollen; my arm is in a lot of pain swollen; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: my arm is in a lot of pain swollen) and swelling arm (Verbatim: my arm is in a lot of pain swollen). The outcome of the pain in arm and swelling arm were not reported.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Arexvy.     It was unknown if the company considered the pain in arm and swelling arm to be related to Arexvy.   Additional Information: GSK Receipt date: 08-APR-2024 This case was reported by patient via (Open field AE monitoring) interactive digital media. The patient reported that his/her arm was in a lot of pain swollen (illegible) was that (illegible).
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: Tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included covid-19 (mild disease 2 times). Previously administered products included COVID-19 vaccine with an associated reaction of no adverse event (did well with Covid vaccine 4 times). Concurrent medical conditions included eye disorder. Concomitant products included azathioprine.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced tiredness (Verbatim: Tired). The outcome of the tiredness was not reported.   It was unknown if the reporter considered the tiredness to be related to Arexvy.     It was unknown if the company considered the tiredness to be related to Arexvy.   Additional Information: GSK Receipt date: 08-APR-2024 This case was reported by patient via interactive digital media. A reporter reported that he/she just took the vaccine yesterday (unspecified date) afternoon, so far, he/she feel a (illegible) tired.  This was a good response because he/she on azathioprine for Sarcoid eye disease in remission and it could reduce his/her immune response some.
Sex: U
Vaccine: RSV
Symptoms: Pain
Clinical narrative: kind of painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (intramuscular). On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain (Verbatim: kind of painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Arexvy.     It was unknown if the company considered the pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-APR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The reporter reported that good some people do not know how to do this, also this injection was kind of painful when administered but the reporter pushed the component into the muscle slowly, so it did not hurt as much he/she thought. This was the only way reporter had been able to get more of his or her patients to get vaccinated.
Sex: U
Vaccine: COVID19, FLUX, RSV
Symptoms: Feeling cold, Nausea, Pain in extremity, Tremor
Clinical narrative: sore arms; was so cold; Feeling a bit nauseous; I had the shakes; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis and COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received Arexvy, Influenza vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arms), tremor (Verbatim: I had the shakes), feeling cold (Verbatim: was so cold) and nausea (Verbatim: Feeling a bit nauseous). The patient was treated with paracetamol (Tylenol) and ibuprofen. The outcome of the pain in arm, feeling cold and nausea were not reported and the outcome of the tremor was resolved (duration 5 hrs).   It was unknown if the reporter considered the pain in arm, tremor, feeling cold and nausea to be related to Arexvy.     It was unknown if the company considered the pain in arm, tremor, feeling cold and nausea to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-APR-2024 The patient did get the RSV vaccine along with flu and Covid injections. The patient never had and problems with the flu or Covid vaccinations. But having the RSV vaccine the patient  have the sore arms but did ice them last night. The patient did not feel bad yesterday after receiving them, but patient had the shakes and was so cold. The patient did take some Tylenol with ibuprofen mixed. The shakes have gone away now 5 hrs later. The patient was feeling a bit nauseous also. It was unknown if the reporter considered the pain in arm, tremor, feeling cold and nausea to be related to Influenza vaccine and COVID-19 vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Stem cell transplant
Clinical narrative: had a stem cell transplant on March 17th 2023; first dose given Jan 7th 2020 and second dose given Oct 23rd 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of stem cell transplant in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 42K4F, expiry date 30-SEP-2022) and (batch number 3ON95, expiry date 06-DEC-2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th January 2020).   On 23-OCT-2020, the patient received the 2nd dose of Shingrix. On 23-OCT-2020, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose given Jan 7th 2020 and second dose given Oct 23rd 2020). On 17-MAR-2023, the patient experienced stem cell transplant (Verbatim: had a stem cell transplant on March 17th 2023). The outcome of the stem cell transplant was not reported and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the stem cell transplant to be related to Shingrix.     It was unknown if the company considered the stem cell transplant to be related to Shingrix.   Additional Information: GSK receipt date: 05-APR-2024 The reporter reported that a patient received two doses of Shingrix vaccine and then had a stem cell transplant, the reporter ask needs to restart the series again or just have a booster dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: inadvertently administered a Havrix pediatric dose to an adult patient; inadvertently administered a Havrix pediatric dose to an adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 58-year-old male patient who received HAV (Havrix 720) (batch number 2YX23, expiry date 10-FEB-2025) for prophylaxis.   On 05-APR-2024, the patient received Havrix 720. On 05-APR-2024, an unknown time after receiving Havrix 720, the patient experienced accidental underdose (Verbatim: inadvertently administered a Havrix pediatric dose to an adult patient) and adult use of a child product (Verbatim: inadvertently administered a Havrix pediatric dose to an adult patient). The outcome of the accidental underdose and adult use of a child product 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: 08-APR-2024 The registered pharmacist reported they inadvertently administered a Havrix pediatric dose to an adult patient, which led to accidental underdose and adult use of a child product. The reporter also mentioned they were trying to administer a Havrix dose but just grabbed the wrong vaccine.  The outbound called was placed to the reporter after to 2nd line, per consult with expert due to the reporter providing different details.  The call was placed for clarity on adverse event (AE) details on pediarix or Havrix dose. The reporter inquired how to proceed and do we give the patient an adult dose version or pediatric dose version. The reporter did not consent to follow-up.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: underdose/ only received 0.2 ml of Arexvy due to patient moved during the administration of the vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9RP9M, expiry date 04-OCT-2025) for prophylaxis.   On 04-APR-2024, the patient received Arexvy .2 ml. On 04-APR-2024, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: underdose/ only received 0.2 ml of Arexvy due to patient moved during the administration of the vaccine). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 08-APR-2024 and 10-APR-2024 The MA (medical assistant) requested the data on the underdosing of Arexvy during administration of vaccine.  The health care professional (HCP) stated that the patient only received 0.2 ml of Arexvy due to patient moved during the administration of the vaccine and 0.3 ml stayed in the syringe after administration, which led to an accidental underdose. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Got one Shingrix shot on April 9th 2018 and never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 09-APR-2018). Additional patient notes included patient was immunocompetent.   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: Got one Shingrix shot on April 9th 2018 and never got the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-APR-2024 The pharmacist had an immunocompetent patient who only got one Shingrix shot and never got the 2nd dose till the time of reporting, which led to an incomplete course of vaccination. The reporter consent to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: inadvertently gave a Havrix pediatric dose to an adult patient/ underdose; gave a Havrix pediatric dose to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult male patient who received HAV (Havrix 720) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   On 03-APR-2024, the patient received Havrix 720 .5 ml. On 03-APR-2024, an unknown time after receiving Havrix 720, the patient experienced accidental underdose (Verbatim: inadvertently gave a Havrix pediatric dose to an adult patient/ underdose) and adult use of a child product (Verbatim: gave a Havrix pediatric dose to an adult patient). The outcome of the accidental underdose and adult use of a child product 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: 08-APR-2024 The health care professional reported that they inadvertently gave a Havrix pediatric dose to an adult patient, which led to an accidental underdose and adult use of a child product. The clinic manger wanted to know what was the correct protocol to correct this. The reporter did not consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number 5M93R, expiry date 05-APR-2024) for prophylaxis.   On 08-APR-2024, the patient received the 1st dose of Engerix B. On 08-APR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired vaccine given). 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: 08-APR-2024 The nurse manager informed that he/she had a vaccine that was Engerix-B that was given to a child, however, the person who gave it realized that it expired on Friday, and it was given today (on the day of reporting), which led to expired vaccine used. The vaccine administration facility was the same as primary reporter.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: received a third dose of Rotarix by mistake; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number H29H4, expiry date 13-JAN-2025) for prophylaxis.   Previously administered products included Rotarix (Received 1st dose of Rotarix on 27th November 2023) and Rotarix (Received 2nd dose of Rotarix on 29th January 2024).   On 04-APR-2024, the patient received the 3rd dose of Rotarix lyophilized formulation. On 04-APR-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: received a third dose of Rotarix by mistake). 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: 09-APR-2024 and 10-APR-2024 The nurse reported that they accidentally administered third dose of Rotarix by mistake to the patient, which led to extra dose administered. The reporter did not know lot number or expiration date of the two prior doses. The reporter consented to follow up.