chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Neuralgia, Pain in extremity, Tremor
Clinical narrative: Immediate Pain upon injection, sore arm fro 48 hours, then nerve pain began, along with muscle weakness. Nerve pain down left arm into hand and fingers, sometimes feels very hot, fingers tremble. Muscle upon use is very sore and feels as if it will fail, visible shaking in arm upon exertion. extends into shoulder girdle and also up along left side of neck, ongoing has not abated since 10/19/2024. Arm aches all the time from shoulder/deltoid area. upper arm, bicep tricep -sore to touch.
Age: 16.0
Sex: F
Vaccine: COVID19, FLUN3
Symptoms: Device malfunction
Clinical narrative: Device malfunction- After I administered the dose in the left nare, I realized the stopper separating the doses was missing.  Therefore the entire dose went into the left nare.  None dripped out.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Severe headache, extreme fatigue, dizziness, weakness
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Severe headache, extreme fatigue, dizziness, weakness
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Hyperhidrosis, Impaired work ability
Clinical narrative: Severe redness, swelling and pain in (L) arm. Headache, body aches, fever, chills, sweats all of which began two days after vaccine. Lost two days of work due to symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Severe redness, swelling and pain in (L) arm. Headache, body aches, fever, chills, sweats all of which began two days after vaccine. Lost two days of work due to symptoms.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second dose of RSV. He informed us after receiving the vaccine he had gotten it last year. No side effects reported so far.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Vitreous floaters
Clinical narrative: Patient said that they experienced black floaters shortly after receiving the Moderna vaccine on Thursday, October 31st. On Sunday, November 3rd, patient temporary lost vision for a short amount of time.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives at the right forearm, dorsal and ventral that started 20+ minutes after vaccination that were observed not to spread further with 30 more minutes of monitoring.
Age: 59.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Unevaluable event
Clinical narrative: The adverse event was prior to the vaccine but after I developed COVID in May 2024.  Eyes got clean bill of health the end of April 2024. Developed pink 3 times after COVID diagnosis. Family practice doctor has referred me to an ophthalmologist.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthropathy
Clinical narrative: Patient began experiencing issues with her shoulder several hours after vaccine administration.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: patient states the arm area is hard, red, hot to the touch, swollen and hurts.  states that the area is large around the actual site the needle puncture
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain upper, Chills, Cough, Decreased appetite, Eye pain
Clinical narrative: Very sick 11 pm to 12 pm 11/3. Muscle aches, chills, no sleep moaning all night, stomach pain.  Coughing seemed dry but spit out phelm.  Morning chills subsided, headache, eyes hurt, difficult to get out of bed.  Cough seemed in chest.  Took 2 day quil tablets on 11/3 afternoon.  No appetite, headache continues, laying down. Dayquil seems to help a little.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Malaise, Moaning, Mobility decreased, Myalgia
Clinical narrative: Very sick 11 pm to 12 pm 11/3. Muscle aches, chills, no sleep moaning all night, stomach pain.  Coughing seemed dry but spit out phelm.  Morning chills subsided, headache, eyes hurt, difficult to get out of bed.  Cough seemed in chest.  Took 2 day quil tablets on 11/3 afternoon.  No appetite, headache continues, laying down. Dayquil seems to help a little.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Productive cough, Sleep disorder
Clinical narrative: Very sick 11 pm to 12 pm 11/3. Muscle aches, chills, no sleep moaning all night, stomach pain.  Coughing seemed dry but spit out phelm.  Morning chills subsided, headache, eyes hurt, difficult to get out of bed.  Cough seemed in chest.  Took 2 day quil tablets on 11/3 afternoon.  No appetite, headache continues, laying down. Dayquil seems to help a little.
Age: 83.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site cellulitis, Injection site haemorrhage, Ultrasound Doppler normal
Clinical narrative: Patient requested both vaccines in left arm (per our protocol we recommend separating them in different arms). He developed a massive bleeding at the injection site (started the following day after administration and became worse), but it was his entire upper arm so it's impossible to tell which vaccine he's reacted to this way.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient reported to pharmacy on 11/1 with rash on her arm where she received her second dose of Shingrix on 10/31 advised patient to use topical Benadryl and cold compress. Followed up with patient on 11/3 she reports the rash has since resolved after 1 application of topical Benadryl cream
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgic amyotrophy, Pneumothorax
Clinical narrative: Patient said he developed Parsonage-Turner syndrome from the vaccine and a collapsed lung.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Dyspnoea, Fatigue, Wheezing
Clinical narrative: Wheezing, rhonchi  fatigue. Very short of breath. Seen in urgent care by Dr.  Treatment: Albuterol nebulizer TID and Pulmacort nebulizer BID. Seen by PCP Dr 10/21/2024. Z-pack and prednisone 40mg x7 days ordered. Follow up scheduled 11-8-2024 for continued wheezing and shortness of breath
Age: 8.0
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong patient
Clinical narrative: INCORRECT PATIENT, PATIENT WAS GIVEN GARDASIL , GARDASIL WAS REQUESTED FOR HIS 2 YEAR ELDER SISTER
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram normal, Fatigue, Hyperhidrosis, Loss of consciousness
Clinical narrative: Episode of syncope. The morning after my vaccine, at 10 am, got up out of bed feeling tired, dizzy, and nauseous. Went to bathroom and passed out in bathroom. Lost consciousness for probably about 2 minutes. Woke up drenched in sweat. Fatigue continued until the evening, nausea and dizziness went away in a couple hours. This is not my first COVID shot- have gotten a vaccine yearly since it came out. This is my first major adverse reaction.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Orthostatic heart rate response increased, Syncope
Clinical narrative: Episode of syncope. The morning after my vaccine, at 10 am, got up out of bed feeling tired, dizzy, and nauseous. Went to bathroom and passed out in bathroom. Lost consciousness for probably about 2 minutes. Woke up drenched in sweat. Fatigue continued until the evening, nausea and dizziness went away in a couple hours. This is not my first COVID shot- have gotten a vaccine yearly since it came out. This is my first major adverse reaction.
Age: 59.0
Sex: F
Vaccine: FLU3, PNC20, UNK
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: patients blood pressure and HR was elevated patient was hospitalized for a few days about a week after taking the  vaccines
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Seizure
Clinical narrative: Patient felt dizzy after vaccine admininstration. After about 10 seconds after, patient became unconcious for about 5-7 seconds. Patient awoke stood, up very abrubtly and then sat down immediately going into a seizure for another 5 seconds. Patient became unconcious again. Woke up slowly on the chair after about 5 seconds. Patient was given water and told to breathe slowly in an out. Patient does not remember anything after become unconcious the first time. 911 came to the pharmacy to check on patient. All tests normals. BP, pulse. 12 lead. Patient mother declined hospitalization. Patient felt better and went home
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Feeling hot, Mobility decreased
Clinical narrative: Patient reported waking up feeling his temperature burning up and weakness causing limited mobility. This started a 3 AM the morning after the vaccine was given. These lasted until he woke up the next morning.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Urticaria, Vomiting
Clinical narrative: Patient reported nausea/vomiting starting evening after receiving vaccine.  Woke the following morning with hives on chest and back.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient came to pharmacy on 11/2/2024 to show a rash that had appeared after receiving the first shingles shot. The rash appeared to be localized to the site around the injection. It was not itchy and her arm was just sore. At this time, she still had the rash.
Sex: U
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Rash erythematous, Rash pruritic, Skin burning sensation
Clinical narrative: pt received flu vaccine around 4 pm on Saturday, 11/2.  Mother called in on Sunday 11/3 to report that around 10:30 pm that night, the pt became feverish, nauseous and began vomiting. pt was given tylenol and motrin for fever around 11:30. Around 3:30 am, fever and vomiting subsided.  At 6:30 am on 11/3, pt woke up with a red, itchy, bumpy rash that the patient described as burning. Father took pt to urgent care, where she was given steroids for the rash.
Sex: U
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: pt received flu vaccine around 4 pm on Saturday, 11/2.  Mother called in on Sunday 11/3 to report that around 10:30 pm that night, the pt became feverish, nauseous and began vomiting. pt was given tylenol and motrin for fever around 11:30. Around 3:30 am, fever and vomiting subsided.  At 6:30 am on 11/3, pt woke up with a red, itchy, bumpy rash that the patient described as burning. Father took pt to urgent care, where she was given steroids for the rash.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes day after injection. saw physician. deemed rxn from vaccine
Age: 71.0
Sex: M
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient stated he developed a rash over the chest which on 10/18/24 he went to urgent care who prescribed Famciclovir and Prednisone.  His rash has subsided but has a severe itchiness lingering of which urgent care prescribed Medrol and Lyrica.
Age: 71.0
Sex: M
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Chills, Herpes zoster, Pruritus, Rash
Clinical narrative: Patient stated he developed a rash over the chest which on 10/18/24 he went to urgent care who prescribed Famciclovir and Prednisone.  His rash has subsided but has a severe itchiness lingering of which urgent care prescribed Medrol and Lyrica.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Peripheral swelling
Clinical narrative: patient called stated swelling in her arm, she noticed when she woke up the day after the vaccine, states are was really sore the night previous.  states swelling was about the size of the bottom of a 2l soda bottle, but was already starting to go down.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Patient called today to ask if she was overreacting to the Shingrix vaccine she received on Thursday. She stated that night she had a fever of 102.5, sweating, shivers, headache. The next day she felt wiped out, headache, body aches and the fever resolved. Yesterday she had headache, body aches and her body was sore, and joint pain. She said her arm still hurts at injection site and feels wiped out. She stated for 3 nights she sweated so hard she saturated her sheets and hair and had to get up and take a shower. We discussed not getting the 2nd vaccine due to the reaction she had this time. We thoroughly discussed the fact she had shingles in her 30's and the likelihood of having a reaction to the vaccine. I explained in my experience over the years patients who have had a shingles outbreak previously tend to have more adverse reactions, fever, body aches, headaches and a general feeling of being unwell that could last several days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Night sweats, Pain, Pyrexia
Clinical narrative: Patient called today to ask if she was overreacting to the Shingrix vaccine she received on Thursday. She stated that night she had a fever of 102.5, sweating, shivers, headache. The next day she felt wiped out, headache, body aches and the fever resolved. Yesterday she had headache, body aches and her body was sore, and joint pain. She said her arm still hurts at injection site and feels wiped out. She stated for 3 nights she sweated so hard she saturated her sheets and hair and had to get up and take a shower. We discussed not getting the 2nd vaccine due to the reaction she had this time. We thoroughly discussed the fact she had shingles in her 30's and the likelihood of having a reaction to the vaccine. I explained in my experience over the years patients who have had a shingles outbreak previously tend to have more adverse reactions, fever, body aches, headaches and a general feeling of being unwell that could last several days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Cyanosis, Herpes zoster, Skin lesion
Clinical narrative: Pt states he has had a shingles flare, starting ~10/25/24, on his L foot, encompassing the side, several toes, and around his ankle that he attributes to having received the shingles vaccine. He also stated his lower leg became black and blue. When he came in to tell me this, he stated that the lesions were healing slowly and that he was using peroxide and triple antibiotic ointment to clean them.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm is warm to touch, swollen and has a 4 to 5 inch rounded red area below the injection site.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore arm & shoulder
Age: 1.08
Sex: F
Vaccine: UNK, UNK
Symptoms: Rash
Clinical narrative: Rash all over body after receiving MMRV and seasonal flu. First time for both.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: administered by pharmacy, and developed swelling, painful, tender along the injection site, and then spread to distal elbow.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Brain fog, Headache, Lethargy, Myalgia, Somnolence
Clinical narrative: severe full body muscle aches, lethargy, drowsy, headache, foggy mental status.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Heart rate increased, Impaired work ability
Clinical narrative: ADVERSE EVENT: Rapid, pounding, racing heartbeat, short of breath, palpitations, fatigue, lightheaded  TREATMENT: None   OUTCOME: Symptoms continued  I have not shared this information with my primary care because I was convinced that it would resolve. I was also concerned that it would negatively impact my employment.  I have decrease my work schedule to one day per week.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: ADVERSE EVENT: Rapid, pounding, racing heartbeat, short of breath, palpitations, fatigue, lightheaded  TREATMENT: None   OUTCOME: Symptoms continued  I have not shared this information with my primary care because I was convinced that it would resolve. I was also concerned that it would negatively impact my employment.  I have decrease my work schedule to one day per week.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was administered the high-dose vaccine when the regular vaccine was indicated
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I came down with Covid Sep30; I came down with Covid Sep30; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An 84-year-old male patient received BNT162b2 (BNT162B2 NOS), in 2023 as dose 4 (booster), single (Batch/Lot number: unknown) and in 2023 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Humira, stop date: Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Sep2024, outcome "unknown" and all described as "I came down with Covid Sep30". Clinical course: Patient came down with Covid 30Sep, and they struggled for the last three weeks, he could not be giving the standard medication.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300075651 same reporter/patient/product, different events;
Sex: U
Vaccine: YF, YF
Symptoms: Hypotension, Intensive care, Liver function test increased, Neurological symptom, Thrombocytopenia
Clinical narrative: acquire Systemic Inflammatory Response Syndrome (SIRS); Initial information received on 22-Oct-2024 regarding an unsolicited valid  serious case received from a pharmacist.  This case involves an unknown age and gender patient who had acquired systemic inflammatory response syndrome (sirs) after receiving Yellow Fever Vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect 0.5ml Yellow Fever Vaccine - US Solution for injection (unknown strength, expiry date, lot number and  route) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed acquire systemic inflammatory response syndrome (SIRS) (systemic inflammatory response syndrome) (unknown latency) following the administration of Yellow Fever Vaccine - US.   Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 29-Oct-2024: This case involves an unknown age and gender patient who had acquired systemic inflammatory response syndrome (sirs) after receiving Yellow Fever Vaccine - [YF-VAX]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: YF, YF
Symptoms: Systemic inflammatory response syndrome
Clinical narrative: acquire Systemic Inflammatory Response Syndrome (SIRS); Initial information received on 22-Oct-2024 regarding an unsolicited valid  serious case received from a pharmacist.  This case involves an unknown age and gender patient who had acquired systemic inflammatory response syndrome (sirs) after receiving Yellow Fever Vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect 0.5ml Yellow Fever Vaccine - US Solution for injection (unknown strength, expiry date, lot number and  route) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed acquire systemic inflammatory response syndrome (SIRS) (systemic inflammatory response syndrome) (unknown latency) following the administration of Yellow Fever Vaccine - US.   Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 29-Oct-2024: This case involves an unknown age and gender patient who had acquired systemic inflammatory response syndrome (sirs) after receiving Yellow Fever Vaccine - [YF-VAX]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 59.0
Sex: F
Vaccine: MEN, MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administered with Meningococcal A-Y-C-W135 (T Conj) Vaccine [Menquadfi] instead of intended dose of Mesales Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) with no reported adverse event; administered with Meningococcal A-Y-C-W135 (T Conj) Vaccine [Menquadfi] instead of intended dose of Mesales Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) with no reported adverse event; This spontaneous report was received from other health professional via other company letter, concerning to a 59-year-old (reported as "60-year-old, conflicting information) female patient.  Her medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 26-JUL-2024, the patient was vaccinated with the 1st dose of meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI) solution for injection, strength: standard, 0.5 milliliter, once, lot #W028734, expiration date 08-SEP-2024, administered intramuscularly (IM) in the left deltoid as immunization, instead of the intended dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (reported as "measles vaccine, mumps vaccine, and rubella vaccine [MMR]" and "mmr") injection (dosage regimen, intended exact dose, lot #, expiry date, anatomical location and route of administration were not provided) (wrong product administered) which would be administered as prophylaxis.  There were not reported adverse events (no adverse event.)  Lot # of mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) is being requested and will be submitted if received.  This is one of two reports derived from same other company letter.; Sender's Comments:  US-009507513-2410USA010742:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received late; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th July 2022).   On 07-OCT-2024, the patient received the 2nd dose of Shingrix. On 07-OCT-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-OCT-2024 The patient stated that she just got a Shingrix vaccine. The patient did not realized that she had one on 6th July 2022. The reporter asked did she still needed to get a second Shingrix vaccine since the first one was over two years ago. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: part of it ran down my arm; underdose; accidental exposure to vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of exposure via skin contact 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 received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced exposure via skin contact (Verbatim: part of it ran down my arm ), accidental underdose (Verbatim: underdose) and inadvertent exposure to vaccine (Verbatim: accidental exposure to vaccine). The outcome of the exposure via skin contact, accidental underdose and inadvertent exposure to vaccine were unknown.   Additional Information: GSK Receipt Date: 08-OCT-2024 The patient had Shingrix vaccine (both) three and a half years ago, just after turning 50. When the patient got the second shot, part of it ran down on arm instead of going in which led to exposure via skin contact, accidental underdose and inadvertent exposure to vaccine. The patient wondered if still getting the full effect of the vaccine or if should repeat it. Patient reported that when the 2nd dose was administered the liquid was dripping all the way down to her elbow. Patient believed vaccine was received in the left arm, but she was not sure. The patient was concerned if she was protected or did she need to take the dose again. Customer provided the pharmacy information where she received the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the vaccine and I have shingles now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the vaccine and I have shingles now). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 25-OCT-2024 This case was reported by a patient via interactive digital media. The patient had vaccine and had shingles now. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Everyone I know who got the shot got shingles.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Everyone I know who got the shot got shingles.). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date : 25-OCT-2024 This case was reported by a patient via interactive digital media. Patient reported that everyone he /she who got the shot got shingles. So, that was a no for him/her. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding herpes zoster were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got a shot and got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got a shot and got it). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-OCT-2024 The case was received from the patient via interactive digital media. The reporter reported that got a shingles shot and got it (shingles). This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did the Shingrix first dose and didn't do the second dose for over a year; This non-serious case was reported by a nurse 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: did the Shingrix first dose and didn't do the second dose for over a year). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-OCT-2024 Nurse stated that they had a patient here who did the Shingrix first dose and did not do the second dose for over a year. No further information available. Specialist attempted to collect additional details, but nurse stated she only knows it was a female patient. No further information was available, and she did not consent to follow up from safety. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Decreased appetite, Fatigue, Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; shingles rash; shingles rash; tired; no appetite; COVID; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown arm) .5 ml. On 04-AUG-2024, 2 days after receiving Shingrix, the patient experienced covid-19 (Verbatim: COVID), tiredness (Verbatim: tired) and appetite absent (Verbatim: no appetite). On 05-AUG-2024, the patient experienced shingles (Verbatim: shingles rash) and rash (Verbatim: shingles rash). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: postherpetic neuralgia). The outcome of the covid-19, shingles, rash, tiredness and appetite absent were resolved and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the covid-19, post herpetic neuralgia, shingles, rash, tiredness and appetite absent to be related to Shingrix.     It was unknown if the company considered the covid-19, post herpetic neuralgia, shingles, rash, tiredness and appetite absent to be related to Shingrix.   Additional Information: GSK Receipt date:07-October-2024 The reporter was the patient. The patient received Shingrix and she felt well that day.  Two days later, she tested positive for COVID, had no appetite and was tired.  Three days after Shingrix, she developed a shingles rash.  She continued to had non-debilitating post herpetic neuralgia that started at an unknown time after the shingles rash.  Nothing else was reported.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, SARS-CoV-2 test positive
Clinical narrative: postherpetic neuralgia; shingles rash; shingles rash; tired; no appetite; COVID; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown arm) .5 ml. On 04-AUG-2024, 2 days after receiving Shingrix, the patient experienced covid-19 (Verbatim: COVID), tiredness (Verbatim: tired) and appetite absent (Verbatim: no appetite). On 05-AUG-2024, the patient experienced shingles (Verbatim: shingles rash) and rash (Verbatim: shingles rash). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: postherpetic neuralgia). The outcome of the covid-19, shingles, rash, tiredness and appetite absent were resolved and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the covid-19, post herpetic neuralgia, shingles, rash, tiredness and appetite absent to be related to Shingrix.     It was unknown if the company considered the covid-19, post herpetic neuralgia, shingles, rash, tiredness and appetite absent to be related to Shingrix.   Additional Information: GSK Receipt date:07-October-2024 The reporter was the patient. The patient received Shingrix and she felt well that day.  Two days later, she tested positive for COVID, had no appetite and was tired.  Three days after Shingrix, she developed a shingles rash.  She continued to had non-debilitating post herpetic neuralgia that started at an unknown time after the shingles rash.  Nothing else was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose of Shingrix 2 years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12 August 2022).   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 received the first dose of Shingrix 2 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-OCT-2024 Pharmacist reported that a patient received the first dose of Shingrix 2 years ago and asked if the patient had to re start the series. The reporter did not provide information about first dose such as lot number and expiration date. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adolescent male patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient.). The outcome of the incorrect storage of drug 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-OCT-2024 The reporter stated that Bexsero was exposed to 48.8 F for 78 hours, 35 min and it was administered to a patient, which led to incorrect storage of vaccine. The reporter consented to follow up via email. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments:  US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123897:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123928:Same reporter/Different patient US-GSK-US2024123899:Same reporter/Different patient US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient.). The outcome of the incorrect storage of drug 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-OCT-2024 The reporter stated that Bexsero was exposed to 48.8 F for 78 hours, 35 min and it was administered to a patient, which led to incorrect storage of vaccine. The reporter consented to follow up via email. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments:  US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123899:Same reporter/Different patient US-GSK-US2024123897:Same reporter/Different patient US-GSK-US2024123928:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adolescent female patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient). The outcome of the incorrect storage of drug 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-OCT-2024 The reporter stated that Bexsero was exposed to 48.8 F for 78 hours, 35 min and it was administered to a patient, which led to incorrect storage of vaccine. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via email.; Sender's Comments:  US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123928:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123934:Same reporter/Different patient US-GSK-US2024123926:Same reporter/Different patient US-GSK-US2024123922:Same reporter/Different patient US-GSK-US2024123919:Same reporter/Different patient US-GSK-US2024123909:Same reporter/Different patient US-GSK-US2024123905:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123901:Same reporter/Different patient US-GSK-US2024123899:Same reporter/Different patient US-GSK-US2024123897:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: administration of the second dose of Shingrix the patient noticed that a volume of about "two drops" of the dose was not administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 425CR, expiry date 10-AUG-2023) for prophylaxis.   On 08-OCT-2024, the patient received the 2nd dose of Shingrix. On 08-OCT-2024, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: administration of the second dose of Shingrix the patient noticed that a volume of about "two drops" of the dose was not administered). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date:09-OCT-2024 A pharmacist mentioned that during the administration of the second dose of Shingrix the patient noticed that a volume of about two drops of the dose was not administered, which led to incomplete dose administered. The pharmacist asked if the patient needs an extra dose. The reporter was concerned that patient´s insurance did not cover a third dose.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was given to a 2 month old baby; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was given to a 2 month old baby). The outcome of the inappropriate age at vaccine administration 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-OCT-2024 The Kinrix was given to a 2 month old baby. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: did not get revaccinated until July of 2024; This non-serious case was reported by a pharmacist 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 (1st dose of Shingrix is taken in May 2023.).   In JUL-2024, the patient received the 2nd dose of Shingrix. In JUL-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: did not get revaccinated until July of 2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt Date: 09-OCT-2024 The Healthcare Professional reported that, a patient had received two doses of Shingrix but the first one was in May of 2023 and he did not get revaccinated until July of 2024. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the 2 to 6 month window; This non-serious case was reported by a other health professional 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 on vaccination (Verbatim: missed the 2 to 6 month window). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2024 The pharmacy intern stated that they had a patient that missed the 2 to 6 month window for revaccination with the shingles vaccine and asked was the recommendation to just still give 2 total vaccines regardless of timing, or restart the series  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.