chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Dry eye, Foreign body sensation in eyes, Madarosis
Clinical narrative: weight increased; hair loss on her head and eyelash area; hair loss on her head and eyelash area; redness in eye; Flashes of light and floaters in their vission; vitreous floaters; dry eye; Joint pain; sand like feeling in the eye; This is a spontaneous report received from a Consumer or other non HCP and a Physician from License Party.  A 64-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; dupilumab (DUPILUMAB), first regimen since 15Jan2021) at 600 mg, second regimen since Jan2021) at 300 mg (300 mg, every other week) and third regimen since 2021) at 300 mg (300 mg, every 3 weeks), all subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "recovering", described as "Joint pain"; FOREIGN BODY SENSATION IN EYES (non-serious) with onset 2021, outcome "recovering", described as "sand like feeling in the eye"; PHOTOPSIA (non-serious) with onset 22Jun2021, outcome "unknown", described as "Flashes of light and floaters in their vission"; DRY EYE (non-serious) with onset 22Jun2021, outcome "recovering"; VITREOUS FLOATERS (non-serious) with onset 22Jun2021, outcome "unknown"; WEIGHT INCREASED (non-serious), outcome "unknown"; ALOPECIA (non-serious), MADAROSIS (non-serious), outcome "unknown" and all described as "hair loss on her head and eyelash area"; OCULAR HYPERAEMIA (non-serious), outcome "recovering", described as "redness in eye". The action taken for dupilumab was unknown. Therapeutic measures were taken as a result of dry eye.  Additional information: On 22Jun2021 the experienced dry eye, new onset flashes of light and floaters in their vision. Reportedly it was since receiving their covid vaccine while still on the medication. It was not the first time that patient had used therapy and it was unknown if it was tolerated or not.   Reporter causality: Not reported for alopecia and related for other events.  Company causality: Not reportable for alopecia, Ocular hyperaemia, Foreign body sensation in eyes, Arthralgia, Weight increased, Inappropriate schedule of product administration and reportable for other events.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Photopsia, Vitreous floaters, Weight increased
Clinical narrative: weight increased; hair loss on her head and eyelash area; hair loss on her head and eyelash area; redness in eye; Flashes of light and floaters in their vission; vitreous floaters; dry eye; Joint pain; sand like feeling in the eye; This is a spontaneous report received from a Consumer or other non HCP and a Physician from License Party.  A 64-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; dupilumab (DUPILUMAB), first regimen since 15Jan2021) at 600 mg, second regimen since Jan2021) at 300 mg (300 mg, every other week) and third regimen since 2021) at 300 mg (300 mg, every 3 weeks), all subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "recovering", described as "Joint pain"; FOREIGN BODY SENSATION IN EYES (non-serious) with onset 2021, outcome "recovering", described as "sand like feeling in the eye"; PHOTOPSIA (non-serious) with onset 22Jun2021, outcome "unknown", described as "Flashes of light and floaters in their vission"; DRY EYE (non-serious) with onset 22Jun2021, outcome "recovering"; VITREOUS FLOATERS (non-serious) with onset 22Jun2021, outcome "unknown"; WEIGHT INCREASED (non-serious), outcome "unknown"; ALOPECIA (non-serious), MADAROSIS (non-serious), outcome "unknown" and all described as "hair loss on her head and eyelash area"; OCULAR HYPERAEMIA (non-serious), outcome "recovering", described as "redness in eye". The action taken for dupilumab was unknown. Therapeutic measures were taken as a result of dry eye.  Additional information: On 22Jun2021 the experienced dry eye, new onset flashes of light and floaters in their vision. Reportedly it was since receiving their covid vaccine while still on the medication. It was not the first time that patient had used therapy and it was unknown if it was tolerated or not.   Reporter causality: Not reported for alopecia and related for other events.  Company causality: Not reportable for alopecia, Ocular hyperaemia, Foreign body sensation in eyes, Arthralgia, Weight increased, Inappropriate schedule of product administration and reportable for other events.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Hyperhidrosis
Clinical narrative: Patient received 2 vaccines during his visit, fluzone and spikevax. He received fluzone first, followed by spikevax second.  Patient looked well after receiving both vaccines.  After chatting for a few minutes with the family, I returned to the pharmacy for the evening.  Patient's mother returned to the pharmacy shortly after, stating that Patient was possibly having a vaccine related reaction.  I quickly ran outside and he was sitting by the front door.  His forehead was covered in sweat, and the back of his shirt was wet.  His color looked fine to me, and obvious vital signs were normal.  Patient did not faint, but most likely had a vasovagal episode.  I held a very cold cloth on his forehead and assured him that he was safe and okay.  With his dad's help, we guided Patient back into our patient waiting area and continued to observe him.  I documented all details and discussed a few options for vaccinating in the future, such as spacing out vaccines, etc.  I called Patient's mom that evening and he was already back to normal and feeling well.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT REPORTS REDNESS AND SWELLING AT THE SITE
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Given dose of 12+ age (instead of age 5-12). No adverse event at this time.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Vaccine stored in a fridge that had a temperature excursion and inadvertently administered to patient.
Age: 28.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fall, Head injury, Malaise
Clinical narrative: Pt was sitting in the waiting area, she didn't feel well so she walked to the register to ask for an ice pack.  She felt backward and hit her head at the register.  We called 911.  She had syncope when she got her Gardasil in the past.  She had both covid and flu shot together before without any problem.  Pt is afraid of needles.  Medics came and check her out.  She was being monitor in the patient waiting area for a long while before she left.  Her fiance was with her and they left together after awhile.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: RED, ITCHY, RAISED WARM AREA ON ARM WHERE VACCINE WAS GIVEN - ABOUT 3 INCHES X 1.5 INCHES OVAL ON ARM - PT REPORTED TRYING ZYRTEC AND HAVING WORSENING THE NEXT DAY.
Age: 48.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Patient stated he got both the flu and covid 19 (Moderna ) shot on one arm on 9/16/24, and felt numb feeling over 50% of his body starting about Monday 9/23/24. He sough ER medical treatment on 9/26/24, was discharged with "no treatment" aside from OTC pain relief and referred to follow up with a neurologist. He followed up with a neurologist 2 weeks later who "concluded no neurological reason why other than from the vaccines". He stated he is to be worked with MRI, CAT Scan with appointments on 11/1 and 11/4. Has multiple appointments for followup as symptoms has still persist.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT IS 62 YEARS OLD. WAS GIVEN A FLUAD FOR 65 YEARS OLD AND OLDER. IS NOT AN ORGAN TRANSPLANT OR IMMUNOCOMPROMISED PATIENT.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Shoulder injury related to vaccine administration, Surgery
Clinical narrative: Patient reported pain and swelling at injection site that worsened over time. She sought medical attention. Several months after vaccine, she stated that she developed SIRVA and required surgery
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered Flublok to 10 year old patient.  Licensed for 18 and over.   No signs/symptoms of adverse effect through observation period.  Per immunize.org, "dose does not need to be repeated and should be considered valid."
Age: 1.08
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Vaccine stored in a fridge that had a temperature excursion and inadvertently administered to patient.
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Mobility decreased, Pain
Clinical narrative: Right arm is unable to be lifted above shoulder level since 0900 10/15. I am having body aches that began last night around 2300.  I am also unable to cross my legs and my right knee is very achy. I have not ever had any problems with my right knee. This is unusual from the previous boosters I have received.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Red diffuse rash all over body.
Age: 84.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Epistaxis
Clinical narrative: Patient's husband called pharmacy around 3:45pm and said she was having a bloody nose. Husband stated it had been bleeding for ~10 minutes but patient said it was more like 45 minutes. I advised them to be seen  by her doctor if they could not get bleeding to stop as she is on a blood thinner. They went to the office where the NP packed it with gauze then later came to our other pharmacy to pick up a phenylephrine nasal spray as recommended by the nurse practitioner.  The doctor and NP told her to hold her doses of Eliquis and aspirin for tonight and tomorrow.
Age: 52.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain in extremity
Clinical narrative: 7-10 days after vaccine administration developed severe pain and inability to raise arm (left) that vaccine was administered in.  Administered with flu vaccine same arm.  Symptoms are improving, continues to have limited range of motion of left arm. sensation intact. Passive range of motion intact.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Myalgia, Odynophagia, Oropharyngeal pain, Pain in jaw
Clinical narrative: About 21 hours after injection, mild sore throat. 24 hours after injection, severe sore throat. Throat is very red. Hurts to swallow and speak. Jaw pain 6/10. Lethargy. Muscle pain.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal erythema
Clinical narrative: About 21 hours after injection, mild sore throat. 24 hours after injection, severe sore throat. Throat is very red. Hurts to swallow and speak. Jaw pain 6/10. Lethargy. Muscle pain.
Age: 1.08
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Vaccine stored in a fridge that had a temperature excursion and inadvertently administered to patient.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Vaccine stored in a fridge that had a temperature excursion and inadvertently administered to patient.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS ADMINISTERED FLUAD (ADJUVANTED FLU VACCINE) RECOMMENDED FOR +65 YEARS OLD WHEN SHE DIDN'T MEET THE AGE RECOMMENDATION.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Product storage error
Clinical narrative: Vaccine stored in a fridge that had a temperature excursion and inadvertently administered to patient.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient verbally requested flu vaccine in the presence of pharmacist, technician and student,  but checked off covid vaccine on form- patient was billed for and received flu vaccine at pharmacy on 10/8/24 - some hours later patient called pharmacy and said he noticed he had gotten a flu vacine and meant to get the covid vaccine as he had gotten a flu vaccine at a different facility 2 weeks earlier
Age: 84.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient had sore arms and couldn't move them the next day. They went to their PCP to be evaluated.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Soreness, Warmth, Swelling and Redness at injection site.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Throat tightness
Clinical narrative: Rash, Throat starting to close. EPI Pen Given, Sent To local ED.
Age: 78.0
Sex: F
Vaccine: COVID19, FLU3, PNC21, VARZOS
Symptoms: Infection, Pain in extremity, Peripheral swelling, Rash, Skin warm
Clinical narrative: The patient's right arm had swollen up, sore, hot, rash, and painful. Started up on Friday 10/11/2024 She went to urgent care and they gave her Keflex on Sunday 10/13/2024. She was admitted to the hospital on 10/14/2024. As of 10/15/2025 the doctors were still not sure what the infection was and were starting steroids.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a flucelvax on 8/18/24, and again on 10/14/24. No unusual side effects noted. Patient forgot that she received vaccine in August.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Oxygen saturation decreased
Clinical narrative: Nausea and dizziness, low spo2 86%
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Severe Headache, fever, chills, body aches.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: The Pfizer Covid-19 6m-4y (3mcg/0.3mL) vaccine was administered undiluted. Per the manufacturer instructions for dilution,  1.1 mL of sterile 0.9% Sodium Chloride Injection, USP should be injected into the vial. There should be 3 doses of 0.3 mL after dilution. The patient received 0.3mL of undiluted vaccine. No complaints of adverse reaction at this time.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Whelp rash spread from vaccination site down the arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Swelling
Clinical narrative: Bruising, swelling, sore
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: The Pfizer Covid-19 6m-4y (3mcg/0.3mL) vaccine was administered undiluted. Per the manufacturer instructions for dilution,  1.1 mL of sterile 0.9% Sodium Chloride Injection, USP should be injected into the vial. There should be 3 doses of 0.3 mL after dilution. The patient received 0.3mL of undiluted vaccine. No complaints of adverse reaction at this time.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event
Clinical narrative: no adverse effects noted
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient inadvertently received 2 brands of covid shots at the same appointment. No adverse events at time of reporting. Patient will follow up with pharmacy with any issues over next few days that are beyond expected side effects of the vaccine
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Patient was given vaccine on in the deltoid muscle and claims it was given too high. Patient is experiencing arm pain and spasms.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Duplicate flu vaccine, Patient has received two doses of flu vaccine on 08/14/2024 and 10/14/2024
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Patient under age 65, received 65+ (HD) flu vaccine
Age: 24.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within 48 the injection site had swelled significantly; my mom was even concerned and pointed it out to me! The pain/tenderness at the injection site is equivalent to the first dose I received in my right arm, being minimal. However, the whole underside wrapping around the outer part of my arm and down to almost my elbow (a vast area around the injection site) has turned bright red, a little warm to the touch. A few days later and it?s the same/a bit less. Overall, I don?t feel like the monkeypox vaccine had much impact on my body, perhaps some general malaise.
Age: 77.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Blood pressure increased, Feeling abnormal
Clinical narrative: Patient stops by the pharmacy on 10/14/24 to relay adverse reaction he had to vaccines he had received the past weekend. Patient received Flu and Tdap vaccines on 10/12/2024 at 3:30 PM. Patient reports he started to feel "weird and not right" after arriving home. Patient took his blood pressure approximately 1.5 hours after the vaccine administration at around 5:00PM. Patient states his blood pressure reading was 204/102. He immediately took nitroglycerin and said he was planning on heading to the hospital if his BP continued to be high. Patient second BP reading was in the 160s. Patient then waited 10 minutes to take a second nitroglycerin tablet where his BP reading afterwards dropped to 135. Patient states he felt reassured and decided not to go to the emergency room. Additionally, patient states he has been closely monitoring his BP since 10/12/2024 and all values thus far have been normal.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: pain and soreness of arm
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea, Rash
Clinical narrative: Rash/pityriasis rosea 7-8 days after vaccine ;  dermatologist diagnosed me of pityriasis rosea; no treatment given. Rashes continue to spread at this point.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swollen tongue, Urticaria
Clinical narrative: patient reports are hives on the mouth and neck, edema of tongue throat, and lips, a tingling and burning sensation of lips and left foot; patient reports are hives on the mouth and neck; edema of tongue; edema of throat; edema of lips; burning sensation of lips; tingling sensation of lips; a tingling sensation of left foot; burning sensation of left foot; This non-serious case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 10-AUG-2024, 3 hrs after receiving Shingrix, the patient experienced allergic reaction (Verbatim: patient reports are hives on the mouth and neck, edema of tongue throat, and lips, a tingling and burning sensation of lips and left foot), hives (Verbatim: patient reports are hives on the mouth and neck), tongue edema (Verbatim: edema of tongue), throat edema (Verbatim: edema of throat), lip edema (Verbatim: edema of lips), burning lips (Verbatim: burning sensation of lips), tingling lips (Verbatim: tingling sensation of lips), tingling of extremity (Verbatim: a tingling sensation of left foot) and burning foot (Verbatim: burning sensation of left foot). The patient was treated with methylprednisolone, diphenhydramine, famotidine and sodium chloride. The outcome of the allergic reaction was unknown and the outcome of the hives, tongue edema, throat edema, lip edema, burning lips, tingling lips, tingling of extremity and burning foot were resolved.   It was unknown if the reporter considered the allergic reaction, hives, tongue edema, throat edema, lip edema, burning lips, tingling lips, tingling of extremity and burning foot to be related to Shingrix.     It was unknown if the company considered the allergic reaction, hives, tongue edema, throat edema, lip edema, burning lips, tingling lips, tingling of extremity and burning foot to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-OCT-2024 The reporter was the patient. The patient stated that adverse event had been reported via VAERS and identifies suspect vaccine. The patient stated a visit to urgent care was required after suspect vaccine administration. Symptoms that patient reported were hives on the mouth and neck, edema of tongue throat, and lips, a tingling and burning sensation of lips and left foot. All symptoms resolved within 5 hours after intravenous medication was given at the urgent care. The patient stated diagnosis on urgent care paperwork was allergic reaction. The emergency room visit required. The patient called seeking medical bill payment for cost that husband insurance did not cover. The patient did not want follow up with her physician.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Lip oedema, Oral discomfort, Paraesthesia, Paraesthesia oral
Clinical narrative: patient reports are hives on the mouth and neck, edema of tongue throat, and lips, a tingling and burning sensation of lips and left foot; patient reports are hives on the mouth and neck; edema of tongue; edema of throat; edema of lips; burning sensation of lips; tingling sensation of lips; a tingling sensation of left foot; burning sensation of left foot; This non-serious case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 10-AUG-2024, 3 hrs after receiving Shingrix, the patient experienced allergic reaction (Verbatim: patient reports are hives on the mouth and neck, edema of tongue throat, and lips, a tingling and burning sensation of lips and left foot), hives (Verbatim: patient reports are hives on the mouth and neck), tongue edema (Verbatim: edema of tongue), throat edema (Verbatim: edema of throat), lip edema (Verbatim: edema of lips), burning lips (Verbatim: burning sensation of lips), tingling lips (Verbatim: tingling sensation of lips), tingling of extremity (Verbatim: a tingling sensation of left foot) and burning foot (Verbatim: burning sensation of left foot). The patient was treated with methylprednisolone, diphenhydramine, famotidine and sodium chloride. The outcome of the allergic reaction was unknown and the outcome of the hives, tongue edema, throat edema, lip edema, burning lips, tingling lips, tingling of extremity and burning foot were resolved.   It was unknown if the reporter considered the allergic reaction, hives, tongue edema, throat edema, lip edema, burning lips, tingling lips, tingling of extremity and burning foot to be related to Shingrix.     It was unknown if the company considered the allergic reaction, hives, tongue edema, throat edema, lip edema, burning lips, tingling lips, tingling of extremity and burning foot to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-OCT-2024 The reporter was the patient. The patient stated that adverse event had been reported via VAERS and identifies suspect vaccine. The patient stated a visit to urgent care was required after suspect vaccine administration. Symptoms that patient reported were hives on the mouth and neck, edema of tongue throat, and lips, a tingling and burning sensation of lips and left foot. All symptoms resolved within 5 hours after intravenous medication was given at the urgent care. The patient stated diagnosis on urgent care paperwork was allergic reaction. The emergency room visit required. The patient called seeking medical bill payment for cost that husband insurance did not cover. The patient did not want follow up with her physician.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pharyngeal oedema, Tongue oedema, Urticaria
Clinical narrative: patient reports are hives on the mouth and neck, edema of tongue throat, and lips, a tingling and burning sensation of lips and left foot; patient reports are hives on the mouth and neck; edema of tongue; edema of throat; edema of lips; burning sensation of lips; tingling sensation of lips; a tingling sensation of left foot; burning sensation of left foot; This non-serious case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 10-AUG-2024, 3 hrs after receiving Shingrix, the patient experienced allergic reaction (Verbatim: patient reports are hives on the mouth and neck, edema of tongue throat, and lips, a tingling and burning sensation of lips and left foot), hives (Verbatim: patient reports are hives on the mouth and neck), tongue edema (Verbatim: edema of tongue), throat edema (Verbatim: edema of throat), lip edema (Verbatim: edema of lips), burning lips (Verbatim: burning sensation of lips), tingling lips (Verbatim: tingling sensation of lips), tingling of extremity (Verbatim: a tingling sensation of left foot) and burning foot (Verbatim: burning sensation of left foot). The patient was treated with methylprednisolone, diphenhydramine, famotidine and sodium chloride. The outcome of the allergic reaction was unknown and the outcome of the hives, tongue edema, throat edema, lip edema, burning lips, tingling lips, tingling of extremity and burning foot were resolved.   It was unknown if the reporter considered the allergic reaction, hives, tongue edema, throat edema, lip edema, burning lips, tingling lips, tingling of extremity and burning foot to be related to Shingrix.     It was unknown if the company considered the allergic reaction, hives, tongue edema, throat edema, lip edema, burning lips, tingling lips, tingling of extremity and burning foot to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-OCT-2024 The reporter was the patient. The patient stated that adverse event had been reported via VAERS and identifies suspect vaccine. The patient stated a visit to urgent care was required after suspect vaccine administration. Symptoms that patient reported were hives on the mouth and neck, edema of tongue throat, and lips, a tingling and burning sensation of lips and left foot. All symptoms resolved within 5 hours after intravenous medication was given at the urgent care. The patient stated diagnosis on urgent care paperwork was allergic reaction. The emergency room visit required. The patient called seeking medical bill payment for cost that husband insurance did not cover. The patient did not want follow up with her physician.
Age: 82.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU3
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Itchy rash from ankles to shoulders that lasted seven days.
Age: 82.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU3
Symptoms: Rash pruritic
Clinical narrative: Itchy rash from ankles to shoulders that lasted seven days.
Age: 53.0
Sex: M
Vaccine: FLU3, COVID19, FLU3
Symptoms: Induration, Joint range of motion decreased, Mass, Pain
Clinical narrative: Received above vaccinations on 09/28/2024. Felt intense right arm pain the evening of 10/01/2024. The morning of 10/02/24 I had right shoulder/deltoid pain at injection site and limited range of motion; lack of right deltoid muscle control to raise arm upward (above my head) or laterally about 48 hours after flu vaccine injection to right deltoid. I'm a nurse and I've never had any previous reactions to any vaccines. Saw my primary physician Dr on 10/02/2024 and he referred me to a neurologist Dr on 10/07/2024.   Dr ordered labs and performed an EMG to the entire right arm on 10/10/2024. I went to an urgent care on 10/02/24 for anti-flammatory medication and received methyprednisone 4mg course - without relief.  I went to an orthopedic urgent care on 10/05/2024 trying to seek further diagnostic testing or a possible cortisone injection to relive the pain because I'm having difficulty sleeping due to the pain. I received a right shoulder and neck x-ray; the NP declined a cortisone injection until I got an MRI. I have an upcoming orthopedic appt. on 10/24/2024 at Orthopedic Institute to see a shoulder specialist Dr.  placed me on temporary disability until the issue is diagnosed. Physical therapy is ordered but will not begin until proper diagnosis in order not to aggravate the right shoulder.  So far OTC pain medication (acetaminophen or ibuprofen), ice packs and resting the right arm haven't decreased the pain or limited ROM.
Age: 53.0
Sex: M
Vaccine: FLU3, COVID19, FLU3
Symptoms: Arthralgia, Electromyogram, Injected limb mobility decreased, Injection site pain, Muscle disorder
Clinical narrative: Received above vaccinations on 09/28/2024. Felt intense right arm pain the evening of 10/01/2024. The morning of 10/02/24 I had right shoulder/deltoid pain at injection site and limited range of motion; lack of right deltoid muscle control to raise arm upward (above my head) or laterally about 48 hours after flu vaccine injection to right deltoid. I'm a nurse and I've never had any previous reactions to any vaccines. Saw my primary physician Dr on 10/02/2024 and he referred me to a neurologist Dr on 10/07/2024.   Dr ordered labs and performed an EMG to the entire right arm on 10/10/2024. I went to an urgent care on 10/02/24 for anti-flammatory medication and received methyprednisone 4mg course - without relief.  I went to an orthopedic urgent care on 10/05/2024 trying to seek further diagnostic testing or a possible cortisone injection to relive the pain because I'm having difficulty sleeping due to the pain. I received a right shoulder and neck x-ray; the NP declined a cortisone injection until I got an MRI. I have an upcoming orthopedic appt. on 10/24/2024 at Orthopedic Institute to see a shoulder specialist Dr.  placed me on temporary disability until the issue is diagnosed. Physical therapy is ordered but will not begin until proper diagnosis in order not to aggravate the right shoulder.  So far OTC pain medication (acetaminophen or ibuprofen), ice packs and resting the right arm haven't decreased the pain or limited ROM.
Age: 53.0
Sex: M
Vaccine: FLU3, COVID19, FLU3
Symptoms: Pain in extremity, Sleep disorder, X-ray, X-ray limb
Clinical narrative: Received above vaccinations on 09/28/2024. Felt intense right arm pain the evening of 10/01/2024. The morning of 10/02/24 I had right shoulder/deltoid pain at injection site and limited range of motion; lack of right deltoid muscle control to raise arm upward (above my head) or laterally about 48 hours after flu vaccine injection to right deltoid. I'm a nurse and I've never had any previous reactions to any vaccines. Saw my primary physician Dr on 10/02/2024 and he referred me to a neurologist Dr on 10/07/2024.   Dr ordered labs and performed an EMG to the entire right arm on 10/10/2024. I went to an urgent care on 10/02/24 for anti-flammatory medication and received methyprednisone 4mg course - without relief.  I went to an orthopedic urgent care on 10/05/2024 trying to seek further diagnostic testing or a possible cortisone injection to relive the pain because I'm having difficulty sleeping due to the pain. I received a right shoulder and neck x-ray; the NP declined a cortisone injection until I got an MRI. I have an upcoming orthopedic appt. on 10/24/2024 at Orthopedic Institute to see a shoulder specialist Dr.  placed me on temporary disability until the issue is diagnosed. Physical therapy is ordered but will not begin until proper diagnosis in order not to aggravate the right shoulder.  So far OTC pain medication (acetaminophen or ibuprofen), ice packs and resting the right arm haven't decreased the pain or limited ROM.
Sex: M
Vaccine: UNK, UNK
Symptoms: Dysphagia, Ear pain, Headache, Neck pain, Oropharyngeal pain
Clinical narrative: Refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines).; Refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines).; This spontaneous case, initially received on 03-Oct-2024, was reported by a non-health professional and concerns an elderly male patient.  Administration of company suspect drugs: On an unknown date, the patient received Flucelvax (TIV) for seasonal influenza, Dosing regimen: not reported, route of administration: not reported, Lot number: No batch number available, would be requested upon follow up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines) (outcome: Not Reported), Refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines) (outcome: Not Reported).  Refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines). Adds that went to his HCP about three time in the past 2-3 weeks, but his doctor just says for him to go to the ER, but he can't afford that.  Non-drug treatment/Other action taken:  Flucelvax (TIV) action taken: Not Applicable  Reporter assessment: The reporter did not provide the seriousness and causality assessment of all events.  Linked Case ID(s): US-BEH-2024181014 (same patient)  14-OCT-2024 (System Update): Linked Case ID(s):2024181014 (Patient Link); Reporter's Comments: Company causality for events as related
Sex: M
Vaccine: UNK, UNK
Symptoms: Somnolence
Clinical narrative: Refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines).; Refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines).; This spontaneous case, initially received on 03-Oct-2024, was reported by a non-health professional and concerns an elderly male patient.  Administration of company suspect drugs: On an unknown date, the patient received Flucelvax (TIV) for seasonal influenza, Dosing regimen: not reported, route of administration: not reported, Lot number: No batch number available, would be requested upon follow up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines) (outcome: Not Reported), Refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines) (outcome: Not Reported).  Refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines). Adds that went to his HCP about three time in the past 2-3 weeks, but his doctor just says for him to go to the ER, but he can't afford that.  Non-drug treatment/Other action taken:  Flucelvax (TIV) action taken: Not Applicable  Reporter assessment: The reporter did not provide the seriousness and causality assessment of all events.  Linked Case ID(s): US-BEH-2024181014 (same patient)  14-OCT-2024 (System Update): Linked Case ID(s):2024181014 (Patient Link); Reporter's Comments: Company causality for events as related
Sex: M
Vaccine: UNK, UNK
Symptoms: Migraine, Oropharyngeal pain
Clinical narrative: Refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines).; Refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines).; This spontaneous case, initially received on 03-Oct-2024, was reported by a non-health professional and concerns an elderly male patient.  Administration of company suspect drugs: On an unknown date, the patient received Flucelvax (TIV) for seasonal influenza, Dosing regimen: not reported, route of administration: not reported, Lot number: No batch number available, would be requested upon follow up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines) (outcome: Not Reported), Refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines) (outcome: Not Reported).  Refers that called last week reporting the adverse event following the administration of a Seqirus vaccine (sore throat, migraines). Adds that went to his HCP about three time in the past 2-3 weeks, but his doctor just says for him to go to the ER, but he can't afford that.  Non-drug treatment/Other action taken:  Flucelvax (TIV) action taken: Not Applicable  Reporter assessment: The reporter did not provide the seriousness and causality assessment of all events.  Linked Case ID(s): US-BEH-2024181014 (same patient)  14-OCT-2024 (System Update): Linked Case ID(s):2024181014 (Patient Link); Reporter's Comments: Company causality for events as related
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Skin discolouration, Tenderness
Clinical narrative: bruising x1 week.  turning green. soreness to touch. not infected per pt.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram, Escherichia infection, Fatigue
Clinical narrative: I received the vaccine. I remember the same night I got very sick. I could not move or get out of bed. The week after I felt extremely week and tired. I since learned they use ecoli to make the vaccine. About a week and a half after receiving both vaccines I remember clear as day it was after my birthday nivemeber 22nd. I was in the hospital in December for 6 days. I had sepsis  with organ failure. My heart was about to have a heart attack from having a very high fever. I never had Covid this entire pandemic. I always had a pretty strong immune system  until the vaccine. I had a bad urinary tract / kidney infection and the cause was ecoli in my blood. How the ecoli got there I have no idea. I am a very hygienic person. I am constantly washing my hands and showering.  This was definitely from the vaccine.  My body has never felt the same since. I regret getting the vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection, Malaise, Mobility decreased, Organ failure, Pyrexia
Clinical narrative: I received the vaccine. I remember the same night I got very sick. I could not move or get out of bed. The week after I felt extremely week and tired. I since learned they use ecoli to make the vaccine. About a week and a half after receiving both vaccines I remember clear as day it was after my birthday nivemeber 22nd. I was in the hospital in December for 6 days. I had sepsis  with organ failure. My heart was about to have a heart attack from having a very high fever. I never had Covid this entire pandemic. I always had a pretty strong immune system  until the vaccine. I had a bad urinary tract / kidney infection and the cause was ecoli in my blood. How the ecoli got there I have no idea. I am a very hygienic person. I am constantly washing my hands and showering.  This was definitely from the vaccine.  My body has never felt the same since. I regret getting the vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis, Urinary tract infection, Urine analysis
Clinical narrative: I received the vaccine. I remember the same night I got very sick. I could not move or get out of bed. The week after I felt extremely week and tired. I since learned they use ecoli to make the vaccine. About a week and a half after receiving both vaccines I remember clear as day it was after my birthday nivemeber 22nd. I was in the hospital in December for 6 days. I had sepsis  with organ failure. My heart was about to have a heart attack from having a very high fever. I never had Covid this entire pandemic. I always had a pretty strong immune system  until the vaccine. I had a bad urinary tract / kidney infection and the cause was ecoli in my blood. How the ecoli got there I have no idea. I am a very hygienic person. I am constantly washing my hands and showering.  This was definitely from the vaccine.  My body has never felt the same since. I regret getting the vaccine.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Pt came to outreach site for vaccination. Pt came back after 10 mins saying he  felt dizzy, could not breathe well. Had pt sit down and drink water. Pt has not  had lunch yet.  vitals:  P: 81 O2: 98  Pt sat down for 15 mins and said he felt better after resting. Pt then said he  can go back to class.   I went to the office and saw the pt eating and pt stated that he felt way better  now that he is eating.  Pt encounter form stated that pt was nervous about the vaccination -- which could  have been the reason for the dizziness/sob.
Age: 5.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Injection site inflammation, Joint swelling, Pruritus, Urticaria
Clinical narrative: Joint pain; joint swelling; hives noted to chest, arms, and right eye; generalized itchiness; inflammation on right thigh injection site
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: - FLU SHOT THIS SEASON WAS GIVEN LAST 10/7/24 AT CLINIC BUT BASED ON   DOCUMENTATION, IT WAS INVALID BECAUSE FLU SHOT WAS EXPIRED (6/5/21) WITH LOT #  J24SK, SO OUR TEAM FLU OUTREACH AND I ADMINISTERED FLU VACCINE YESTERDAY, 10/15/24 AT SCHOOL. - VERIFIED THAT THE FLU VACCINE GIVEN LAST 10/7/24 IS NOT EXPIRED (LOT #: J245K, EXPIRATION: 6/5/25) - PARENT ALREADY INFORMED OF READMINISTRATION OF FLU SHOT YESTERDAY BY EMPLOYEE W/ THEIR SIGNED  CONSENT FORM.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: injection site reactions, sore arm and red spots; injection site reactions, sore arm and red spots.; Initial information received on 20-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to US-SA-2024SA285980, US-SA-2024SA285853, US-SA-2024SA286193 (Cluster cases).  This case involves a 21 year old female patient who experienced injection site reactions, sore arm and red spots after receiving rabies (HDC) vaccine [IMOVAX Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Sep-2024, the patient received 0.1 ml of dose 1 of rabies (HDC) vaccine Powder and solvent for suspension for injection with strength standard (lot W1C931M and expiry date- 31-Oct-2025) once via intramuscular route in the right arm and on 16-Sep-2024 she also received an 0.1 ml of dose 2 of same vaccine (lot W1C931M and expiry date- 31-Oct-2025) once via unknown route in unknown administration site all for Immunization.  On an unknown date in Sep-2024 the patient developed injection site reactions, sore arm and red spots (vaccination site pain) (vaccination site erythema) (latency- approximately few days) following the administration of rabies (HDC) vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, there was no other vaccines.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.; Sender's Comments:  US-SA-2024SA285980: US-SA-2024SA285853: US-SA-2024SA286193: US-SA-2024SA286884: US-SA-2024SA286755:02232595
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 61 years old patient received the FLUZONE HD with no adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an 61 years old patient received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] with no adverse event.  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 Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot- UT8437BA, expiry date: 30-Jun-2025) (unknown strength, dosage, formulation and route) in unknown administration site for prophylactic vaccination.  On an unknown date the 61 years old patient received the Influenza Usp Trival A-B High Dose Subvirion Vaccine. with no adverse event (product administered to patient of inappropriate age) (latency-same day).  Reportedly, caller asked about the adverse reactions. Do we need to bring her back in to give the regular dose or would the patient be okay for the rest of the flu season.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received FLUZONE trivalent pfs instead of Fluzone HD that was ordered (with no reported adverse event); Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 66-year-old male patient who received influenza usp trival A-B subvirion no preservative vaccine [Fluzone] instead of influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose] that was ordered (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2024, the patient received a 0.5 ml dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection of lot ZR3ED and expiry date: 30-Jun-2025 via intramuscular route in the left deltoid as Immunization instead of fluzone High dose (Suspension for injection in pre-filled syringe) that was ordered (with no reported adverse event) (wrong product administered) (latency: on same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.