chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PNC20, UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Muscular weakness, Neck pain
Clinical narrative: On 10/11/2024 I received both flu (I don?t know the brand they used it just is marked as, ?Influenza, High Dose Seasonal?) and the Prevnar 20 vaccine in my right arm. The male nurse (??) gave the injections at the same location of the right arm. My daughter took a photo of my arm afterwards so I could see where the injections were made. He was standing up and I was sitting down.  Injections were given at around 11:00 AM and pain in arm was immediate. The pneumonia vaccine was very painful when injected. By 7:00 PM that evening the pain in right arm was increasing to a solid 7 on the pain index scale. Pain radiates down the front and underside of the right deltoid muscle. There was radiation down the forearm, upper right shoulder into the top of the right side of upper back and neck area even into the wrist when trying to use my hand.  Shooting pain whenever I tried to use my hand, wrist or arm.  I was unable to move or lift my arm from its normal relaxed position without intense pain. It was difficult to grasp things in my hand because of the weakness. Nearly impossible to undress to use the bathroom, change clothes to go to bed or actually get into the bed without the use of my arm. My medications, ice and heat didn?t touch the pain.  At one point whenI was moving I felt an icy feeling in my upper back on the right side for about an hour. I had no fever but started having chills. Chills were diminished the following morning but pain increased. In a sitting position the pain increased when barely shifting my upper body to reposition myself. On day 5, I began to finally have more range of motion with somewhat less intense pain-it being at 6 on the pain scale instead of 7. On day 6 I?m able to have further range of motion with the pain at a 5.  I?m still very limited using my arm to do household tasks, changing sheets, carrying laundry, personal care such as dressing, shampooing hair, due to my range and pain level.  On 10/17/2024, six days after the vaccination, I requested an appointment to be seen at the clinic to evaluate my arm. She looked at the arm and felt the skin. No redness or warmth and suggested heat application or lidocaine patch. I asked her about whether the location of injection was too high, but she said it wasn?t. She stated it was just a strong reaction to the pneumonia vaccine since previously having never received one before. She said no imaging was necessary and to just give it time to resolve over the next weeks.
Age: 66.0
Sex: F
Vaccine: PNC20, UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: On 10/11/2024 I received both flu (I don?t know the brand they used it just is marked as, ?Influenza, High Dose Seasonal?) and the Prevnar 20 vaccine in my right arm. The male nurse (??) gave the injections at the same location of the right arm. My daughter took a photo of my arm afterwards so I could see where the injections were made. He was standing up and I was sitting down.  Injections were given at around 11:00 AM and pain in arm was immediate. The pneumonia vaccine was very painful when injected. By 7:00 PM that evening the pain in right arm was increasing to a solid 7 on the pain index scale. Pain radiates down the front and underside of the right deltoid muscle. There was radiation down the forearm, upper right shoulder into the top of the right side of upper back and neck area even into the wrist when trying to use my hand.  Shooting pain whenever I tried to use my hand, wrist or arm.  I was unable to move or lift my arm from its normal relaxed position without intense pain. It was difficult to grasp things in my hand because of the weakness. Nearly impossible to undress to use the bathroom, change clothes to go to bed or actually get into the bed without the use of my arm. My medications, ice and heat didn?t touch the pain.  At one point whenI was moving I felt an icy feeling in my upper back on the right side for about an hour. I had no fever but started having chills. Chills were diminished the following morning but pain increased. In a sitting position the pain increased when barely shifting my upper body to reposition myself. On day 5, I began to finally have more range of motion with somewhat less intense pain-it being at 6 on the pain scale instead of 7. On day 6 I?m able to have further range of motion with the pain at a 5.  I?m still very limited using my arm to do household tasks, changing sheets, carrying laundry, personal care such as dressing, shampooing hair, due to my range and pain level.  On 10/17/2024, six days after the vaccination, I requested an appointment to be seen at the clinic to evaluate my arm. She looked at the arm and felt the skin. No redness or warmth and suggested heat application or lidocaine patch. I asked her about whether the location of injection was too high, but she said it wasn?t. She stated it was just a strong reaction to the pneumonia vaccine since previously having never received one before. She said no imaging was necessary and to just give it time to resolve over the next weeks.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pfizer Comirnaty 12+ was given to a 10 year old. The patient did not have any adverse reactions at the time of the shot and has not reported any problems since. We have tried to contact her pediatrician multiple times, but have not heard back .
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Delirium, Feeling cold, Peripheral coldness, Thirst
Clinical narrative: Patient stated "shocking pain" in the lower back, "terrible pain". She stated having deliriums overnight. Very thirsty and extremely cold. Feet like ice blocks.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Misadministration of high-dose flu vaccine to pediatric patient.  No adverse affects reported at this time.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Very itchy and painful at the site location . The skin is red,  hard, and hot. The reaction is the size of a drink coaster.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Gait disturbance, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Morning after, woke with extreme joint pain. Just walking was difficult & painful. Joint pain diminished the next day, and has almost resolved today. Also had knot at injection site about 1 inch in diameter. It was red, hard, itchy, & painful. Still the same size today, Thursday 10/17, still painful & itchy.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Pain
Clinical narrative: Morning after, woke with extreme joint pain. Just walking was difficult & painful. Joint pain diminished the next day, and has almost resolved today. Also had knot at injection site about 1 inch in diameter. It was red, hard, itchy, & painful. Still the same size today, Thursday 10/17, still painful & itchy.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT COMPLAINED OF REDNESS, WARM TO TOUCH, RAISED BUMP, SWELLING TO AREA OF INJECTION
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt reported swelling, itching, burning, redness in injection site that spread down arm beginning day after vaccination. No other sx, but current sx still present
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Computerised tomogram spine, Dizziness
Clinical narrative: I took my flu shot 10/01/2024 in the afternoon, as required for my job. By Friday, 10/04/24, I was feeling really lethargic, dizzy, headache with tingling in legs. I went around 9pm and woke up Saturday morning, 10/05/24, at 3am not being able to feel my legs from the knees down. I thought maybe I had pinched a nerve, so I tried a hot shower with rubs with the help of a relative. By noon on Saturday,  I couldn't feel from my waist down.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Lethargy, Lumbar puncture, Magnetic resonance imaging head
Clinical narrative: I took my flu shot 10/01/2024 in the afternoon, as required for my job. By Friday, 10/04/24, I was feeling really lethargic, dizzy, headache with tingling in legs. I went around 9pm and woke up Saturday morning, 10/05/24, at 3am not being able to feel my legs from the knees down. I thought maybe I had pinched a nerve, so I tried a hot shower with rubs with the help of a relative. By noon on Saturday,  I couldn't feel from my waist down.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: I took my flu shot 10/01/2024 in the afternoon, as required for my job. By Friday, 10/04/24, I was feeling really lethargic, dizzy, headache with tingling in legs. I went around 9pm and woke up Saturday morning, 10/05/24, at 3am not being able to feel my legs from the knees down. I thought maybe I had pinched a nerve, so I tried a hot shower with rubs with the help of a relative. By noon on Saturday,  I couldn't feel from my waist down.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient presented to the pharmacy and asked for a flu vaccination. She received the vaccination and later was found that she had previously received the vaccination at another pharmacy location two months prior. She was unaware that she had previously received the vaccination.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lymphadenopathy
Clinical narrative: Shivers and left neck lymph node swollen.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was given the pediatric dose instead of the adult dose .
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Unable to get details from patient, doctor office called and complained that we gave patient a second shot of RSV vaccine a year later. Patient was only supposed to get one vaccination of RSV.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. patient notified. No reaction stated
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 12.0
Sex: F
Vaccine: COVID19, HPV9, IPV
Symptoms: Blood pressure decreased, Heart rate decreased, Hypotonia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Pt had syncopal episode immediately after administration of HPV vaccine which had followed administration of IPV and Pfizer Covid vaccines. Pt lost consciousness, became pale and limp. Pt had decreased heart rate, low blood pressure and decreased respirations. Pt was laid to the floor by staff and legs were raised. Vital signs were taken approximately every 5 minutes. Pt's level of consciousness , heart rate, blood pressure, and respiratory rate improved. Pt was alert and oriented 30 minutes later and walked out of site within 75 minutes.
Age: 12.0
Sex: F
Vaccine: COVID19, HPV9, IPV
Symptoms: Pallor, Respiratory rate decreased, Syncope
Clinical narrative: Pt had syncopal episode immediately after administration of HPV vaccine which had followed administration of IPV and Pfizer Covid vaccines. Pt lost consciousness, became pale and limp. Pt had decreased heart rate, low blood pressure and decreased respirations. Pt was laid to the floor by staff and legs were raised. Vital signs were taken approximately every 5 minutes. Pt's level of consciousness , heart rate, blood pressure, and respiratory rate improved. Pt was alert and oriented 30 minutes later and walked out of site within 75 minutes.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: The patient was given the pediatric dose  instead of the adult dose
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reactions stated.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient described feeling light-headed and about to faint around 10-15 minutes after receiving vaccine. Immediately and periodically checked in on patient to see how she was feeling and if symptoms were getting worse, the same, or getting better. Patient reported symptoms were getting better and attempted to sit up and stand up. Patient waited close to pharmacy until she had a ride who showed up at 7:10 pm. Patient reported they were feeling better and around to where they were prior to vaccination.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3, FLU3, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient inadvertently received two flu shots, due to mistaking one for Boostrix until after administered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: The following morning after being vaccinated patient woke up and noticed the vaccination site was 'real red and swollen- about the same size or slightly smaller than a golf ball'  she tried ibuprofen and naproxen (not at the same time) which provided only marginal benefit.  Today, 10/17 she reports that it looks almost the same, improving only slightly.  Recommended cold compress would be worthwhile and possibly Benadryl may reduce redness/swelling.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Dizziness, Electrocardiogram normal, Fatigue, Headache
Clinical narrative: 24 hours post vaccine developed fatigue, mild headache, malaise. Approximately 36 hours later started to improve, primarily felt fatigue. On the 4th day post vaccine woke up feeling nauseas and dizzy, progressed into vertigo. On the 4th day in the evening went into the ER due to consistent, unrelenting vertigo (Hospital). Now eight days post vaccine, still experiencing intermittent vertigo, nausea, mild to moderate headache, and fatigue.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myocardial necrosis marker normal, Nausea, Vertigo
Clinical narrative: 24 hours post vaccine developed fatigue, mild headache, malaise. Approximately 36 hours later started to improve, primarily felt fatigue. On the 4th day post vaccine woke up feeling nauseas and dizzy, progressed into vertigo. On the 4th day in the evening went into the ER due to consistent, unrelenting vertigo (Hospital). Now eight days post vaccine, still experiencing intermittent vertigo, nausea, mild to moderate headache, and fatigue.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: this event was not reported to our office until today one year later when they came in for another wellness visit and another flu vaccine, dad showed us a picture and the arm was all blue bruised and reddened in a large circuference around the area of the shot approx 9cm around. This did not appear to be any type of normal reaction to a vaccine in times past every year child has gotten the flu vaccine however we usually use sanofi 2023 was the first year we used flucelvax instead
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Immediate post-injection reaction, Injection site pain
Clinical narrative: The patient presented to the pharmacy on 10/17/24. She said her right arm has been weak and had difficulty raising it. She demonstrated by trying to lift her arm and acting like it was heavy. She said the injection was in her left shoulder and soon after she received the injection she felt pain radiating throughout her shoulder and into her neck.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Pain, Paraesthesia, Visual impairment
Clinical narrative: The patient presented to the pharmacy on 10/17/24. She said her right arm has been weak and had difficulty raising it. She demonstrated by trying to lift her arm and acting like it was heavy. She said the injection was in her left shoulder and soon after she received the injection she felt pain radiating throughout her shoulder and into her neck.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Mobility decreased, Muscular weakness, Neck pain, Pain
Clinical narrative: The patient presented to the pharmacy on 10/17/24. She said her right arm has been weak and had difficulty raising it. She demonstrated by trying to lift her arm and acting like it was heavy. She said the injection was in her left shoulder and soon after she received the injection she felt pain radiating throughout her shoulder and into her neck.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No additional AE; a dose of GARDASIL 9 was accidentally administered to a pregnant patient; a dose of GARDASIL 9 was accidentally administered to a pregnant patient. The patient was supposed to be receiving a flu vaccine.; This spontaneous report was received from a nurse practitioner referring to a 28-year-old female patient who was 35-week-3-day pregnant. The patient's last menstruation period (LMP) was 09-FEB-2024. The patient's concomitant drugs included cefalexin for her concurrent condition frequent urinary tract infection (UTI). The patient's past drug reactions or allergies was not known.   On 14-OCT-2024, the patient was supposed to be receiving a flu vaccine (wrong product administered). However, the pregnant patient was administered a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (0.5 ml, lot#: Y007193, expiration date: 06-JUN-2026; strength was not reported) intramuscularly for prophylaxis (exposure during pregnancy). The patient waited for 15 minutes in the lobby per office protocol after her vaccine and did not exhibit any adverse reactions. No additional adverse events (AE) were reported (no adverse event).
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant, Parkinson's disease
Clinical narrative: Parkinson; cancer; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARKINSON'S DISEASE (medically significant), outcome "unknown", described as "Parkinson"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer". Clinical course: The customer stated that one of her neighbors develop Parkinson and cancer after receiving the Pfizer vaccine. Reporter considered event as caused by suspect product(s).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400131855 same product, reporter, different events and patient.;
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Biopsy skin, Cutaneous T-cell lymphoma, Imaging procedure
Clinical narrative: primary cutaneous gamma-delta T cell lymphoma/Cutaneous T-cell lymphoma due to tozinameran; This is a literature report for the following literature source(s).  A 71-year-old man developed cutaneous T-cell lymphoma following COVID-19 immunisation with tozinameran. The man, who had a history of hypertension and diabetes, presented with altered mental status and acute on chronic confluent purpura and crusted plaque over the complete body, including tongue and palate. He had received tozinameran (Pfizer COVID-19 vaccine; route and dosage not stated) one year prior. His initial biopsies revealed atopic dermatitis and despite the treatments, the rash recurred a few months later. Thus, he was admitted to the hospital for further evaluation. Upon current admission, the concern for sepsis was raised due to elevated lactate, mild leukocytosis, thrombocytopenia and tachycardia. His imaging study showed signs of esophagitis, COPD and diverticulitis. After multidisciplinary team discussion, he was treated in the ICU with unspecified antibiotics, unspecified vasopressors and fluid resuscitation. However, he continued to deteriorate and progressed to purpura fulminans in setting of critical illness, DIC/coagulopathy and septic shock. Thereafter, he died (cause of death not stated) prior to the result of the skin biopsy that showed primary cutaneous gamma-delta T cell lymphoma with Ki67 IHC stain of 90%. Cutaneous T-cell lymphoma due to tozinameran was concluded (duration of treatment to reaction onset not stated). Although the correlation between the COVID-19 vaccine and cutaneous T-cell lymphoid infiltrates remained uncertain, further research and time might provide more insight into their potential link.  No follow-up attempts are needed.; Sender's Comments: Based on observed clinical outcome after vaccine was administered and temporal relationship, the causal association of reported event cutaneous T cell Lymphoma cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: died
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: hot to touch; redness; swelling; Initial information received on 02-Oct-2024 regarding an unsolicited valid  non-serious case received from patient.  This case involves a 71 years old female patient who experienced hot to touch, redness and swelling, after receiving vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Oct-2024, the patient received a  dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (strength: not reported) (lot number, expiry date: not reported) via intramuscular route in unknown administration site for prophylactic vaccination (immunization).  On 02-Oct-2024 the patient developed redness (erythema), hot to touch (feeling hot) and swelling (latency: 1 day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  No lab data reported.  Action taken : not applicable.  No corrective treatment was received for the event (redness). It was not reported if the patient received corrective treatment for the events (hot to touch, swelling).  At time of reporting, the outcome was Recovering / Resolving for all the events.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: nurse gave fluzone t to a patient subcutaneously instead of giving it intramuscularly (with no reported ae); Initial information received on 02-Oct-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who stated that nurse gave Influenza Usp Trival A-B Subvirion Vaccine [Fluzone] to a patient subcutaneously instead of giving it intramuscularly (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Influenza Usp Trival A-B Subvirion Vaccine (Suspension for injection) strength, expiry date, lot number not reported via subcutaneous route (incorrect route of product administration) in unknown administration site for Prophylactic vaccination (Immunization).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to a nurse that gave FLUZONE T to a patient subcutaneously instead of giving it intramuscularly. Pharmacist called to report that a nurse, from a doctor's office, accidentally gave FLUZONE T subcutaneously instead of giving it intramuscularly. He called to ask if the patient needed revaccination for this scenario."   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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Myalgia, Pyrexia
Clinical narrative: Slight fever, chills, muscle aches, loss of appetite, fatigue
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: reported no adverse events after receiving the injection; expired dose of PNEUMOVAX 23 was given to a patient; This spontaneous report was received from a pharmacy technician concerning to a 67-year-old female patient. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On 09-OCT-2024, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #W027449, expiration date: 25-SEP-2024, administered for prophylaxis in the right arm (strength, dose, and route of administration were not provided) (Expired product used). The patient reported no adverse events after receiving the injection.
Age: 83.0
Sex: F
Vaccine: RVX
Symptoms: Chronic kidney disease
Clinical narrative: Chronic Kidney Disease; This serious case was reported by a consumer via call center representative and described the occurrence of chronic kidney disease in a 83-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 01-JUL-2024, the patient received RSV vaccine. In AUG-2024, between 1 and 2 months after receiving RSV vaccine, the patient experienced chronic kidney disease (Verbatim: Chronic Kidney Disease) (serious criteria GSK medically significant). The outcome of the chronic kidney disease was unknown.   It was unknown if the reporter considered the chronic kidney disease to be related to RSV vaccine.     The company considered the chronic kidney disease to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 10-OCT-2024 The patient self-reported this case. The patient received an RSV vaccine and was diagnosed with chronic kidney disease in August 2024.   The reporter did not had any identifying information about the vaccine and the manufacturer could not be identified. This report included all information that was given during the call.; Sender's Comments: Chronic kidney disease is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Sore arm; a week after arm swelled, was hard and hot to the touch, painful ending with itchiness the second week; a week after arm swelled, was hard and hot to the touch, painful ending with itchiness the second week; a week after arm swelled, was hard and hot to the touch, painful ending with itchiness the second week; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (a week after arm swelled, was hard and hot to the touch, painful ending with itchiness the second week), FEELING HOT (a week after arm swelled, was hard and hot to the touch, painful ending with itchiness the second week) and PRURITUS (a week after arm swelled, was hard and hot to the touch, painful ending with itchiness the second week) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (a week after arm swelled, was hard and hot to the touch, painful ending with itchiness the second week), FEELING HOT (a week after arm swelled, was hard and hot to the touch, painful ending with itchiness the second week) and PRURITUS (a week after arm swelled, was hard and hot to the touch, painful ending with itchiness the second week). At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (a week after arm swelled, was hard and hot to the touch, painful ending with itchiness the second week), FEELING HOT (a week after arm swelled, was hard and hot to the touch, painful ending with itchiness the second week) and PRURITUS (a week after arm swelled, was hard and hot to the touch, painful ending with itchiness the second week) outcome was unknown.            Concomitant product use was not provided by the reporter. After the first shot, the patient had sore arm. After a week after the second shot the patient had arm swelled, was hard and hot to the touch, painful ending with itchiness the second week. After the third shot, patient again had sore arm. Reporter causality was not reported. Treatment information was not provided.   This case was linked to MOD-2024-775032 (Patient Link).
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, FLU3, MMRV
Symptoms: Pyrexia, Seizure
Clinical narrative: fever, then 5-10 minute generalized seizure. Went to ED. Self resolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: Patient diagnosed wtih Cellulitis of left lower extremity. Per APRNP note; Patient was seen three days ago and received Kinrix vaccine in her left thigh. Parents noticed redness surronding the injection the next morning. Redness has continued to spread. Yesterday her leg was so tender she did not want to pull her underwear down as it would rub on it. Parents applied ice and gave her Benadryl last evening but noted redness spread further this morning. Assesment/Plan-- cefdinir (OMNICEF) 125 mg/5 mL suspension; Take 4.3 mLs by mouth 2 times daily for 10 days. Dispense: 86 mLs; Refill: 0. Continue to ice and Benadryl as needed. Follow up in four days, sooner if worsening or develops fever.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site haemorrhage, Limb discomfort, Pain in extremity, Sleep disorder
Clinical narrative: I went upstairs to the flu clinic to get my annual flu shot. I arrived around 7:30am and was taken into a room around 7:40am. The nurse gave me the shot in my right arm and when she removed the needle my arm started to bleed and she wiped and it twice and then put a band aid on. My arm was sore and uncomfortable for the next few days after which I assumed was normal. As we got to day 6 it was still very sore and uncomfortable. My arm arm is still very sore two weeks later. I have constant pain. It hurts from my collar bone down past my elbow. I'm unable to really move my right arm, can't sleep, can't raise my arm. ESH sent in a prescription for a 3 day supple of prednisone which hasn't helped at all.
Age: 16.0
Sex: F
Vaccine: FLU3, MENB, MNQ
Symptoms: Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had initial itching & redness on right upper arm within 24 hrs of the vaccination. This progressed to a half dollar sized area of subcutaneous swelling, warmth & discomfort with overlying erythema. Patient was treated with 10 day cephalexin course for suspected cellulitis.
Age: 16.0
Sex: F
Vaccine: FLU3, MENB, MNQ
Symptoms: Injection site warmth
Clinical narrative: Patient had initial itching & redness on right upper arm within 24 hrs of the vaccination. This progressed to a half dollar sized area of subcutaneous swelling, warmth & discomfort with overlying erythema. Patient was treated with 10 day cephalexin course for suspected cellulitis.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling upper part of my body from waist and up.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Coronary artery disease, Emphysema, Immune thrombocytopenia, Laboratory test
Clinical narrative: Listed on my shot records as "Vac A 0.5cc" and "Vac A #2 0/5cc". Over time I have been diagnosed with ITP, coronary heart disease, and emphysema (I have never smoked).
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in 41-year old female EUA medical countermeasure recipient. The victim was 37 years 11 months old at the time of second inoculation. Victim has a social media page with a copy of her "vax card". Due to her common name unable to ascertain any information about any potential post inoculation adverse events or prior existing medical conditions. As online report state she had two children and was found dead. Victim was an active athlete in high school. She participated in basketball, cheerleading and volleyball. DOSE #1 Date 04/08/21 LOT# 036321A DOSE #2 date 05/07/21 LOT # 025C21A  Review of available info, a lifetime friend, wrote a long social media post about the victim, she may have relevant info.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Adult patient was given the pediatric dose of the Moderna 2024-2025 vaccine .025 ml. No adverse reactions, wrong dose administered for patient's age.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Diplopia, Eye haemorrhage, Eye irritation, Eye pain
Clinical narrative: it was the pfizer bivalent booster. the day after the event, I had terrible pain and muscle cramping that wrapped my torso, went to emergency room and was given flexeril, then aroundTwo days after the event, I had swelling of the lips with big red hives,. Then approximately ten days later after we returned home, I woke up and my lower eyelids were drooped, i was seeing double, my eyes and head ached terribly adn were red and buring. Myupper lids were also, swollen over my eyes. I had little bubble of blood popping outof my eyes.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid ptosis, Headache, Lip swelling, Muscle spasms, Myalgia
Clinical narrative: it was the pfizer bivalent booster. the day after the event, I had terrible pain and muscle cramping that wrapped my torso, went to emergency room and was given flexeril, then aroundTwo days after the event, I had swelling of the lips with big red hives,. Then approximately ten days later after we returned home, I woke up and my lower eyelids were drooped, i was seeing double, my eyes and head ached terribly adn were red and buring. Myupper lids were also, swollen over my eyes. I had little bubble of blood popping outof my eyes.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Swelling of eyelid, Urticaria
Clinical narrative: it was the pfizer bivalent booster. the day after the event, I had terrible pain and muscle cramping that wrapped my torso, went to emergency room and was given flexeril, then aroundTwo days after the event, I had swelling of the lips with big red hives,. Then approximately ten days later after we returned home, I woke up and my lower eyelids were drooped, i was seeing double, my eyes and head ached terribly adn were red and buring. Myupper lids were also, swollen over my eyes. I had little bubble of blood popping outof my eyes.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Injection site discolouration, Skin discolouration
Clinical narrative: Subject Title: Urgent Investigation Request: Adverse Reactions to Flu Vaccination at Pharmacy  Request for Investigation:  Dear Office of Communication, Outreach, and Development (OCOD), FDA  I am writing to request an urgent investigation into a serious adverse reaction following a flu vaccination administered at pharmacy. Approximately three weeks ago, I received a flu shot at this location. Not long after the vaccination, I began experiencing alarming symptoms, including changes in skin color (from purple to green to yellow) spreading from the injection site to my chest, and pulsating chest pains throughout the day.  Given the severity and unusual nature of these symptoms, I suspect they may be related to the flu vaccination I received. Additionally, I am currently taking the following medications daily: B12, Central multivitamin, Sertraline 50mg, and Lisinopril 20mg.  I am seeking your assistance to investigate pharmacy for potential medical negligence and the distribution of problematic flu vaccinations.  I kindly request that your office:  Conduct a thorough investigation into the batch of flu vaccinations administered at the mentioned location.  Examine the pharmacy's compliance with vaccination storage and administration protocols.  Review any similar reports of adverse reactions from other individuals who received vaccinations at this pharmacy.  Take appropriate regulatory actions to ensure public safety and prevent further incidents.  Thank you for your attention to this matter. I look forward to your prompt response and assistance.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Myalgia, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Per teammate "I received flu shot on October 14th, an hour later I received an email stating that I was administered high dose of the flu vaccine I have been experiencing continuous low grade fever, headache, muscle pain and soreness which is not normal compared to the prior flu shot I have had in the past."
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia
Clinical narrative: Pain and numbness in right shoulder and joint.
Age: 6.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient initially received the influenza vaccine instead of the COVID vaccine - this was her second influenza vaccine this year.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site bruising
Clinical narrative: She has bruises on upper and lower parts of the left arm
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received Covid pediatric dose
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: mild fever, extreme joint pain (predominantly wrist, ankles), fatigue. lasted for 48 hrs post symptom onset Mitigated by taking ibuprofen. resolved after two days
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient was slightly feverish later in the evening.  No issues the day after.
Age: 0.42
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flu vaccine was ordered by Dr. and given prior to the child being 6 months old.  Mom has been made aware that this dose was invalid and child will need to receive two more doses of flu vaccine after 6 months of age.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: PATIENT STATED A FEW HOURS AFTER GETTING FLU SHOT THAT SHE HAD BACK PAIN.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Pulmonary embolism
Clinical narrative: Pt claims hospital doctor told him the flu shot was what caused his pulmonary embolism.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain
Clinical narrative: Patient reported adverse reaction on 10/17/2024. Patient stated that she felt instant pain when she got the vaccine on 10/09/2024 and believe she got the shot in her bone/joint. She states she went to a chiropractor and got a massage in the area. She stated she did not get it medically evaluated by a medical doctor. She stated she is able to move her arm around.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Crying, Mobility decreased, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Pharmacist on duty gave adult 12+ Moderna COVID vaccine to a child (2 years old); child was crying, not walking or crawling as usual, fever
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: PT received the flu shot on 9/25/24 to her left shoulder and stated she developed hives in the inner part her left arm. PT was seen in the ED on 9/30/24 for worsening hives throughout her body. PT was given steroids for her symptoms and instructed to follow up with Dr.. PT is currently taking Benadryl, Allegra, Zyrtec, and steroids for her symptoms as instructed by her PCP.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event
Clinical narrative: Provider ordered Pentacel and Hib and these were administered to the patient. No adverse events occurred per mother of patient.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Atrioventricular block, Cardiac arrest, Cardiac pacemaker insertion, Heart rate decreased, Resuscitation
Clinical narrative: Heart Block. By 11/17/23, pulse rate had dropped to 35. On 11/19/23, flat-lined at hospital and was resuscitated. Pace maker implanted on the morning of 11/20/23. Normal activities since then.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Periorbital swelling
Clinical narrative: swelling around both eyes
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face, Swollen tongue
Clinical narrative: About 4 hours after injection resident complained of his tongue feeling swollen and the left side of his face was swollen
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Clinic intended for patient to receive >= 12 year old formulation. Nurse pulled 6 month - 11 year formulation and administered to the patient. No harm observed to patient. Patient will return to clinic for follow-up to receive appropriate dose for age. Patient's last received two doses 12/10/21 and 12/31/21 of the Pfizer 5 - 11 years old formulation.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb mass, Peripheral swelling
Clinical narrative: Patient has a big lump on her left arm that is swollen and red. Patient go to see provider and believes the shot was given too low on the arm.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient experiencing vomiting starting at 2AM the morning after the vaccine, still experiencing at 9:15am.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing, Headache, Muscle spasms, Neck pain
Clinical narrative: Patient felt like the air was squeezed out of her lungs and then that they were filled up with fluid. Patient flushed and her heart began to race. Flushing went down after about 3 minutes, pain radiated up into neck and head. Patient began to have spasms in lower and mid back that worsened with breathing. Slight difficulty with breathing, mainly related to back spasm. No swelling of lips, tongue, or throat. Patient was monitored at pharmacy, EMS was called and they reported to the pharmacy. Patient was escorted to hospital via EMS.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Palpitations
Clinical narrative: Patient felt like the air was squeezed out of her lungs and then that they were filled up with fluid. Patient flushed and her heart began to race. Flushing went down after about 3 minutes, pain radiated up into neck and head. Patient began to have spasms in lower and mid back that worsened with breathing. Slight difficulty with breathing, mainly related to back spasm. No swelling of lips, tongue, or throat. Patient was monitored at pharmacy, EMS was called and they reported to the pharmacy. Patient was escorted to hospital via EMS.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: evening of vaccination day, low grade fever, and chills and site soreness.  Through the night developed muscle soreness  especially in neck and shoulders with a pounding headache.  The following day noticed a large red welt on injection site ( nearly 2 inches in diameter)  welt very circular, heated and raised.  As second day progressed the welt was itchy at times and didnot decrease in size.  Evening of second day low grade fever returned with chills although not with headache or muscle soreness.  Welt slightly decreased in size to day 1.3/4 inches in diameter still slightly rasied and giving off heat
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Pyrexia, Urticaria
Clinical narrative: evening of vaccination day, low grade fever, and chills and site soreness.  Through the night developed muscle soreness  especially in neck and shoulders with a pounding headache.  The following day noticed a large red welt on injection site ( nearly 2 inches in diameter)  welt very circular, heated and raised.  As second day progressed the welt was itchy at times and didnot decrease in size.  Evening of second day low grade fever returned with chills although not with headache or muscle soreness.  Welt slightly decreased in size to day 1.3/4 inches in diameter still slightly rasied and giving off heat
Age: 84.0
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea, Rash macular, Skin irritation
Clinical narrative: Sunburn-like skin irritation beginning on neck then extending to arms and legs where I had been in the sun the week before.  Then blotches all over my body.  Third day my breathing became difficult and I went to Urgent care, where they gave me a prescription for Prednazone (2 per day).    My Dermatologist had given me two creams for my skin before closing shop on Friday.  The day after Holiday the Dermatologist saw me first thing, increased my dose of Prednazone to three a day for three days, tapering off over the week.  After about 10 days the symptoms subsided.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Vomiting
Clinical narrative: Pt experienced vomiting starting at 2 am the morning after vaccine, has subsided some as of 9:15am but still not completely resolved. Also experiencing headache, no fever or muscle aches.
Age: 10.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt received the wrong covid vaccine for age, they received Pfizer for 12yo+ when they are 10yo. No known AE, reporting on website as well. Spoke to pts mom who said pt has had no known AE from vaccine, pt is 10yo however 5'6" and about 210lbs.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pancreatic carcinoma
Clinical narrative: Pt started having stomach pain.  Work up showed pancreatic cancer