chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Skin test
Clinical narrative: TINGLING AND NUMBNESS FROM LEFT ELBOW DOWN TO HALF OF LEFT HAND INCLUDING PINKY, RING FINGER AND PART OF MIDDLE FINGER.  THIS STARTED 5-10 MINUTES AFTER INJECTION; PAIN INCREASED OVER NEXT 24HRS AND THEN STABALIZED. PAIN INCREASES WHEN WORKING OR OTHERWISE USING HAND. 10 DAYS HAVE PASSED AND NO IMPROVEMENT BUT NO WORSENING AFTER INITIAL 24HRS. DOCTOR INDICATED IT MAY BE ULNAR NERVE RELATED.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event
Clinical narrative: pt did not report any adverse reaction so no treatment was needed
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: red circle on upper left arm that has a welt like appearance - hot to the touch and itchy per patient
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Wheezing
Clinical narrative: PATIENT STARTED HAVING DIFFICULTY BREATHING AND WHEEZING.  WE ELEVATED HER LEGS AND HAD HER STAY SEATED.  SHE WAS GIVEN AN ALBUTEROL INHALER AND USED 2 PUFFS IN WHICH IMMEDIATELY SHE FELT BETTER AND WAS ABLE TO BREATHE AGAIN.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, C-reactive protein increased, Gastrointestinal pain, Gluten sensitivity, Lymphadenopathy
Clinical narrative: Within a few weeks of booster dose (third Moderna shot in life), perpetual hives on the skin started. Two courses of prednisone were prescribed to stop the hives. Hives did not fully subside until daily Zyrtec was taken. After 9 months with hives subsided with Zyrtec, Zyrtec was weaned off. At that time, hives would only return when gluten was ingested (an allergy that was never present before). Ingestion of gluten caused intestinal bloating and pain. Avoiding gluten entirely fully prevent hives and intestinal symptoms. Other noticeable symptoms that appeared within weeks post booster vaccine were weight gain (possibly from prednisone) as well as chronic weight retention even with diet and exercise. Also within weeks of vaccination, golf ball size lymph nodes appeared under the armpits only subsiding after months. Gluten intolerance has persisted for now nearly two years since vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test, Urticaria, Weight increased, Weight loss poor
Clinical narrative: Within a few weeks of booster dose (third Moderna shot in life), perpetual hives on the skin started. Two courses of prednisone were prescribed to stop the hives. Hives did not fully subside until daily Zyrtec was taken. After 9 months with hives subsided with Zyrtec, Zyrtec was weaned off. At that time, hives would only return when gluten was ingested (an allergy that was never present before). Ingestion of gluten caused intestinal bloating and pain. Avoiding gluten entirely fully prevent hives and intestinal symptoms. Other noticeable symptoms that appeared within weeks post booster vaccine were weight gain (possibly from prednisone) as well as chronic weight retention even with diet and exercise. Also within weeks of vaccination, golf ball size lymph nodes appeared under the armpits only subsiding after months. Gluten intolerance has persisted for now nearly two years since vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: It's great.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Single component of a two-component product administered
Clinical narrative: Patient was given the Arexvy vaccine adjuvant without the antigen. The patient got another vaccine with the adjuvant mixed with the antigen right after the pharmacist noticed that the first was not mixed first with the antigen.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TD, VARCEL
Symptoms: Depressed level of consciousness, Hyperhidrosis
Clinical narrative: Hep A IM, Hep B IM, IPV IM, MMR Subcutaneous, Td (adult formulation) IM and Varicella Subcutaneous given per protocol using proper technique. After receiving vaccines at 9:56 am, patient reported not feeling well and started to feel dizzy, skin color was pale and clammy. V/S vital signs were taken immediately HR 49, BP 120/66 , O2 saturation at 95 percent. Provider was notified immediately while still remaining with patient. Patient started to close his eyes and nurse kept him aroused to keep him from losing consciousness, patient was still oriented person, place and location. Patient was sweating profusely and 2 ice packs were given to patient to hold on both hands by provider. Legs were elevated, and reminded patient to breath in and out and follow command given to remain consciousness, patient was instructed to move toes and squeeze hands without any problem or loss of grip. Patient was also given a small snack, and patient was able to intake with no issue. Father and Son reported not having breakfast before coming to appointment, Provider gave patient water to sip on and was able to tolerate it. Second set of Vital signs were taken at 10:03 am BP 126/79, HR 65 O2 saturation at 100 percent. Patient regained skin color and sweating has stopped. Patient was alert and oriented x3. Patient reported, " I'm feeling better now." Patient remained seated. Vital signs were taken at 10:08am BP 132/83, HR 71 O2 saturation at 100 percent. At 10:13 am, patient was instructed to stand up while nurse on the side, patient was able to stand up without assistance and take a few steps without assistance. Patient and dad were instructed to seek emergency care if symptoms arise and worsen immediately. Both Father and patient verbalized understanding. No EMS was called and were released from our care at 10:17am. VAERS report submitted. Supervisor notified.
Age: 72.0
Sex: M
Vaccine: FLU4, RSV, VARZOS
Symptoms: Chills, Dizziness, Lethargy, Mobility decreased, Myalgia
Clinical narrative: Patient called after getting 3 imz yesterday about some side effects/ reactions. Patient had received Shingrix, Fluzone HD, and Arexvy. He was fine after the vaccines, but later that night got chills, fever, muscle aches, lethargy, some dizziness. This morning he had some difficulty getting around due to the muscle aches and dizziness and had some difficulty with vision. He said he had glasses on but it was like he still didn't, was very blurry and unable to focus or read things. This was currently getting better. He called us to verify which vaccines he had received. I went over them with him and discussed how most of that are side effects that can happen with the vaccines but the change in vision is abnormal. I told him he could take some Tylenol to help with fever, chills, and body aches. He appreciated that. I told him if anything worsens or does not go away to go in to the doctor. He stated he would and would let his doctors know as well. I called patient 9/10/23 and patient was doing better.
Age: 72.0
Sex: M
Vaccine: FLU4, RSV, VARZOS
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Patient called after getting 3 imz yesterday about some side effects/ reactions. Patient had received Shingrix, Fluzone HD, and Arexvy. He was fine after the vaccines, but later that night got chills, fever, muscle aches, lethargy, some dizziness. This morning he had some difficulty getting around due to the muscle aches and dizziness and had some difficulty with vision. He said he had glasses on but it was like he still didn't, was very blurry and unable to focus or read things. This was currently getting better. He called us to verify which vaccines he had received. I went over them with him and discussed how most of that are side effects that can happen with the vaccines but the change in vision is abnormal. I told him he could take some Tylenol to help with fever, chills, and body aches. He appreciated that. I told him if anything worsens or does not go away to go in to the doctor. He stated he would and would let his doctors know as well. I called patient 9/10/23 and patient was doing better.
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Patient adverse reaction to Shingrix redness, swelling 24h after injection. 5 days post vaccine, some improvement w/bandage hydrocortisone . Pt concerned w/administration too low immunization 12ph, PharmD, confirms 3 finger technique
Age: 69.0
Sex: F
Vaccine: FLU4, HEPAB, RSV
Symptoms: Syncope
Clinical narrative: Patient experienced syncope after the vaccines were administered to her.
Age: 16.0
Sex: M
Vaccine: FLUC4, MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Patient presents 2 days after vaccinations with widespread hives that began more than 24 hrs after he received his menquadfi, trumenba, and flucelvax. Symptoms partially resolved with use of some benadryl
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: felt light headed with Gardasil.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administration error
Clinical narrative: Patient claimed that they did not receive a covid vaccination and a second dose of Pfizer Bivalent inadvertently administered 28 days later
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Patient claimed that they did not receive a covid vaccine and received a second dose of Pfizer Bivalent 28 days after the first dose at another pharmacy
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Cardiac arrest, Cerebral disorder, Death, Electroencephalogram abnormal, Resuscitation
Clinical narrative: Cardiac arrest, pt revived but EEG revealed no cortical, only brainstem functioning; (pt died 3 days after being placed in hospice)
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriogram coronary normal, Bundle branch block left, Cardiac failure, Dyspnoea, Echocardiogram abnormal
Clinical narrative: Rx Heart Failure (L bundle branch block with 25% ejection fraction found in 7/2022 by MD via an echocardiogram) Symptoms: extreme SOB, lethargy angiogram done no blockages in cardiac arteries
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction decreased, Fatigue, Implantable defibrillator insertion, Lethargy
Clinical narrative: Rx Heart Failure (L bundle branch block with 25% ejection fraction found in 7/2022 by MD via an echocardiogram) Symptoms: extreme SOB, lethargy angiogram done no blockages in cardiac arteries
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Headache, Hyperhidrosis, Syncope
Clinical narrative: PATIENT EXPERIENCED SYNCOPE REACTION - AFTER THE VACCINE, SHE EXPERIENCED BLURRY VISION, HEADACHE, DIZZY, COLD CLAMMY SKIN, SWEATY AND FAINTED.  AFTER SHE CAME TO US,SHE WAS INSTRUCTED TO LAY DOWN WITH FEET UP UNTIL SHE FELT BETTER WHICH TOOK ABOUT 15 MINUTES. PATIENT WAS ABLE TO WALK OUT OF THE STORE AFTER
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Vision blurred
Clinical narrative: PATIENT EXPERIENCED SYNCOPE REACTION - AFTER THE VACCINE, SHE EXPERIENCED BLURRY VISION, HEADACHE, DIZZY, COLD CLAMMY SKIN, SWEATY AND FAINTED.  AFTER SHE CAME TO US,SHE WAS INSTRUCTED TO LAY DOWN WITH FEET UP UNTIL SHE FELT BETTER WHICH TOOK ABOUT 15 MINUTES. PATIENT WAS ABLE TO WALK OUT OF THE STORE AFTER
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient experienced symptoms of cellulitis red, hot tender at injection site
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Nurse reported 5-year-old patient received GARDASIL 9. The operator of the product was a healthcare professional. No additional AE/no PQC.; This spontaneous report as received from a nurse referring to a 5 year old patient. Information regarding the patient medical history, concomitant medications drug allergies or reactions was not provided.       On 12-AUG-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 for prophylaxis (strength, administration route, lot number and expiry date were not provided) (product administered to patient of inappropriate age). No additional adverse event was provided.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a health worker and refers to a 4-year-old male patient.  The patient's concurrent conditions included asthma. His medical history, drug allergies or reactions and concomitant therapies were not reported.  On 17-AUG-2023, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant human albumin (rHA)) 1 dose, lot #W000996 (which was confirmed to be a valid lot # for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (PROQUAD)), expiration date 08-JUL-2024 subcutaneously in left arm (strength not provided) as prophylaxis, that prior underwent a temperature excursion of 29 degrees Fahrenheit for 4 hours and 30 minutes due to a power outage (product storage error). No additional adverse events were reported.  This is one of several cases reported by the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: The healthcare worker is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAQTA w038118   4/6/2024 Temperature : 50F Time f; The healthcare worker is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAQTA w038118   4/6/2024 Temperature : 50F Time f; Information has been received from a health care professional, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-AUG-2023, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, lot #W038118, expiration date: 06-APR-2024, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse events were reported.  The vaccine had a temperature excursion of 50 Fahrenheit degrees (F) during 3 hours. It was confirmed that no previous temperature excursions occurred.
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Wrong product administered
Clinical narrative: a dose of Tdap was given instead a dose of GARDASIL 9.; This spontaneous report was received from an officer manager referring to a female patient of unspecified age. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.   On unspecified different dates, the patient received 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported) as prophylaxis.  On 31-AUG-2023, the patient was administered a dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (indication, dose, route of administration, lot# and expiration date were not reported) instead of a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (indication: prophylaxis) (wrong product administered). The reporter was requesting information regarding concomitant administration of the aforementioned vaccines; however, it was unknown if the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on that day.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incomplete course of vaccination, No adverse event, Product dose omission issue
Clinical narrative: No additional AE; A 4-month-old child missed his 2nd dose of ROTATEQ.; A 4-month-old child missed his 2nd dose of ROTATEQ.; This spontaneous report was received from a consumer (patient's mother) and refers to a 4 months old infant patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date in 2023, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (strength, dose, lot #, and expiration date were not provided) for prophylaxis. On an unknown date in 2023, the patient missed the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Incomplete course of vaccination). No adverse events were reported (No adverse event).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage intracranial, Ischaemic stroke
Clinical narrative: Acute ischemic stroke Intracranial hemorrhage
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pharmacist administered Fluzone Quadrivalent High-Dose to patient who is 63 years old without a prescription from their doctor. Patient was recommended high dose by their doctor, but did not have prescription. The recommended age for this vaccination is 65 years and older.
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Chills, Dysphagia, Dysstasia, Muscle fatigue
Clinical narrative: I just wanted to report that I'm experiencing an adverse reaction to the flu shot beyond what I would consider normal limits. At approx 7PM 9/12/2023, I started experiencing severe chills, muscle fatigue, inability to stand up straight (weakness) tingling in jawline, difficulty swallowing, and high fever (104-105 degrees farenheit at the highest). Fever slow to respond to Tylenol and cold compress. This is an early report so final outcome is not available yet.
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: I just wanted to report that I'm experiencing an adverse reaction to the flu shot beyond what I would consider normal limits. At approx 7PM 9/12/2023, I started experiencing severe chills, muscle fatigue, inability to stand up straight (weakness) tingling in jawline, difficulty swallowing, and high fever (104-105 degrees farenheit at the highest). Fever slow to respond to Tylenol and cold compress. This is an early report so final outcome is not available yet.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: The authorization for Bivalent Covid vaccines ended before we administered the vaccine here. We are in another country and did not receive the notice until 09/13/2023 our time.
Sex: U
Vaccine: MMRV
Symptoms: Product dose omission issue
Clinical narrative: missed dose; no adverse event; This spontaneous report as received from a registered nurse refers to a currently 17 years old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route and lot # not reported).   The nurse reported that on an unknown date, the patient missed the last dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) series and was now out of the range in the prescribing information as patient was 17 years old.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion, Rash pruritic
Clinical narrative: itchy rash; severe bruising; This spontaneous case was reported by a physician and describes the occurrence of RASH PRURITIC (itchy rash) and CONTUSION (severe bruising) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism, High cholesterol and Disorder gastrointestinal (unusual gastrointestinal problems). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR), OMEPRAZOLE, URSODIOL, RIFAXIMIN, LIOTHYRONINE SODIUM (CYTOMEL), LORAZEPAM, COLECALCIFEROL (VIT D [COLECALCIFEROL]), CYANOCOBALAMIN (VIT B12) and PARACETAMOL (TYLENOL) for an unknown indication.    On 01-Mar-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced RASH PRURITIC (itchy rash) and CONTUSION (severe bruising). At the time of the report, RASH PRURITIC (itchy rash) and CONTUSION (severe bruising) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   After she got the 1st dose of the bivalent vaccine, she had very itchy rash and severe bruising. She consulted a colleague and was told that it was concerning and that if she was getting another bivalent dose, she should take premedication like antihistamines or steroid. She did not have a problem with her 1st 2 doses.   This case was linked to US-MODERNATX, INC.-MOD-2023-739852 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739852:same reporter ( Different Dose 2)
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Menstrual cycle changes; no longer regular and flow rate has decreased, excessive spotting
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Nausea, Pyrexia
Clinical narrative: Nausea, fever, insomnia, headache
Age: 88.0
Sex: F
Vaccine: RSV
Symptoms: Decreased appetite, Haematology test normal, Impaired driving ability, Pyrexia, Urine analysis
Clinical narrative: I started having a fever by Friday ( the second day after the vaccine was administered).  I was unable to drive safely, experienced confusion.  Lost appetite.  On Monday, Sept 11, I was driven to an ER by a friend.  There all tests were negative and they concluded it was a reaction to the RSV vaccine.  I've never had any reactions to ANY vaccines, so this was a complete surprise!
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Contusion, Pain
Clinical narrative: Bruise appeared 2 days after with some pain x2 weeks. No fever. Bruise improving but still present. No pain or others symptoms.
Age: 29.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient called the pharmacy to report adverse reactions after getting their flu shot. Patient's arm started getting red and swelled up 1 and 1/2 hours after getting their vaccine. Patient reported that it swelled up to 3x in size. It has come  down today and has not spread further. The patient did report they have a history of reactions caused by an unknown cause. I told the patient to take ibuprofen and put ice on the area. They cannot take Benadryl. If they have worsening signs to seek emergency care.
Sex: M
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node in his neck; This spontaneous report was received from an administrator (also reported as health business professional (HBP)) via company representative and refers to an 11-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered intramuscularly for prophylaxis (reported as routine vaccination) (anatomical location, lot #, and expiration date were not reported).  On an unknown date, the patient experienced swollen lymph node in his neck. He sought medical attention (contacted primary care physician [PCP]), but no treatment was given for the event. It was unknown if any laboratory diagnostics or study procedures were performed. At the time of reporting, the outcome of the event was unknown.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccinated on 21-SEP-2004, 29-NOV-2004, 21-JAN-2005, 22-SEP-2010; Vaccinated on 21-SEP-2004, 29-NOV-2004, 21-JAN-2005, 22-SEP-2010; This spontaneous report has been received from a lawyer and physician, via a fact sheet and immunization record from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2303USA000650), concerning a 9-week-old female patient (pt). The pt's pertinent medical history or concurrent conditions were not reported.   On 21-SEP-2004, 29-NOV-2004, 21-JAN-2005 and 22-SEP-2010, the pt was vaccinated with Hepatitis B Vaccine (manufacturer unknown) (exact dose, anatomical location, route of administration, lot # and expiration date were not reported) for prophylaxis, which was considered an inappropriate schedule of vaccine administered.   The pt's vaccines also included: haemophilus b vaccine (manufacturer unknown) (administered on: 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005), unspecified diphtheria (+) tetanus (+) pertussis (DTaP) vaccine (administered on: 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005, 24-SEP-2009), unspecified inactivated Poliovirus vaccine (IPV) (administered on 29-NOV-2004, 21-JAN-2005, 27-DEC-2005, 24-SEP-2009), unspecified pneumococcal conjugate-7 vaccine (PCV7) (administered on: 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 22-SEP-2005), measles (+) mumps (+) rubella (MMR) vaccine (manufacturer unknown)(administered on: 22-SEP-2005, 24-SEP-2009), varicella vaccine (manufacturer unknown) (administered on: (22-SEP-2005, 24-SEP-2009), hepatitis A vaccine (manufacturer unknown) (administered on:22-MAR-2006, 26-SEP-2006), unspecified meningococcal conjugate vaccine (MCV4), unspecified influenza vaccine (administered on: 03-OCT-2012, 16-OCT-2013, 01-OCT-2014, 01-OCT-2015, 03-OCT-2016), unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid vaccine (TDAP) (administered on 01-OCT-2015), HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (administered on 03-OCT-2016), unspecified hpv vaccine (manufacturer unknown) (administered on 03-OCT-2017).   This is one of the three reports concerning the same patient.; Sender's Comments:  US-009507513-2309USA001194: US-009507513-2303USA000650:
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; an expired dose of GARDASIL 9 was administered to a patient today on 8SEP2023; This spontaneous report was received from a medical assistant referring to a 17-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were reported.   On 08-SEP-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (0.5 ml/ once, lot#: U008316, expiration date: 15-AUG-2023; strength and route of administration was not provided) for prophylaxis (expired product administered). No adverse effects were noted. No additional information was provided (no adverse event).
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash vesicular, Vaccination failure
Clinical narrative: Itchy; eruptions of new vesicles; Suspected vaccination failure; symptoms of Shingles/Shingles; This serious case was reported by a nurse and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In OCT-2020, the patient received the 2nd dose of Shingrix (left arm). In JUL-2020, the patient received the 1st dose of Shingrix (left arm). On 30-AUG-2023, 3 years after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: symptoms of Shingles/Shingles). On an unknown date, the patient experienced pruritus (Verbatim: Itchy) and vesicular eruption (Verbatim: eruptions of new vesicles).The patient was treated with valaciclovir (Valacyclovir) and antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus and vesicular eruption were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and vesicular eruption to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles, pruritus and vesicular eruption to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2023 and 08-SEP-2023 The reporter was a retired nurse called to report that she developed a significant case of shingles almost three years after receiving her Shingrix. The reporter reported that the shingles were on her left trunk and going around to the back midline. The most outbreak was on the front and just a small outbreak on her back.  The reporter reported that she was on her last dose of antiviral.  The shingles have not resolved, as some areas were still itchy.  She began to have symptoms of Shingles.  It was not a mild case and she continued to have eruptions for the next week.  The patient went on Valacyclovir within 72 hours but it did little to prevent more eruptions. The patient did not believe the reports that the vaccine was 90 percent effective in her age group. It was if it did nothing to reduce the severity or duration of the disease.  The patient was a week out now and she still had daily eruptions of new vesicles. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Scar, Skin mass
Clinical narrative: Knot softball size; Some discomfort; Softball size knot turned to a reddish; Softball size knot turned to a reddish scar; This non-serious case was reported by a consumer and described the occurrence of skin nodule in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced skin nodule (Verbatim: Knot softball size), discomfort (Verbatim: Some discomfort), erythema (Verbatim: Softball size knot turned to a reddish) and scar (Verbatim: Softball size knot turned to a reddish scar).  The outcome of the skin nodule and discomfort were resolved and the outcome of the erythema and scar were not reported.   It was unknown if the reporter considered the skin nodule, discomfort, erythema and scar to be related to Shingles vaccine.     It was unknown if the company considered the skin nodule, discomfort, erythema and scar to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-SEP-2023 The patient reported that he or she received Shingles vaccine and initially experienced softball size and some discomfort. After a week, softball size turned into a reddish scar with no pain. The patient stated that the knot and discomfort gone. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: received Tdap (Boostrix) vaccine instead of HepB vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 01-SEP-2023, the patient received Boostrix. On 01-SEP-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: received Tdap (Boostrix) vaccine instead of HepB vaccine). The outcome of the wrong vaccine administered was unknown.  Additional Information: GSK Receipt Date: 05-SEP-2023 The reporter was an officer in charge of initial processing center, reported that a trainee (patient) received Tdap (Boostrix) vaccine instead of Hepatitis B vaccine, which led to wrong vaccine administered. The reporter did not had information about lot number, expiry date, patient initials, gender, date of birth, healthcare professional (HCP) contact information of the trainee, and mailing address of the camp she was calling from. The reporter stated that, she would need to contact her internal team to collect detailed information. This was 1 of the 112 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023121025:Same reporter (1st Master case US2023121025 out of 112 cases)
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first Shingrix vaccine 3 years ago, but has not received the second Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received at unknown arm 3 years ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first Shingrix vaccine 3 years ago, but has not received the second Shingrix vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2023 The reporter was a patient's friend. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose of Engerix on 18June2023 and is late for the 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: received 1st dose of Engerix on 18June2023 and is late for the 2nd dose.).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 07-SEP-2023 Health care professional (HCP) was at home and did not have any patient and vaccination details other than the date. Patient received 1st dose of Engerix on 18th June2023 and was late for the 2nd dose. Till the date of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. The HCP consented to follow-up via email.
Age: 58.0
Sex: M
Vaccine: HEP, MMR
Symptoms: No adverse event, Product use issue
Clinical narrative: Pt was given MMR while taking an immune suppressant. Pt had been vaccinated at least 2 times as a child. A CDC conference of experts was held to review the case in full.  Pt had NO adverse events.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: pt reported adverse reaction of hives and shortness of breath
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: After administering the vaccine to the patient, it was discovered that the vaccine expiration date was September 3. The vaccine manufacturer was contacted and the representative from the company stated the vaccine was good for 1 month after the expiration date.  The dose given is considered valid since it was within that month and the patient does not need to be revaccinated. Patient did not experience any adverse events related to the administration of this vaccine.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: To date, symptoms have persisted for five days. They include: fatigue, joint pain, neck stiffness, headache, left arm pain; continued redness, pain and topical heat at site of injection.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: To date, symptoms have persisted for five days. They include: fatigue, joint pain, neck stiffness, headache, left arm pain; continued redness, pain and topical heat at site of injection.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: Only MenCYW-135 Liquid was given, it was NOT combined with the MenA Lyophilized powder. No adverse reaction, signs or symptoms.
Age: 65.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Arthralgia, Diarrhoea, Erythema, Incorrect route of product administration, Pain in extremity
Clinical narrative: Patient was given Arexvy subcutaneously instead of intramuscularly by mistake.  The day after vaccination, patient had soreness, redness, joint aches in both arms and diarrhea off and on through Day3 after vaccination.  As of Day 3 the redness, soreness and joint aches had resolved and only mild diarrhea was ongoing.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received pediatric dosage of Hepatitis B Engerix B vaccine (10mcg/0.5mL) rather than indicated dosage of 20mcg/1mL. Patient experienced no adverse effects as a result of this error.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient received incorrect vaccine. Patient received Hep A vaccine rather than Tdap vaccine. Patient was notified of the mistake, was then asked if she wanted the Hep A vaccine as well, patient agreed since it had already been administered. patient now has to return for second Hep A vaccine to complete the series.
Age: 0.5
Sex: M
Vaccine: COVID19-2, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Patient received the wrong dose of the COVID 19 vaccine. Patient was given 0.2ml of the vial containing the 0.2ml/10mcg dose instead of the 0.25ml/25mcg
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Blood urine, Computerised tomogram, Seizure
Clinical narrative: Seizure
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Gait disturbance, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient developed a swollen left leg, with redness and swelling. The parent described it as a red blotchy rash. Patient could not walk on that leg for 4 days. He saw his healthcare provider who prescribed antibiotics and this helped. Patient did have a lack of appetite, fever up to 100 F and body aches.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pain, Rash erythematous, Rash macular
Clinical narrative: Patient developed a swollen left leg, with redness and swelling. The parent described it as a red blotchy rash. Patient could not walk on that leg for 4 days. He saw his healthcare provider who prescribed antibiotics and this helped. Patient did have a lack of appetite, fever up to 100 F and body aches.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Brain fog, Exophthalmos, Fatigue
Clinical narrative: Thyroid disease. Every symptom, except elevated thyroid levels.  Extreme fatigue, lack of stamina, weight gain, memory issues, brain fog, bulging eyes,  debilitating headaches caused by pressure inside head, blurry vision, seeing floaters in my eye. Pseudo tumor reaction behind my right eye.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Idiopathic orbital inflammation, Magnetic resonance imaging, Memory impairment
Clinical narrative: Thyroid disease. Every symptom, except elevated thyroid levels.  Extreme fatigue, lack of stamina, weight gain, memory issues, brain fog, bulging eyes,  debilitating headaches caused by pressure inside head, blurry vision, seeing floaters in my eye. Pseudo tumor reaction behind my right eye.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroid disorder, Vision blurred, Vitreous floaters, Weight increased
Clinical narrative: Thyroid disease. Every symptom, except elevated thyroid levels.  Extreme fatigue, lack of stamina, weight gain, memory issues, brain fog, bulging eyes,  debilitating headaches caused by pressure inside head, blurry vision, seeing floaters in my eye. Pseudo tumor reaction behind my right eye.
Age: 1.08
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given dose 1 from the wrong vial.  Patient was administered 0.2ml from the 0.2ml/10mcg vial.  Patient should have received 0.25ml/25mcg based on age and previous vaccination status.
Age: 8.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was given
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given dose 1 from the wrong vial.  Patient was administered 0.2ml from the 0.2ml/10mcg vial.  Patient should have received 0.25ml/25mcg based on age and previous vaccination status.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Brain fog, Echocardiogram normal, Fatigue, Tachycardia
Clinical narrative: Tachycardia, fatigue and 'brain fog' Noticed in October 2022 and started to wane in May/June 2023. Started on Cardizem for tachycardia in March 2023.
Age: 1.08
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given dose  from the wrong vial.  Patient was administered 0.2ml from the 0.2ml/10mcg vial.  Patient should have received 0.25ml/25mcg based on age and previous vaccination status.  Patients will be  notified. Based on current recommendations from CDC we will not revaccinate.
Age: 7.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: patient given expired vaccine
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the liquid portion of Menveo; administered only the liquid portion of Menveo; This was the booster dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA758A, expiry date 31-OCT-2024) for prophylaxis.   On 08-SEP-2023, the patient received Menveo. On 08-SEP-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered only the liquid portion of Menveo), inappropriate dose of vaccine administered (Verbatim: administered only the liquid portion of Menveo) and extra dose administered (Verbatim: This was the booster dose).  The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and extra dose administered were unknown.   Additional Information: GSK Receipt date: 08-SEP-2023 The reporter stated that she administered only liquid portion of Menveo to a patient. The reporter reported that this was a booster dose of Menveo that was given to patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The reporter stated that she administered only liquid portion of Menveo to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter reported that patient received Menveo as booster dose, which led to extra dose.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: The backs of my arms and my armpits started aching on the left side ar first, then both arms after a week.
Age: 20.0
Sex: F
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Physician ordered flulaval on patient but was administered Prevnar 20 instead. Nurse advised and physician of incident. Patient was made aware while still here in the office.  When nurse reported it was found that proper second check was not completed. Both physician and nurse are new to the office. Education was provided again to both physician and nurse regarding the proper second check protocol. Patient refused flulaval vaccine.
Age: 0.75
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given dose  from the wrong vial.  Patient was administered 0.2ml from the 0.2ml/10mcg vial.  Patient should have received 0.25ml/25mcg based on age and previous vaccination status.  Patients will be  notified. Based on current recommendations from CDC we will not revaccinate.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cold-stimulus headache, Electroencephalogram, Feeling cold, Immediate post-injection reaction
Clinical narrative: I felt a cold shock on the left side of my head like brain freeze right after injection then started seizing for the first time of my life 20 minutes later.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Seizure
Clinical narrative: I felt a cold shock on the left side of my head like brain freeze right after injection then started seizing for the first time of my life 20 minutes later.
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given dose  from the wrong vial.  Patient was administered 0.2ml from the 0.2ml/10mcg vial.  Patient should have received 0.25ml/25mcg based on age and previous vaccination status.  Patients will be  notified. Based on current recommendations from CDC we will not revaccinate.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Injection site pain, swelling spreading erythema and blister formation
Age: 60.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Dyspnoea, SARS-CoV-2 test negative
Clinical narrative: Sunday, I started having breathing problems, I had to use my rescue inhaler, on Monday, my breathing was getting worst, I had to use oxygen, and nebulizer and inhaler every 9-12 hours. I have been on oxygen for two days. My oxygen is on a level 2.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: About 14.5 hours after injection, I began to experience chills, some shivering, and some muscle aches.  I took some generic Tylenol and got under the blankets.  Symptoms subsided after a couple of hours.
Age: 0.75
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given dose  from the wrong vial.  Patient was administered 0.2ml from the 0.2ml/10mcg vial.  Patient should have received 0.25ml/25mcg based on age and previous vaccination status.  Patients will be  notified. Based on current recommendations from CDC we will not revaccinate.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received vaccine in his former clinic but the system did not have update, so it seemed like he was missing those vaccines. No adverse events were noticed. No signs or symptoms were reported.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Eye movement disorder, Headache, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient experienced seizure like activity including eyes rolling, shaking, pale skin and sweating. After a few seconds, patient alert but experienced nausea and headache.  Patient was provided ice packs behind the neck, arms and groin. Once able to sit up, patient was provided with juice. After 30min, color back to baseline, no further nausea/headache. Patient able to sit up, stand slowly and ambulate  normally. Patient left the office with mom.