chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Both she and her father contracted COVID-19 and had recently received booster shots; Both she and her father contracted COVID-19 and had recently received booster shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Both she and her father contracted COVID-19 and had recently received booster shots". Clinical course: Caller called on behalf of her father, currently battling COVID-19, seeking information on how to obtain Paxlovid due to financial constraints. She clarified that while she followed her doctor's prescription for a different medication, her father is now grappling with COVID-19. Caller's father hasn't gotten his Paxlovid yet and might miss the recommended timeframe for the medication.  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-202300457472 same reporter/product/event, different patient;
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient only received the hibb part that was administered with the sterile water (with no reported adverse event); Initial information received on 20-Dec-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and gender patient who only received the hibb part that was administered with the sterile water with no reported adverse event while receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, Suspension for injection (batch number: UJ957AB; expiry date: 01-Jun-2024; Frequency: once) via unknown route in unknown administration site for Immunization; patient only received the hibb part that was administered with the sterile water with no reported adverse event (single component of a two-component product administered) (same day latency).  Reportedly, Nurse called to report that , had been administered to 2 patients yesterday but 1 patient only received the hibb part that was administered with the sterile water.    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: 0.33
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: instead of reconstituting the ActHIB powder with the DTaP-IPV solution, she mixed it with sterile water with no reported adverse event; DTaP-IPV and ActHIB given as 2 separate injections with no reported adverse event; Initial information received on 20-Dec-2023 regarding an unsolicited valid non-serious case received via Nurse.  This case involves a 4-month-old male patient and the reporter reported instead of reconstituting the acthib powder with the dtap-ipv solution, she mixed it with sterile water with no reported adverse event and dtap-ipv and acthib given as 2 separate injections with no reported adverse event after receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 18-Dec-2023, the patient received a 0.5 ml total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ858AA, expiry date: 29-Mar-2024) via intramuscular route in unknown administration site for Immunisation, instead of reconstituting the acthib powder with the dtap-ipv solution, she mixed it with sterile water with no reported adverse event (product preparation error) and dtap-ipv and acthib given as 2 separate injections with no reported adverse event (wrong technique in product usage process) (latency: same day)  Action Taken: Not applicable    Outcome: Unknown   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: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient who was administered with ACTHIB that was reconstituted using a different saline diluent, rather it was reconstituted with the diluent of the Mmr Varicella vaccine they had with no reported adverse event; Initial information received on 21-Dec-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient where reporter reported that patient who was administered with hib (prp/t) vaccine [ACT-HIB] that was reconstituted using a different saline diluent, rather it was reconstituted with the diluent of the mmr varicella vaccine they had with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Dec-2023, the patient received 0.5 ml dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (lot UJ862AAand Expiration Date: 24-Mar-2024) via intramuscular route in the right thigh (strength: not provided) for Immunisation (product preparation error) (unknown latency).  Action Taken: Not applicable    Outcome: Unknown  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: 68.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: product administered to a patient after the excursion (with no reported adverse event); Initial information received on 27-Dec-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 68 years old female patient (INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]) to whom product administered after the excursion (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Dec-2023, the patient received 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UT8150DA, expiry- 30-Jun-2024 via intramuscular route in the left deltoid for immunization (strength: unknown), product administered to a patient after the excursion (with no reported adverse event) (poor quality product administered) (latency same day).  Reportedly, Max/Low Temperature reached: -22.7 C Duration out of labelled range: 50 mins Human Error: Unknown.  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: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Patient received Fluzone HD with us on 12/17/2023 and came in today mentioning that she has been having pain at the injection site that has not been responded to Tylenol or Ibuprofen. According to patient, her doctor told her that we injected at a wrong site; not into the muscle, that caused shoulder injury that she might have to go to physical therapy.  Patient hope that this pain will go away in couple weeks.
Age: 77.0
Sex: F
Vaccine: TD
Symptoms: Atrial flutter, Cardioversion, Echocardiogram, Echocardiogram abnormal, Tachycardia
Clinical narrative: Wednesday Nov 29: tachycardia.  Cardiologist seen on Tuesday December 5; diagnosed atrial flutter
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Hyperhidrosis, Influenza like illness, Pain
Clinical narrative: PATIENT WAS INADVERTANTLY ADMINISTERED 2 DOSES OF MODERNA SPIKEVAX ON 12/30/23 (ONE DOSE IN LEFT DELTOID AND ONE IN RIGHT DELTOID).  SIDE EFFECTS REPORTED WERE BRAIN FOG ALMOST IMMEDIATELY AFTER VACCINATION. THE BRAIN FOG LASTED TIL 5:30 TO 6PM THAT SAME DAY  12/30/23. THAT EVENEING THE PATIENT WOKE UP IN THE MIDDLE OF THE NIGHT (APPROXOMATLY MIDNIGHT) WITH ARMS BEING SORE.   (AS IF HE HAD A HEAVY GYM WORKOUT) HE DID NOT SLEEP WELL THAT NIGHT BECUASE HE COULD NOT GET COMFORTABLE.THE ARM SORENESS WAS GONE BY MORNING. (SUNDAY 12/31/23) 3PM IS WHEN HE STARTED TO FEEL MILD FLU LIKE SYMPTOMS .... IN WHICH GENERALIZED BODY ACHES SHIVERS SWEATING (NO FEVER AS MEASURED BY THERMOMETER) . THE FLU LIKE SYMPTOMS LASTED 5 TO 6 HOURS AND THEN PT RETURNED TO FEELING NORMAL AGAIN AND HAS FELT FINE SINCE AS OF 01/02/24 10:30AM.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: PATIENT WAS INADVERTANTLY ADMINISTERED 2 DOSES OF MODERNA SPIKEVAX ON 12/30/23 (ONE DOSE IN LEFT DELTOID AND ONE IN RIGHT DELTOID).  SIDE EFFECTS REPORTED WERE BRAIN FOG ALMOST IMMEDIATELY AFTER VACCINATION. THE BRAIN FOG LASTED TIL 5:30 TO 6PM THAT SAME DAY  12/30/23. THAT EVENEING THE PATIENT WOKE UP IN THE MIDDLE OF THE NIGHT (APPROXOMATLY MIDNIGHT) WITH ARMS BEING SORE.   (AS IF HE HAD A HEAVY GYM WORKOUT) HE DID NOT SLEEP WELL THAT NIGHT BECUASE HE COULD NOT GET COMFORTABLE.THE ARM SORENESS WAS GONE BY MORNING. (SUNDAY 12/31/23) 3PM IS WHEN HE STARTED TO FEEL MILD FLU LIKE SYMPTOMS .... IN WHICH GENERALIZED BODY ACHES SHIVERS SWEATING (NO FEVER AS MEASURED BY THERMOMETER) . THE FLU LIKE SYMPTOMS LASTED 5 TO 6 HOURS AND THEN PT RETURNED TO FEELING NORMAL AGAIN AND HAS FELT FINE SINCE AS OF 01/02/24 10:30AM.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Aphonia, Chest X-ray abnormal, Chest discomfort, Computerised tomogram abdomen normal, Computerised tomogram head normal
Clinical narrative: I started with extreme fatigue the night of the shot and was only able to stay awake a few hours all weekend, I developed an intense headache and facial pain, body aches and muscle pain. I went into the walk in clinic a few days later and was diagnosed with possible sinus infection and ear infection  (sinus and nasal congestion, sore throat and bilateral ear pain). The following day I started having a deep constant cough, fever, shortness of breath, and loss of voice. The doctor did a covid test and chest x ray and it was thought to be bronchitis. These symptoms continued to worsen over the course of the next few weeks and I developed dizziness, chest tightness, light headedness,  increased respiratory rate, and continued extreme fatigue . I ended up having 3 er visits and 14 doctor visits (walk in, pulmonology, internal med, family med, neurology and chiropractic) between 10/8 and 11/14.  I had a pulmonary work up, labs, ekg, chest/brain/abdomen ct, 21 panel virus swab on 2 occasions, mono test, elevated d dimer test which was followed by a nuc med scan for a blood clot, headache infusion and injections. All scans and tests ended up negative. I did not respond to multiple courses of steroids, antibiotics, inhalers or nebulizer. It was thought by the pulmonologist that since this all started with my flu shot that I had an allergic reaction that caused all of these symptoms to occur.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram thorax normal, Cough, Dizziness, Dyspnoea, Ear pain
Clinical narrative: I started with extreme fatigue the night of the shot and was only able to stay awake a few hours all weekend, I developed an intense headache and facial pain, body aches and muscle pain. I went into the walk in clinic a few days later and was diagnosed with possible sinus infection and ear infection  (sinus and nasal congestion, sore throat and bilateral ear pain). The following day I started having a deep constant cough, fever, shortness of breath, and loss of voice. The doctor did a covid test and chest x ray and it was thought to be bronchitis. These symptoms continued to worsen over the course of the next few weeks and I developed dizziness, chest tightness, light headedness,  increased respiratory rate, and continued extreme fatigue . I ended up having 3 er visits and 14 doctor visits (walk in, pulmonology, internal med, family med, neurology and chiropractic) between 10/8 and 11/14.  I had a pulmonary work up, labs, ekg, chest/brain/abdomen ct, 21 panel virus swab on 2 occasions, mono test, elevated d dimer test which was followed by a nuc med scan for a blood clot, headache infusion and injections. All scans and tests ended up negative. I did not respond to multiple courses of steroids, antibiotics, inhalers or nebulizer. It was thought by the pulmonologist that since this all started with my flu shot that I had an allergic reaction that caused all of these symptoms to occur.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Facial pain, Fatigue, Fibrin D dimer increased, Headache
Clinical narrative: I started with extreme fatigue the night of the shot and was only able to stay awake a few hours all weekend, I developed an intense headache and facial pain, body aches and muscle pain. I went into the walk in clinic a few days later and was diagnosed with possible sinus infection and ear infection  (sinus and nasal congestion, sore throat and bilateral ear pain). The following day I started having a deep constant cough, fever, shortness of breath, and loss of voice. The doctor did a covid test and chest x ray and it was thought to be bronchitis. These symptoms continued to worsen over the course of the next few weeks and I developed dizziness, chest tightness, light headedness,  increased respiratory rate, and continued extreme fatigue . I ended up having 3 er visits and 14 doctor visits (walk in, pulmonology, internal med, family med, neurology and chiropractic) between 10/8 and 11/14.  I had a pulmonary work up, labs, ekg, chest/brain/abdomen ct, 21 panel virus swab on 2 occasions, mono test, elevated d dimer test which was followed by a nuc med scan for a blood clot, headache infusion and injections. All scans and tests ended up negative. I did not respond to multiple courses of steroids, antibiotics, inhalers or nebulizer. It was thought by the pulmonologist that since this all started with my flu shot that I had an allergic reaction that caused all of these symptoms to occur.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Hypersomnia, Magnetic resonance imaging normal, Mononucleosis heterophile test negative, Myalgia
Clinical narrative: I started with extreme fatigue the night of the shot and was only able to stay awake a few hours all weekend, I developed an intense headache and facial pain, body aches and muscle pain. I went into the walk in clinic a few days later and was diagnosed with possible sinus infection and ear infection  (sinus and nasal congestion, sore throat and bilateral ear pain). The following day I started having a deep constant cough, fever, shortness of breath, and loss of voice. The doctor did a covid test and chest x ray and it was thought to be bronchitis. These symptoms continued to worsen over the course of the next few weeks and I developed dizziness, chest tightness, light headedness,  increased respiratory rate, and continued extreme fatigue . I ended up having 3 er visits and 14 doctor visits (walk in, pulmonology, internal med, family med, neurology and chiropractic) between 10/8 and 11/14.  I had a pulmonary work up, labs, ekg, chest/brain/abdomen ct, 21 panel virus swab on 2 occasions, mono test, elevated d dimer test which was followed by a nuc med scan for a blood clot, headache infusion and injections. All scans and tests ended up negative. I did not respond to multiple courses of steroids, antibiotics, inhalers or nebulizer. It was thought by the pulmonologist that since this all started with my flu shot that I had an allergic reaction that caused all of these symptoms to occur.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal congestion, Oropharyngeal pain, Pain, Pyrexia, Respiratory rate increased
Clinical narrative: I started with extreme fatigue the night of the shot and was only able to stay awake a few hours all weekend, I developed an intense headache and facial pain, body aches and muscle pain. I went into the walk in clinic a few days later and was diagnosed with possible sinus infection and ear infection  (sinus and nasal congestion, sore throat and bilateral ear pain). The following day I started having a deep constant cough, fever, shortness of breath, and loss of voice. The doctor did a covid test and chest x ray and it was thought to be bronchitis. These symptoms continued to worsen over the course of the next few weeks and I developed dizziness, chest tightness, light headedness,  increased respiratory rate, and continued extreme fatigue . I ended up having 3 er visits and 14 doctor visits (walk in, pulmonology, internal med, family med, neurology and chiropractic) between 10/8 and 11/14.  I had a pulmonary work up, labs, ekg, chest/brain/abdomen ct, 21 panel virus swab on 2 occasions, mono test, elevated d dimer test which was followed by a nuc med scan for a blood clot, headache infusion and injections. All scans and tests ended up negative. I did not respond to multiple courses of steroids, antibiotics, inhalers or nebulizer. It was thought by the pulmonologist that since this all started with my flu shot that I had an allergic reaction that caused all of these symptoms to occur.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test, Sinus congestion, Viral test negative
Clinical narrative: I started with extreme fatigue the night of the shot and was only able to stay awake a few hours all weekend, I developed an intense headache and facial pain, body aches and muscle pain. I went into the walk in clinic a few days later and was diagnosed with possible sinus infection and ear infection  (sinus and nasal congestion, sore throat and bilateral ear pain). The following day I started having a deep constant cough, fever, shortness of breath, and loss of voice. The doctor did a covid test and chest x ray and it was thought to be bronchitis. These symptoms continued to worsen over the course of the next few weeks and I developed dizziness, chest tightness, light headedness,  increased respiratory rate, and continued extreme fatigue . I ended up having 3 er visits and 14 doctor visits (walk in, pulmonology, internal med, family med, neurology and chiropractic) between 10/8 and 11/14.  I had a pulmonary work up, labs, ekg, chest/brain/abdomen ct, 21 panel virus swab on 2 occasions, mono test, elevated d dimer test which was followed by a nuc med scan for a blood clot, headache infusion and injections. All scans and tests ended up negative. I did not respond to multiple courses of steroids, antibiotics, inhalers or nebulizer. It was thought by the pulmonologist that since this all started with my flu shot that I had an allergic reaction that caused all of these symptoms to occur.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events - vaccine administered was one day beyond expiration date
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Broke out into hives lasted about month called doctor office as soon as it started and was told was normal
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache, Swollen tongue, Throat tightness
Clinical narrative: given 23-24 COVID-19. Short of breath- hard to get my breath, tongue swelling, throat tightness Headache, chest heaviness
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Box of Moderna Covid-19 Vaccine for 6 months through 11 years, 10 single dose vials, each dose is 0.25ml was pulled from the fridge, a dose was drawn up and administered. After administration it was noted that the sticker on the box stated it was pulled and thawed on 11/27/23 and was dated to expire on 12/27/23, 30 days after thawing.  The patient did not show any adverse signs or symptoms during monitoring in the clinic.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient was administered a second dose of rsv
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death
Clinical narrative: My mother was very healthy.  Just 2 months after the vaccine, she started having strokes. I got 1 vaccine and couldn?t get a 2nd one because my heart kept palpitating. My aunt had to go to the emergency room just 2 hours after the vaccine because she thought she was having a heart attack. My family has a history of autoimmune diseases & none of us responded well.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Decreased appetite, Gait disturbance, Weight decreased
Clinical narrative: PATIENT REPORTER DIFFICULTY WALKING FOR SEVERAL DAYS AND LOSS OF APETITE AND WEIGHT
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Induration, Lip swelling, Myalgia
Clinical narrative: PATIENT STATED HAD MUSCLE ACHES AND LOW GRADE TEMP NIGHT OF VACCINE. STATE WOKE UP IN AM WITH SWOLLEN LIPS, HARD TO TOUCH. NO REDNESS OR WARMTH. AFEBRILE IN AM. ADVISED FOLLOWUP WITH PRIMARY CARE PROVIDER IF SYMPTOMS DO NOT RESOLVE OR WORSEN. PATIENT STATED SHE HAS HAD LIP FILLERS IN THE PAST. TALKED TO DR WHO ADMINISTERED AND STATED HE DID FIND A CASE STUDY WITH SAME SYMPTOMS. CAN BE TREATED WITH LOW DOSE LISINOPRIL. PATIENT OPTED TO WAIT IT OUT STATING TOOK 48 HOURS FOR SYMPTOMS TO SUBSIDE
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nasopharyngitis, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Cold symptoms, fever
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/PQC; Patient date of birth 11OCT2023/first dose was administered on 22NOV2023/second dose of ROTATEQ on 15DEC2023; This spontaneous report was received from other health professional and refers to a 9-week-old patient of unknown gender.  The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by reporter.  On 22-NOV-2023, the patient started therapy with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, doce, lot # and expiry date were not provided).  On 15-DEC-2023, the patient received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot number 1947622 (which was a valid lot# for the vaccine ;expiration date established as 04-MAY-2024)  (strength and dose were not provided), administered for prophylaxis (inappropriate schedule of vaccine administered). No other medical information reported, no adverse event was reported.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Intestinal resection, Intussusception, Product use in unapproved indication, Vitello-intestinal duct remnant
Clinical narrative: susception and inverted meckel diverticulum; susception; Indication: Rotavirus gastroenteritis; This spontaneous report was received from a nurse referring to a 9-week-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 13-NOV-2023, the patient was vaccinated with rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid (2 ml; strength, lot#, and expiration date were not reported) orally by a healthcare professional (HCP) for rotavirus gastroenteritis (product administered for unapproved indication).  On 20-NOV-2023 (also reported as "approximately 1 week after receiving rotavirus vaccine live, pentavalent (ROTATEQ)"), the patient experienced susception and inverted meckel diverticulum. The patient was taken to the emergency room (E.R.) and admitted receiving a bowel resection as treatment. On 07-DEC-2023, the patient was released from the hospital and the patient was actively recovering from the events. The causal relationship between the events above and rotavirus vaccine live, pentavalent (ROTATEQ) was not provided.   Upon internal review, the events of intussusception and Meckel's diverticulum were considered as medically significant. The events of intussusception and Meckel's diverticulum were considered as life-threatening by the reporter.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE; pediatric doses were accidentally administered to adult patients.; This spontaneous report was received from a physician referring to an adult patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 26-OCT-2023, the patient was vaccinated with Hepatitis A Vaccine, inactivated (VAQTA) intramuscular injection (dose: pediatric dose; lot#: W029899, expiration date: 16-MAY-2024; strength, and route of administration were not reported) accidentally for prophylaxis (incorrect dose administered). No additional adverse events (AE) were reported (no adverse event).  This case was received from the same reporter with another case 02526626, 02526668, 02526670 and 02526672.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: HCP stated that the patient had shoulder pain; HCP states that the patient had hip pain; This spontaneous case was reported by a pharmacist and describes the occurrence of ARTHRALGIA (HCP stated that the patient had shoulder pain) and ARTHRALGIA (HCP states that the patient had hip pain) in a 77-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058876) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 21-Nov-2023, the patient experienced ARTHRALGIA (HCP stated that the patient had shoulder pain) and ARTHRALGIA (HCP states that the patient had hip pain). At the time of the report, ARTHRALGIA (HCP stated that the patient had shoulder pain) and ARTHRALGIA (HCP states that the patient had hip pain) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient stated, it has now been 4 weeks since the patient received the vaccine, and the pain was getting worse and not getting any better. No treatment information was reported.   Reporter did not allow further contact
Age: 12.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Vasovagal syncope. Patient drank water and candy then placed supine. Blood pressure, HR rate taken serially. Oxygen saturation taken as well. patient recovered within 5 minutes, her lips turned pink and denies dizziness.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus, Vertigo
Clinical narrative: Bilateral tinnitus developed about 2 weeks after vaccination with some  mild intermittent vertigo, lasting for 3 months.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Bilateral Tinnitus starting 2 weeks after vaccine with some associated mild intermittent vertigo.  Right sided tinnitus persists to date of report.
Sex: U
Vaccine: PNC15, PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient symptoms have been reported; patient received 1 dose of ROTATEQ and 1 dose of VAXNEUVANCE after the products were involved in a temperature excursion.; This spontaneous report was received from a registered nurse referring to a 5-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 27-DEC-2023, the patient was vaccinated with rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid (1 dose, lot#: 1947628 with expiration date 0f 11-JUN-2024; strength was not reported) orally for prophylaxis; and pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (1 dose, lot# was X022026 with expiration date of 22-OCT-2025 or X022028 with expiration date of 22-OCT-2025 (there were two lots of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) and the reporter was unable to confirm which lot number was administered); strength and route of administration were not reported) for prophylaxis. The vaccines administered were involved in a temperature excursion of 13.08C for 1 hour 15 minutes (product storage error). There was no previous temperature excursion. No patient symptoms were reported (no adverse event).  This case was received from the same reporter with another 16 cases (02527167, 02527189, 02527199, 02527203, 02527212, 02527222, 02527229, 02527240, 02527246, 02527263, 02527269, 02527282, 02527306, 02527313, 02527322, and 02527330).
Sex: F
Vaccine: RVX
Symptoms: Pyrexia
Clinical narrative: Fever chills; This non-serious case was reported by a consumer and described the occurrence of fever chills in a 76-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included thyroid gland cancer (The patient had thyroid cancer.). Concomitant products included levothyroxine sodium (Synthroid).   On 20-DEC-2023, the patient received RSV vaccine. On 20-DEC-2023, less than a day after receiving RSV vaccine, the patient experienced fever chills (Verbatim: Fever chills). The outcome of the fever chills was not resolved.   It was unknown if the reporter considered the fever chills to be related to RSV vaccine.     It was unknown if the company considered the fever chills to be related to RSV vaccine.   Additional Information: GSK receipt date: 29-DEC-2023 The reporter was patient. The patient was received the RSV vaccine (unknown expiry date) and Synthroid for the thyroid cancer. The patient was experienced fever chill. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This non-serious case was reported by a nurse via sales rep and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced rash (Verbatim: Rash). The outcome of the rash was not reported.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK receipt date: 29-DEC-2023 The patient reported rash 3 weeks post injection. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, Foetal heart rate deceleration abnormality, Premature labour, Prenatal screening test
Clinical narrative: First pregnancy, EDD 1/20/2024.  Went into labor at 36 weeks and 4 days gestation age.  SVD at 36 weeks and 5 days gestation age on 12/28/2023.  Pregnancy uncomplicated with normal prenatal labs.  Occasional late decelerations on FHM noted during labor.  Amniotomy performed by healthcare provider to advance labor.  The rest of intrapartum and postpartum were uncomplicated.  Infant did not require transfer to NICU, and was discharged home with mother two days after birth.  Birth weight was 6 lbs, 13 oz.
Age: 34.0
Sex: F
Vaccine: RSV
Symptoms: Primigravida, Ultrasound antenatal screen normal
Clinical narrative: First pregnancy, EDD 1/20/2024.  Went into labor at 36 weeks and 4 days gestation age.  SVD at 36 weeks and 5 days gestation age on 12/28/2023.  Pregnancy uncomplicated with normal prenatal labs.  Occasional late decelerations on FHM noted during labor.  Amniotomy performed by healthcare provider to advance labor.  The rest of intrapartum and postpartum were uncomplicated.  Infant did not require transfer to NICU, and was discharged home with mother two days after birth.  Birth weight was 6 lbs, 13 oz.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chronic obstructive pulmonary disease, Diabetes mellitus, Hypocalcaemia, Hypoxia
Clinical narrative: Hospitalization for COVID-19 pneumonia, hypocalcemia, hypoxemia, microcytic anemia, diabetes, leukocytosis, and COPD  on dates 12/16/2023-12/31/2023. Treated with dexamethasone and Remdesivir.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Leukocytosis, Microcytic anaemia
Clinical narrative: Hospitalization for COVID-19 pneumonia, hypocalcemia, hypoxemia, microcytic anemia, diabetes, leukocytosis, and COPD  on dates 12/16/2023-12/31/2023. Treated with dexamethasone and Remdesivir.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Hyperglycaemia
Clinical narrative: Hospitalization for acute hypoxic respiratory failure requiring BIPAP support, acute/decompensated COPD exacerbation, COVID-19 infection, hyponatremia, hyperglycemia on dates 12/15/2023- 12/26/2023. Treated with dexamethasone,  Remdesivir.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hyponatraemia, Positive airway pressure therapy
Clinical narrative: Hospitalization for acute hypoxic respiratory failure requiring BIPAP support, acute/decompensated COPD exacerbation, COVID-19 infection, hyponatremia, hyperglycemia on dates 12/15/2023- 12/26/2023. Treated with dexamethasone,  Remdesivir.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, Blood potassium decreased, Blood pressure increased, COVID-19
Clinical narrative: Patient is a 79 y.o. male patient of MD with history of Atrial fibrillation, CAD, depression, DM, GERD, chronic diastolic heart failure, hypertension, hyperlipidemia, on Auto PAP, benign essential tremor who was transferred to Hospital from ER for further management of COVID 19 .   Acute hypoxic respiratory failure-Resolved COVID 19 infection Date of onset of symptoms: 11/22/23 Symptoms present on admission: fever, weakness, hypoxia  Date of covid positive test: 11/25/23  Vaccination status: vaccinated Imaging: CXR with no acute process Oxygen requirements on admission: 2L NC Current oxygen requirements: 2L NC Medical therapy: steroids, prednisone  Consultants following: N/A Anticipated special isolation end date: 12/3/23 PT/OT consulted-recommending up to 5 days SW consulted-patient opting for IPR and accepted to mount caramel IPR. Medically stable for discharge on 11/30   Hypertension Elevated resume cozaar, lasix, coreg   Atrial fibrillation Rate Controlled Cotinued home Coreg and Eliquis   IDDM2, controlled resume Lantus 30 units BID  + SSI  Home meds ( trulicity, metformin, glucotrol) have been held As A1c 6.1 10/23   Chronic diastolic Heart failure: Euvolemic on exam Continued home Lasix   Diabetic neuropathy resume gabapentin + tylenol   Overactive Bladder UA unremarkable Follows at clinic Has scheduled procedure cancelled multiple times Recent PSA unremarkable 10/23 Advised to follow with urologist  Thrombocytopenia 107 on admission In the setting of infection Improving daily Hypokalemia 3.2-3.4 In the setting of diuresis and decreased p.o. intake Replace and recheck   Essential tremors Ongoing and chronic per patient Follows with neurologist  Started on Cymbalta recently but stopped due to increasing tremors Improvement noted to baseline tremors once medication stopped Follow-up with neurology on discharge   Gout Continued home Allopurinol   Morbid Obesity BMI 44 Follow with PCP on lifestyle modifications
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Condition aggravated, Essential tremor, Glycosylated haemoglobin normal, Hypokalaemia
Clinical narrative: Patient is a 79 y.o. male patient of MD with history of Atrial fibrillation, CAD, depression, DM, GERD, chronic diastolic heart failure, hypertension, hyperlipidemia, on Auto PAP, benign essential tremor who was transferred to Hospital from ER for further management of COVID 19 .   Acute hypoxic respiratory failure-Resolved COVID 19 infection Date of onset of symptoms: 11/22/23 Symptoms present on admission: fever, weakness, hypoxia  Date of covid positive test: 11/25/23  Vaccination status: vaccinated Imaging: CXR with no acute process Oxygen requirements on admission: 2L NC Current oxygen requirements: 2L NC Medical therapy: steroids, prednisone  Consultants following: N/A Anticipated special isolation end date: 12/3/23 PT/OT consulted-recommending up to 5 days SW consulted-patient opting for IPR and accepted to mount caramel IPR. Medically stable for discharge on 11/30   Hypertension Elevated resume cozaar, lasix, coreg   Atrial fibrillation Rate Controlled Cotinued home Coreg and Eliquis   IDDM2, controlled resume Lantus 30 units BID  + SSI  Home meds ( trulicity, metformin, glucotrol) have been held As A1c 6.1 10/23   Chronic diastolic Heart failure: Euvolemic on exam Continued home Lasix   Diabetic neuropathy resume gabapentin + tylenol   Overactive Bladder UA unremarkable Follows at clinic Has scheduled procedure cancelled multiple times Recent PSA unremarkable 10/23 Advised to follow with urologist  Thrombocytopenia 107 on admission In the setting of infection Improving daily Hypokalemia 3.2-3.4 In the setting of diuresis and decreased p.o. intake Replace and recheck   Essential tremors Ongoing and chronic per patient Follows with neurologist  Started on Cymbalta recently but stopped due to increasing tremors Improvement noted to baseline tremors once medication stopped Follow-up with neurology on discharge   Gout Continued home Allopurinol   Morbid Obesity BMI 44 Follow with PCP on lifestyle modifications
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hypophagia, Hypoxia, Infection, Platelet count decreased, Polyuria
Clinical narrative: Patient is a 79 y.o. male patient of MD with history of Atrial fibrillation, CAD, depression, DM, GERD, chronic diastolic heart failure, hypertension, hyperlipidemia, on Auto PAP, benign essential tremor who was transferred to Hospital from ER for further management of COVID 19 .   Acute hypoxic respiratory failure-Resolved COVID 19 infection Date of onset of symptoms: 11/22/23 Symptoms present on admission: fever, weakness, hypoxia  Date of covid positive test: 11/25/23  Vaccination status: vaccinated Imaging: CXR with no acute process Oxygen requirements on admission: 2L NC Current oxygen requirements: 2L NC Medical therapy: steroids, prednisone  Consultants following: N/A Anticipated special isolation end date: 12/3/23 PT/OT consulted-recommending up to 5 days SW consulted-patient opting for IPR and accepted to mount caramel IPR. Medically stable for discharge on 11/30   Hypertension Elevated resume cozaar, lasix, coreg   Atrial fibrillation Rate Controlled Cotinued home Coreg and Eliquis   IDDM2, controlled resume Lantus 30 units BID  + SSI  Home meds ( trulicity, metformin, glucotrol) have been held As A1c 6.1 10/23   Chronic diastolic Heart failure: Euvolemic on exam Continued home Lasix   Diabetic neuropathy resume gabapentin + tylenol   Overactive Bladder UA unremarkable Follows at clinic Has scheduled procedure cancelled multiple times Recent PSA unremarkable 10/23 Advised to follow with urologist  Thrombocytopenia 107 on admission In the setting of infection Improving daily Hypokalemia 3.2-3.4 In the setting of diuresis and decreased p.o. intake Replace and recheck   Essential tremors Ongoing and chronic per patient Follows with neurologist  Started on Cymbalta recently but stopped due to increasing tremors Improvement noted to baseline tremors once medication stopped Follow-up with neurology on discharge   Gout Continued home Allopurinol   Morbid Obesity BMI 44 Follow with PCP on lifestyle modifications
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen normal, Pyrexia, SARS-CoV-2 test positive, Thrombocytopenia, Urine analysis normal
Clinical narrative: Patient is a 79 y.o. male patient of MD with history of Atrial fibrillation, CAD, depression, DM, GERD, chronic diastolic heart failure, hypertension, hyperlipidemia, on Auto PAP, benign essential tremor who was transferred to Hospital from ER for further management of COVID 19 .   Acute hypoxic respiratory failure-Resolved COVID 19 infection Date of onset of symptoms: 11/22/23 Symptoms present on admission: fever, weakness, hypoxia  Date of covid positive test: 11/25/23  Vaccination status: vaccinated Imaging: CXR with no acute process Oxygen requirements on admission: 2L NC Current oxygen requirements: 2L NC Medical therapy: steroids, prednisone  Consultants following: N/A Anticipated special isolation end date: 12/3/23 PT/OT consulted-recommending up to 5 days SW consulted-patient opting for IPR and accepted to mount caramel IPR. Medically stable for discharge on 11/30   Hypertension Elevated resume cozaar, lasix, coreg   Atrial fibrillation Rate Controlled Cotinued home Coreg and Eliquis   IDDM2, controlled resume Lantus 30 units BID  + SSI  Home meds ( trulicity, metformin, glucotrol) have been held As A1c 6.1 10/23   Chronic diastolic Heart failure: Euvolemic on exam Continued home Lasix   Diabetic neuropathy resume gabapentin + tylenol   Overactive Bladder UA unremarkable Follows at clinic Has scheduled procedure cancelled multiple times Recent PSA unremarkable 10/23 Advised to follow with urologist  Thrombocytopenia 107 on admission In the setting of infection Improving daily Hypokalemia 3.2-3.4 In the setting of diuresis and decreased p.o. intake Replace and recheck   Essential tremors Ongoing and chronic per patient Follows with neurologist  Started on Cymbalta recently but stopped due to increasing tremors Improvement noted to baseline tremors once medication stopped Follow-up with neurology on discharge   Gout Continued home Allopurinol   Morbid Obesity BMI 44 Follow with PCP on lifestyle modifications
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None stated
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Angiogram pulmonary abnormal, Blood culture negative, Brain natriuretic peptide increased, COVID-19
Clinical narrative: Patient is a 80 y.o. male patient of MD with history of BPH, COPD, CAD, dyslipidemia, hypertension, OSA on CPAP presented to Hospital with chest pain and shortness of breath.   Chest pain Acute on top of chronic hypoxic respiratory failure COPD  COVID 19 infection Possible aspiration pneumonia Bilateral pleural effusion CXR showed small bilateral pleural effusion with bibasilar opacity could be aspiration/pneumonia CT pulmonary arteries was negative for PE, shows moderate emphysema and possible of aspiration or infection WBC on admission 11.9 Patient is COVID 19 positive Blood cultures negative to date  Continue O2 support, currently on 4  L Infectious disease consult Cont Continue Decadron, remdesivir Continue bronchodilators, nebs as needed IV Lasix 20 mg once on 11/29  SLP to rule out aspiration, negative for aspiration ID Dr okay with discharge, discharged home 3 days course of dexamethasone     CAD with previous stenting Troponin negative on admission, BNP 300s Continue Ranexa, Plavix, Imdur and statin Continue oral Lasix Echo pending   Hypertension Continue metoprolol, lisinopril   Dyslipidemia Continue statin   BPH  continue finasteride and Flomax   GERD Continue PPI   Morbid obesity BMI 40.34 Lifestyle modification counseled to the patient.   Hypomagnesemia Hypophosphatemia Rellete as needed
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest X-ray abnormal, Chest pain, Chronic obstructive pulmonary disease, Dyspnoea, Emphysema
Clinical narrative: Patient is a 80 y.o. male patient of MD with history of BPH, COPD, CAD, dyslipidemia, hypertension, OSA on CPAP presented to Hospital with chest pain and shortness of breath.   Chest pain Acute on top of chronic hypoxic respiratory failure COPD  COVID 19 infection Possible aspiration pneumonia Bilateral pleural effusion CXR showed small bilateral pleural effusion with bibasilar opacity could be aspiration/pneumonia CT pulmonary arteries was negative for PE, shows moderate emphysema and possible of aspiration or infection WBC on admission 11.9 Patient is COVID 19 positive Blood cultures negative to date  Continue O2 support, currently on 4  L Infectious disease consult Cont Continue Decadron, remdesivir Continue bronchodilators, nebs as needed IV Lasix 20 mg once on 11/29  SLP to rule out aspiration, negative for aspiration ID Dr okay with discharge, discharged home 3 days course of dexamethasone     CAD with previous stenting Troponin negative on admission, BNP 300s Continue Ranexa, Plavix, Imdur and statin Continue oral Lasix Echo pending   Hypertension Continue metoprolol, lisinopril   Dyslipidemia Continue statin   BPH  continue finasteride and Flomax   GERD Continue PPI   Morbid obesity BMI 40.34 Lifestyle modification counseled to the patient.   Hypomagnesemia Hypophosphatemia Rellete as needed
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lung opacity, Pleural effusion, Respiratory failure, SARS-CoV-2 test positive, Troponin normal
Clinical narrative: Patient is a 80 y.o. male patient of MD with history of BPH, COPD, CAD, dyslipidemia, hypertension, OSA on CPAP presented to Hospital with chest pain and shortness of breath.   Chest pain Acute on top of chronic hypoxic respiratory failure COPD  COVID 19 infection Possible aspiration pneumonia Bilateral pleural effusion CXR showed small bilateral pleural effusion with bibasilar opacity could be aspiration/pneumonia CT pulmonary arteries was negative for PE, shows moderate emphysema and possible of aspiration or infection WBC on admission 11.9 Patient is COVID 19 positive Blood cultures negative to date  Continue O2 support, currently on 4  L Infectious disease consult Cont Continue Decadron, remdesivir Continue bronchodilators, nebs as needed IV Lasix 20 mg once on 11/29  SLP to rule out aspiration, negative for aspiration ID Dr okay with discharge, discharged home 3 days course of dexamethasone     CAD with previous stenting Troponin negative on admission, BNP 300s Continue Ranexa, Plavix, Imdur and statin Continue oral Lasix Echo pending   Hypertension Continue metoprolol, lisinopril   Dyslipidemia Continue statin   BPH  continue finasteride and Flomax   GERD Continue PPI   Morbid obesity BMI 40.34 Lifestyle modification counseled to the patient.   Hypomagnesemia Hypophosphatemia Rellete as needed