chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Walking aid user
Clinical narrative: She got her vaccine, her arm was just sore, very sore.  She has graft VS host disease of her eyes, GVHD and she is treated with steroids in her eyes.  She was doing pretty good and on Friday before that she went and saw her doctors and was fine.  On Monday her eye started really bad pain in her eye, Monday on 1/15/24 was terrible.  Tuesday it was better.  Wednesday it was horrible, she could not walk and had to use a cane due to the pain in her eye.  So Thursday 1/18/24 she called the doctors office and told them that somebody had to see her due to the severe pain.  She was told to come in and saw Dr. at Medical Group, Ophthalmology Dept and he examined her eye and that her epithelium was peeling off her bad, it was really bad.  He could see why she had so much pain.  He said that she had herpes zoster in her eye.   He was put on Acyclovir hydrochloride 1 tablet 3 times a day for 10 days.  He put her also on Moxifloxacin 0.5% eye drops to use 4 x a day.  The real issue about this is that she could not use the steroids anymore in her eye and he also put a bandage over her eye, and told her that it would help.  She went home, and the bad part is that she could not use the steroids due to the herpes as it would interfere with the healing process.  She has the two problems in her eye.  The medicine is helping her symptoms, but she can't use the steroids.  She went to see the doctor again and that it was pretty well healed and is in terrible pain due to not using the steroids in her eyes.  She did message the doctor that her last dose of the medicine he gave her was Sunday and she would start her steroids back on Monday and she has an APT on 2/2/24 and feels she needs to see him sooner.    She had no reactions to the RSV and the Prevnar vaccines in November.   The nurses told her that this was a breakthrough infection and feels that it should have been part of the advertisement for Shingrix that you can get a breakthrough infection.  If she did she would probably not have taken the vaccine.  Nobody informed her that she could get a breakthrough infection or shingles from it, and she is suffering from this as she doesn't only have herpes zoster in her eyes and GVHD in her eyes, and is disgusted that she has to use a cane to walk.  It throws you off balance when you have so much pain in your eyes that you cannot open your eyes and it keeps her off balance.   She does not use a cane on a regular basis.
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient got PPSV23 instead of ordered PCV15. No adverse effects noted. Error caught on a subsequent visit. Patient got re-dosed for PCV15 later on.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose of the vaccine that was expired from 01/25/2024. Pfizer BioNTech COVID-19 Vaccine manufacturer stated that there is an additional 2 days after the expiration date (10 weeks after the vial is transferred from freezer to refrigerator) in which the dose is still valid.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness, swelling at site on most of upper anterior thigh
Age: 20.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PT was given a covid vaccine that had already had one on 12/23. As well as a Flu vaccine that had already received on 10/23.  no adverse signs or symptoms
Age: 44.0
Sex: F
Vaccine: HPV9, PNC20
Symptoms: Dyspnoea, Lymph node pain, Oedema peripheral, Pain in extremity, Wheezing
Clinical narrative: Patient was given Prevnar 20 at office visit on 1/18/24. Patient had tetanus vaccines and toxoid listed as an allergy. (swelling)  Patient was given Prevnar 20 and reported approximately 6-8 hrs. later became moderately short of breath at home.  she reported she had to self-administer -breathing treatments at home due to symptoms of wheezing and shortness of breath.  She also reported severe lymph node pain and swelling of right axilla as well as right arm pain.   Reviewed VIS for pneumococcal conjugate and it is reported on VIS talk with your health care provider had an allergic reaction to any vaccine containing diphtheria toxoid (for example DTap).  I updated patients' allergies on 1/23/24 to reflect reaction as: shortness of breath and added Prevnar 20 and tetanus vaccines and toxoid as well as diphtheria Toxin preparations.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Erythema of eyelid, Eye pruritus, Injection site erythema, Injection site pruritus, Lacrimation increased
Clinical narrative: Left arm injection site red and itchy shortly after the injection, over the next 2 weeks red pinpoint rash spread from left arm across back and chest , itchy watery eyes, red swollen eye lids. Diagnosed by PCP as RSV reaction, treated with methylpredisone and triamcinolone cream
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Rash, Rash erythematous, Swelling of eyelid
Clinical narrative: Left arm injection site red and itchy shortly after the injection, over the next 2 weeks red pinpoint rash spread from left arm across back and chest , itchy watery eyes, red swollen eye lids. Diagnosed by PCP as RSV reaction, treated with methylpredisone and triamcinolone cream
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea, Hepatic enzyme increased, Laboratory test, Pericardial effusion
Clinical narrative: 15 days after her Spikevax  was administered, patient started having symptoms of difficulty breathing.  She initially thought it was a virus and her primary care doctor gave her prednisone, but when the symptoms did not resolve after 5 weeks, she went to the emergency room and was admitted into the hospital with fluid around her heart and lungs.  (reported to me by patient)
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Ultrasound scan
Clinical narrative: 15 days after her Spikevax  was administered, patient started having symptoms of difficulty breathing.  She initially thought it was a virus and her primary care doctor gave her prednisone, but when the symptoms did not resolve after 5 weeks, she went to the emergency room and was admitted into the hospital with fluid around her heart and lungs.  (reported to me by patient)
Age: 0.17
Sex: M
Vaccine: MMR, PNC20, RV1
Symptoms: Decreased appetite, Infantile spitting up, Injection site induration, Irritability, Somnolence
Clinical narrative: Mother brought pt. in today with concerns of pt. being more fussy, sleeping more than usual, and spitting up his formula after receiving his 2 month vaccines on 1/25/2024.  States he's only drinking 2 oz and he normally drinks 5oz. A mild induration was noted in exam on pt. Lt thigh where he received Vaxelis, no pain, redness or rash. Mother was advised to give pedialyte in the mean time by Dr. and to follow up on Monday if appetite has not improved.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left arm deltoid area swelling, itching, tenderness and painful to the touch was reported by patient and mother.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 12 years old and received the 5-11 year old dose
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Started feeling body aches and tiredness in the evening on the day of receiving the vaccine.  Symptoms improved with taking Ibuprofen.  Through the night and next  morning, extreme body aches and chills.  Also tiredness throughout the day.  Took ibuprofen and Tylenol throughout the day, which helped quite a bit.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient is 4 years old and received the 5-11 year old dose
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis that engulfed left tricep and extended from the shoulder to the elbow. She was seen in Urgent Care for worsening cellulitis.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Eye movement disorder, Muscle twitching, Screaming
Clinical narrative: Per mother, about 15-20 min after vaccines given, patient with twitching of head/shoulder and screaming with eyes rolling back while in the car. Took a nap shortly afterwards, no abnormal movements noted during that time. When waking up from nap still with some twitching but less than initial episode. Took about 3 days before back to normal. Has been acting normally since without return of symptoms noted following vaccine.
Age: 1.17
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult dose of Hep A administered versus the pediatric dose.
Sex: F
Vaccine: PNC, PPV
Symptoms: Pneumococcal bacteraemia, Streptococcus test
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded from Regulatory Authority.   The report was received from an unspecified reporter and refers to a child female patient between 5 and 9-years-old. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.     On an unknown date, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) for prophylaxis (quantity dose, lot #, expiration date and route were not reported). On unknown dates, the patient was vaccinated with a first, second and third dose of pneumococcal vaccine conj 7v (crm197)(PREVENAR) ) for prophylaxis (quantity dose, lot #, expiration date and route were not reported).  On unknown date in 2010, the patient experienced bacteraemia (pneumococcal bacteraemia). Streptococcus pneumoniae serotyping tested with not available result.  At the time of the report, the outcome of pneumococcal bacteraemia and the relationship between pneumococcal bacteraemia and suspect therapies were not reported.        Upon internal review, the event of pneumococcal bacteraemia was determined to be medically significant.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Neck pain, Pain, Paraesthesia
Clinical narrative: Employee received the Tdap vaccine in the morning of 01/24/24. Throughout the day, she began to feel "feverish" and began to experience body aches/pain by the end of the day. She reported the generalized body aches/pain "felt like needles." On 01/25/24, her fever peaked at 39.5C. She reported injection site was sore and had mild swelling. On 01/26/24, she reported her symptoms to us. On 01/26/24, her fever has subsided; latest temperature of 37.7C and lingering mild pain in her neck region. She reported about 15 years ago, she received the Tdap vaccine and developed a high grade fever and generalized pain within 24 hours as well. She reported she "forgot" about her previous reaction.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Employee received the Tdap vaccine in the morning of 01/24/24. Throughout the day, she began to feel "feverish" and began to experience body aches/pain by the end of the day. She reported the generalized body aches/pain "felt like needles." On 01/25/24, her fever peaked at 39.5C. She reported injection site was sore and had mild swelling. On 01/26/24, she reported her symptoms to us. On 01/26/24, her fever has subsided; latest temperature of 37.7C and lingering mild pain in her neck region. She reported about 15 years ago, she received the Tdap vaccine and developed a high grade fever and generalized pain within 24 hours as well. She reported she "forgot" about her previous reaction.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site pallor, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Cellulitis of right lower extremity. Blanching, warm erythematous rash proximal to 7 cm on right thigh concerning for cellulitis.  Negative for fluctuance or discharge to indicate abscess. ? Will treat with cephalexin 4 times daily x 7 days.  Discussed with mother plan to take Tylenol as needed for pain or fever ? Will schedule close follow-up in 3 days ?Reviewed RTC/ED precautions.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On an unknown date, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics (Temperature  -14C (-14°C up to-10°C) for 10 minutes). Confirmed no side effects or symptoms reported. Diluent lot number and expiration number unknown. No additional AE/no PQC.  Lot Number X018584 is valid for V221 and therapy type is rHA.  This case is non-valid case due to no patients identifiers.  Follow-up was received from medical assistant on 23-JAN-2024: This spontanous report refers to 4-years-olf patient of unknown gender. The patient identifiers were updated. On 27-SEP-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Customer called and report that VAQTA involved in a temperature excursion was administered to a patient after the excursion. Caller stated no patient symptoms have been reported. Caller also provided patient information for other patients that receiv; This spontaneous report was received from a physician, concerning a patient of unknown age and gender. No information was provided regarding the patient's relevant medical history, concomitant medications, and drug reactions or allergies.  On 15-JAN-2024, the patient was administered an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) prefilled syringe (lot number X021007, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 26-DEC-2024) (anatomical location, vaccination scheme and route of administration were not reported), as prophylaxis. The vaccine experienced a temperature excursion of 61.2F during a time frame of 7 hours 45 minutes 0 seconds (product storage error). There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2401USA009432: US-009507513-2401USA009485: US-009507513-2401USA008754: US-009507513-2401USA008919: US-009507513-2401USA009432:
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called to report temperature excursion for the following vaccines:  VAQTA, PEDVAXHIB, ROTATEQ, and GARDASIL 9.  Upon reviewing excursion questions, Nurse stated unsure if vaccines had been administered as the vaccines had several prior excursio; This spontaneous report as received from a nurse refers to a 2-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 28-DEC-2023, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot # 1947634, expiration date: 05-MAY-2024, oral (exact dose and anatomical location were not provided); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), formulation: intramuscular injection, lot # X008998, expiration date: 14-NOV-2025, intramuscular in the left thigh (exact dose was not provided); diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) (GSK), lot # reported as: 39KS9, expiration date reported as: 07-SEP-2028, intramuscular in the left thigh (formulation and exact dose were not provided); pneumococcal vaccine conj 7v (crm197)(PREVNAR)(Pfizer), lot # reported as GW7964, expiration date reported as: 31-DEC-2024, intramuscular in the right thigh (formulation and exact dose were not provided) for prophylaxis.   It was reported that the vaccines storage unit temperature excursion was identified after vaccines administered on 28-DEC-2023. Administered doses of vaccines were exposed to the current temperature excursion on 04-JAN-2024 of 1.9 (units not provided) for 34 minutes. The previous temperature excursion had occurred and was reported as follow: on 20-DEC-2023 of 1.6 (units not provided); on 21-DEC-2023 of 1.1 C for 3 hours and 41 minutes; on 22-DEC-2023 of 1.0 (units not provided) for 5 hours and 24 minutes; on 23-DEC-2023 of 1.4 (units not provided) for 4 hours and 25 minutes; on 24-DEC-2023 of 1.4 C for 4 hours and 47 minutes; on 25-DEC-2023 of 1.0 (units not provided) for 5 hours and 36 minutes; on 27-DEC-2023 of 0.3 (units not provided) for 4 hours and 37 minutes; on 28-DEC-2023 of 2.4 (units not provided) for 4 hours and 8 minutes; on 29-DEC-2023 of 1.7 (units not provided) for 1 hour and 44 minutes; on 30-DEC-2023 of 1.8 (units not provided) for 3 hours and 21 minutes; on 31-DEC-2023 of 1.8 (units not provided) for 3 hours and 19 minutes; on 01-JAN-2024 of 1.8 (units not provided) for 3 hours and 11 minutes; on 02-JAN-2024 of 1.6 (units not provided) for 3 hours and 3 minutes and on 03-JAN-2024 of 1.5 (units not provided) for 2 hours and 57 minutes (product storage error). No additional adverse event reported (no adverse event).
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called to report temperature excursion for the following vaccines:  VAQTA, PEDVAXHIB, ROTATEQ, and GARDASIL 9.  Upon reviewing excursion questions, Nurse stated unsure if vaccines had been administered as the vaccines had several prior excursio; This spontaneous report as received from a nurse refers to a 2-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 04-JAN-2024, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot # 1947634, expiration date: 05-MAY-2024, oral (exact dose and anatomical location were not provided); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), formulation: intramuscular injection, lot # X007543, expiration date: 15-NOV-2025, intramuscular in the left thigh (exact dose was not provided); diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) (GSK), lot # reported as: A32BB, expiration date reported as: 10-AUG-2025, intramuscular in the left thigh (formulation and exact dose were not provided); pneumococcal vaccine conj 7v (crm197)(PREVNAR)(Pfizer), lot # reported as GW7964, expiration date reported as: 31-DEC-2024, intramuscular in the right thigh (formulation and exact dose were not provided) for prophylaxis.   It was reported that the vaccines storage unit temperature excursion was identified after vaccines administered on 04-JAN-2024. Administered doses of vaccines were exposed to the current temperature excursion on 04-JAN-2024 of 1.9 (units not provided) for 34 minutes. The previous temperature excursion had occurred and was reported as follow: on 20-DEC-2023 of 1.6 (units not provided); on 21-DEC-2023 of 1.1 C for 3 hours and 41 minutes; on 22-DEC-2023 of 1.0 (units not provided) for 5 hours and 24 minutes; on 23-DEC-2023 of 1.4 (units not provided) for 4 hours and 25 minutes; on 24-DEC-2023 of 1.4 C for 4 hours and 47 minutes; on 25-DEC-2023 of 1.0 (units not provided) for 5 hours and 36 minutes; on 27-DEC-2023 of 0.3 (units not provided) for 4 hours and 37 minutes; on 28-DEC-2023 of 2.4 (units not provided) for 4 hours and 8 minutes; on 29-DEC-2023 of 1.7 (units not provided) for 1 hour and 44 minutes; on 30-DEC-2023 of 1.8 (units not provided) for 3 hours and 21 minutes; on 31-DEC-2023 of 1.8 (units not provided) for 3 hours and 19 minutes; on 01-JAN-2024 of 1.8 (units not provided) for 3 hours and 11 minutes; on 02-JAN-2024 of 1.6 (units not provided) for 3 hours and 3 minutes and on 03-JAN-2024 of 1.5 (units not provided) for 2 hours and 57 minutes (product storage error). No additional adverse event reported (no adverse event).
Age: 8.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issue or side effects; A HCP called to report an AE in which a dose of VAQTA was administered to a patient on 01/15/2024 after experiencing three current temperature excursions.  The patient did not report any adverse issues or side effects.  Please reference additional AE; This spontaneous report has been received from a nurse, regarding an 8-years-old patient. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 03-JAN-2024, 04-JAN-2024 and 12-JAN-2024, doses of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (lot number: X017083, which was determined to be valid as syringe formulation, with an expiration date on 13-DEC-2024) underwent 3 temperature excursions of 9.4 degrees Celsius (C) for 2 minutes, 8.2 C for 1 minute and 10.3 C for 10 minutes respectively.  Then on 15-JAN-2024, the patient was vaccinated with the above-mentioned improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, a dose of 0.5 milliliters once as prophylaxis (strength, scheme, route and anatomical location of administration were not reported).  No prior excursions were reported.   The patient did not report any adverse issue or side effects  This is one of 3 cases form the same reporter. ; Sender's Comments:  US-009507513-2401USA014305: US-009507513-2401USA014130:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP. A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing), notes: other medical history: mild hypertension. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 02Jan2024 to 07Jan2024.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202400012347 same patient, different vaccine dose/event;
Sex: U
Vaccine: PNC20
Symptoms: Product contamination physical
Clinical narrative: 2 prefilled syringes have particulate in them; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 16Jan2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: HE6173) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "2 prefilled syringes have particulate in them".  Additional information: It was reported that no patients were involved.  The reporter considered "2 prefilled syringes have particulate in them" not related to pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein). Causality for "2 prefilled syringes have particulate in them" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein).
Age: 0.83
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient in office around noon for 2nd influenza vaccination. First one was given 12/27/23 with no adverse reactions reported. Mother states patient ate lunch, went down for a nap and woke up around 2:15 PM vomiting. She called the clinic to report emesis X4. Denies difficulty breathing, swelling of the face/lips/tongue/throat, rash, or mentation changes. Waited 30 mins. to breastfeed. Patient ate and went down for another nap. No further emesis episodes. Scheduled patient to see primary care provider at 4 PM today.
Age: 60.0
Sex: M
Vaccine: RSV
Symptoms: Feeling abnormal, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Patients stated " Right after the vaccine, I feels like in "la-la land" ; after got home, feels the numbness  in left shoulder blade - on/off - not all the time; after >1 month, numbness seem to be in his scalp.  Patient call our pharmacy today at about 4-5pm, from his MD's office to ask about adverse effects of vaccines. I, as pharmacist on duty, looked up the adverse affects listed on Manufacture info sheet, then communicated with patient.  Systemic Adverse Reactions listed: Fatigue, Myalgia, Headache, Arthralgia and Fever.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Somnolence
Clinical narrative: By the evening of the day I had the vaccine, I had bad chills -- was physically shivering, but otherwise fine. The following day I was achy and feverish, spent most of the day sleeping, could hardly keep my eyes open. But by the end of the second day I was pretty much fine. No problems since then.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Patient got a rash after 5 days.  It was red, itchy and hot.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects at the moment, patient had received a vaccination after the medication's beyond use date
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Erythema, Induration, Nodule
Clinical narrative: Patient stated his arm was red and had a big knot
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Extrasystoles, Palpitations
Clinical narrative: Patient states that within 12 hours of receiving her Moderna Spikevax immunization (09/22/2023), she felt her heart beating abnormally. She went in and had an EKG done and states she had "Bigeminy." She was not hospitalized, and didn't receive any medications as treatment. She states that she has mostly recovered but still feels her heart beating abnormally every once in a while.
Age: 1.67
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Decreased appetite, Gait disturbance, Injection site erythema, Injection site movement impairment, Injection site nodule
Clinical narrative: Child ran a low grade fever first day, second day, and then fever returned higher day 8 post vaccine. Child wouldn?t bend legs day 1 and 2 and didn?t want to walk. Child?s legs very sore to the touch (still to this day cries if touch the injection site). Large red welt appeared on right leg on first day of vaccine that was about 1.25in in diameter and hot to touch but begin to shrink in size around day 4 and now looks as if a mild bruise. Nodules formed under all injection sites. Left leg had nodules that now are red and swollen and continue to grow in size. Child is fussy to this day, not eating or drinking well, not sleeping well, and all around not their normal self.
Age: 1.67
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Child ran a low grade fever first day, second day, and then fever returned higher day 8 post vaccine. Child wouldn?t bend legs day 1 and 2 and didn?t want to walk. Child?s legs very sore to the touch (still to this day cries if touch the injection site). Large red welt appeared on right leg on first day of vaccine that was about 1.25in in diameter and hot to touch but begin to shrink in size around day 4 and now looks as if a mild bruise. Nodules formed under all injection sites. Left leg had nodules that now are red and swollen and continue to grow in size. Child is fussy to this day, not eating or drinking well, not sleeping well, and all around not their normal self.
Age: 1.67
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Poor quality sleep, Pyrexia, Urticaria
Clinical narrative: Child ran a low grade fever first day, second day, and then fever returned higher day 8 post vaccine. Child wouldn?t bend legs day 1 and 2 and didn?t want to walk. Child?s legs very sore to the touch (still to this day cries if touch the injection site). Large red welt appeared on right leg on first day of vaccine that was about 1.25in in diameter and hot to touch but begin to shrink in size around day 4 and now looks as if a mild bruise. Nodules formed under all injection sites. Left leg had nodules that now are red and swollen and continue to grow in size. Child is fussy to this day, not eating or drinking well, not sleeping well, and all around not their normal self.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer's Comirnaty vaccine (NDC 00069-2392-10; Lot Number:HG9498) had an expiration date of 1/31/24 but the BUD (Best Use Date) per auxiliary sticker-label said 01/09/2024. One  shots had been provided to the patient on 01/08/2024 from that box. No adverse reaction, side effect or injury has been reported so far by the patient.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Dizziness, Syncope
Clinical narrative: chills, elevated temp 100.9, dizziness, light-headedness, fainted for a few minutes. Took Tylenol, feeling recoverey by 5 PM
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer's Comirnaty vaccine (NDC 00069-2392-10; Lot Number:HG9498) had an expiration date of 1/31/24 but the BUD (Best Use Date) per auxiliary sticker-label said 12/18/23. One  shots had been provided to the patient on 01/10/2024 from that box. No adverse reaction, side effect or injury has been reported so far by the patient.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer's Comirnaty vaccine (NDC 00069-2392-10; Lot Number:HG9498) had an expiration date of 1/31/24 but the BUD (Best Use Date) per auxiliary sticker-label said 12/18/23. One  shots had been provided to the patient on 01/10/2024 from that box. No adverse reaction, side effect or injury has been reported so far by the patient.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Periarthritis, X-ray limb abnormal
Clinical narrative: Left shoulder pain developed approximately a week after the injection that slowly got worse. After x-rays, on January 19, 2024 it was diagnosed as frozen shoulder.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer's Comirnaty vaccine (NDC 00069-2392-10; Lot Number:HG9498) had an expiration date of 1/31/24 but the BUD (Best Use Date) per auxiliary sticker-label said 12/18/23. One  shots had been provided to the patient on 01/12/2024 from that box. No adverse reaction, side effect or injury has been reported so far by the patient.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer's Comirnaty vaccine (NDC 00069-2392-10; Lot Number:HG9498) had an expiration date of 1/31/24 but the BUD (Best Use Date) per auxiliary sticker-label said 12/18/23. One  shots had been provided to the patient on 01/13/2024 from that box. No adverse reaction, side effect or injury has been reported so far by the patient.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer's Comirnaty vaccine (NDC 00069-2392-10; Lot Number:HG9498) had an expiration date of 1/31/24 but the BUD (Best Use Date) per auxiliary sticker-label said 12/18/23. One  shots had been provided to the patient on 01/15/2024 from that box. No adverse reaction, side effect or injury has been reported so far by the patient.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer's Comirnaty vaccine (NDC 00069-2392-10; Lot Number:HG9498) had an expiration date of 1/31/24 but the BUD (Best Use Date) per auxiliary sticker-label said 12/18/23. One  shots had been provided to the patient on 01/15/2024 from that box. No adverse reaction, side effect or injury has been reported so far by the patient.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: 11 days after the covid vaccine I developed a skin reaction consisting of hives that came and went all over my body. If I scratch the skin it raises and becomes really itchy and red. I can also write on my skin (dermatographism). Symptoms are still on going as of this submission. I had the same reaction to a moderna covid booster in fall of 2021 (symptoms that time lasted about a month and then went away completely without treatment). For treatment this time, my doctor recommended Zyrtec daily and Benadryl in the evenings if needed. But I am breastfeeding so I'm trying to use those sparingly. I have taken only two doses of Zyrtec one week apart. One dose of Zyrtec relieves the itchiness but wears off after about four to five days. The Zyrtec does not stop the dermatographism from occuring. My sister also had the same reaction to the moderna covid booster in fall of 2021 so I wonder if it genetic (hers resolved on its own too after several weeks I think).
Age: 16.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was screened by facility healthcare staff based off of records and cleared to get vaccine. After vaccine was administered, parents said patient had already received vaccines
Age: 1.08
Sex: F
Vaccine: FLUC4
Symptoms: Irritability, Lip swelling, Pyrexia, Urticaria, Vomiting
Clinical narrative: Fever, vomiting, Fussy, hives, lip swelling
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy breast abnormal, Biopsy pancreas abnormal, Breast cancer female, Invasive ductal breast carcinoma, Pancreatic carcinoma
Clinical narrative: Patient had two Covid Pfizer vaccine in 2021, recently she was diagnosed with breast cancer and new pancreatic neoplasm with atypical cells.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pancreatic neoplasm
Clinical narrative: Patient had two Covid Pfizer vaccine in 2021, recently she was diagnosed with breast cancer and new pancreatic neoplasm with atypical cells.
Sex: M
Vaccine: PNC, PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS) and refers to a child male patient (age reported as 02-04 years old).   The patient's pertinent medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (strength, dose, Lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis. Secondary suspect vaccine included 3 doses of pneumococcal vaccine conj 7v (crm197) (PREVENAR) in total.   It was reported that the patient had received only 1 dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) in total.   On an unspecified date in 2011, the patient developed Bacteremia (Pneumococcal bacteraemia) and the Streptococcus pneumoniae serotyping was not available at the time of the report. It was reported that vaccine was not available for serotype.   At the time of the report, the outcome of the event was unknown.    The causal relationship between Bacteremia (Pneumococcal bacteraemia) and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) and pneumococcal vaccine conj 7v (crm197) (PREVENAR) was unknown.   Upon internal review, the event Bacteremia (Pneumococcal bacteraemia) was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority and refers to an adult male patient (age reported as 40-44 years old).   The patient's pertinent medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (strength, dose, Lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis.   It was reported that the patient had received only 1 dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) in total.   On an unspecified date in 2011, the patient developed Pneumonia (Pneumonia pneumococcal) and the Streptococcus pneumoniae serotyping was not available at the time of the report. It was reported that vaccine was given for serotype.   At the time of the report, the outcome of the event was unknown.    The causal relationship between Pneumonia (Pneumonia pneumococcal) and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.   Upon internal review, the event Pneumonia (Pneumonia pneumococcal) was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test
Clinical narrative: Pneumococcal infection; This spontaneous report has been downloaded from Regulatory Authority.   The report was received from an unspecified reporter and refers to an adult female patient between 50 and 54-years-old. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.     On an unknown date, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) for prophylaxis (quantity dose, lot #, expiration date and route were not reported).   On unknown date in 2010, the patient experienced pneumococcal infection. Streptococcus pneumoniae serotyping was tested with not available result.  At the time of the report, the outcome of pneumococcal infection and the relationship between pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not reported.        Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority and refers to an elderly female patient (age reported as 65-69 years old).   The patient's pertinent medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with 1 dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (strength, dose, Lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis.   It was reported that the patient had received only 1 dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) in total.   On an unspecified date in 2021, the patient developed Pneumonia (Pneumonia pneumococcal) and the Streptococcus pneumoniae serotyping was reported as "not available" at the time of the report. It was reported that vaccine was provided for serotype.   At the time of the report, the outcome of the event was unknown.    The causal relationship between Pneumonia (Pneumonia pneumococcal) and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.   Upon internal review, the event Pneumonia (Pneumonia pneumococcal) was determined to be medically significant.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pneumococcal infection, Streptococcus test
Clinical narrative: Pneumococcal infection; This spontaneous report has been downloaded from Surveillance System.  The report was received from an unspecified reporter and refers to an elderly female patient between 75 and 79-years-old. Patient's vaccination history included unspecified vaccines. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.     On an unknown date, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) for prophylaxis (quantity dose, lot #, expiration date and route were not reported). On unknown date, the patient was vaccinated with a first dose of pneumococcal vaccine pneumococcal vaccine conj 13v (crm197)(PREVENAR 13) for prophylaxis (quantity dose, lot #, expiration date and route were not reported).  On unknown date in 2022, the patient experienced pneumococcal infection. Streptococcus pneumoniae serotyping was tested with not available result.  At the time of the report, the outcome of pneumococcal infection and the relationship between pneumococcal infection and suspect therapies were not reported.        Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test
Clinical narrative: Pneumococcal infection; This spontaneous report has been downloaded from Regulatory Authority.  The report was received from an unspecified reporter and refers to an adult male patient between 55 and 59-years-old. Patient's vaccination history included unspecified vaccines. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.     On an unknown date, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) for prophylaxis (quantity dose, lot #, expiration date and route were not reported).   On unknown date in 2022, the patient experienced pneumococcal infection. Streptococcus pneumoniae serotyping was tested with not available result.  At the time of the report, the outcome of pneumococcal infection and the relationship between pneumococcal infection and of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not reported.        Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: pneumonia; This spontaneous report has been downloaded from Regulatory Authority, concerning an elderly male patient between 70-74 years of age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2014, the patient experienced pStreptococcus pneumoniae pneumonia. The Streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the Streptococcus pneumoniae pneumonia was unknown.   The causal relationship between Streptococcus pneumoniae pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.   Upon internal review, the event Streptococcus pneumoniae pneumonia was determined to be medically significant.
Age: 1.0
Sex: U
Vaccine: HEPA, PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient symptoms have been reported/No additional AE; Nurse called and reported VAQTA and VAXNEUVANCE involved in a temperature excursion have been administered to a patient since the excursion; This spontaneous report has been received from a nurse and refers to a 12-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was not provided.  It was reported that hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, 1 dose (lot number X010373 has been verified to be valid, expiration date 13-NOV-2024) and pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, 1 dose (lot number X020316 has been verified to be valid, expiration date 18-OCT-2025) (routes of administration and anatomical locations of vaccinations were not provided), which were involved in a temperature excursion had been administered as prophylaxis to the patient on 11-DEC-2023 (product storage error).   The temperature of the vaccines administered was reported as 59.45 Fahrenheit (F) during a time frame of 18 hours and 30 minutes. The previous temperature excursions were reported as 53.29 F during a time frame of 1 hour and 45 minutes; and 49.73 F during a time frame of 1 hour.  No symptoms or additional adverse events had been reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2401USA006342:MSD US-009507513-2401USA005789:MSD US-009507513-2401USA006039:MSD US-009507513-2401USA005828:MSD US-009507513-2401USA005851:MSD US-009507513-2401USA006334:MSD US-009507513-2401USA005923:MSD US-009507513-2401USA006004:MSD US-009507513-2401USA005823:MSD US-009507513-2401USA006082:MSD US-009507513-2401USA005734:MSD
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Patient Received 1st Dose Of Heplisav-B and A Month Later Got Engerix-B; Initial report received on 13-Nov-2023  A pharmacist in the reported that a 23-year-old female patient (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and a month later received Engerix-B.  Medical history, allergies, and concomitant mediations at the time of vaccination were not reported.   On 11-May-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, and injection site were unknown, NDC # 43528-002-01) intramuscularly.   On 12-Jun-2023, 33 days after having been vaccinated with HEPLISAV-B, the patient received Engerix-B as the second dose (no details provided).  No additional information was available.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.