chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Internal haemorrhage, International normalised ratio increased, Malaise, Nerve injury, Nodule
Clinical narrative: She got her vaccine, everything went fine initially.  She then woke up at 2:00 AM drenched in sweat, her left arm throbbing.  She came to work the next day, called employee health.  A coworker got the vaccine right after her, she sent her a text that she was not feeling well and going to stay home.  She went to employee health and told them that she was sick, and her arm was in a lot of pain.  Thursday, still had pain, nothing taking away the pain, bad headache.  She called her doctor, tried to get into see him and not able to see  him on thursday or Friday.  She went back to Employee health on Thursday and showed it to them, had a softball size knot.  Friday showed it to them again, still had the not.  Sunday, had tingling in the left arm, headache and brusing started to appear.  From Sunday to Monday her bruise went from a little yellow spot to an area down to her elbow.  She went to her doctor and was told that she had a hematoma, nerve damage, internal bleeding.  Her INR is normally a 2, is 6.4.  They made a comment about the preservative, and had a reaction to the COVID vaccine, and feels that the preservative from the COVID wa sin her system and had problems with this vaccine.  She has bruises all over her body, arm looks like it was torn off by a dog and has had  a headache for a week now.  Her doctor gave her Phytonadione 5 mg tablet to take one by moouth for 10 days, and he instructed her to stop taking her Coumadin and goes on Friday to see him, and going to double check the hematoma and her INR levels.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: She got her vaccine, everything went fine initially.  She then woke up at 2:00 AM drenched in sweat, her left arm throbbing.  She came to work the next day, called employee health.  A coworker got the vaccine right after her, she sent her a text that she was not feeling well and going to stay home.  She went to employee health and told them that she was sick, and her arm was in a lot of pain.  Thursday, still had pain, nothing taking away the pain, bad headache.  She called her doctor, tried to get into see him and not able to see  him on thursday or Friday.  She went back to Employee health on Thursday and showed it to them, had a softball size knot.  Friday showed it to them again, still had the not.  Sunday, had tingling in the left arm, headache and brusing started to appear.  From Sunday to Monday her bruise went from a little yellow spot to an area down to her elbow.  She went to her doctor and was told that she had a hematoma, nerve damage, internal bleeding.  Her INR is normally a 2, is 6.4.  They made a comment about the preservative, and had a reaction to the COVID vaccine, and feels that the preservative from the COVID wa sin her system and had problems with this vaccine.  She has bruises all over her body, arm looks like it was torn off by a dog and has had  a headache for a week now.  Her doctor gave her Phytonadione 5 mg tablet to take one by moouth for 10 days, and he instructed her to stop taking her Coumadin and goes on Friday to see him, and going to double check the hematoma and her INR levels.
Age: 9.0
Sex: M
Vaccine: HEP, TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: On March 25, 2024, at approximately 1:10 pm client received a second dose of TDAP. This happened because the adult TDAP administered on January 16, 2024 that was in FL SHOTS was inadvertenly deleted on February 20, 2024, by another employee.    The vaccine on March 25, 2024 was an additional vaccine that the patient did not require, and was not counted as a valid dose according to the recommendations of the Advisory Committee on Immunization Practices.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Rash
Clinical narrative: Patient was given vaccine orally and was doing fine. Medical Assistant went to discharge patient and mom reported rash on patient body. Mom was instructed to take patient to emergency room, per Pediatrician's instructions.
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Discomfort, Dyspnoea, Injection site discomfort, Injection site swelling
Clinical narrative: Slight difficulty and discomfort with breathing about an hour after vaccine administered. Swelling and discomfort at injection site also noted.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Mom reports on 3/25/24 that she noticed on Saturday 3/23 that patient right thigh became "very inflamed, red, and hard to touch".  Also reports warm to touch.  Area of concern was softball size around injection site. Itchiness present. Mom provided antihistamines, hydrocortisone cream and applied ice. On 3/25, reports swelling and firmness had decreased. Still some warmth present. Redness was "deep red" now instead of "angry red" and appeared to be fading but had spread approximately 1/2" since area marked on Sunday. Itchiness continues. Mom submits photo of reaction. Provider treats patient with cephalexin for possible cellulitis and advised to follow up in clinic on 3/26.  Office visit for 3/26 cancelled by patient's father with note "father stated that she is doing a lot better, swelling is down, and they do not need this appointment."
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: Mom reports on 3/25/24 that she noticed on Saturday 3/23 that patient right thigh became "very inflamed, red, and hard to touch".  Also reports warm to touch.  Area of concern was softball size around injection site. Itchiness present. Mom provided antihistamines, hydrocortisone cream and applied ice. On 3/25, reports swelling and firmness had decreased. Still some warmth present. Redness was "deep red" now instead of "angry red" and appeared to be fading but had spread approximately 1/2" since area marked on Sunday. Itchiness continues. Mom submits photo of reaction. Provider treats patient with cephalexin for possible cellulitis and advised to follow up in clinic on 3/26.  Office visit for 3/26 cancelled by patient's father with note "father stated that she is doing a lot better, swelling is down, and they do not need this appointment."
Age: 64.0
Sex: F
Vaccine: COVID19, FLU4, PNC20, RSV, VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age, Vaccination error
Clinical narrative: Vaccination Error: Nurse administered Fluzone HD QIV to a 64 year old patient. Also, nurse noted when entering this immunization into database that patient received Fluarix in November  8, 2023. No side effects reported from vaccination error. Patient received the only Spikevax and Fluzone HD QIV at County Health Department on 1/4/24. The other vaccinations were given at  Pharmacy on the same day.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Chills, Cough, Diarrhoea, Erythema
Clinical narrative: Headache, redness and some swelling on the arm, fever (101.4), congestion, cough, chills, diarrhea.  I took Panadol and Nyquill to treat the symptoms which have lasted 6 days and am now beginning to feel better.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Peripheral swelling, Pyrexia, Respiratory tract congestion, White blood cell count decreased
Clinical narrative: Headache, redness and some swelling on the arm, fever (101.4), congestion, cough, chills, diarrhea.  I took Panadol and Nyquill to treat the symptoms which have lasted 6 days and am now beginning to feel better.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Pyrexia, Respiratory acidosis, Respiratory pathogen panel
Clinical narrative: Shortness of breath, fever, cough
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation
Clinical narrative: patient developed afib shortly after receiving the RSV vaccine
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus developed shortly after booster vaccine (original vaccine was Janssen). Tried to treat with OTC vitamins, then by eliminating Ciprofloxacin, but nothing worked.
Age: 28.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Hypersomnia, Syncope
Clinical narrative: Patient returned home after vaccination in office and fainted. EMS was called, vitals were taken, and began feeling better. No additional treatment given. Patient feels much better today, 3/27/24, and has been sleeping most of the time.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV
Symptoms: Wrong product administered
Clinical narrative: Vaxelis was mistakenly given.  patient should have recieved DTap - Daptacel vaccine.  the mistake was only noticed on March 26th which is when action was taken. Department of Health Division of Vaccine Excellence called, agency repersentative stated that no harm was done to the patient, and the vaccine given is safe and effective.  No further action needs to be taken and the patient can continue with the recomended vaccine schedule for children.  The mother of the child was notified in a face to face meeting with the nursing staff. She verbalized understanding that her daughter was mistakenly given Vaxelis instead of the recomended Daptacel, but that the vaccine given is safe and effective, and no further action is required.  The mother also stated that her daughterdisplayed no signs and symptoms of an adverse reaction to getting Vaxelis instead of Daptacel.  The mother was advided to monitor for signs and symptoms of a adverse reaction in her daughter and to report them imediately to office by calling, or by going to the Emergency Room.  She verbalizes understanding.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Blood culture, C-reactive protein increased, Full blood count normal, Injection site erythema, Injection site induration
Clinical narrative: 6 yo with right upper arm reaction after flu shot administration -with rapidly spreading redness, warmth to injections site, tenderness, will treat for possible cellulitis to right upper arm, patient remains very playful and active, with no signs of systemic illness.    Start antibiotics to cover for possible cellulitis Watch for spreading redness, swelling, area was marked with a sharpie If spreads beyond lines or patient with worsening pain fever can go to er.  Return tomorrow for recheck Cont tylenol, motrin for pain   Parents feeling nervous-  If patient shows signs of worsening they will go to er tonight Case signed out to Dr. who Is on call. Parents would like provider to call ER in case of speading . MD notes from 03/21/2023  She has been followed for swelling of her right upper extremity, after influenza vaccine was given on 3/18/2024. Yesterday when she saw Dr. there was swelling and induration and redness over her right upper arm and shoulder almost to the elbow, he was tender to touch, patient was placed on Bactrim to cover for cellulitis.  Later on at night parents call that the arm was getting worse therefore she went to the emergency room, I was reported that the child was alert active reactive in no apparent distress.Her right upper extremity swollen but not crossing the demarcated areas treated by Dr., ultrasound of the upper extremity negative for fluid collection. CRP minimally elevated, blood culturs taken, CBC normal WBC with shift to the right.. Mother here for f/u this morning. The right upper extremely swelling has decreased, less induration, no evidence of infection.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Metabolic function test, Procalcitonin
Clinical narrative: 6 yo with right upper arm reaction after flu shot administration -with rapidly spreading redness, warmth to injections site, tenderness, will treat for possible cellulitis to right upper arm, patient remains very playful and active, with no signs of systemic illness.    Start antibiotics to cover for possible cellulitis Watch for spreading redness, swelling, area was marked with a sharpie If spreads beyond lines or patient with worsening pain fever can go to er.  Return tomorrow for recheck Cont tylenol, motrin for pain   Parents feeling nervous-  If patient shows signs of worsening they will go to er tonight Case signed out to Dr. who Is on call. Parents would like provider to call ER in case of speading . MD notes from 03/21/2023  She has been followed for swelling of her right upper extremity, after influenza vaccine was given on 3/18/2024. Yesterday when she saw Dr. there was swelling and induration and redness over her right upper arm and shoulder almost to the elbow, he was tender to touch, patient was placed on Bactrim to cover for cellulitis.  Later on at night parents call that the arm was getting worse therefore she went to the emergency room, I was reported that the child was alert active reactive in no apparent distress.Her right upper extremity swollen but not crossing the demarcated areas treated by Dr., ultrasound of the upper extremity negative for fluid collection. CRP minimally elevated, blood culturs taken, CBC normal WBC with shift to the right.. Mother here for f/u this morning. The right upper extremely swelling has decreased, less induration, no evidence of infection.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Shift to the right, Ultrasound scan normal
Clinical narrative: 6 yo with right upper arm reaction after flu shot administration -with rapidly spreading redness, warmth to injections site, tenderness, will treat for possible cellulitis to right upper arm, patient remains very playful and active, with no signs of systemic illness.    Start antibiotics to cover for possible cellulitis Watch for spreading redness, swelling, area was marked with a sharpie If spreads beyond lines or patient with worsening pain fever can go to er.  Return tomorrow for recheck Cont tylenol, motrin for pain   Parents feeling nervous-  If patient shows signs of worsening they will go to er tonight Case signed out to Dr. who Is on call. Parents would like provider to call ER in case of speading . MD notes from 03/21/2023  She has been followed for swelling of her right upper extremity, after influenza vaccine was given on 3/18/2024. Yesterday when she saw Dr. there was swelling and induration and redness over her right upper arm and shoulder almost to the elbow, he was tender to touch, patient was placed on Bactrim to cover for cellulitis.  Later on at night parents call that the arm was getting worse therefore she went to the emergency room, I was reported that the child was alert active reactive in no apparent distress.Her right upper extremity swollen but not crossing the demarcated areas treated by Dr., ultrasound of the upper extremity negative for fluid collection. CRP minimally elevated, blood culturs taken, CBC normal WBC with shift to the right.. Mother here for f/u this morning. The right upper extremely swelling has decreased, less induration, no evidence of infection.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after its beyond use date of 03/16/2024. Manuf expiration 04/30/24.
Age: 34.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Fever, body aches, muscle soreness, nausea
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: Vaccine administration error report only. No adverse health event. Nurse reviewed vaccination record brought in by patient noting polio vaccines given with no IPV indicated (unknown polio). The nurse forgot the rule that any polio given before April 2016 counted toward school vaccine requirements along with proper spacing between doses. The client's records were compliant with state laws so the IPV given this day was not needed. Client's family and our medical director were notified immediately. Follow up with client 3/20/2024: "slight fever" but denied any redness, swelling or other local or systemic effects. Follow up 3/27/24: Client had no side effects currently and fever resolved after our conversation 3/20/24.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was given after beyond use date of 03/16/2024. Manuf expiration 04/30/2024
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Loss of personal independence in daily activities, Magnetic resonance imaging abnormal, Mobility decreased, Muscular weakness
Clinical narrative: It began within hours that I was unable to move my arm.  I struggled to lift it at all. After a few days I could move it a little. Over time I got some movement back but with pain and weakness. Eventually I went to my primary who recommended I follow up with ortho and PT. Ortho did an XRAY and ordered PT. I was diagnosed with SIRVA.  PT made some progress not full recovery. MRI was ordered. Showed subacromial bursitis and SIRVA. I have had several cortisone shots but still suffer with pain and limited an activity at times.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Shoulder injury related to vaccine administration, X-ray limb
Clinical narrative: It began within hours that I was unable to move my arm.  I struggled to lift it at all. After a few days I could move it a little. Over time I got some movement back but with pain and weakness. Eventually I went to my primary who recommended I follow up with ortho and PT. Ortho did an XRAY and ordered PT. I was diagnosed with SIRVA.  PT made some progress not full recovery. MRI was ordered. Showed subacromial bursitis and SIRVA. I have had several cortisone shots but still suffer with pain and limited an activity at times.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was given after beyond use date of 03/16/2024. Manuf expiration 04/30/2024
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was given after beyond use date of 03/16/2024. Manuf expiration 04/30/2024
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was given after beyond use date of 03/16/2024. Manuf expiration 04/30/2024
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: PATIENT REPORTED FEELING NUMB ON HIS LEFT LEG BELOW THE KNEES WITHIN MINUTES OF RECEIVING VACCINE. NO OTHER SIDE EFEFCTS REPORTED. MONITORED BLOOD PRESSURE ( AVERAGE 155/85) , LOWER WITH EACH MEASUREMENT. HE REFUSED A 911 CALL AND FELT OK TO DRIVE TO THE HOSPITAL AFER SITTING DOWN FOR FEW MINUTES AND NUMBNESS STILL REMAINED.
Age: 68.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Injection site discomfort, Product administered at inappropriate site
Clinical narrative: Patient was improperly administered Rabavert into the Gluteal for both the 2nd (right) and 3rd (left) doses. The charting by the MA was noted at L vastus lateralis, which were confirmed to be incorrect by both the Medical Assistant and the patient. The patient after the 3rd does went to the ED as he had discomfort in the L gluteal region and was concerned for an allergic reaction to the Rabavert.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Erythema, Feeling abnormal, Headache, Heart rate increased
Clinical narrative: Evening of March 20 patient started with heart palpitations and racing heart rate.  Thursday, March 21 patient experienced high blood pressure, 180/150, 130 pulse, racing heart rate, not feeling right.  These continued through out the day Thursday.  Friday, March 22 patient reportes having head ache, continued elevated pulse and blood pressure but lower than what had on Thursday.  Pulse continued in the 100s.  On left arm red swollen circle that was painful appeared, 3 cm in diameter.  Each day blood pressure and heart rate improved.  Swollen circle on arm started to decrease and become less red.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Palpitations, Peripheral swelling
Clinical narrative: Evening of March 20 patient started with heart palpitations and racing heart rate.  Thursday, March 21 patient experienced high blood pressure, 180/150, 130 pulse, racing heart rate, not feeling right.  These continued through out the day Thursday.  Friday, March 22 patient reportes having head ache, continued elevated pulse and blood pressure but lower than what had on Thursday.  Pulse continued in the 100s.  On left arm red swollen circle that was painful appeared, 3 cm in diameter.  Each day blood pressure and heart rate improved.  Swollen circle on arm started to decrease and become less red.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella post vaccine
Clinical narrative: SMALL CHICKEN POX OUTBREAK ON CHEST
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Aldolase normal, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Asthenia, Atrophy
Clinical narrative: Muscle weakness, right leg pain with inability to walk or move knee for 4 mos then left knee for 1 wk. Ongoing muscle spasms and burning sensation from his lower back into his feet that lasted for months. Ongoing atrophy of the right leg. Patient also experienced 9 months of stomach issues with diarrhea. Patient experienced numbness and muscle spasms. Low energy.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase normal, Burning sensation, Diarrhoea, Gait inability, Gastrointestinal disorder
Clinical narrative: Muscle weakness, right leg pain with inability to walk or move knee for 4 mos then left knee for 1 wk. Ongoing muscle spasms and burning sensation from his lower back into his feet that lasted for months. Ongoing atrophy of the right leg. Patient also experienced 9 months of stomach issues with diarrhea. Patient experienced numbness and muscle spasms. Low energy.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Muscle spasms, Muscular weakness, Pain in extremity
Clinical narrative: Muscle weakness, right leg pain with inability to walk or move knee for 4 mos then left knee for 1 wk. Ongoing muscle spasms and burning sensation from his lower back into his feet that lasted for months. Ongoing atrophy of the right leg. Patient also experienced 9 months of stomach issues with diarrhea. Patient experienced numbness and muscle spasms. Low energy.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid factor negative
Clinical narrative: Muscle weakness, right leg pain with inability to walk or move knee for 4 mos then left knee for 1 wk. Ongoing muscle spasms and burning sensation from his lower back into his feet that lasted for months. Ongoing atrophy of the right leg. Patient also experienced 9 months of stomach issues with diarrhea. Patient experienced numbness and muscle spasms. Low energy.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Pain in extremity
Clinical narrative: Patient reports her arm from her shoulder to her elbow has been aching and burning for the 12 days since her vaccination.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Pruritus, Urticaria
Clinical narrative: Patient stated she had itchy whelps at injection site, one leg, both sides, and back today. Took Benadryl this morning.  Recommended that she contact her physician. Her physician told her to continue Benadryl and it should resolve symptoms. Today, 4pm, called patient and she stated she was much better. She said itching had almost gone away and only affected area now was injection site.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Pt said she has a history of fainting after vaccines. A couple minutes after receiving vaccine, she fainted in a sitting position, slumped slightly to her right side. I immediately took her shoulders and righted her, and held both her hands while saying, "hey there, wake up please" and she immediately opened her eyes and asked if she had fainted. I said yes, for less than 30 seconds.  We gave her a couple of cups of water as she sat in the waiting room. After about 15 minutes, she said she was feeling fine, and wasn't going to drive. Her friend was picking her up. Called pt the next day to check on her, she said she was still feeling fine.
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No reaction Expired Vaccine given 03/25/2024
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Dyspnoea
Clinical narrative: Patient returned to his next visit at the Pharmacy and mentioned to a pharmacy associate that when he got to the parking lot and stated he was short of breath, he did not call or return to the pharmacy after vaccine administration and said his symptoms had resolved
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Abdominal X-ray, Chest X-ray normal, Diarrhoea, Influenza A virus test negative, Influenza B virus test negative
Clinical narrative: Fever, vomiting, diarrhea started on 03/19/2024.   Parent took patient to Medical Center 03/19/2024.   Parents followed up with PCP on 03/21/2024 when patient continued to present with same symptoms.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Polymerase chain reaction, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Fever, vomiting, diarrhea started on 03/19/2024.   Parent took patient to Medical Center 03/19/2024.   Parents followed up with PCP on 03/21/2024 when patient continued to present with same symptoms.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Vomiting, X-ray normal
Clinical narrative: Fever, vomiting, diarrhea started on 03/19/2024.   Parent took patient to Medical Center 03/19/2024.   Parents followed up with PCP on 03/21/2024 when patient continued to present with same symptoms.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: The Hib vaccine that was administered to the patient was expired. Hib vaccine expired 03/25/24. No symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: Pharmacist reported that a patient's recent varicella titer came back negative.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (reported as in early 2000s), the patient was vaccinated with 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date (reported as recent), the patient's recent varicella titer came back negative (varicella virus test negative). The outcome of the event was unknown. The action taken was not applicable.  The causal relationship between varicella virus test negative and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report inadvertent administration of VARIVAX to multiple patients after a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-FEB-2024, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #X021284, expiration date: 20-AUG-2025, administered for prophylaxis [strength, dose and route of administration were not provided]) which experienced a temperature excursion (Product storage error). Temperature was -13.1C, time frame was 0 hours 18 minutes 0 seconds. No previous temperature excursion. No additional adverse event (AE) (No adverse event).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP called to report inadvertent administration of expired RECOMBIVAX HB to a patient. Product expired on 26FEB2024 and was administered to a patient on 29FEB2024. No additional AE/PQC.; HCP called to report inadvertent administration of expired RECOMBIVAX HB to a patient. Product expired on 26FEB2024 and was administered to a patient on 29FEB2024. No additional AE/PQC.; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 29-FEB-2024, the patient was inadvertently vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular, (expiration date 26-FEB-2024, lot #: W002452; (strength, dose were not reported) for prophylaxis (expired product administered). No additional adverse event or product quality complains were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE/no PQC reported; Nurse practitioner called to report that a dose of VARIVAX was reconstituted with normal saline instead of the Merck sterile diluent and was then administered to a patient. Caller stated no patient symptoms have been reported. Caller also reported on; Nurse practitioner called to report that a dose of VARIVAX was reconstituted with normal saline instead of the Merck sterile diluent and was then administered to a patient.; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 03-FEB-2024 the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, dose number, route and site of administration were not provided) that was reconstituted with normal saline (NORMAL SALINE) instead of the sterile diluent (STERILE DILUENT).  Other suspect therapies included sterile diluent (STERILE DILUENT) and normal saline (NORMAL SALINE) (product preparation error, incorrect product formulation administered and no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient has reported no issues; HCP called to report that a single dose of PROQUAD was given to a patient on 3/4/2024 after a TE occurred on 3/2/2024.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patients concurrent conditions, medical history, and concomitant therapies were not reported.   On 04-MAR-2024, the patient was vaccinated with a single dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, lot #X018570 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) with expiration date: 05-JAN-2025, administered as prophylaxis (dose, frequency, strength, and route of administration were not provided) after temperature excursion on 02-MAR-2024 (product storage error) of 15 degrees Fahrenheit for 1 hour 5 minutes 0 seconds. No previous temperature excursions or additional adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No AE; adult patient received a pediatric dose of VAQTA; This spontaneous report was received from medical assistant and refers to a adult patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 13-MAR-2024, the patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (1 dose, lot #W036135 was valid for formulation pre-filled syringe, expiration date: 13-MAY-2024, route of administration and anatomical location were not provided) for prophylaxis (Adult use of a child product). No further details provided. No additional adverse event (AE)/no product quality complaint (PQC).
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PROQUAD was administered to a consumer who was 13 years and 4 months old.; No additional AEs; This spontaneous report was received from a nurse and refers to a 13-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered after a temperature excursion to one patient.; This spontaneous report was received from other (an office manager) and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-MAR-2024, the patient was vaccinated once with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) injection, lot #X018732, expiration date: 06-JAN-2025, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of vaccine was exposed to the temperature excursion on an unspecified date: 6.3 Fahrenheit (F) for 13 hours (product storage error, onset date: 19-MAR-2024). Previous temperature excursion was reported as no. There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; administration of PROQUAD to a patient on 20MAR2024 after a temperature excursion; This spontaneous report was received from an other health professional (nurse) and refers to a patient of an unknown age and gender (limited patient's demographics provided).  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 20-MAR-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) injection, lot #X025096 (lot # was validated as valid), expiration date: 16-APR-2025, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of suspect vaccine was exposed to the temperature excursion on an unknown date: 4.8 Celsius degrees for 120 hours (product storage error, onset date:20-MAR-2024). Previous temperature excursion was reported as no. There was no additional adverse event reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller stated no patient symptoms have been reported; 1 dose of VARIVAX was administered to a patient after the product was involved in a temperature excursion.; This spontaneous report was received from a medical assistant and refers to a patient (age and gender were not provided). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) VARIVAX was involved in a temperature excursion of 16.77 F, during a time frame of 1 hour 50 minutes 0 seconds. On 20-MAR-2024 (after the excursion), the patient was vaccinated with improperly storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #X024540 has been verified to be a valid lot number, expiration date was reported and confirmed as 10-OCT-2025 (strength, exact dose and route of administration were not provided) administered for prophylaxis (Product storage error). There was not previous temperature excursion. The reporter stated no patient symptoms have been reported. No additional adverse event (AE) and no product quality complaint (PQC) were reported.
Age: 0.25
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: 4th dose administered; 3rd dose administered on 24-SEP-2002; 2nd dose administered on 05-JUL-2002; This spontaneous report has been received from an other health care professional, via a medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL) (MARRS # 2402USA003398), concerning a female 4-month-old (at the time of the event) patient. The patient's concomitant therapies included diphteria vaccine toxoid (+)  pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid, hepatitis B vaccine and polio vaccine. The patient's historical vaccines included hepatitis B vaccine. Her concurrent conditions and  medical history were not provided.   On 29-MAY-2002, at the age of 12 weeks, the patient was vaccinated with the first dose of Haemophilus b conjugate vaccine (manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis. On 05-JUL-2002, she received the second dose of Haemophilus b conjugate vaccine (manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). On 24-SEP-2002, the patient was vaccinated with the third dose of Haemophilus b conjugate vaccine (manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). On 06-MAR-2003, the patient received the fourth dose of Haemophilus b conjugate vaccine (manufacturer unknown) (extra dose administered).    This is one of 5 reports created for the same patient (linked MARRS # 2402USA003398, 2403USA007989, 2403USA007991 and 2403USA007992).; Sender's Comments:  US-009507513-2402USA003398:
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Malaise
Clinical narrative: got GB after the Shingles vax; extremely sick; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: got GB after the Shingles vax) (serious criteria GSK medically significant) and sickness (Verbatim: extremely sick). The outcome of the guillain barre syndrome and sickness were not reported.   It was unknown if the reporter considered the guillain barre syndrome and sickness to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2024 The reporter was the patient's friend who reported this case via (social media) interactive digital media. Reporter's friend (patient) got GB after the Shingles vax (vaccine). He was extremely sick. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Viral infection
Clinical narrative: sore arm; akin to viral symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm) and viral infection (Verbatim: akin to viral symptoms). The outcome of the pain in arm and viral infection were resolved.   It was unknown if the reporter considered the pain in arm and viral infection to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and viral infection to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2024 This case was reported by a patient viaoo interactive digital media. Patient had got something akin to viral symptoms for a day or two after the second shot, along with a very sore arm. It passed. The patient guessed it happens as he/she have heard others mention it.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pain of skin, Skin ulcer
Clinical narrative: developed shingles it started like a beck sting then traveled to shoulder and firm left arm left upper chest and back of shoulder; water blisters; sores/ deep pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: developed shingles it started like a beck sting then traveled to shoulder and firm left arm left upper chest and back of shoulder), blister (Verbatim: water blisters) and pain (Verbatim: sores/ deep pain). The outcome of the shingles, blister and pain were resolving.   It was unknown if the reporter considered the shingles, blister and pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles, blister and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2024 This case was reported by a patient via interactive digital media. Patient took one shot and developed shingles. It started like a beck sting then traveled to his/her shoulder and firm his/her left arm left upper chest and back of shoulder sores looked like water blisters. It went away within 2 weeks after meds but then they went inward 15 months later. Patient had deep pain that comes and goes with pressure or rubbing of clothes. The patient said that, he/she ready to feel better.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: at the most a sore arm for a few days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: at the most a sore arm for a few days). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2024 This case was reported by a patient via interactive digital media. The patient had at the most a sore arm for a few days. No other reaction. The patient has had the shingles shot when it first came out and a booster since. The patient had two friends that had shingles. Did not get the shot. One still (at the time of reporting) had nerve pain, 5 years later. The other friend of patient passed away from Covid. She did not get that shot either.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: Uncomfortable; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced discomfort (Verbatim: Uncomfortable). The outcome of the discomfort was not reported.   It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.     It was unknown if the company considered the discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2024 This case was reported by a reporter via interactive digital media. The reporter stated that those jabs only lasted for a split second but they sure were uncomfortable. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Awful pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Awful pain). The outcome of the pain was resolved (duration 6 weeks).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she had six weeks awful pain. And had the vaccine. Seemed it needed to be updated. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Eye disorder, Skin disorder
Clinical narrative: scalp issues, miserable; eyes are an issue too; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of scalp disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced scalp disorder (Verbatim: scalp issues, miserable) and eye disorder (Verbatim: eyes are an issue too). The outcome of the scalp disorder and eye disorder were not reported.   It was unknown if the reporter considered the scalp disorder and eye disorder to be related to Shingles vaccine.     It was unknown if the company considered the scalp disorder and eye disorder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-Mar-2024 This case was reported by a patient via interactive digital media. Patient had got two shots. Patient was having scalp issues, miserable. The eyes were an issue too. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: somebody punched me in the shoulder; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shoulder pain (Verbatim: somebody punched me in the shoulder). The outcome of the shoulder pain was not reported.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.     It was unknown if the company considered the shoulder pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-Mar-2024 This case was reported by a patient via interactive digital media. Patient got vaccine a few days ago. Patient stated, the only side effect does it just feels like somebody punched him/her in the shoulder. Patient felt so relieved that he/she got it (vaccine). The follow-up could not be possible as no contact details were available.