chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Scan with contrast abnormal, Ventricular tachycardia, Vertigo, Vomiting, White blood cell count increased
Clinical narrative: New onset atrial fibrillation, systemic inflammation, brain demyelination, and possible myocarditis.  On 6/22/23 he awoke a felt a little weird. At about 11 AM he looked up and had vertigo. He saw everything spinning. Any movement of the head would bring on severe vertigo and he started vomiting. It was bad for about 3 weeks and then improved and it went away after a month. It was constant not episodic. He still has a little lightheadedness.  He was admitted 6/22/23 and found to have atrial fibrillation with RVR. He was treated with ASA 81 mg daily. WBC and CRP and BNP elevated. He had event monitor 8/7 to 9/5/23 showing a run of 9 beats of ventricular tachycardia 8/8/23 1227 AM. He was then started on bisoprolol 5 mg daily, now on 2.5 mg qd. He feels pretty well now.   NCCT 6/22/23 showed a hypodense lesion left temporal lobe.  MR noncontrast 6/24/23 showed a left temporal cystic lesion with surrounding edema and a left periatrial lesion and a small right frontal deep white matter lesion. MR with contrast 7/28/23 showed improvement in the left temporal lesion and no change in the others.  Cardiac MRI pending
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: White matter lesion
Clinical narrative: New onset atrial fibrillation, systemic inflammation, brain demyelination, and possible myocarditis.  On 6/22/23 he awoke a felt a little weird. At about 11 AM he looked up and had vertigo. He saw everything spinning. Any movement of the head would bring on severe vertigo and he started vomiting. It was bad for about 3 weeks and then improved and it went away after a month. It was constant not episodic. He still has a little lightheadedness.  He was admitted 6/22/23 and found to have atrial fibrillation with RVR. He was treated with ASA 81 mg daily. WBC and CRP and BNP elevated. He had event monitor 8/7 to 9/5/23 showing a run of 9 beats of ventricular tachycardia 8/8/23 1227 AM. He was then started on bisoprolol 5 mg daily, now on 2.5 mg qd. He feels pretty well now.   NCCT 6/22/23 showed a hypodense lesion left temporal lobe.  MR noncontrast 6/24/23 showed a left temporal cystic lesion with surrounding edema and a left periatrial lesion and a small right frontal deep white matter lesion. MR with contrast 7/28/23 showed improvement in the left temporal lesion and no change in the others.  Cardiac MRI pending
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: rash on upper third of left arm - started a few hours after vaccine administered and still present. Rash is red and itchy.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: Headache, muscle weakness, feeling tired, chills, weak, rash, itching, swollen, red, severe dizziness
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Muscular weakness, Pruritus, Rash, Swelling
Clinical narrative: Headache, muscle weakness, feeling tired, chills, weak, rash, itching, swollen, red, severe dizziness
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram abdomen, Culture urine, Pollakiuria, Ultrasound abdomen, Urinary tract infection
Clinical narrative: Urinary tract infection that would go away...treated with 4 medications... so severe required procedure intervention...now I'm struggling with continued uutis and excessive urination
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: RN administered vaccine on 09/19/2023 and the Vaccine expired on 09/16/2023. Patient to be notified, vaccines have been pulled and discarded.  RN has been reminded to check expiration dates on all medications/vaccines given to patients.
Age: 74.0
Sex: M
Vaccine: FLUC4
Symptoms: Wrong product administered
Clinical narrative: It was reported on 9/20/2023, an employee administered a 19+ influenza vaccine to patient instead of a 65+ influenza vaccine.
Age: 69.0
Sex: F
Vaccine: FLUC4
Symptoms: Wrong product administered
Clinical narrative: It was reported on 9/20/2023, an employee administered a 19+ influenza vaccine to patient instead of a 65+ influenza vaccine.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Feeling abnormal, Mobility decreased, Peripheral swelling
Clinical narrative: I was ok, I drove home, I ate soup. 1 hour later I felt dizzy. I sat on the couch and i was so dizzy I couldnt get up. I stayed there all night. I was vomitting. My arm also swelled up really big. It is still a little swollen and red today (9/20/23). This all lasted about 24 hours and then it subsided. I dont feel great but I feel some better. Today is the 3rd day.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: I was ok, I drove home, I ate soup. 1 hour later I felt dizzy. I sat on the couch and i was so dizzy I couldnt get up. I stayed there all night. I was vomitting. My arm also swelled up really big. It is still a little swollen and red today (9/20/23). This all lasted about 24 hours and then it subsided. I dont feel great but I feel some better. Today is the 3rd day.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient received immunizations of the day his 5 year well check on 9/18/2023. Later in the evening, hours after receiving he developed hives: generalized hives - face, upper and lower extremities and abdomen. He did not have any respiratory difficulty, facial swelling, joint pains, fever, vomiting/ abdominal upset.
Age: 72.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: pt had localized redness to the area, has lasted for 8 days now, a little tender upon pushing on the arm
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Decreased vibratory sense, Facial asymmetry, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: 30 minutes after receiving the vaccine report numbness in the right cheek  progressed to numbness to the right side of the face and numbness to the right portion of the mouth upper and lower lip, with altered sensation in chewing ,  and abnormal sensation to the teeth upper and lower on the right side,  this afternoon noted pain in the right hand between 2nd and 3rd metacarpals , a slight facial asymmetry noted on the right side of the face.  Also developed pain to the right side of the neck and shoulder 1 hour after the vaccine
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain in extremity, Sensory disturbance, Vibration test abnormal
Clinical narrative: 30 minutes after receiving the vaccine report numbness in the right cheek  progressed to numbness to the right side of the face and numbness to the right portion of the mouth upper and lower lip, with altered sensation in chewing ,  and abnormal sensation to the teeth upper and lower on the right side,  this afternoon noted pain in the right hand between 2nd and 3rd metacarpals , a slight facial asymmetry noted on the right side of the face.  Also developed pain to the right side of the neck and shoulder 1 hour after the vaccine
Age: 46.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient was given a second dose of Prevnar 20 one year after receving previous dose of Prevnar 20
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Influenza virus test negative, Pyrexia, Respiratory viral panel, Vomiting
Clinical narrative: Mom states "daughter had shots on Friday, fever Sunday 101.5-102, 103.5 yesterday and vomited last night seen ER last night and given antinausea medication, they tried to collect urine unable to giving her Motrin and Tylenol every 3 hours no rash, no redness to shot site."
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: I experienced redness and warmth to my arm after receiving the flu vaccine. this was of extra concern because it covered a much larger portion of my arm than the previous year.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient received vaccine at around 12:00 noon of 9/19/2023, this vaccine was given by another nurse. Patient notified office today 9/20/23 regarding reactions she felt last night after receiving the flu vaccine. Patient report night of 9/19/23 at about 9:30pm  she felt left arm pain that she rates a 6-7 in a scale of 1-10 and stiffness to her neck, denies any other reaction. Patient took Tylenol 1000mg by mouth night of 9/19/23 at around 11:00pm and another dose of Tylenol 1000mg morning of 9/20/2023 at around 5:30am.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling around injection site, shortness of breath, rapid heart rate (112 bpm), tingling lips, chest pain
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral
Clinical narrative: redness and swelling around injection site, shortness of breath, rapid heart rate (112 bpm), tingling lips, chest pain
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Received monovalent booster after deauthorization
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Adverse drug reaction, Chills, Decreased appetite, Headache, Impaired work ability
Clinical narrative: Lethargic, fever, chills, headache, lack of appetite, sore hands/feet/neck This started the evening that I received the vaccine and was so ill that I missed work the next day (Tuesday). Went back to work on Wednesday and continued to have headaches and body pain for the next 8 days, took Tylenol, which helped.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Influenza A virus test negative, Influenza B virus test, Lethargy, Malaise, Neck pain
Clinical narrative: Lethargic, fever, chills, headache, lack of appetite, sore hands/feet/neck This started the evening that I received the vaccine and was so ill that I missed work the next day (Tuesday). Went back to work on Wednesday and continued to have headaches and body pain for the next 8 days, took Tylenol, which helped.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pain in extremity, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Lethargic, fever, chills, headache, lack of appetite, sore hands/feet/neck This started the evening that I received the vaccine and was so ill that I missed work the next day (Tuesday). Went back to work on Wednesday and continued to have headaches and body pain for the next 8 days, took Tylenol, which helped.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Tdpa vaccines applied before schedule time
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: within five days of vaccination, I developed actual shingles.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: within five days of vaccination, I developed actual shingles.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Injection site pain, Pain, Pain in extremity
Clinical narrative: patient describes shot as high - felt hit bone (I suspect joint).  Shoulder pain, arm pain, systemic pain, "can barely walk"  This was called in about 4 hours after shot given
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: patient describes shot as high - felt hit bone (I suspect joint).  Shoulder pain, arm pain, systemic pain, "can barely walk"  This was called in about 4 hours after shot given
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Reporting a vaccine administration error. The vaccine given was past it's Beyond Use Date by 20 days. Spoke with both Pfizer and CDC and recommendation was made that child be re-vaccinated. No wait period needed. Patient's father stated no adverse reaction was noticed.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Received monovalent booster after deauthorization
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient was given vaccine on 9/18/23. When billing was processed, insurance said patient already had flu vaccine on 8/30/23.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Received monovalent booster after deauthorization
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Received monovalent booster after deauthorization
Age: 50.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: Left arm had flu shot, mild and small soreness at injection site. Right arm had Shingrix at approx. 10AM. By 10PM right arm was sore and swollen from shoulder to elbow, fever hit 100° by midnight. At 2AM began to have chills and body nausea, at 3AM severe abdominal cramping and diarrhea, considered ER as pain was approaching 5/5. During this profuse sweating and uncontrollable shivering, dizziness, and intense headache. Took warm shower and waited it out, by 5AM most symptoms eased. Headache eased after consuming fluids, abdominal soreness, "aftershocks" of diarrhea, and body soreness lasted for a few days.
Age: 50.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Left arm had flu shot, mild and small soreness at injection site. Right arm had Shingrix at approx. 10AM. By 10PM right arm was sore and swollen from shoulder to elbow, fever hit 100° by midnight. At 2AM began to have chills and body nausea, at 3AM severe abdominal cramping and diarrhea, considered ER as pain was approaching 5/5. During this profuse sweating and uncontrollable shivering, dizziness, and intense headache. Took warm shower and waited it out, by 5AM most symptoms eased. Headache eased after consuming fluids, abdominal soreness, "aftershocks" of diarrhea, and body soreness lasted for a few days.
Age: 50.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia
Clinical narrative: Left arm had flu shot, mild and small soreness at injection site. Right arm had Shingrix at approx. 10AM. By 10PM right arm was sore and swollen from shoulder to elbow, fever hit 100° by midnight. At 2AM began to have chills and body nausea, at 3AM severe abdominal cramping and diarrhea, considered ER as pain was approaching 5/5. During this profuse sweating and uncontrollable shivering, dizziness, and intense headache. Took warm shower and waited it out, by 5AM most symptoms eased. Headache eased after consuming fluids, abdominal soreness, "aftershocks" of diarrhea, and body soreness lasted for a few days.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Cardiac failure congestive, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Pt was hospitalized 9/12/2023 for COPD/CHF exacerbation
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Urticaria
Clinical narrative: Severe hives all over various parts of my body for the past two nights. Significantly less during the day. Some help from antihistamines. Hoping they don't flare up again tonight.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Patient reports over phone on 09/20/23 that it was given by pharmacist in area between the armpit and elbow of patient's arm. There is bruising and redness that has grown overtime since shot on 09/12/23. Patient has not report going to seek a PCP or ER or Urgent care.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Client is 14 weeks and is reporting rash on her left arm.
Age: 0.75
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: Covid-19 Bivalent vaccine not authorized after 09/12/2023. Patient was given the vaccine on 09/13/2023.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Influenza, Insomnia, Listless, Loss of personal independence in daily activities
Clinical narrative: Same night as injection; sleepness night, following morning, feeling very sick as if I had Covid or the flu. Very weak and listless; unable to perform daily tasks.  Took a Xanax to go to sleep and slept soundly, feeling much better today (9/20).  Although very unpleasant, not life threatening just unexpected since I didn't have any reactions to all the previous injections. Just a note: have only received the Maderna Covid vaccines.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise
Clinical narrative: Same night as injection; sleepness night, following morning, feeling very sick as if I had Covid or the flu. Very weak and listless; unable to perform daily tasks.  Took a Xanax to go to sleep and slept soundly, feeling much better today (9/20).  Although very unpleasant, not life threatening just unexpected since I didn't have any reactions to all the previous injections. Just a note: have only received the Maderna Covid vaccines.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Gait inability
Clinical narrative: Patient contacted pharmacy stating within 48 hours of the second dose they are experiencing severe joint pain. Patient stated no adverse effects from the first dose. Patient stating the joint pain is affecting her to the point she is not able to walk and is in discomfort.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Contraindication to vaccination
Clinical narrative: Patient answered no to the screening questions for the flu mist. The flu mist was given prior to scanning the product. After administration and the flu mist was scanned, an error prompted a contraindication with flu mist and the methotrexate that the patient is currently taking.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Patient Received ProQuad and Kinrix in her left upper thigh. Pt reported back to the clinic two days later complaining of having a rash, skin being red and hot to the touch.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Balance disorder, Dizziness, Hyporesponsive to stimuli
Clinical narrative: Patient received HPV and influenza vaccine on a mobile medical van.  After vaccine administration client reported feeling lightheaded and had delayed verbal responses. Client observed to sway in his seated position but did not fall or lose consciousness. Blood pressure, heart and oxygen saturation vitals were gathered. Patient given snacks and bottled water. Cooled with ice packs and elevated legs.  Client still reported feeling lightheaded. Patient walked into school accompanied but with no assistance. School Principal was notified of condition and student's family was notified. In the school patient given milk and cereal but still was swaying with delayed verbal responses and reported feeling dizzy. Vitals were taken again. Decision to call 911 for further assessment was made. Relayed patient's condition to paramedics on ambulance. Family member accompanied student on ambulance to hospital. Patient never appeared to lose consciousness, remained verbally responsive and answered questions appropriately throughout whole encounter.
Age: 54.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient who is 54, received vaccine that is only recommended in those over 60.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error, Single component of a two-component product administered
Clinical narrative: This RN was made aware that pt was supposed to receive a Shingles Vaccine however only the diluent was administered. This RN contacted the provider to report incident. Pt daughter notified. Verbalized understanding. No injuries reported.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: patient received 1st dose of Heplisav B vaccine for pre-employment  physical when she was 10-11 weeks pregnant
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC.; HBP called to report inadvertent administration of a pediatric dose of VAQTA to an adult patient. The adult patient received a pediatric dose of 0.5ml instead of the adult dose of 1 ml on 09/06/2023. HBP did not know any patient demographics or any a; HBP called to report inadvertent administration of a pediatric dose of VAQTA to an adult patient. The adult patient received a; This spontaneous report was received from Other and refers to an adult patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5ml/once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 06-SEP-2023, HBP called to report inadvertent administration of a pediatric dose of VAQTA to an adult patient. The adult patient received a pediatric dose of 0.5ml instead of the adult dose of 1 ml on 09/06/2023. HBP did not know any patient demographics or any additional details. No additional AE/PQC.
Sex: F
Vaccine: HPV9
Symptoms: Cervix carcinoma, Hysterectomy
Clinical narrative: diagnosed with cervical cancer in july 2022; This spontaneous report has been received from a physician assistant and refers to a 36-year-old female patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliters (mL), administered intramuscularly for prophylaxis. By an unspecified date in may 2022, the patient had completed all three doses. (strength, lot #, and expiry date were not provided).  On an unknown date in july 2022, the patient was diagnosed with cervical cancer (cervix carcinoma), which resulted in a hysterectomy to treat it. At the time of reporting, the patient was recovering from the event.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event was determined to be medically significant.
Sex: U
Vaccine: RV5, UNK
Symptoms: Product storage error
Clinical narrative: No further AE; PCC transfer RN calls to report VAXELIS and ROTATEQ given during a TE.  No further AE.  No PQC.  See TE case 02473804; This spontaneous report was received from a registered nurse and refers to a unknown patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-SEP-2023, the patient was vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, one time, lot #u7535aa, expiration date: 23-SEP-2025, administered for prophylaxis (strength, and route of administration were not provided); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, one time, administered for prophylaxis lot #X007337 and expiration date 29-OCT-2024 (strength, lot #, expiry date, and route of administration were not provided). Those vaccine underwent temperature excursion before administration (Product storage error). No additional adverse event was reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The healthcare worker is reporting that a patient received improperly stored vaccine.; No additional AEs were reported; This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medications was not provided.  On unknown day, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (1 dosage form, lot #x0006983 was not valid, expiration date 07-MAR-2025 or lot #x000999, expiration date 09-JAN-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). It was unknown which of two lots was given to patient.   On unknown dates, the vaccines experienced temperature excursion of 6 degrees Fahrenheit (F) up to 14 F for 10 hours and 14 F up to 46 F for 3 hours 30 minutes. No additional adverse events (AEs) were reported (No adverse event). No further information provided. No previous temperature excursion.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Ileus
Clinical narrative: HCP states patient received ROTATEQ, PEDIARIX, PEDVAX HIB and VAXNEUVANCE as part of 2 month vaccination series on 7/17/2023.  Per mom, patient developed ileus that same evening, ending up in the ED.  HCP calling today to ask if ileus could be caused; This spontaneous report was received from Other Health Professional and refers to a 4-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, single dose (strength, lot #, expiry date, route of administration, and indication were not provided); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, single dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, single dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unknown date, the patient started therapy with diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX),  (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided).  On 17-JUL-2023, HCP stated that the patient received ROTATEQ, PEDIARIX, PEDVAX HIB and VAXNEUVANCE as part of 2 month vaccination series. Per mom, patient developed ileus that same evening, ending up in the ED. HCP calling today to ask if ileus could be caused. No other reactions or adverse events mentioned. No PQC. At the time of reporting, the outcome of the event ileus was not known. The action taken with ROTATEQ regarding ileus was reported as Not Applicable. The action taken with VAXNEUVANCE regarding ileus was reported as Not Applicable. The action taken with LIQUID PEDVAXHIB regarding ileus was reported as Not Applicable.  The causal relationship between ileus and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown. The causal relationship between ileus and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was unknown. The causal relationship between ileus and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was unknown. Upon internal review, the event ileus was determined to be medically significant.
Sex: M
Vaccine: UNK
Symptoms: Computerised tomogram normal, Device function test, Hemiplegia, Laboratory test normal
Clinical narrative: right side paralysis; This serious case was reported by a consumer and described the occurrence of right sided paralysis in a 78-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included implantable cardioverter defibrillator insertion. Concomitant products included amiodarone, amiodarone, atenolol, acetylsalicylic acid (Aspirin (Baby)), losartan potassium (Cosaar (Losartan)) and atorvastatin calcium (Lipitor).   On 09-SEP-2023, the patient received RSV vaccine. On 09-SEP-2023, less than an hour after receiving RSV vaccine, the patient experienced right sided paralysis (Verbatim: right side paralysis) (serious criteria hospitalization, GSK medically significant, clinically significant/intervention required and other: serious as per reporter). On 09-SEP-2023, the outcome of the right sided paralysis was resolved.   It was unknown if the reporter considered the right sided paralysis to be related to RSV vaccine.     It was unknown if the company considered the right sided paralysis to be related to RSV vaccine.   Additional Information: GSK receipt date: 13-SEP-2023 This case was reported by patient's wife. The patient was in hospital for 30 minutes after the injection of the RSV vaccine patient experienced right side paralysis.  The reporter called 911 and he was transported to the hospital. By the time, he was taken to the Emergency department (ED), intervention required (unspecified). The patient's Implantable cardioverter defibrillator (ICD) was interrogated on September 2011 and showed no issues and NO AFIB, he had completely recovered.  All tests in the hospital were normal including 2 CT scans and he could not do MRI due to his ICD. The reporter consented to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Malaise
Clinical narrative: Patient felt sick; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: Patient felt sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-SEP-2023 The reporter reported that the patient received Shingrix vaccine and experienced bad reaction and felt sick but there was no rash or other allergic reactions. The reporter asked for information about the efficacy of only one dose of Shingrix vaccine. The reporter could not provided more details since she mentioned this happened a while ago. The reporter consented to follow up.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a dose of Infanrix was given to an 8 year old patient. The patient was supposed to be given Boostrix.; a dose of Infanrix was given to an 8 year old patient. The patient was supposed to be given Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a dose of Infanrix was given to an 8 year old patient. The patient was supposed to be given Boostrix.) and wrong vaccine administered (Verbatim: a dose of Infanrix was given to an 8 year old patient. The patient was supposed to be given Boostrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-SEP-2023 The nurse practitioner reported a 8 year old patient who was supposed to administered the Boostrix was administered with Infanrix which lead to wrong vaccine administration and Inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Abdominal discomfort, Fatigue, Gastrointestinal disorder, Injection site erythema, Oropharyngeal discomfort
Clinical narrative: Redness at the injection site like an amoeba; Throat issues /doesn't feel right; Stomach issues or doesn't feel right; Feel fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-SEP-2023, the patient received Arexvy (left arm). On 07-SEP-2023, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: Redness at the injection site like an amoeba). In SEP-2023, the patient experienced throat discomfort (Verbatim: Throat issues /doesn't feel right), stomach discomfort (Verbatim: Stomach issues or doesn't feel right) and fatigue (Verbatim: Feel fatigue).  The patient was treated with non-drug therapy (Ice Pack (No Medication)). The outcome of the injection site erythema was resolved and the outcome of the throat discomfort, stomach discomfort and fatigue were not resolved.   It was unknown if the reporter considered the injection site erythema, throat discomfort, stomach discomfort and fatigue to be related to Arexvy.     It was unknown if the company considered the injection site erythema, throat discomfort, stomach discomfort and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-SEP-2022 The patient was self-reported this case. The patient reported that she received Arexvy vaccine and experienced redness at the injection site that looked like an amoeba and it resolved after putting ice on the site.  A couple of days ago patient stated that her throat and stomach does not felt right.  Patient also stated that she started to feel fatigue.  These symptoms had not yet resolved. The reporter did not consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: Pharyngeal disorder
Clinical narrative: Redness at the injection site like an amoeba; Throat issues /doesn't feel right; Stomach issues or doesn't feel right; Feel fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-SEP-2023, the patient received Arexvy (left arm). On 07-SEP-2023, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: Redness at the injection site like an amoeba). In SEP-2023, the patient experienced throat discomfort (Verbatim: Throat issues /doesn't feel right), stomach discomfort (Verbatim: Stomach issues or doesn't feel right) and fatigue (Verbatim: Feel fatigue).  The patient was treated with non-drug therapy (Ice Pack (No Medication)). The outcome of the injection site erythema was resolved and the outcome of the throat discomfort, stomach discomfort and fatigue were not resolved.   It was unknown if the reporter considered the injection site erythema, throat discomfort, stomach discomfort and fatigue to be related to Arexvy.     It was unknown if the company considered the injection site erythema, throat discomfort, stomach discomfort and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-SEP-2022 The patient was self-reported this case. The patient reported that she received Arexvy vaccine and experienced redness at the injection site that looked like an amoeba and it resolved after putting ice on the site.  A couple of days ago patient stated that her throat and stomach does not felt right.  Patient also stated that she started to feel fatigue.  These symptoms had not yet resolved. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Flank pain, Herpes zoster, Rash, Vaccination failure
Clinical narrative: received her second dose of Shingrix about one year prior to developing shingles/suspected vaccination failure; shingles; rash from mid back to mid abdomen; side pain; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid) and the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: received her second dose of Shingrix about one year prior to developing shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), rash (Verbatim: rash from mid back to mid abdomen) and pain (Verbatim: side pain).The outcome of the vaccination failure, shingles, rash and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 13-SEP-2023 The GlaxoSmithKline Field Representative reported that a nurse practitioner stated that a patient (DOB, age and initials were unknown) presented to the office with side pain and rash from mid back to mid abdomen and was diagnosed with shingles. The patient had received her second dose of Shingrix about one year prior to developing shingles. Nothing else was reported. The reporter consented to follow up.  This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 50-year-old female patient who received HBV (Engerix B adult) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis.   Previously administered products included Engerix B adult (1st dose received on 28th June 2023).   On 13-SEP-2023, the patient received the 2nd dose of Engerix B adult. On 13-SEP-2023, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-SEP-2022 The patient received 2nd dose of Engerix B adult, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Facial pain, Herpes zoster, Insomnia, Rash
Clinical narrative: Shingles / Suspect Vaccination Failure; Shingles; painful rash on face; couldn't sleep; discomfort of the shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 3 years after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Shingles / Suspect Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), exanthema facial (Verbatim: painful rash on face), sleeplessness (Verbatim: couldn't sleep) and discomfort (Verbatim: discomfort of the shingles).  The patient was treated with valaciclovir (Valacyclovir) and pregabalin. The outcome of the vaccination failure and shingles were unknown and the outcome of the exanthema facial, sleeplessness and discomfort were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, exanthema facial, sleeplessness and discomfort to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and exanthema facial to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles, exanthema facial, sleeplessness and discomfort to be related to Shingrix. It was unknown if the company considered the vaccination failure, shingles and exanthema facial to be related to Shingrix.   Additional Information: GSK Receipt date: 07-SEP-2023 A physician reported that they had a patient that had gotten Shingrix in 2020.  The physician did not have the specific dates of immunization but did know that the patient did receive both doses.  Three years later this patient ended up with severe painful rash on face which was diagnosed as shingles.  The patient was not hospitalized, and the patient could not sleep (well, due to discomfort of the shingles).  The patient was prescribed 7 days of valacyclovir and Pregabalin tablets.  The reporter consented to follow up. This case was linked with case US2023127596 and US2023127594, as reported by same reporter.; Sender's Comments:  US-GSK-US2023127596:Same reporter US-GSK-US2023127594:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Shingles / Suspect Vaccination Failure; Shingles; painful rash on face; couldn't sleep; discomfort of the shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 3 years after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Shingles / Suspect Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), exanthema facial (Verbatim: painful rash on face), sleeplessness (Verbatim: couldn't sleep) and discomfort (Verbatim: discomfort of the shingles).  The patient was treated with valaciclovir (Valacyclovir) and pregabalin. The outcome of the vaccination failure and shingles were unknown and the outcome of the exanthema facial, sleeplessness and discomfort were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, exanthema facial, sleeplessness and discomfort to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and exanthema facial to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles, exanthema facial, sleeplessness and discomfort to be related to Shingrix. It was unknown if the company considered the vaccination failure, shingles and exanthema facial to be related to Shingrix.   Additional Information: GSK Receipt date: 07-SEP-2023 A physician reported that they had a patient that had gotten Shingrix in 2020.  The physician did not have the specific dates of immunization but did know that the patient did receive both doses.  Three years later this patient ended up with severe painful rash on face which was diagnosed as shingles.  The patient was not hospitalized, and the patient could not sleep (well, due to discomfort of the shingles).  The patient was prescribed 7 days of valacyclovir and Pregabalin tablets.  The reporter consented to follow up. This case was linked with case US2023127596 and US2023127594, as reported by same reporter.; Sender's Comments:  US-GSK-US2023127596:Same reporter US-GSK-US2023127594:Same reporter
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Flushing, Suspected COVID-19, Swelling face
Clinical narrative: FACE SWELLING; CHEEK AREA VERY HOT AND RED; SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, seasonal allergies, and drug allergy (sulfa quinolones (antibiotics)). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 21-MAR-2021 for covid-19 prophylaxis. Concomitant medications included diphenhydramine hydrochloride, and montelukast sodium.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 1).  The patient additionally received Pfizer BioNTech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: FL3197 expiry: UNKNOWN) dose was not reported, administered at left arm on 30-DEC-2021 at 15:15 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2).  On an unspecified date in 2023, the patient experienced suspected covid-19 infection (dose number in series 2). The patient took non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered from 19-AUG-2023 to 22-AUG-2023 for treatment of covid-19. On 21-AUG-2023, the patient experienced trouble breathing (subsumed under suspected covid-19 infection), face swelling, and cheek area was very hot and red (dose number in series 2). Treatment medications (dates unspecified) included: steroids. Patient had recovered from trouble breathing on 29-AUG-2023. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient recovered from face swelling, and cheek area very hot and red on 29-AUG-2023, and the outcome of revaccination with different covid-19 vaccine and suspected covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: UNK
Symptoms: Headache
Clinical narrative: Adverse reaction from the COVID-19 vaccine; Headache; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Adverse reaction from the COVID-19 vaccine) and HEADACHE (Headache) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Adverse reaction from the COVID-19 vaccine) and HEADACHE (Headache). At the time of the report, IMMUNISATION REACTION (Adverse reaction from the COVID-19 vaccine) outcome was unknown and HEADACHE (Headache) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication information was reported.  Patient was not clinical trial participant.  She had a question on the new Moderna Covid-19 vaccine. Patient experienced an adverse reaction from the COVID-19 vaccine.  The event of headache lasted for 7 weeks.  No treatment information was reported.