chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Pallor, Staring
Clinical narrative: 3-5 minutes after receiving vaccines infant had an event of sweating, pallor including oral pallor and decreased responsiveness. SpO2 98%. self resolved and returned to baseline color w/ in 3-5 min, was active and cooing. then became more upset, crying. had intermittent episodes of staring/ eye deviation between crying. Mild belly breathing
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Mydriasis, Pallor, Presyncope
Clinical narrative: Patient received his vaccine while looking at his phone as a distraction, he was fine and MA walked out of the room and within 1 minute father came out of the room stating that his son almost fainted and was very pale. MA returned to the room and noticed patient pale, with pupils dilated and awake. MA informed provider and patient was evaluated and given juice. Per father patient had another episode like this happen before after shots (those were not at golden valley health centers). Patient stayed in clinic under provider supervision then released.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain, Peripheral vein occlusion, Pulmonary thrombosis, Thrombosis
Clinical narrative: Blood clots developed in the leg and presented themselves in each lung.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Blood clots developed in the leg and presented themselves in each lung.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Haemorrhage, Hypotonia, Syncope
Clinical narrative: This was all reported by RN who gave the immunization. Patient received Boostrix first followed by IPOL vaccine on the right arm. Per RN, patient then fainted and started sliding down the chair. "She went limp". Patient's dad saw what happened and picked up the patient. It took about one minute before patient woke up. Patient did bleed a little from the right arm. Patient also stated that she was very tired. After a wait period, dad carried patient to the car.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Computerised tomogram limb, Computerised tomogram normal, Erythema, Local reaction
Clinical narrative: 7/24/24  - Red, warm, swelling  (patient was seen via telemedicine on 7/24/24). Patient was given a Dx of Cellulitis and given Keflex 500mg PO 4x day for 7 days, Hydrocortisone 2.5% cream, and Zofran 4mg.        On 7/27/24 patient was seen in Urgent Care due to redness somewhat spreading, but overall symptoms were better. Pt was started on Zyrtec as well for localized reaction treatment and advised to continue antibiotics.  On 7/29/24 patient was seen in the emergency room as patient was reporting 1 week of persistent left arm pain. CT Upper extremity with IV contrast was ordered, Vascular venous duplex left extremity ultrasound was ordered - both were negative/normal. The ER dept extended the patients antibiotics up to the full 10 day course to assist with healing.  As of today 8/16/24 we are trying to reach out to patient to schedule a follow up to ensure healing and have been unsuccessful.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Scan with contrast normal, Skin warm, Swelling, Ultrasound Doppler normal
Clinical narrative: 7/24/24  - Red, warm, swelling  (patient was seen via telemedicine on 7/24/24). Patient was given a Dx of Cellulitis and given Keflex 500mg PO 4x day for 7 days, Hydrocortisone 2.5% cream, and Zofran 4mg.        On 7/27/24 patient was seen in Urgent Care due to redness somewhat spreading, but overall symptoms were better. Pt was started on Zyrtec as well for localized reaction treatment and advised to continue antibiotics.  On 7/29/24 patient was seen in the emergency room as patient was reporting 1 week of persistent left arm pain. CT Upper extremity with IV contrast was ordered, Vascular venous duplex left extremity ultrasound was ordered - both were negative/normal. The ER dept extended the patients antibiotics up to the full 10 day course to assist with healing.  As of today 8/16/24 we are trying to reach out to patient to schedule a follow up to ensure healing and have been unsuccessful.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Feeling abnormal, Malaise, Visual impairment
Clinical narrative: Shot administered 03:15pm, patient's daughter  presented to Pharmacy drop off window  at 03:35pm and let me know that her mother wasn't feeling good. Patient was sitting on one of the  electric  store carts and complained about feeling unwell. We called 911. She complained that she feel like she need "air",. Later on she said she was seeing black spots and it progressed into her gasping with shortness of breath. I attempted to give her liquid Benadryl , but wasn't successful. Since she started gasping for air I decided to give her 1 dose of epipen at 3:45pm. She seemed to be better initially after the epipen administration, but started breathing labored after about 10 minutes after the shot. EMS arrived just about at that time where they took over from there. They monitored pt's bloodpressure, and heartrate and oxygen levels and they gave her an oxygen cannula. She seemed to be calmer after EMS's reassurance. They took her to hospital for observation.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 2 days after injection, patient experienced pain, redness, warmth, and swelling of upper arm and forearm
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abnormal loss of weight, Antibody test negative, Antinuclear antibody positive, Arthralgia, Condition aggravated
Clinical narrative: Patient developed hives on L arm starting 2 days after receiving Covid booster vaccine injection 9/23/2022. Also received high strength flu shot on 9/21/2022 although no symptoms until after COVID booster. Pt described feeling very sick with hives developing on other parts of the body and having subj fevers and joint pain. Hives started to resolve on 9/30/2022, but then persisted in waves through October 5, 2022. He did not have any swelling in the mouth/tongu, throat constriction  or wheezing. In the months that followed, he developed unintentional weight loss, which he felt was likely related to vaccination. Weight did not stabilize until August 2024.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Laboratory test normal, Malaise, Prostatic specific antigen, Pyrexia, Urticaria
Clinical narrative: Patient developed hives on L arm starting 2 days after receiving Covid booster vaccine injection 9/23/2022. Also received high strength flu shot on 9/21/2022 although no symptoms until after COVID booster. Pt described feeling very sick with hives developing on other parts of the body and having subj fevers and joint pain. Hives started to resolve on 9/30/2022, but then persisted in waves through October 5, 2022. He did not have any swelling in the mouth/tongu, throat constriction  or wheezing. In the months that followed, he developed unintentional weight loss, which he felt was likely related to vaccination. Weight did not stabilize until August 2024.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: none
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blister, Erythema, Induration, Injection site erythema, Injection site vesicles
Clinical narrative: R arm became red, hard to touch, swollen, and had blisters that began to ooze per mom on 8/15; itchy, not painful per pt. On exam 8/16, the pt had small vesicles/blisters at the injection site with a large area of surrounding erythema measuring approx 11X12 cm. Blisters were not actively oozing on exam. Pt stated it felt better today. Mom stated the area was already less red and not as swollen as on 8/15. Mom was instructed on 8/15 to give benadryl but did not know dose. Mom instructed today to use cool compresses, can use tylenol/ibuprofen if any pain, and to give benadryl for itching relief. Gave mom handout with benadryl dosing for children and her child's age. Will f/u with mom next week.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Peripheral swelling, Pruritus, Wound secretion
Clinical narrative: R arm became red, hard to touch, swollen, and had blisters that began to ooze per mom on 8/15; itchy, not painful per pt. On exam 8/16, the pt had small vesicles/blisters at the injection site with a large area of surrounding erythema measuring approx 11X12 cm. Blisters were not actively oozing on exam. Pt stated it felt better today. Mom stated the area was already less red and not as swollen as on 8/15. Mom was instructed on 8/15 to give benadryl but did not know dose. Mom instructed today to use cool compresses, can use tylenol/ibuprofen if any pain, and to give benadryl for itching relief. Gave mom handout with benadryl dosing for children and her child's age. Will f/u with mom next week.
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Chills, Headache, Lethargy, Nausea, Pain
Clinical narrative: Given annual flu vaccine at 7:45 PM.  At 5:00 AM that morning after I was nauseous, lethargic and had a horrible headache.  Through the day I developed a headache around. 11:00 AM folled by aches and pains.   The lasted a total of two days and had. Light chills and temp of 99.6.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: none
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Craniotomy, Drainage, Drug hypersensitivity, Intensive care
Clinical narrative: It is certified that patient suffering from severe valvular mitral insufficiency on the waiting list with priority class A, needs surgical correction (repair of the mitral valvular in minitoratotomy) with an assumed date 29/07/2023  The hospitalization will take place on 29/07/2023 at the ordinary inpatient ward, at the end of the intervention the patient will be transferred to intensive care where the average stay is 24 hours. Subsequently, it is planned to transfer to the cardiac-surgical intensive care unit where the average hospitalization of an additional 24-48 hours is planned. Finally, he will be transferred back to the ordinary inpatient ward with a post-operative hospitalization that is on average 5-7 days, at the end of which the patient will be transferred to the cardiological rehabilitation for a course of about 15 days.      After this surgical procedure complications arrived with the use of Coumadin that caused an allergic reaction and a brain bleed where he needed a surgical intervention. He had his skull drilled to drain the excess liquor produced. Patient never had any prior complications with his health and this  is why we are reporting this adverse event.  Director
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Mitral valve incompetence, Mitral valve repair, Post procedural complication, Surgery, Thoracotomy
Clinical narrative: It is certified that patient suffering from severe valvular mitral insufficiency on the waiting list with priority class A, needs surgical correction (repair of the mitral valvular in minitoratotomy) with an assumed date 29/07/2023  The hospitalization will take place on 29/07/2023 at the ordinary inpatient ward, at the end of the intervention the patient will be transferred to intensive care where the average stay is 24 hours. Subsequently, it is planned to transfer to the cardiac-surgical intensive care unit where the average hospitalization of an additional 24-48 hours is planned. Finally, he will be transferred back to the ordinary inpatient ward with a post-operative hospitalization that is on average 5-7 days, at the end of which the patient will be transferred to the cardiological rehabilitation for a course of about 15 days.      After this surgical procedure complications arrived with the use of Coumadin that caused an allergic reaction and a brain bleed where he needed a surgical intervention. He had his skull drilled to drain the excess liquor produced. Patient never had any prior complications with his health and this  is why we are reporting this adverse event.  Director
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Palpitations, Pyrexia, Vaccination site cellulitis, Vaccination site erythema
Clinical narrative: After receiving vaccination, spent evening with high fever, heart palpitations, unable to sleep. The next day, hoped I'd be better. But less than 2 days later, my right shoulder at vax site was size of golf ball, red & painful. An infection had spread from shoulder to elbow-all red, with hanging skin all the way down where infection was gathering. Went to ER that afternoon. had 'cellulitus'! Took antibiotics for 4 days, got so sick I had to stop. Took another 10 days before I felt safe agan. Arm feels different ever since. I never had a horrible reaction before. Two things to consider: The 3 days span between 2 vaccines, and: The first pneumoccal vax I got a yr ago was Vaxneuvance (PCV15) from Merck, lot # W036242. This one was ok. But the 2nd one was a different kind: (PPSV23) Vaxneuvance, from Merck, lot # X02287. This one I had bad reaction to.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site infection, Vaccination site pain, Vaccination site swelling
Clinical narrative: After receiving vaccination, spent evening with high fever, heart palpitations, unable to sleep. The next day, hoped I'd be better. But less than 2 days later, my right shoulder at vax site was size of golf ball, red & painful. An infection had spread from shoulder to elbow-all red, with hanging skin all the way down where infection was gathering. Went to ER that afternoon. had 'cellulitus'! Took antibiotics for 4 days, got so sick I had to stop. Took another 10 days before I felt safe agan. Arm feels different ever since. I never had a horrible reaction before. Two things to consider: The 3 days span between 2 vaccines, and: The first pneumoccal vax I got a yr ago was Vaxneuvance (PCV15) from Merck, lot # W036242. This one was ok. But the 2nd one was a different kind: (PPSV23) Vaxneuvance, from Merck, lot # X02287. This one I had bad reaction to.
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Pruritus, Urticaria
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; 10037087:PRURITUS; 10046735:URTICARIA;  Narrative: Other Relevant HX: Other: URTICARIA; ANAPHYLAXIS
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Anxiety, Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness, Pallor
Clinical narrative: STAFF PRESENT NOTED THAT WITHIN A MINUTE OR TWO OF RECEIVEING THE VACCINE, PATIENT'S ARMS AND LEGS STIFFENED. HIS MOTHER REPORTED THAT HIS EYES ROLLED UP. PATIENT WAS OBSERVED TO BE PALE AROUND THE LIPS AND WAS BREATHING NORMALL. HIS STIFFENED LEGS AND ARMS RELAXED AND PATIENT WAS ABLE TO BE LIE SUPINE ON THE TABLE. I EXAMINED HIM AND OFFERED HIM WATER AND ENSURE. HE WAS AWAKE AND APPEARED ANXIOUS. IN PATIENT'S OWN WORDS "I BLAKCED OUT" PATIENT ONLY HAD CAFFEINE FREE COFFEE AROUND 11:00AM. PATIENT WAS OBSERVED FOR ABOUT 30 MINUTES TO ENSURE RECOVERY AND STABILITY. HE WAS THEN DISCHARGED HOME WITH MOTHER.  Patient recovered at the time he left the offive. He was alert and ambulation normally. Physician called mother at 6:33pm to check on patient. There was no answer. Left voice-mail message.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alcohol withdrawal syndrome, Chills, Electrolyte imbalance, Fatigue, Hyponatraemia
Clinical narrative: Reported Symptoms: 10021038:HYPONATREMIA; 10043071: TACHYCARDIA;  Narrative: Patient received the Pfizer COVID 19 vaccine on 2 January 2022 and then presented to the hospital with lethargy, chills, nausea, and tachycardia on 5 January 2022. The patient was admitted to the hospital with tachycardia and alcohol withdrawal on 5 January 2022. The patient was treated and was discharged on 9 January 2022, but was readmitted on 11 January 2022 with fatigue, hyponatremia, elevated LFTs, and tachycardia, electrolyte imbalances, and migraine. The patient was discharged on 14 January 2022. Other Relevant HX: Other: hyponatremia
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Liver function test increased, Migraine, Nausea, Tachycardia
Clinical narrative: Reported Symptoms: 10021038:HYPONATREMIA; 10043071: TACHYCARDIA;  Narrative: Patient received the Pfizer COVID 19 vaccine on 2 January 2022 and then presented to the hospital with lethargy, chills, nausea, and tachycardia on 5 January 2022. The patient was admitted to the hospital with tachycardia and alcohol withdrawal on 5 January 2022. The patient was treated and was discharged on 9 January 2022, but was readmitted on 11 January 2022 with fatigue, hyponatremia, elevated LFTs, and tachycardia, electrolyte imbalances, and migraine. The patient was discharged on 14 January 2022. Other Relevant HX: Other: hyponatremia
Age: 38.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No side effects/ reactions were reported/ No additional adverse event; 38 years female received GARDASIL 9: 1st dose on 4/17/2024, second dose on 6/24/2024 and third dose on 8/12/2024. HCP stated the 3rd dose was given inadvertently sooner than recommended time interval; This spontaneous report has been received from a nurse concerning to a 38-year-old female patient. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 17-APR-2024 and 24-JUN-2024, the patient was vaccinated with the first and second doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection respectively (strengths, doses, routes and anatomical locations of administration, lot numbers and expiration dates were not provided). On 12-AUG-2024, she was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot number X02668 than was verified to be an invalid lot number (expiration date reported as 10-APR-2026) (strength, dose, route, and anatomical location of administration, were not provided). All administered as prophylaxis. The reporter stated that the third dose was given inadvertently sooner than recommended time interval (inappropriate schedule of product administration). No side effects/ reactions were reported. No other information was known or provided. No additional AE reported.
Age: 38.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No side effects/ reactions were reported/ No additional adverse event; 38 years female received GARDASIL 9: 1st dose on 4/17/2024, second dose on 6/24/2024 and third dose on 8/12/2024. HCP stated the 3rd dose was given inadvertently sooner than recommended time interval; This spontaneous report has been received from a nurse concerning to a 38-year-old female patient. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 17-APR-2024 and 24-JUN-2024, the patient was vaccinated with the first and second doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection respectively (strengths, doses, routes and anatomical locations of administration, lot numbers and expiration dates were not provided). On 12-AUG-2024, she was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot number X02668 than was verified to be an invalid lot number (expiration date reported as 10-APR-2026) (strength, dose, route, and anatomical location of administration, were not provided). All administered as prophylaxis. The reporter stated that the third dose was given inadvertently sooner than recommended time interval (inappropriate schedule of product administration). No side effects/ reactions were reported. No other information was known or provided. No additional AE reported.
Sex: U
Vaccine: PNC15
Symptoms: Device defective, Device issue, Poor quality device used, Syringe issue
Clinical narrative: HCP reported 5 VAXNEUVANCE syringes whose finger flanges "popped off".; No injuries reported; HCP reported 5 VAXNEUVANCE syringes whose finger flanges "popped off"/ One occurred while product was being administered; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not provided.  On 31-JUL-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number Y002963, expiration date reported and validated as 04-OCT-2024) as prophylaxis, whose finger flange "popped off" while product was being administered (poor quality device used). The healthcare professional (HCP) reported other 5 pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) syringes whose finger flanges "popped off" (Syringe issue). The remaining occurred while product was being picked up prior to use. No injuries reported. Office disposed of 3 of the defective units but has placed the 2 remaining aside for retrieval. Reporter stated replacements were not necessary at this time.  This case was considered non-valid due to the lack of patient's identifiers.  This is an amended report. Device problem code should be not blank if malfunction was selected as "Yes".
Age: 40.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Additional AE/ No PQC.; received their third dose on 06/29/2024; This spontaneous report was received from a pharmacist concerning to a 41-year-old female patient.  Her pertinent  medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On an unknown dates in August 2022, and September 2022, the patient was vaccinated with the first and second doses of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strengths, doses, lot numbers, expiry dates, anatomical locations, and routes of administration were not provided). However, the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 mL, lot #w013388, expiration date: 16-DEC-2024, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) was received on 29-JUN-2024, given by a health care professional , so the reporter considered there had been a schedule interruption(Inappropriate schedule of product administration). No further information, additional adverse events, nor product quality complaints were provided.   Lot number was being requested and would be provided upon received.
Sex: M
Vaccine: MMR
Symptoms: Antibody test, Blood immunoglobulin G abnormal, Blood immunoglobulin M normal, Chlamydia test positive, Malaise
Clinical narrative: These results suggest that symptomatic cases do not have protective levels of antibodies to JL and genotype G prior to mumps infection; This literature marketed report had been received from the authors of a published article and refers to a 20-year-old male patient. The article aimed that in 2017, a mumps outbreak occurred in a barracks, so serum collected at service entry was used to compare pre-exposure with presumptive vaccine-induced antibody levels from persons who developed mumps (cases) and potentially exposed persons who did not develop mumps (non-cases).  Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with 2 dose childhood regimen of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).  On 15-JUN-2016, a sample was collected and showed Jeryl Lynn (JL) titer at 301.5 (units not provided) and genotype G titer at 50.4 (units not provided), CDC IgM was negative (-), Zeus IgG was positive (+) (Zeus Index value: 3.16 (units not provided)), avidity was 65 percent (High). It was reported that results suggested that symptomatic cases do not have protective levels of antibodies to JL and genotype G prior to mumps infection (mumps antibody test negative).  On 20-APR-2017, the patient received outbreak dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, anatomical location, lot number and expiration date were not reported).  On 25-APR-2017, the patient was symptomatic and exhibited typical mumps symptoms (parotid/salivary gland swelling, orchitis, fever, malaise). On the same date, CDC laboratory classification report not case of mumps. Also, sample collected show JL titer at 217.4 (units not provided) and genotype G titer at 40.6 (units not provided), CDC IgM was negative (-), Zeus IgG positive (+) (Zeus Index value: 3.21 (units not provided)), avidity was 59 percent (High), and PCR was negative. Other testing and alternative diagnosis were positive Chlamydia pneumoniae (C. pneumoniae).   The outcome of the event mumps antibody test negative was not provided. The causal relationship between the event mumps antibody test negative and the suspect therapy measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was considered as related.  Lot # is being requested and will be submitted if received.  This is one of several reports received from the literature.  Sender's Comments:  US-009507513-2408USA003357: US-009507513-2408USA003354: US-009507513-2407USA014510: US-009507513-2408USA003353:
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative, Orchitis, Parotid gland enlargement, Polymerase chain reaction, Pyrexia
Clinical narrative: These results suggest that symptomatic cases do not have protective levels of antibodies to JL and genotype G prior to mumps infection; This literature marketed report had been received from the authors of a published article and refers to a 20-year-old male patient. The article aimed that in 2017, a mumps outbreak occurred in a barracks, so serum collected at service entry was used to compare pre-exposure with presumptive vaccine-induced antibody levels from persons who developed mumps (cases) and potentially exposed persons who did not develop mumps (non-cases).  Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with 2 dose childhood regimen of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).  On 15-JUN-2016, a sample was collected and showed Jeryl Lynn (JL) titer at 301.5 (units not provided) and genotype G titer at 50.4 (units not provided), CDC IgM was negative (-), Zeus IgG was positive (+) (Zeus Index value: 3.16 (units not provided)), avidity was 65 percent (High). It was reported that results suggested that symptomatic cases do not have protective levels of antibodies to JL and genotype G prior to mumps infection (mumps antibody test negative).  On 20-APR-2017, the patient received outbreak dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, anatomical location, lot number and expiration date were not reported).  On 25-APR-2017, the patient was symptomatic and exhibited typical mumps symptoms (parotid/salivary gland swelling, orchitis, fever, malaise). On the same date, CDC laboratory classification report not case of mumps. Also, sample collected show JL titer at 217.4 (units not provided) and genotype G titer at 40.6 (units not provided), CDC IgM was negative (-), Zeus IgG positive (+) (Zeus Index value: 3.21 (units not provided)), avidity was 59 percent (High), and PCR was negative. Other testing and alternative diagnosis were positive Chlamydia pneumoniae (C. pneumoniae).   The outcome of the event mumps antibody test negative was not provided. The causal relationship between the event mumps antibody test negative and the suspect therapy measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was considered as related.  Lot # is being requested and will be submitted if received.  This is one of several reports received from the literature.  Sender's Comments:  US-009507513-2408USA003357: US-009507513-2408USA003354: US-009507513-2407USA014510: US-009507513-2408USA003353:
Sex: M
Vaccine: MMR
Symptoms: Salivary gland enlargement, Viral titre
Clinical narrative: These results suggest that symptomatic cases do not have protective levels of antibodies to JL and genotype G prior to mumps infection; This literature marketed report had been received from the authors of a published article and refers to a 20-year-old male patient. The article aimed that in 2017, a mumps outbreak occurred in a barracks, so serum collected at service entry was used to compare pre-exposure with presumptive vaccine-induced antibody levels from persons who developed mumps (cases) and potentially exposed persons who did not develop mumps (non-cases).  Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with 2 dose childhood regimen of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).  On 15-JUN-2016, a sample was collected and showed Jeryl Lynn (JL) titer at 301.5 (units not provided) and genotype G titer at 50.4 (units not provided), CDC IgM was negative (-), Zeus IgG was positive (+) (Zeus Index value: 3.16 (units not provided)), avidity was 65 percent (High). It was reported that results suggested that symptomatic cases do not have protective levels of antibodies to JL and genotype G prior to mumps infection (mumps antibody test negative).  On 20-APR-2017, the patient received outbreak dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, anatomical location, lot number and expiration date were not reported).  On 25-APR-2017, the patient was symptomatic and exhibited typical mumps symptoms (parotid/salivary gland swelling, orchitis, fever, malaise). On the same date, CDC laboratory classification report not case of mumps. Also, sample collected show JL titer at 217.4 (units not provided) and genotype G titer at 40.6 (units not provided), CDC IgM was negative (-), Zeus IgG positive (+) (Zeus Index value: 3.21 (units not provided)), avidity was 59 percent (High), and PCR was negative. Other testing and alternative diagnosis were positive Chlamydia pneumoniae (C. pneumoniae).   The outcome of the event mumps antibody test negative was not provided. The causal relationship between the event mumps antibody test negative and the suspect therapy measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was considered as related.  Lot # is being requested and will be submitted if received.  This is one of several reports received from the literature.  Sender's Comments:  US-009507513-2408USA003357: US-009507513-2408USA003354: US-009507513-2407USA014510: US-009507513-2408USA003353:
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Salivary gland enlargement, Viral titre
Clinical narrative: These results suggest that symptomatic cases do not have protective levels of antibodies to JL and genotype G prior to mumps infection; This literature marketed report had been received from the authors of a published article and refers to a 23-years-old male patient. The article aimed that in 2017, a mumps outbreak occurred in a barracks, so serum collected at service entry was used to compare pre-exposure with presumptive vaccine-induced antibody levels from persons who developed mumps (cases) and potentially exposed persons who did not develop mumps (non-cases).  Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with 2 dose childhood regimen of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).  On 14-OCT-2016, a sample was collected and showed Jeryl Lynn (JL) titer at 33.5 (units not provided) and genotype G titer at 5.7 (units not provided), CDC IgM was negative (-), Zeus IgG was positive (+) (Zeus Index value: 1.10 (units not provided)), avidity was undetermined (UND). It was reported that results suggested that symptomatic cases do not have protective levels of antibodies to JL and genotype G prior to mumps infection (mumps antibody test negative).  On 20-APR-2017, the patient received outbreak dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, anatomical location, lot number and expiration date were not reported).  On 01-MAY-2017, the patient was symptomatic and exhibited typical mumps symptoms (parotid/salivary gland swelling, orchitis, fever, malaise).   On 02-MAY-2017, CDC laboratory classification report confirmed case (C) of mumps. Also, sample collected show JL titer at 178.7 (units not provided) and genotype G titer at 84.5 (units not provided), CDC IgM was positive (+), Zeus IgG was positive (+) (Zeus Index value: 5.72 (units not provided)), avidity was 62 percent (High), and PCR was positive. Other testing and alternative diagnosis were negative rhinovirus (rhino).   The outcome of the event mumps antibody test negative was not provided. The causal relationship between the event mumps antibody test negative and the suspect therapy measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was considered as related.  Lot # is being requested and will be submitted if received.  This is one of several reports received from the literature.    Sender's Comments:  US-009507513-2408USA003357: US-009507513-2408USA003354: US-009507513-2407USA014510: US-009507513-2408USA003353: US-009507513-2408USA003358: US-009507513-2408USA003363: US-009507513-2408USA003361: US-009507513-2408USA003355: US-009507513-2408USA003356: US-009507513-2408USA003359: US-009507513-2408USA003360:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Noadditional AE reported; HCP called to report an expired dose of GARDASIL9 was inadvertently administered to a patient on 08/13/2024. Expiration date of the product was 08/09/2024. Caller confirmed the product has no history of temperature excursion. Caller was provided with; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 13-AUG-2024, the patient was inadvertently expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #U039529, which had been confirmed to be a valid lot number, expiration date reported and confirmed as 09-AUG-2024 (expired product administered), administered for prophylaxis (strength, exact dose, route of administration, and anatomical location were not provided). It was confirmed that the product had no history of temperature excursion. No additional adverse event reported (no adverse event).
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered, Interchange of vaccine products, Wrong product administered
Clinical narrative: Extra dose administered; Interchangeability of Men CYW/A brands.; Extra dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 31-JUL-2024, the patient received the 3rd dose of Menveo. On an unknown date, the patient received the 2nd dose of Menveo. On 31-JUL-2024, an unknown time after receiving Menveo and not applicable after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Interchangeability of Men CYW/A brands.) and extra dose administered (Verbatim: Extra dose administered). On an unknown date, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the wrong vaccine administered was unknown and the outcome of the extra dose administered and extra dose administered were not reported.   Additional Information: GSK receipt date: 01-AUG-2024 Health Care Professional called to report that the patient mother called and was saying that the child was going to college and he was going to be on a dorm and they required him to get the meningitis B vaccine,  which told her they had, it was the Bexsero and then she said that the paper also stated that he got a Meningitis A vaccine, which led to wrong vaccine administered.  They recommended him to get the meningitis A vaccine and told her that he had all his meningitis vaccines that had 'A' in it, it covered the A, the C, the Y, and the W; and she said that the paper said that just meningitis  A and told her, that did not thought, there's no meningitis A, said to her the other immunizations they gave was the menquad and the menactra,  asked if bexsero was the meningitis B.  Said that, could be administer that but she said that she wanted  him to have anything they asked to have him for college, and she was like where do got the Men A and told that did not thought there was a meningitis A vaccines.  Said he had all his meningitis vaccines, he had the one at 11 and he get the one when he was 16.  So, she was on gonna call a pharmacy if they did not had that. So, told to had the bexsero.  Well yesterday (fay before reporting) she went, got him the Menveo from , which he already had, the 2 doses that he needed, so she basically got him a third dose which was a year after the second dose, which led to extra dose administered. Consented to follow up.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Adult patient was given a hep B vaccine adult dose and he was not supposed to received it.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 38-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   On 01-AUG-2024, the patient received the 1st dose of Engerix B adult. On 01-AUG-2024, an unknown time after receiving Engerix B adult, the patient experienced wrong vaccine administered (Verbatim: Adult patient was given a hep B vaccine adult dose and he was not supposed to received it.). The outcome of the wrong vaccine administered 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: 06-AUG-2024 The reporter gave a patient a hepatitis B vaccine and guessed that they did not need it and was just wondering if there was going to be a reaction or anything that they should look out for. The patient was not immunocompromised nor pregnant.  She was within the normal range of age and was the first time she received the hep B vaccine, according to the HCP's records. Consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: neurological side effects; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "neurological side effects". It was unknown if therapeutic measures were taken as a result of neurological symptom.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: this is my 3rd time of getting covid and all the Pfizer Vaccines; this is my 3rd time of getting covid and all the Pfizer Vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 45-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "this is my 3rd time of getting covid and all the Pfizer Vaccines". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient stated, "I've already taken this one time already. I've have had Paxlovid one time already and this is my 3rd time of getting covid and all the Pfizer Vaccines and I did Paxlovid and I just got Covid again so I'm not real happy."
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Psoriatic arthropathy
Clinical narrative: Developed psoriasis within 2 months, and psoriatic arthritis within 3 months. Symptoms and overall disease are worsened every time I take a booster
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: About 5 weeks after the first dose was administered in my left arm, shingle outbreak occurred in my left arm pit. I was prescribed an anti viral oral medication for 7 days. After 5 days the lesion in my left arm pit resolved. Fast forward to August 17th 2024 and another lesion appeared in my left arm pit. I did have a shingles out break in I think April of 2024. The outbreak occurred on my right side on my torso just above my waist.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Injection site pain, Myalgia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Felt nothing that same day, next day (Thursday) woke up to a sore throat, Thursday night started to get headache and runny nose, took Xyzal because paient thought it was food allergy symptoms, next day (Friday) had a headache and runny nose all day, also experienced muscle aches and pain in injection area, All symptoms continue into next day (Saturday).
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Gait inability, Joint lock, Pain
Clinical narrative: Pain and grabbing  in both hips. Excruciating pain. Cannot walk.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient came in for a yearly well visit. During this visit provider ordered the vaccines Dtap/Ipv and MMRV to be administered. Patient is 4 years old at the time and needed last doses, but it was overlooked that last dose for Dtap/Ipv was given less than 6 month ago. CMA administered the vaccines during this visit.  As precautionary measure vaccines are double checked to verified the entered the system on a daily basis. After verification I found the adverse event and communicated to the parent. Patient will need to revaccinate for Dtap/IPV after 6 months of this dose. Patient is doing well, no adverse reaction.
Age: 41.0
Sex: M
Vaccine: MMR, MNQ, VARCEL
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient received vaccines on tuesday on thursday he reported arm was swollen and red and also has a fever. He came into pharmacy saturday and reported to the pharmacy and examining his arm it was warm, swollen and red. I instructed the patient to go to urgent care because it appeared to be cellulitis.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cranial nerve paralysis, Diplopia, Laboratory test
Clinical narrative: Diplopia caused by 6th cranial nerve palsy.  After many, many tests doctors could not find a reason for the nerve palsy.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Lymphadenopathy, Pain, Pruritus
Clinical narrative: Swollen lymph nodes on right side face and neck, pain, itching
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: On 8-12-2024 Mom spoke to MD via telephone. Notes as follows: rash started 8/1/2024, still there now buy drying and almost resolved. Located on right chest, 3 inches and 2 small dots around the umbilicus. From email appears like varicella rash- likely side effect from vaccine.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: Tdap (Boostrix) accidentally given to patient outside of age parameters of standing order protocol (age 18 and above). Clinically appropriate vaccine, no adverse events, but should not have been given by pharmacy per standing order.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Brain fog, Cytogenetic analysis abnormal, Fatigue, Night sweats
Clinical narrative: Mild symptoms that have progressed. From night sweats, fever, body ache, brain fog, lack of energy and fatigue.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Still's disease
Clinical narrative: Mild symptoms that have progressed. From night sweats, fever, body ache, brain fog, lack of energy and fatigue.
Age: 22.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Fall, Head injury, Headache, Immediate post-injection reaction, Memory impairment
Clinical narrative: Pt immediately fell after receiving both vaccinations in the right arm (1 in. apart). He fell back and hit his head on the door behind him. He had posturing and was turned to his side. He became alert and was sat in a chair for evaluation. He had sinus bradycardia (HR 44) and BP (100/70's). He was pale and stated he did not remember what happened. He had a bump on the back of his head, no laceration or blood noted, however patient also reported a headache and nausea.  One of our physicians evaluated him, he was alert and oriented x3, PERRLA, with vitals stabilizing once EMS arrived. He reports getting faint at the sight of blood, when asked if this has happened before, however he had not mentioned this during pre-screening. This likely was vasovagal syncope.
Age: 22.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Nausea, Pallor, Posturing, Sinus bradycardia, Skin swelling
Clinical narrative: Pt immediately fell after receiving both vaccinations in the right arm (1 in. apart). He fell back and hit his head on the door behind him. He had posturing and was turned to his side. He became alert and was sat in a chair for evaluation. He had sinus bradycardia (HR 44) and BP (100/70's). He was pale and stated he did not remember what happened. He had a bump on the back of his head, no laceration or blood noted, however patient also reported a headache and nausea.  One of our physicians evaluated him, he was alert and oriented x3, PERRLA, with vitals stabilizing once EMS arrived. He reports getting faint at the sight of blood, when asked if this has happened before, however he had not mentioned this during pre-screening. This likely was vasovagal syncope.