chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On an unspecified day in December 2018, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), subcutaneously, lot # reported as R006344 (lot number R006344 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)) (exact doses and injection site were not reported) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature of 14.4 degree Fahrenheit (F) for a time frame of 46 hours. The digital data logger was involved in recording the temperature excursion details. There was no previous temperature excursion.
Sex: M
Vaccine: MMR, UNK
Symptoms: Product colour issue
Clinical narrative: No adverse effects reported; M-M-R II was a little brownish tint or rust orange in color; M-M-R II was a little brownish tint or rust orange in color; M-M-R II was a little brownish tint or rust orange in color; This spontaneous report was received from a pharmacist regarding a 59-year- old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 03-MAY-2019 (reported as "yesterday"), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength was not provided) (lot# R031616; expiry date: 01-NOV-2020) (lot #: R031636, expiry date not reported) for prophylaxis; and sterile diluent (MERCK STERILE DILUENT) (lot# S005087; expiry date: 30-SEP-2021).    The pharmacist reported that, on the date of vaccination, the vaccine was "a little brownish tint or rust orange in color" (product colour issue, poor quality product administered, and product quality issue). The pharmacist also reported the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  and sterile diluent (MERCK STERILE DILUENT) did not undergo a temperature excursion.  The outcome of product colour issue, poor quality product administered and product quality issue was not reported.    The reporter did not provide causality assessment between product colour issue, poor quality product administered and product quality issue and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) and sterile diluent(MERCK STERILE DILUENT).  Lot number  R031616 is an invalid lot number for  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; the patient received expired dose of M-M-R II; This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concomitant medication, pertinent medical history and drug allergies or reactions. On 09-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), subcutaneous that was expired on 22-OCT-2017, for prophylaxis (expired product administered). No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; The patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date since 22-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R017768, expiration date: 21-JUN-2020 (dose, frequency and anatomical location were not provided), administered subcutaneously as prophylaxis. The vaccine underwent a temperature excursion from -9 Celsius degrees (°C) to 8°C (-7.4C) during a time frame of 55 minutes as recorded by digital data logger. No previous temperature excursion was reported as well as no adverse effects. The sterile diluent used to reconstitute the vaccine (lot # S000130, expiration date: 21-JUN-2020) was properly stored.  This is one of several cases received from the same reporter.; Sender's Comments:  1905USA005488: 1905USA005505: 1905USA005504: 1905USA005507: 1905USA005503:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: Wrong Route of Administration; injection site Swelling; injection site Redness; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, less than a year after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient's husband.  The reporters wife received the second dose of Shingrix vaccine towards the end of 2018.  The patient was vaccinated subcutaneously on the back of the arm instead of intramuscularly.  The patient had red swelling area at injection site 4 inches round that lasted for 3 days. The reporter did not give consent to follow up. No further details were provided. The reporter referred to healthcare professional.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Mobility decreased, Pain in extremity, Vaccination complication
Clinical narrative: patient reported getting up to go to the bathroom around 1 am and experienced extreme leg soreness and the inability to walk to the bathroom  he said he had to "shuffle".  upon waking the next morning he was still sore and having difficulty moving his lower limbs.  He was able to eat a small amount of toast and have a little bit of coffee but his state was not improving so his wife took him to a hospital and  they kept him overnight due to his hx with multiple myeloma.  They concluded that the myeloma had not progressed and that there were no other reasons he experienced these symptoms than a rare side effect of the shingrix vaccination
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red swollen and hot to site
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: "immense pain and burning across entire body" She described the pain as if her blood were on "fire".  She admits to having soreness and pain but it was improved by taking Naproxen OTC.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Nausea, Photophobia, Pyrexia, Vomiting
Clinical narrative: Patient awoke the morning following  with a severe migraine headache with light sensitivity and nausea/vomiting.  It lasted the entire day of 5-11-19.  She also ran a low grade fever.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: slight swelling red and warm to touch
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: PAIN, SWELLING, ERYTHEMA, HOT TO TOUCH
Age: 32.0
Sex: F
Vaccine: PPV, TD
Symptoms: Apparent life threatening event, Chills, Fatigue, Heart rate increased, Hypotension
Clinical narrative: I went to a regular wellness check up where we were going over blood work /thyroid function and vitamin levels. Everything came back that I was healthy. My blood pressure was good and I had no fever but I was in need of two vaccinations, which I got. The next Morning after my appointment I woke up with chills, body aches, couldn't move my arm, had a low grade fever and felt very tired. I did at home care of ibuprofen and lots of water. The next morning I could barley keep my eyes open, my whole body was in excruciating pain and I had a fever of 103. I was rushed to the ER. My blood pressure was low but my heart rate was high and the medication they gave me at the ER was not helping my blood pressure. I was admitted to the ICU in the hospital where I stayed under constant care for 4 days before being released. They did many test that all came back negative and my final diagnosis/ reason I was in the hospital is on record as septic shock (from a muscle infection in her arm or some other virus). I almost died and no one has a answer as to what caused it. I had a clean bill of health on Monday 2 days before being admitted to the ICU.
Age: 32.0
Sex: F
Vaccine: PPV, TD
Symptoms: Intensive care, Laboratory test normal, Mobility decreased, Pain, Pyrexia
Clinical narrative: I went to a regular wellness check up where we were going over blood work /thyroid function and vitamin levels. Everything came back that I was healthy. My blood pressure was good and I had no fever but I was in need of two vaccinations, which I got. The next Morning after my appointment I woke up with chills, body aches, couldn't move my arm, had a low grade fever and felt very tired. I did at home care of ibuprofen and lots of water. The next morning I could barley keep my eyes open, my whole body was in excruciating pain and I had a fever of 103. I was rushed to the ER. My blood pressure was low but my heart rate was high and the medication they gave me at the ER was not helping my blood pressure. I was admitted to the ICU in the hospital where I stayed under constant care for 4 days before being released. They did many test that all came back negative and my final diagnosis/ reason I was in the hospital is on record as septic shock (from a muscle infection in her arm or some other virus). I almost died and no one has a answer as to what caused it. I had a clean bill of health on Monday 2 days before being admitted to the ICU.
Age: 32.0
Sex: F
Vaccine: PPV, TD
Symptoms: Septic shock, Somnolence
Clinical narrative: I went to a regular wellness check up where we were going over blood work /thyroid function and vitamin levels. Everything came back that I was healthy. My blood pressure was good and I had no fever but I was in need of two vaccinations, which I got. The next Morning after my appointment I woke up with chills, body aches, couldn't move my arm, had a low grade fever and felt very tired. I did at home care of ibuprofen and lots of water. The next morning I could barley keep my eyes open, my whole body was in excruciating pain and I had a fever of 103. I was rushed to the ER. My blood pressure was low but my heart rate was high and the medication they gave me at the ER was not helping my blood pressure. I was admitted to the ICU in the hospital where I stayed under constant care for 4 days before being released. They did many test that all came back negative and my final diagnosis/ reason I was in the hospital is on record as septic shock (from a muscle infection in her arm or some other virus). I almost died and no one has a answer as to what caused it. I had a clean bill of health on Monday 2 days before being admitted to the ICU.
Age: 46.0
Sex: M
Vaccine: JEV1
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Mild-grade fever of 101 for two days, moderate to severe muscle aches for three days, and extreme fatigue for three days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received her second dose of the Shingrix vaccine and noticed redness/swelling/hottness around the injection site, starting the following day. She went to her primary care doctor two days later who prescribed her Cephalexin for the reaction.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse reactions happened . I explained to the patient the administration method was incorrect . shingrix should have been given IM not SQ . I advised patient dose is still valid and printed out information per CDC website
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Urticaria
Clinical narrative: hives along with low grade fever of 38C on bilateral arms, face, and back 2 days after 2nd Hep A vaccine.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Urine analysis, Viral rash
Clinical narrative: Fever 5/8-5/12; Developed a rash on 5/12/19; Dx as viral rash.
Age: 75.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects; Patient was inadvertently administered an expired dose of MMR; MMR vaccine given intramuscularly; This initial spontaneous report was received from an office manager concerning a 75-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 09-MAY-2019, the patient was inadvertently vaccinated with and expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II), with lot number N013296 and expiration date 28-APR-2019, intramuscularly (incorrect route of product administration) for prophylaxis (strenght, dose and anatomical location were not reported); reconstituted with sterile diluent with lot number R032161 and expiration date 18-JUL-2021.  No adverse events or product quality complaints (PQC) were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored MMR II was administered; no adverse effect; This spontaneous report was received from a nurse and refers to unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication.  On an unspecified date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 1 dose (strength, frequency, route of administration, anatomical location, indication, lot #, and expiration date were not reported). The informed consent for administration of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was signed by a patient on 08-MAY-2019, but exact date of administration was unknown. It could not be clarified whether administration happened before or after excursion. It was unknown whether sterile diluent was stored in proper range. There was no adverse effect reported.  The administered dose of vaccine experienced the temperature excursion of 48.7 degrees Fahrenheit for 1 hours 30 minutes. There was no previous temperature excursion reported. Data logger was involved.  This is a non-valid case due to the lack of patient identifiers.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administered; no adverse effect reported; This spontaneous report as received from a Nurse refers to a  patient of an unknown age and unknown gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On 09-MAY-2019, the first patient received a dose with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Lot number N030364 and expiry date 06-MAR-2019), route via oral for an unknown indication. The nurse reported that, the patient received expired rotavirus vaccine, live, oral, pentavalent(ROTATEQ)(expired product administered). No adverse effect was reported(No adverse event).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administered; no adverse effect reported; This spontaneous report as received from a Nurse refers to a  second patient of an unknown age and unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-MAY-2019, the second patient received a dose with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Lot number N030364 and expiry date 06-MAR-2019), route via oral for an unknown indication. The nurse reported that, the patient received expired rotavirus vaccine, live, oral, pentavalent(ROTATEQ)(expired product administered). No adverse effect was reported(No adverse event).
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of death nos in a 61-year-old male patient who received SHINGRIX (batch number 23JK5, expiry date 13th April 2020) for prophylaxis. On 4th May 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2019, 4 hrs after receiving SHINGRIX, the patient experienced death nos (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death nos was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death nos to be related to SHINGRIX. Additional details were provided as follows: The patient tolerated the SHINGRIX dose at the pharmacy with no noted issues. The reporter had no specific details on cause of death. Follow up information received on 9th May 2019: Following a review of the inventory status for batch number 23JK5 the entire batch has been distributed as of on 12th April 2019. With regards to the complaint history for this batch number to date there were two complaints neither of which were related to the nature of the reported adverse event. There was no product quality issue noted by the pharmacist upon vaccination and the cause of death for the patient was currently unknown. The pharmacist did not have reason to believe that the vaccine was compromised, but she would like further guidance to be certain. Reported Cause(s) of Death: Death NOS.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: patient reported sever rash head and neck  patient did not report to provider until seen on 05/10/2019
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: 3 days of fever and shivering, swollen sore arm.  Ibprophine to reduce fever and stayed in bed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Severe Itching
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Bursitis, Chest X-ray normal, Dyspnoea, Injection site swelling, Pain
Clinical narrative: Patient came in to see PCP the day after prevnar 13 injection (injection placed on 5/9/19 and patient RTC with swollen left shoulder on 5/10/19). Pt stated that it felt like there was a ball going up left shoulder. Pt reports she had a fever of 101 the night of May 9th, then took tylenol in the morning to help with pain and fever. During 5/10/19 office visit, patient stated feeling  some shortness of breath due to the pain, like she could not take a deep breath. Pt denies chest pain, and sick contacts.   Impression and Recommendation by Dr.: - "Exam consistent with acute bursitis, likely secondary to vaccine. This inflammation may be causing increased fevers as well, although anticipate would be short lasting CBC reassuring that not acute infection XR without specific pocket of inflammation,"  Reviewed likely vaccine complication with patient and expected course of recovery. Apologized that this event happend for pt and explained adverse event reporting system, will follow up with RN team to file. Anticipate that fevers will resolve within 1 day as will most swelling Reactive bursitis may have persistant pain for 2-6 weeks.  Advised tylenol and ibuprofen alternating over the 48 hours with ice. Advised that if fevers persist longer than 24 hours, if SOB worsens or if pain much increased, should come to clinic or ED for further evaluation Pt in agreement and reiterated understanding of the above plan.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, White blood cell count normal
Clinical narrative: Patient came in to see PCP the day after prevnar 13 injection (injection placed on 5/9/19 and patient RTC with swollen left shoulder on 5/10/19). Pt stated that it felt like there was a ball going up left shoulder. Pt reports she had a fever of 101 the night of May 9th, then took tylenol in the morning to help with pain and fever. During 5/10/19 office visit, patient stated feeling  some shortness of breath due to the pain, like she could not take a deep breath. Pt denies chest pain, and sick contacts.   Impression and Recommendation by Dr.: - "Exam consistent with acute bursitis, likely secondary to vaccine. This inflammation may be causing increased fevers as well, although anticipate would be short lasting CBC reassuring that not acute infection XR without specific pocket of inflammation,"  Reviewed likely vaccine complication with patient and expected course of recovery. Apologized that this event happend for pt and explained adverse event reporting system, will follow up with RN team to file. Anticipate that fevers will resolve within 1 day as will most swelling Reactive bursitis may have persistant pain for 2-6 weeks.  Advised tylenol and ibuprofen alternating over the 48 hours with ice. Advised that if fevers persist longer than 24 hours, if SOB worsens or if pain much increased, should come to clinic or ED for further evaluation Pt in agreement and reiterated understanding of the above plan.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Respiratory arrest, Respiratory tract congestion, Skin warm
Clinical narrative: Patient was very congested, her body was very hot and she stopped breathing in her sleep.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Mouth swelling, Oral pain, Oropharyngeal pain
Clinical narrative: Soreness and swelling in mouth soreness in throat  head ache
Age: 1.0
Sex: M
Vaccine: HEP
Symptoms: Product packaging confusion
Clinical narrative: Pt was given Hep B rather than Hep A ordred. Provider, staff and mom were notifed. No harm. Hep A appt was scheduled with parent.  Hep A and Hep B packaging almost identical. Labeled and organized vaccines, in hopes error doesn't happen again.  Staff notified of similarity in packaging.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Chills, Dyspnoea, Physical examination
Clinical narrative: Patient initially experienced chills/fever the evening of day of vaccination.  Symptoms progressed to breathing problems and weakness.  Patient was seen by PCP.  Blood tests were performed and lungs were examined.  Patient stated PCP said everything looked good but they were going to possibly perform more blood test.  Patient contacted pharmacy on 05/14/19 to inform us of issues.  Symptoms are still ongoing.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient initially experienced chills/fever the evening of day of vaccination.  Symptoms progressed to breathing problems and weakness.  Patient was seen by PCP.  Blood tests were performed and lungs were examined.  Patient stated PCP said everything looked good but they were going to possibly perform more blood test.  Patient contacted pharmacy on 05/14/19 to inform us of issues.  Symptoms are still ongoing.
Age: 21.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: patient reported redness, minor itching, and small bumps developing to the left upper arm, above the left elbow up to the shoulder.  Minor redness was noted, but small bumps were not observed by myself.  Offered benadryl but patient declined. Pt denies any difficulty breathing or swelling.  Provided cool compress.  Patient with mother, declines further observation, both state aware to seek medical attention if anything worsens, declines for medication attention to be called at this time, and patient and mother both state they wish to go home at this time - approx 1635.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Rash
Clinical narrative: Rash on arm and welt at the injection site.  Patient has been taking Tylenol and will take a dose of Benadryl.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Memory impairment
Clinical narrative: Patient presented with localized swelling and redness of left upper arm. Warm to the touch. Asked if there was any loss of mobility or any pain and she said no. She did say that she feels like she's more forgetful since the vaccination. She said she forgot where she parked her car after receiving the shot.
Age: 3.0
Sex: F
Vaccine: FLU4, HIBV
Symptoms: Eczema, Exfoliative rash, Rash generalised, Rash pruritic
Clinical narrative: Scaly rash all over her body that was itchy....like eczema except worse. Now possible allergy to dairy.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event. Patient was given a Tdap on 4/2/19  and then again  on 5/9/19.  Tdap on 5/9/19 was given IM in left arm. Same lot and manufacturer as previously stated
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Injection site erythema
Clinical narrative: Day 1 post injection: severe headache, severe pain, inflammation and swelling to left deltoid, pain in all joints, incapacitating fatigue, loss of appetite. Day 2 post injection: moderate headache, improvement in joint pain, fatigue, appetite improved, not yet normal,  left deltoid inflamed and swollen, less painful (could touch it) Day3  post injection: headache resolved by end of day,  improved appetite, improved energy, though still not normal, left deltoid area pink, swelling diminishing
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Day 1 post injection: severe headache, severe pain, inflammation and swelling to left deltoid, pain in all joints, incapacitating fatigue, loss of appetite. Day 2 post injection: moderate headache, improvement in joint pain, fatigue, appetite improved, not yet normal,  left deltoid inflamed and swollen, less painful (could touch it) Day3  post injection: headache resolved by end of day,  improved appetite, improved energy, though still not normal, left deltoid area pink, swelling diminishing
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Somnolence
Clinical narrative: localized reddness, swelling, & itchiness OT  injection site. No pain Patient took OTC Benadryl with relief, but experienced  side effect (i.e. grogginess), So Rx changed to  cetirizine 10 mg PO QD., x 7 days
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Impaired work ability, Injection site erythema, Vomiting
Clinical narrative: I called patient about an upcoming appointment and she reported that she had been up all night with vomiting and diarrhea. Denied a fever. Had a round reddened area on left deltoid where injection was given. She slept until 11 am and stayed home from work. Did not report and vomiting or diarrhea for today.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Motion sickness, Nausea
Clinical narrative: Pt c/o headache and nausea, feeling "car sick", Post vaccine.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: CSF test, Guillain-Barre syndrome, Hypoaesthesia, Muscle spasms
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA(HA#710142) under the Freedom of Information Act. This spontaneous report refers to a 18 year old male patient. The patient's concurrent conditions, concurrent illnesses, medical history, concomitant therapies and prior vaccinations were not reported. On 04-AUG-2017 the patient was vaccinated with the third dose of GARDASIL 9 (dose was not reported, lot# was M040412, expiration date not reported, but upon internal validation established as 30-JUN-2019), intramuscularly in the left arm for prophylaxis. The vaccine was administered at private doctor's office/hospital. On 05-AUG-2017, the patient had cerebrospinal fluid tests (CSF) with no result provided and on the same day he experienced Guillain-Barre syndrome. He had acute inflammatory demyelinating polyneuropathy (AIDP). On an unknown date, the patient was hospitalized. The outcome of the events was unknown. The events was considered as disabling event. The causality between all the events and the suspect vaccine was not reported. Follow-up information has been received from an other healthcare professional via FDA on 15-APR-2019, referring to a patient. On 04-AUG-2017 8:56 (previous reported as 04-AUG-2017), the patient was vaccinated with the third dose of GARDASIL 9. The patient was experienced the events on 05-AUG-2017 8:00 (previous reported as 05-AUG-2017). Follow up information has been received on 08-MAY-2019 from a physician. The patient's history vaccination included MENACTRA on 03-JUL-2017. He had no concomitant medications and illness at vaccination. The patient received his second dose of GARDASIL 9 (previous reported as third dose) in left deltoid and also experienced cramps and numbness lower extremities on 07-AUG-2017 (also reported as 07-AUG-2019), which caused hospitalization and the patient was recovered with sequelae from the events at the time of reporting. Causality assessment was not provided.
Age: 20.0
Sex: F
Vaccine: FLUA3
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 06-Mar-2018 by Seqirus from VAERS (VAERS ID: 713933), concerning a 20-year-old, adult pregnant female patient with 14 weeks at gestation (reported as approximately 15 weeks 2 days gestation). The patient had no medical history and no allergies. Concomitant medication included prenatal vitamins. The patient's last menstrual period (LMP) was on 14-Jun-2017. On 19-Sep-2017, the pregnant patient (under age of 65 years) was administered FLUAD (TIV) [mf59, dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: 179002 and expiry date: not reported] (explicitly coded as vaccine exposure during pregnancy and inappropriate age at vaccine administration) for an unknown indication. The patient's estimated date of delivery (EDD) was 11-Mar-2018. The reporter assessed the events as non-serious. Follow-up received from other health professional on 19-Feb-2019: The reporters' information and literature information were added in the general tab. Added an event 'inappropriate age at vaccine administration' in the event tab. The narrative and case comment were amended accordingly. Case re-opened for completion of full data entry: 19-Feb-2019. Reporter's Comments: A 20-year-old, female pregnant patient (under age of 65 years) was administered FLUAD (TIV) (vaccine exposure during pregnancy and inappropriate age at vaccine administration). The company assessed the causality of the event inappropriate age at vaccine administration as not related to the suspect vaccine due to accidental nature of the event. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of vaccine exposure during pregnancy was assessed as not related considering the intended use of the vaccine.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: injection site pain; loss of personal independence in daily activities; pain in extremity; This report was identified from a line listing obtained on request by the Company from the Food and Drugs Administration (FDA) (HA# 736605) under the Freedom of Information Act and refers to a 26-year-old female patient. The patient had no current illness and medical history reported. She used nonsteroidal anti-inflammatory drugs (unspecified).  On 25-JAN-2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # N021475, expiration date: 01-JAN-2020) intramuscularly in the left arm for prophylaxis.  On 26-JAN-2018, the patient experienced injection site pain, pain in extremity and loss of personal independence in daily activities. She called on 02-FEB-2018, reporting severe pain to arm at injection site and radiating to shoulder and all of the left upper extremity. Pain was mild on day of injection and became increasingly worse (interfering with daily activities) reaching a plateau on 01-FEB-2018 and then continually decreasing. The patient denied any swelling, edema, numbness, tingling, or loss of dexterity to area affected. This nurse reviewed table 1 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) insert regarding severe pain as injection site adverse reactions for her age group and sex. The patient reported some relief of pain with ibuprofen and cold compresses. She declined to seek care of medical provider. The outcome of the events was reported as recovered on an unknown date in 2018.  The causality between the events and the suspect vaccine was not reported.  This spontaneous report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 736605) regarding the female patient. The patient received vaccine at the age of 26. Vaccine administration details were updated. The patient was not taking any other medications, herbal remedies or dietary supplements at the time of vaccination. The patient was not having any chronic illness, allergies to medications, food or other products at the time of vaccination.  Follow-up information has been received form a nurse as a telephone call on 14-MAY-2019: The nurse informed that she was not able to identify the patient based on limited information present. The nurse was provided with all available information and the nurse could not identify a patient.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, HPV9, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: drug administered to patient of inappropriate age; Wrong drug administered; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS#:736757) referring to a 4-month-old White female patient. The patient has no medical history, current illness or other medications.  On 08-FEB-2018, the patient was supposed to get the inactivated polio vaccine (IPV) 2nd dose. The patient was administered the wrong vaccine. Instead of the inactivated polio vaccine (IPV) the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N021475, expiration date not reported, but upon internal validation established as 31-JAN-2020, dose 1, intramuscular in the left thigh for prophylaxis. Other suspect therapies included haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), dose 2, lot#N008079, expiration date not reported, but upon internal validation established as 02-DEC-2019, intramuscular in the right leg for prophylaxis; rotavirus vaccine, live, oral, pentavalent (ROTATEQ), dose 2, lot#N009962, expiration date not reported, but upon internal validation established as 15-NOV-2018, orally for prophylaxis;  diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (INFANRIX) lot#BD52M, dose 2, intramuscular in right leg and pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) dose 2, intramuscular in right leg. The mother was called and asked her how the baby was doing, she stated that she was good and sleeping. Mother stated that she was going to take her to get re-evaluated. It was unknown if mother was taking her to the emergency room (ER) to be seen. Outcome of the events was unknown.   Follow-up information was received on 13-MAY-2019. The birth weight of the patient was reported as 7 lb 14 oz. the patient reportedly has one brother and one sister. The site of administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was reported to be Left vastus lateralis, site of administration of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) right vastus lateralis and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) to be right vastus lateralis. Lot number of pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) was reported as 558703. It was reported that the mother was informed of the event and was also called the next day to check on patient.
Age: 12.0
Sex: M
Vaccine: FLUX, MEA, PPV
Symptoms: Immunoglobulin therapy, Vaccination failure
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS (VAERS ID: 766443) and initially retrieved on 15-Jan-2019, concerning a 12-year-old male adolescent patient. The patient's concurrent conditions included immunodeficiency common variable (CVID), low immunoglobulin M (IgM), elevated immunoglobulin A (IgA), and normal immunoglobulin G (IgG) (since unspecified dates). The patient was prophylactic for an unspecified condition. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (route of administration, anatomical location; unknown, dose, batch number, expiry date, trade name, manufacturer: not reported) and non-company suspect vaccines PNEUMOVAX 23 [route of administration, anatomical location: unknown, dose, batch number and expiry date: not reported] and measles vaccine [route of administration, anatomical location: unknown, dose, batch number and expiry date: not reported] for unknown indications. On an unspecified date, after the vaccinations, the patient showed poor response to the vaccines. Thereafter, the patient was placed on treatment with intravenous (IV) immunoglobulin therapy due to low immunoglobulin M (IgM), elevated immunoglobulin A (IgA), and normal immunoglobulin G (IgG) but poor response to the vaccines. The outcome of the events was unknown. The reporter assessed this case as non-serious and considered the causality of the event as related to the suspect vaccine. Reporter's Comments: A 12-year-old, male patient with medical history (immunodeficiency common variable immune deficiency with low immunoglobulin M, elevated immunoglobulin A, and normal immunoglobulin G) showed poor response to the vaccines (reported as vaccination failure) at an unspecified period after receipt of INN Flu, PNEUMOVAX and measles vaccines. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported events, details regarding vaccination failure company assessed the causality as unassessable. The co-administered PNEUMOVAX and measles vaccine was considered as co-suspects. The case will be reassessed upon receipt of follow-up information. The company assessed this case as serious (medically significant).
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site swelling
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 767528), concerning a 74 year old male patient. The patient's medical history was not reported. The patient's concurrent conditions included hypertension and his concomitant medications included an unspecified blood pressure pill. The patient had no known drug allergies. On 20-Aug-2018, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration: intramuscular, anatomical location: right arm, batch number, expiry date, trade name, manufacturer: not reported) for unknown indication. On the same day, the patient was also administered with PNEUMOVAX (dose, route of administration: intramuscular, anatomical location: left arm, batch number: N025656, expiry date: 19-Apr-2019, trade name, manufacturer: not reported) for unknown indication. On the same day, after vaccination, the patient's left arm was beginning to become red. The patient reported that as of 22-Aug-2018, the left arm was swollen from the shoulder down to the elbow like a cuff. It was reported that the patient sought medical attention by calling the pharmacist and additionally, no treatment had been initiated as of yet. The outcome of the events was not recovered. The reporter assessed this case as non-serious. Reporter's Comments: A 74-year-old male patient experienced redness and injection site erythema, on the same day along with swelling arm, extensive swelling of vaccinated limb and injection site swelling, 2 days after vaccination with INN Flu Vaccine (in right arm) and PNEUMOVAX (in left arm). The causality of the events was assessed as not related as the events were occurred on the left arm where co-suspect vaccine PNEUMOVAX was administered.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous case, reported by other non-healthcare professional to VAERS (VAERS ID: 768427) and initially retrieved on 15-Jan-2019, concerning an elderly female patient of unspecified age. On an unspecified date, the patient received the historical drug: SHINGRIX (reported as first shot) and her arm was barely sore (not enough to complain) at the injection site and not red at all. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (reported as Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) (influenza vaccine, influenza virus vaccine polyvalent, route of administration: injection NOS (reported as SYR), anatomical location, dose, batch number, expiry date, trade name, manufacturer: not reported) for prophylaxis. On an unspecified date, after receiving the vaccine, the patient experienced injection site pain. It was reported that, the pain at the injection site was not different from that, after getting a flu shot. At the time of the report, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent of unspecified season. The reporter assessed this case as non-serious. Reporter's Comments: An elderly female patient of unspecified age developed injection site pain on an unspecified day after receiving INN Flu Vaccine Seasonal. The company assessed the causality of the event as unassessable due to lack of information regarding onset latency.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Product administered at inappropriate site, Skin warm
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 768563), concerning a 66-year-old, elderly, female patient. The patient current conditions included: hypertension (reported as blood pressure elevated due to missed dose of medication that AM), hypercholesterolemia, osteopenia and tiredness. The patient had allergy to penicillin. The patient's concomitant medication included: pravastatin, benazepril, FOSAMAX, hydrochlorothiazide and gabapentin for unknown indications. On 29-Aug-2018, the patient was administered INN flu vaccine seasonal (route of administration: unknown, anatomical location: right arm, dose, frequency, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. On the same day, the patient was also administered non-company suspect product PNEUMOVAX (frequency: reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: R009163, dose and expiry date: not reported] for an unknown indication. It was reported that, the patient received the PNEUMOVAX on front of right deltoid, and flu about 1 plus inches behind that, on more rear side of deltoid. On the next day, after vaccination, the patient developed mildly swelling, redness, and mild heat in arm. Patient claimed there had been some pain. The patient presented to pharmacy about 36 hours after immunization. Upon presentation, the pharmacist gave patient acetaminophen, cold compress, antihistamine and requested the patient to return to pharmacy if symptoms didn't resolve in the following 2 days or gets worse. The patient said after cold compress, the site felt better. The lab investigations were unknown. At the time of the report, the patient was recovering from the events. The reporter assessed the case as non-serious. Significant case amendment (15-Jan-2019): The event vaccine administered at inappropriate site' was corrected as drug administration error' and the description as reported for the same was changed from Received the PNEUMOVAX on front of right deltoid, and flu about 1 plus inches behind that on more rear side of deltoid' to two vaccines administered in right arm'. The narrative was amended accordingly. Case re-opened for completion of full data entry: 15-Jan-2019. Reporter's Comments: A 66-year-old female patient developed warm skin, throbbing pain, redness and swelling arm on the same day after receiving INN flu vaccine seasonal and co-suspect vaccine PNEUMOVAX on the same arm. The company assessed the causality of the event drug administration error as not related to the suspect vaccine due to the accidental nature of the event. The company assessed the causality of the events warm skin, throbbing pain, redness in arm and swelling arm as related due to plausible temporal relationship between suspect vaccine and the events. However, the causality of the co-suspect vaccine cannot be ruled out.
Age: 80.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: This is a spontaneous case reported by other non-health professional to VAERS (VAERS ID: 769691) initially retrieved on 26-Nov-2018, concerning an 80-year-old, elderly female patient. On 24-Aug-2018, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, manufacturer: Seqirus, anatomical location: right arm, dose, route of administration, batch number, trade name and expiry date: not reported) for prophylaxis. On the same day, the patient was also administered a non-company suspect vaccine, Varicella zoster vaccine (reported as SHINGRIX, frequency: 1, anatomical location: left arm, dose, route of administration, batch number, trade name and expiry date: not reported) for prophylaxis. The patient was fine taking both the vaccine together. On the same day after vaccination, the patient experienced injection site pain which recovered on 27-Aug-2018. On 29-Aug-2018, the patient experienced nausea. The patient did mention that the arm she received SHINGRIX in was worse as far as soreness. The patient had not recovered from nausea and had recovered from injection site pain. The reporter assessed the case as non-serious. Reporter's Comments: An 80-year-old, female patient experienced injection site pain on the same day after vaccination and experienced nausea 5 days after the administration of INN Flu Vaccine Seasonal and Varicella zoster vaccine (co-suspect). The company assessed the causality as related due to plausible temporal relationship between the events and the suspect vaccine.