chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse event; HCP reports that the patient received a dose of VARIVAX that has suffered a TE.  Supported TE case is 02452082. AE cases 02452088 and 02452120 are from the same office and involve similar events with different patients. No Additional AE/PQC reported.; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 11-AUG-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters as prophylaxis (lot number: w039292, which was determined to be valid, with an expiration date on 11-DEC-2024) (strength, scheme, route and anatomical location of administration were not reported) (Product storage error).   The administered dose underwent a temperature excursion of -14.3 degrees Celsius for 13 minutes, with a previous temperature excursion of -10.6 degrees Celsius for 38 minutes.   No additional adverse event was reported.  This is one of three cases form the same reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy
Clinical narrative: COVID-19; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced COVID-19 (COVID-19) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, COVID-19 (COVID-19) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Reported that patient is in first trimester and had received three shots of the Moderna. And she also had COVID.  Company Comment: This is a spontaneous case concerning an adult female patient (exact age unknown) with Maternal exposure during pregnancy and no reported medical history, who experienced the non-serious unexpected, event of COVID-19, which occurred related to the mRNA-1273 vaccination, patient received three doses. At the moment of the report the patient is in her first trimester. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: PT PARENTS CAME TO CLINIC 8/19/23 AND INFORMED CLINIC STAFF THAT PT HAD SMALL, RAISED BUMPS (RASH) ON ARM, HANDS, AND ABDOMINAL AREA. PT PARENT SAID RASH IS NOW SPREADING TO LEGS. PT PARENT BROUGHT PT TO ER DAY AFTER VACCINATIONS 8/13/2023 AND ER ASSESSED AND ADVISED PT PARENT TO BRING TO DOCTORS. I ADVISED THE SAME. PT PARENT CLAIMS NO FEVER AND MINIMAL ITCHINESS.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Gastrooesophageal reflux disease, Lip swelling, Oesophageal pain, Urticaria
Clinical narrative: Swollen lips for 24 hours, then hives, fatigue, and esophageal reflux with pain
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Flatulence, Pyrexia, Vomiting
Clinical narrative: Fevers, Vomiting, Gas
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Anal incontinence, Asthenia, Ataxia, Dissociation, Dysarthria
Clinical narrative: Ataxia, fine tremor both arms and body, isolated falls, inability to walk or stand without support, severe fatigue, loss of bowel and bladder control,  motor skill to brain disassociation, severe weakness, inability to walk or stand without assistance.  Slurring if speak, dribbling, unable to feed self.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysstasia, Fall, Fatigue, Feeding disorder, Fine motor skill dysfunction
Clinical narrative: Ataxia, fine tremor both arms and body, isolated falls, inability to walk or stand without support, severe fatigue, loss of bowel and bladder control,  motor skill to brain disassociation, severe weakness, inability to walk or stand without assistance.  Slurring if speak, dribbling, unable to feed self.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait inability, Post viral fatigue syndrome, Tremor, Urinary incontinence
Clinical narrative: Ataxia, fine tremor both arms and body, isolated falls, inability to walk or stand without support, severe fatigue, loss of bowel and bladder control,  motor skill to brain disassociation, severe weakness, inability to walk or stand without assistance.  Slurring if speak, dribbling, unable to feed self.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Headache, Pulmonary oedema, Pyrexia
Clinical narrative: April 2023 developed cough that lasted several days.  Headache, fluid retention in lungs, fever.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Immediate post-injection reaction, Muscle tightness, Myalgia
Clinical narrative: Joint and muscle pain. My ankles and feet hurt so much that it is hard to walk. My legs are sore.  My right arm hurt all the way down. It feels better this morning.  And my right side of my neck and jaw hurt immediately after but both feel better. Although my back right shoulder muscle is tight.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: Joint and muscle pain. My ankles and feet hurt so much that it is hard to walk. My legs are sore.  My right arm hurt all the way down. It feels better this morning.  And my right side of my neck and jaw hurt immediately after but both feel better. Although my back right shoulder muscle is tight.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dysarthria, Swollen tongue, Throat irritation, Throat tightness
Clinical narrative: Patient reported slurred speech, swollen tongue, blurry vision, dizziness at about 10:30am. Patient finally agreed to benadryl and swallowed one 25mg tablet about 10:47am. Patient's throat was getting itchy and tight and agreed to epinephrine 0.3mg injection in the right anterior thigh at 10:58am. Patient refused wanting us to call 911. Patient threw up at 11:06am, and refused 2nd epip shot. She did report she felt better by 11:09AM. At 11:12am, she reported less tongue swelling and throat tightening.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred, Vomiting
Clinical narrative: Patient reported slurred speech, swollen tongue, blurry vision, dizziness at about 10:30am. Patient finally agreed to benadryl and swallowed one 25mg tablet about 10:47am. Patient's throat was getting itchy and tight and agreed to epinephrine 0.3mg injection in the right anterior thigh at 10:58am. Patient refused wanting us to call 911. Patient threw up at 11:06am, and refused 2nd epip shot. She did report she felt better by 11:09AM. At 11:12am, she reported less tongue swelling and throat tightening.
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Pt had shot on 8/17. Stated she woke up on 8/18 with hives and rash all over body. Patient came into pharmacy 8/19 at 10:47am saying she had gone to urgent care and was told she can never have another flu shot and was prescribed a steriod pack
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Injection site erythema, Post procedural erythema, Procedural site reaction, Pruritus, Rash
Clinical narrative: Pt had shot on 8/17. Stated she woke up on 8/18 with hives and rash all over body. Patient came into pharmacy 8/19 at 10:47am saying she had gone to urgent care and was told she can never have another flu shot and was prescribed a steriod pack
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Rash erythematous, Rash macular, Rash papular
Clinical narrative: Pt had shot on 8/17. Stated she woke up on 8/18 with hives and rash all over body. Patient came into pharmacy 8/19 at 10:47am saying she had gone to urgent care and was told she can never have another flu shot and was prescribed a steriod pack
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Blood pressure measurement, Injection site erythema, Pruritus, Rash, Rash erythematous
Clinical narrative: Pt had shot on 8/17. Stated she woke up on 8/18 with hives and rash all over body. Patient came into pharmacy 8/19 at 10:47am saying she had gone to urgent care and was told she can never have another flu shot and was prescribed a steriod pack
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Rash macular, Rash papular
Clinical narrative: Pt had shot on 8/17. Stated she woke up on 8/18 with hives and rash all over body. Patient came into pharmacy 8/19 at 10:47am saying she had gone to urgent care and was told she can never have another flu shot and was prescribed a steriod pack
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site erythema
Clinical narrative: PATIENT (DOB XX/XX/XXXX) REPORTED TO THE PHARMACY TODAY WITH A RED CIRCLE AROUND THE AREA WHERE SHE RECEIVED HER SECOND SHINGRIX VACCINATION. PATIENT WAS INFORMED THAT THIS WAS NOT AN UNUSUAL REACTION, AND THAT APPLYING A COLD PACK WOULD HELP QUITE A BIT. PATIENT WAS ALSO INFORMED TO KEEP AN EYE ON THE REACTION AND IF IT SPREADS, LET US AND HER PRESCRIBER KNOW. PATIENT EXPRESSED UNDERSTANDING AND THANKED ME FOR THE ADVICE OF THE COLD PACK. WILL FOLLOW UP NEXT WEEK.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Booster vaccine selected for administration was past its 10-week manufacturer refrigeration period (8/18/23). Patient has been contacted (8/19/23) and is making plans for re-vaccination with Moderna to ensure full booster protection. No adverse reactions or symptoms reported.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Booster vaccine selected for administration was past its 10-week manufacturer refrigeration period (8/18/23). Patient has been contacted (8/19/23) and is making plans for re-vaccination with Moderna to ensure full booster protection. No adverse reactions or symptoms reported.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site pain, Neck pain, Pain
Clinical narrative: Pain in left deltoid  that radiates into shoulder and neck      Mobic 15 mg at bedtime and Cyclobenzaprine  5 mg  twice a day and warm compresses and Tiger balm twice a day as needed
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: After finishing my second Shingrix vaccination shot in February 2023, I have since had shingles on June5 , again on July 19, and again on August 16. My dr prescribed Valacyclover HCI, 1 gram, 3 times a day for 7 days.  After finishing that Rx in June, I developed Shingles again about a month after finishing the Rx.  So with the July outbreak my Dr. told me to take ValACYclovir (same Rx) for two weeks, which I did.  Approximately one week after finishing that prescription, I had another outbreak in August.  Now he has me on the same Rx for 3 months!
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Condition aggravated, Cough, Dyspnoea
Clinical narrative: Severe muscle ache in upper chest at site of previous muscle stain. Caused severe shortness of breath for 2 days. Fatigue that did not exist before vaccination. Skin outbreaks with small bumpy rash on right side of face, neck, arms. Sore and swollen breast tissue on right side.  Phlegm and coughing (this condition existed prior to vaccine, for many decades).
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Productive cough, Rash
Clinical narrative: Severe muscle ache in upper chest at site of previous muscle stain. Caused severe shortness of breath for 2 days. Fatigue that did not exist before vaccination. Skin outbreaks with small bumpy rash on right side of face, neck, arms. Sore and swollen breast tissue on right side.  Phlegm and coughing (this condition existed prior to vaccine, for many decades).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: Patient states after receiving her second dose of Shingrix vaccine, she initially experienced a large knot under the skin that was painful to the touch. The knot has gotten smaller over the last two months but patient states that it is still present and is still painful. She experiences pain when reaching and holding, such as when she opens the mailbox as well as when pressure is applied to the area.  Patient has made her primary care physician aware of the issue but no treatment was performed.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injected limb mobility decreased, Limb discomfort, Myalgia
Clinical narrative: First two days after vaccine patient had headache and chills, pain and discomfort in the arm, limited range of motion in the left arm.  In the two week since the vaccine patient had continued to have pain in the muscle, a small bump that shows up in the morning and goes away throughout the day and returns again then next morning.  Pain and discomfort in the arm, and limited range of motion.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: First two days after vaccine patient had headache and chills, pain and discomfort in the arm, limited range of motion in the left arm.  In the two week since the vaccine patient had continued to have pain in the muscle, a small bump that shows up in the morning and goes away throughout the day and returns again then next morning.  Pain and discomfort in the arm, and limited range of motion.
Sex: F
Vaccine: VARCEL
Symptoms: Menstruation delayed
Clinical narrative: she should have started her menstrual cycle on 7/21/2023 and as of today is four days late; varicella titer to be low; This spontaneous report was received from a consumer concerning herself, a 43-year-old female patient, who is no pregnant. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On an unknown date in 1998, the patient received at least one and maybe two varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccines (dose, strength, lot #, and expiry date, route were not provided) as prophylaxis.   The patient's health care professional (HCP) performed blood work on an unknown date in June 2023 and found her varicella titer to be low (antibody test negative) and recommended she receive an additional varicella virus vaccine live (Oka/Merck) (VARIVAX). On 20-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered intramuscularly for prophylaxis (dose, strength, lot #, and expiry date were not provided). The patient asked if the vaccine could affect her menstrual cycle. The patient stated she should have started her menstrual cycle on 21-JUL-2023 and as of today (25-JUL-2023) was four days late (menstruation delayed). On an unknown date, the patient received unspecified COVID vaccine. The patient mentioned the COVID vaccine affected her menstrual cycle but did not elaborate on those details. No treatment was given for menstruation delayed. The patient also reported her HCP instructed her to avoid pregnancy for one month (not the 3 months as suggested in PI). At the time of reporting, the patient had not recovered from the event of menstruation delayed, the outcome of the event antibody test negative was unknown. The action taken with varicella virus vaccine live (Oka/Merck) (VARIVAX) regarding events not applicable.   The causal relationship between menstruation delayed, antibody test negative and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported vaccine administered after temperature excursions.  No additional information provided.  No additional AEs or PQC reported.       ?    Names of vaccines involved (including lot/exp) PROQUAD W038809  6/4/2024         ?    Temperatu; This spontaneous report was received from a nurse referring to a patient (unknown age/gender). The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-AUG-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5ml, lot #W038809, expiration date: 04-JUN-2024, administered intramuscularly (IM) for prophylaxis (strength was not provided) (Product storage error). The vaccines involved underwent temperature excursion at 18.3F with time frame 1 hour and 5 minutes. There was no previous temperature excursion. No additional adverse events (AEs).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported vaccine administered after temperature excursions.  No additional information provided.  No additional AEs or PQC reported.       ?    Names of vaccines involved (including lot/exp) PROQUAD W038809  6/4/2024         ?    Temperatu; This spontaneous report was received from a nurse referring to a patient (unknown age/gender). The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-AUG-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5ml, lot #W038809, expiration date: 04-JUN-2024, administered intramuscularly (IM) for prophylaxis (strength was not provided) (Product storage error). The vaccines involved underwent temperature excursion at 18.3F with time frame 1 hour and 5 minutes. There was no previous temperature excursion. No additional adverse events (AEs)(No adverse event).
Sex: U
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: confirmed a patient may have received MMRII reconstituted with non-MERCK supplied DILUENT and HCP used sterile water in place of the Merck DILUENT; confirmed a patient may have received MMRII reconstituted with non-MERCK supplied DILUENT and HCP used sterile water in place of the Merck DILUENT; No additional AE; This spontaneous report was received from a pharmacist and refers to an adult (also reported as middle aged) patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided. Vaccination history unknown by reporter were not provided  On 09-AUG-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) which reconstituted with non-MERCK supplied diluent and HCP used sterile water in place of the Merck diluent (product preparation issue; product use issue)  There was no additional adverse event (AE) or product quality complaint (PQC).
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Patient reported redness and swelling at the injection site along with fatigue
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: An extra dose of MMRV was administered because outside records were not properly reconciled.
Age: 53.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Head discomfort, Hypertension, Suicidal ideation, Tinnitus
Clinical narrative: TINNITUS It has not stopped I reported it to Dr and she dismissed it and told me we wouldnt know for another 5 years. I fired her. I told another Dr. Dr an infectious disease Dr in another city about it and she told me to ignore it. I went to the emergency room. They did nothing. I finally gave up and found a new PCP but I did not tell him because I thought if I did he wouldnt see me again. I'm also now on high blood pressure meds for the first time in my life. I seriously just want to kill myself it's that bad. Mine is llouder than road noise. It's like a plane taking off in my head and there's massive amounts of pressure. I just want to die. My mother and sister all have it. My life is over.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Asthenia, C-reactive protein normal, CSF culture, CSF glucose normal, CSF lymphocyte count increased
Clinical narrative: Patient had Pneumovax on 08/02.  Fourth day following vaccination, he started having leg pain into his left and into his right leg in the back going down to his size.  Over the next couple of days started with numbness in his feet which then progressed to numbness in his fingertips and hands.  Subsequently he had a fall face forward and hit his head which prompted the hospitalization. Ascending weakness with respiratory compromise and was intubated on 8/18 for obtundation and hypoxemic respiratory failure.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: CSF protein increased, CSF test abnormal, CSF white blood cell count increased, Depressed level of consciousness, Endotracheal intubation
Clinical narrative: Patient had Pneumovax on 08/02.  Fourth day following vaccination, he started having leg pain into his left and into his right leg in the back going down to his size.  Over the next couple of days started with numbness in his feet which then progressed to numbness in his fingertips and hands.  Subsequently he had a fall face forward and hit his head which prompted the hospitalization. Ascending weakness with respiratory compromise and was intubated on 8/18 for obtundation and hypoxemic respiratory failure.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Fall, Gram stain negative, Head injury, Herpes simplex test negative, Hypoaesthesia
Clinical narrative: Patient had Pneumovax on 08/02.  Fourth day following vaccination, he started having leg pain into his left and into his right leg in the back going down to his size.  Over the next couple of days started with numbness in his feet which then progressed to numbness in his fingertips and hands.  Subsequently he had a fall face forward and hit his head which prompted the hospitalization. Ascending weakness with respiratory compromise and was intubated on 8/18 for obtundation and hypoxemic respiratory failure.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Imaging procedure artifact, Laboratory test normal, Magnetic resonance imaging spinal abnormal, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Patient had Pneumovax on 08/02.  Fourth day following vaccination, he started having leg pain into his left and into his right leg in the back going down to his size.  Over the next couple of days started with numbness in his feet which then progressed to numbness in his fingertips and hands.  Subsequently he had a fall face forward and hit his head which prompted the hospitalization. Ascending weakness with respiratory compromise and was intubated on 8/18 for obtundation and hypoxemic respiratory failure.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Respiratory disorder, Respiratory failure, Spinal disorder, Spondylolisthesis, Thecal sac compression
Clinical narrative: Patient had Pneumovax on 08/02.  Fourth day following vaccination, he started having leg pain into his left and into his right leg in the back going down to his size.  Over the next couple of days started with numbness in his feet which then progressed to numbness in his fingertips and hands.  Subsequently he had a fall face forward and hit his head which prompted the hospitalization. Ascending weakness with respiratory compromise and was intubated on 8/18 for obtundation and hypoxemic respiratory failure.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Vertebral foraminal stenosis
Clinical narrative: Patient had Pneumovax on 08/02.  Fourth day following vaccination, he started having leg pain into his left and into his right leg in the back going down to his size.  Over the next couple of days started with numbness in his feet which then progressed to numbness in his fingertips and hands.  Subsequently he had a fall face forward and hit his head which prompted the hospitalization. Ascending weakness with respiratory compromise and was intubated on 8/18 for obtundation and hypoxemic respiratory failure.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Intensive care, Laboratory test, Lumbar puncture
Clinical narrative: Patient had Pneumovax on 08/02.  Fourth day following vaccination, he started having leg pain into his left and into his right leg in the back going down to his size.  Over the next couple of days started with numbness in his feet which then progressed to numbness in his fingertips and hands.  Subsequently he had a fall face forward and hit his head which prompted the hospitalization. Ascending weakness with respiratory compromise and was intubated on 8/18 for obtundation and hypoxemic respiratory failure.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Magnetic resonance imaging spinal abnormal, Muscular weakness, Plasmapheresis, Respiratory distress, Spondylolisthesis
Clinical narrative: Patient had Pneumovax on 08/02.  Fourth day following vaccination, he started having leg pain into his left and into his right leg in the back going down to his size.  Over the next couple of days started with numbness in his feet which then progressed to numbness in his fingertips and hands.  Subsequently he had a fall face forward and hit his head which prompted the hospitalization. Ascending weakness with respiratory compromise and was intubated on 8/18 for obtundation and hypoxemic respiratory failure.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Spondylolysis, Thecal sac compression, Vertebral foraminal stenosis
Clinical narrative: Patient had Pneumovax on 08/02.  Fourth day following vaccination, he started having leg pain into his left and into his right leg in the back going down to his size.  Over the next couple of days started with numbness in his feet which then progressed to numbness in his fingertips and hands.  Subsequently he had a fall face forward and hit his head which prompted the hospitalization. Ascending weakness with respiratory compromise and was intubated on 8/18 for obtundation and hypoxemic respiratory failure.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Ascending flaccid paralysis, Guillain-Barre syndrome, Imaging procedure, Laboratory test
Clinical narrative: Patient had Pneumovax on 08/02.  Fourth day following vaccination, he started having leg pain into his left and into his right leg in the back going down to his size.  Over the next couple of days started with numbness in his feet which then progressed to numbness in his fingertips and hands.  Subsequently he had a fall face forward and hit his head which prompted the hospitalization. Ascending weakness with respiratory compromise and was intubated on 8/18 for obtundation and hypoxemic respiratory failure.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen and painful lymph nodes
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs; Caller reported vaccine administered after temperature excursions.  No additional information provided.  No additional AEs or PQC reported.       ?    Names of vaccines involved (including lot/exp) PROQUAD X011979  7/18/2024        ?    Temperatu; This spontaneous report was received from a nurse referring to a patient (unknown age/gender). The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-AUG-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5ml, lot #X011979, expiration date: 18-JUL-2024, administered intramuscularly (IM) for prophylaxis (strength was not provided)(Product storage error). The vaccines involved underwent temperature excursion at 18.3F with time frame 1 hour and 5 minutes. There was no previous temperature excursion. No additional adverse events (AEs) (No adverse event).
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient had an ActHIB vaccine on 15Aug2023, however the vaccine had expired on 07Aug2023 with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 years old female patient who had an HIB (PRP/T) vaccine [ACT-HIB] on 15aug2023, however the vaccine had expired on 07aug2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine inact (Havrix); measles vaccine, mumps vaccine, rubella vaccine (MMR); pneumococcal vaccine conj 13V (CRM197) (Prevnar 13); varicella zoster vaccine live (OKA/MERCK) (Varivax); and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3V (vero), tetanus vaccine toxoid (Kinrix) all for prophylactic vaccination (Immunisation).  On 15-Aug-2023, the patient received 0.5 mL dose of expired suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch number: UJ735AAB; expiry date: 07-Aug-2023) via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient had an acthib vaccine on 15aug2023, however the vaccine had expired on 07aug2023 with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, nausea, headache, body aches. Not abating six days after vaccination.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Soreness at injection site, fever, headache, nausea  Advil/Tylenol, rest, hydration   Still feeling terrible/feverish
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: Rash moving all over, migrating,  intermittent, urticarial. Treated with Kenalog 40mg IM x 1, Cetirizine,
Age: 68.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Itching rash surrounding base of neck and back of same
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Hyperhidrosis, Lethargy, Loss of consciousness, Nausea, Skin warm
Clinical narrative: Pharmacy was notified pt was experiencing nausea and needed to come up front. Went to front of store and saw pt propped in chair surrounded by 4 to 5 other people. Her eyes were closed. Was notified pt was unconscious (pt was breathing and EMS already ready been dispatched). Pt seemed sweaty and heat, so cold drinks and wet paper towels were applied to skin. We were able to get pt to the floor, but by that time pt was coming to though still lethargic. Orientation questions like name, place, who she was with were asked, which she was able to answer. First responders arrived, and asked pt if she was able to sit up/stand up. Pt was able to sit up-right, however you could still tell she was lethargic, so discouraged pt from rising. Shortly after the ambulance arrived, pt was carried away on a stretcher by EMS.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Later in the day, patient developed pruritic erythematous rash near site of injection (left upper arm) and chest; there was no cough, wheeze, shortness of  breath, chest tightness, or GI symptoms. Rash still present 3 days later.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Joint swelling
Clinical narrative: Patient woke up next day with swollen knee.  The patient took an antiinflammatory and felt better after 3 days.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Premature menopause
Clinical narrative: After receiving the hpv vaccine I was diagnosed with premature ovarian failure at the age of 15. I received these vaccines in 2008, and twice in 2009, I was 11 and 12
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: ADVERSE EVENT DID NOT OCCUR. PATIENT GIVEN VACCINE THAT MAY CONTAIN LATEX AND PATIENT REPORTS LATEX ALLERGY.
Age: 61.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Back pain, Malaise, Myalgia, Pyrexia
Clinical narrative: body malaise, back ache. muscle pain, joint pain, fever as high as 102F started  4 hrs after receiving the vaccine . treatments- rest, back massage, tylenol
Age: 61.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, chills, fever
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Rash erythematous, Vaccination site reaction
Clinical narrative: patient reports systemic fatigue and body aches similar to influenza for 3 days, which subsided on their own. Localized red rash at vaccine site spreading down arm about 6 inches long and 2 inches wide on day 4. Patient advised to take diphenhydramine 50mg by mouth and monitor rash when presented on 5th day post-vaccine.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vision blurred
Clinical narrative: Patient received the vaccine on 8/15 from another store and he came in our pharmacy on 8/19 reporting blurry vision when he tries to focus on letters or words after 5 seconds.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine expiration date was 8/11/23.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: A fever in the arm that started the evening after injection. Been only using cold compressions. Then today a rash developed.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: MMR II given IM.  Clinic guidelines state MMR II needs to be given SC.  No adverse event.
Age: 20.0
Sex: M
Vaccine: MMR, MNQ, TDAP, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event.  MMR II given IM not SC. Pharmacy guidelines advise MMR to be given SC.
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No actual adverse event occurred. Patient was ineligible to receive second bivalent booster due to age and lack of being immunocompromised.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No actual adverse event occurred. Patient was ineligible to receive second bivalent booster due to age and lack of being immunocompromised.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Syncope
Clinical narrative: Within 5 minutes of vaccine, patient felt dizzy and then fainted. She was sitting in chair when she fainted and then was moved to floor by pharmacist and another person. Patient regained consciousness within 30 seconds and declined emergency services. Patient was initially nervous about getting vaccine and later stated she had not eaten all day. Patient was then given water and orange juice. Patients friend came to pharmacy to get her and she left on her own.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No actual adverse event occurred. Patient was ineligible to receive second bivalent booster due to age and lack of being immunocompromised.
Age: 66.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Contusion, Injection site bruising, Peripheral swelling, Skin warm, Swelling
Clinical narrative: Patient Reported extreme swelling and bruising that began 2 days after vaccine administration.  Patient presented 1 week later with a large Bruise covering his entire Deltoid and Bicep region of his Left arm.  Arm was cool to the touch and their was no significant swelling noted currently.  Patient did state that initially it was quite swollen and warm to the touch a few days prior.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No actual adverse event occurred. Patient was ineligible to receive second bivalent booster due to age and lack of being immunocompromised.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Pain in extremity
Clinical narrative: LEFT ARM SORENESS AND REDNESS AND WARM DAY AFTER SHOT.  KEPT EXPANDING WITH REDNESS BY  DATE 8/19/23
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.25ml on 8/14/2023. Patient was asked to come back to the pharmacy to receive another 0.25ml dose on 8/14/2023. Patient received  full 0.5ml dose for that day 8/14/2023.
Age: 0.33
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Dermatitis atopic
Clinical narrative: SEVERE ATOPIC DERMATITIS RESULTED FROM THE VACCINES THE FOLLOWING DAYS AFTER THEY WERE GIVEN. THE CONDITION HAS LASTED EVER SINCE, FLARING UP AGAIN AND GETTING WORSE AFTER HIS 6 MONTH VACCINATIONS FROM THE SAME CARE FACILITY AND THE SAME VACCINES.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: patient reports hives starting 48 hours after injection, at injection site and extending to shoulder and left breast. took zyrtec for itching.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired vaccine.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Myalgia
Clinical narrative: Dizziness, Myalgia, CHILLS Narrative:
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Extreme fatigue, fever of 101, diarrhea, abdominal cramps
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Fatigue
Clinical narrative: tiredness
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Genital rash, Injection site rash, Rash
Clinical narrative: Within 24 hours of the vaccine, Patient had a rash that broke out over her legs, arms, vaginal and gluteal areas, and her stomach.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Immediately felt burning in left deltoid. Continued with pain in left shoulder that radiates up neck
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Neck pain, Pain
Clinical narrative: Immediately felt burning in left deltoid. Continued with pain in left shoulder that radiates up neck
Age: 50.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Cough, Electrocardiogram, Pharyngeal swelling, Throat clearing
Clinical narrative: allergic reaction - throat swelling
Age: 50.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Hypersensitivity, Pharyngeal swelling
Clinical narrative: allergic reaction - throat swelling
Age: 0.25
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other adverse events were reported. No additional AE/PQC.; HCP reported inadvertently administering MMR-II to a patient that was 3 months and 28 days old on 28JULY2023. No other adverse events were reported. No additional AE/PQC.; This spontaneous report was received from a medical assistant and refers to a 3 months and 28 days old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 28-JUL-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). No other adverse events were reported (No adverse event). No additional AE/PQC.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inappropriate schedule of vaccine administered; no adverse event; This spontaneous report was received from a pharmacist referred to a current 26-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection when the patient was 16 years old, administered as prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On an unknown date, 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) injection at 20 years old, administered as prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). No additional adverse events were reported (no adverse event). The patient is now 26 years old and did not get the third dose yet.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; vaccine administered after temperature excursions; This spontaneous report was received from an Other Health Professional and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 11-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X006983, expiration date: 07-MAR-2025, administered intramuscularly for prophylaxis (strength was not provided). On an unknown date before vaccination, the varicella virus vaccine live (oka/merck) (VARIVAX) was underwent a temperature excursion of 18.3 degree Fahrenheit (F) for 1 hour and 5 minutes (product storage error). No previous temperature excursion. No additional adverse events (AEs).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report a T/E, improperly stored VARIVAX administered to patients. See related AE case #02450961. Date of administration today, 14AUG2023. Confirmed no symptoms or sided effects reported. No additional AE/PQC.          ?    Names of va; No additional AE/PQC.; This spontaneous report has been received from an other Health Professional referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliters (lot #X002101 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 19-JAN-2025) for prophylaxis (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of -7.1 degrees Celsius (C), for a time frame of 2 hours and 43 minutes, as recorded by a digital data logger. There was no previous temperature excursion reported. There was no adverse effect reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Pharmacist called to report a16 years old female patient received her 1st dose of GARDASIL 9 on 3/16/2023. Patient missed 2nd dose and it was given on 8/12/2023.; This spontaneous report was received from a pharmacist referring a 16-year-old female patient. Information regarding her concurrent conditions, medical history, drug allergies or reactions and concomitant therapies was not provided.  On 16-MAR-2023, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose description, lot #, expiry date, and route of administration were not provided). The patient missed the second dose, and it was administered on 12-AUG-2023 (inappropriate schedule of product administration). No adverse event was reported.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5, UNK
Symptoms: Cerebral haemorrhage, Cerebral venous thrombosis
Clinical narrative: DEVELOPED BRAIN BLEED; CERIBRAL VENOUSTHROMBOCIOUS; This serious case was reported by a nurse via sales rep and described the occurrence of hemorrhage brain in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included Hib (Hiberix) for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR VACCINE) for prophylaxis and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis.   On 11-JUL-2023, the patient received Pediarix, Hiberix, PREVNAR VACCINE and ROTATEQ. In JUL-2023, less than 3 weeks after receiving Pediarix and Hiberix, the patient experienced hemorrhage brain (Verbatim: DEVELOPED BRAIN BLEED) (serious criteria GSK medically significant) and cerebral venous thrombosis (Verbatim: CERIBRAL VENOUSTHROMBOCIOUS) (serious criteria GSK medically significant). The outcome of the hemorrhage brain and cerebral venous thrombosis were not reported.   It was unknown if the reporter considered the hemorrhage brain and cerebral venous thrombosis to be related to Pediarix and Hiberix.     It was unknown if the company considered the hemorrhage brain and cerebral venous thrombosis to be related to Pediarix and Hiberix.   Additional Information: GSK receipt date: 14-AUG-2023 The patient received 2 month vaccines on and went to emergency room on 26th July 2023 and  developed brain bleed and ceribral venousthrombocious. In JUL-2023, less than 3 weeks after receiving PREVNAR VACCINE and ROTATEQ, the patient experienced hemorrhage brain and cerebral venous thrombosis. It was unknown if the reporter considered the hemorrhage brain and cerebral venous thrombosis to be related to hemorrhage brain and cerebral venous thrombosis. The reporter agreed to follow up from GlaxoSmithKline (GSK).