chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: gave an expired tenivac dose staff misread the expiration date as it was expired on 24jun2023 with no reported adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 26-years-old male patient who was given an expired diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult [Tenivac] dose as the staff misread the expiration date as it was expired on 24jun2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Sep-2023, the patient received 0.5 mL expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, suspension for injection (strength: standard) (batch number: unknown; expiry date: 24-Jun-2023) via intramuscular route in the left arm for Immunization as the staff misread the expiration date 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.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: 2.0
Sex: F
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 year old received flublok quadrivalent today with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old female patient who received influenza quadrivalent recombinant vaccine [Flublok QIV] today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2023, the patient received 0.5 ml  dose (once) of suspect influenza quadrivalent recombinant vaccine, (lot U8058BA: expiray date: 31-May-2024) (formulation, strength not reported) via intramuscular route in the left thigh for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  Outcome : Unknown.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: stated fluzone quadrivalent NP,expired 30jun2023 was administered with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who stated influenza quadrival A-B vaccine [fluzone QIV] expired on 30-jun-2023 was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival A-B vaccine Suspension for injection which expired on 30-Jun-2023 (lot number, strength, dose not reported) via unknown route in unknown administration site as Immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: PENTACEL that was administered to a patient after the expiration date with no adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a patient of an unknown age and gender to whom administered diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine [Pentacel (Vero)] to a patient after the expiration date with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown expired dose of suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine Suspension for injection (strength, lot number not reported and expiry date: 09-Sep-2023) via unknown route in unknown administration site as Immunization and (expired product administered) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: 0.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Expired ACT-HIB was administered to a patient with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 months old female patient to whom expired act-hib was administered 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 pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and hepatitis b vaccine for Prophylactic vaccination.  On 13-Sep-2023, the patient received 0.5 ml (dose 1) of suspect HIB (PRP/T) Vaccine,Powder and solvent for solution for injection (lot UJ798AB, expiry date- 11-Sep-2023) via intramuscular route in the left vastus lateralis for prophylactic vaccination (strength: unknown), expired act-hib was administered to a patient with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: 85.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 5x7 cm circle of erythema at injection site, with associated warmth, itching beginning 5 days after vaccine was given.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy skin abnormal, Injection site reaction, Skin cancer, Squamous cell carcinoma
Clinical narrative: SCC Skin cancer at injection site
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Low grade fever, site injection pain and redness, fatigue, achy for 2 days
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine stored in unapproved storage unit
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 23.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Malaise, Nausea
Clinical narrative: About two minutes after the injection of the second (HPV) vaccine, I began to feel dizzy and hear ringing in my ears. I experienced tunnel vision and felt like I could pass out at any moment. I also broke out in a sweat and felt very hot all over my body.  I felt nauseous and like I needed to vomit, but I did not. I let the nurse know that I wasn?t feeling well, and she instructed me to sit down and left the room to retrieve a glass of water. When she came back in the room, she gave me a wet towel to dab my forehead and a cup of water. She then instructed me to lay down on the examination table with my back slightly raised above my legs. Within a few minutes the feeling passed, and I felt well enough to leave. I had not eaten anything prior to the injection.
Age: 23.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Tinnitus, Tunnel vision
Clinical narrative: About two minutes after the injection of the second (HPV) vaccine, I began to feel dizzy and hear ringing in my ears. I experienced tunnel vision and felt like I could pass out at any moment. I also broke out in a sweat and felt very hot all over my body.  I felt nauseous and like I needed to vomit, but I did not. I let the nurse know that I wasn?t feeling well, and she instructed me to sit down and left the room to retrieve a glass of water. When she came back in the room, she gave me a wet towel to dab my forehead and a cup of water. She then instructed me to lay down on the examination table with my back slightly raised above my legs. Within a few minutes the feeling passed, and I felt well enough to leave. I had not eaten anything prior to the injection.
Age: 71.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site induration, Injection site pain, Injection site rash, Rash erythematous
Clinical narrative: Within 2 hrs, injection site became very painful, very hard and a red rash appeared.  Ignored for 48 hrs.  Did not get any better, so went to Pharmacy to show on 9/10/23.   Started applying cool compresses 4 times a day for 3 days.   Pain and hardness went away, but red rash expanded and moved down the bicep and continues to be present.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Feeling abnormal, Hypotension, Influenza virus test negative, Magnetic resonance imaging thoracic
Clinical narrative: In Feb of 2023, the afternoon of the 13th I started to feel something coming on. By the next afternoon I felt feverish and taking my temp confirmed it. I called to reschedule an ENT appt for the next day and to schedule an appt with Dr. At the appt I tested negative for Covid and the flu. They did an MRI of my chest to make sure it wasn't pneumonia and listened to my heart and did my blood pressure and then Rx'd a z-pac and cough syrup. Monday (a holiday) I still felt terrible and decided to check my bp. It was 90/53! Time for the ER! Feb 19:  Not only was my bp low, I was in atrial fibrillation. Lots of things done for me to stabilize me. They kept me overnight for observation and released me the next morning.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: In Feb of 2023, the afternoon of the 13th I started to feel something coming on. By the next afternoon I felt feverish and taking my temp confirmed it. I called to reschedule an ENT appt for the next day and to schedule an appt with Dr. At the appt I tested negative for Covid and the flu. They did an MRI of my chest to make sure it wasn't pneumonia and listened to my heart and did my blood pressure and then Rx'd a z-pac and cough syrup. Monday (a holiday) I still felt terrible and decided to check my bp. It was 90/53! Time for the ER! Feb 19:  Not only was my bp low, I was in atrial fibrillation. Lots of things done for me to stabilize me. They kept me overnight for observation and released me the next morning.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13, DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Irritability, Rash erythematous, Skin discolouration
Clinical narrative: Rash which looks like red bumps and bumps that look white in color.  Fussy/irritable.  Rash broke out 1 hour after vaccines were administered.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13, DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site rash
Clinical narrative: Rash which looks like red bumps and bumps that look white in color.  Fussy/irritable.  Rash broke out 1 hour after vaccines were administered.
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Erythema, Injection site pruritus, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Shot area started to itch shortly after shot was administered. On 9-17 the left arm was red and itched. On 9-18 the arm was slightly swollen and warm to the touch in the red area. I went to the pharmacy to have the pharmacist take a look at it and he said to take Benadryl and Benadryl ointment for the itching. He said to watch it closely to draw a circle around the red area to see if it moves. If it does to contact my provider for further evaluation.
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Rash erythematous
Clinical narrative: Shot area started to itch shortly after shot was administered. On 9-17 the left arm was red and itched. On 9-18 the arm was slightly swollen and warm to the touch in the red area. I went to the pharmacy to have the pharmacist take a look at it and he said to take Benadryl and Benadryl ointment for the itching. He said to watch it closely to draw a circle around the red area to see if it moves. If it does to contact my provider for further evaluation.
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Erythema, Injection site pruritus, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: I had a Pt come in today to show me a red rash on her left arm. She had the RSV and Flu(HD) shots on Fri 9/15. Her arm was red, itched, and had mild swelling all on her bicep area, her deltoid had no issues and she said she couldn't "even feel where they were given any more". When giving the Flu/RSV combo in the same arm I always use the same anatomical location on the deltoid. Flu in Front and RSV in the Rear portion of the deltoid. The Pt believes it to be the RSV as she receives the Flu every year without issue. She claims that shortly after the injections were given, she began to itch mildly on the bicep area. The next day (Saturday) it was red then became mildly swollen this morning, 9/18.
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Rash erythematous
Clinical narrative: I had a Pt come in today to show me a red rash on her left arm. She had the RSV and Flu(HD) shots on Fri 9/15. Her arm was red, itched, and had mild swelling all on her bicep area, her deltoid had no issues and she said she couldn't "even feel where they were given any more". When giving the Flu/RSV combo in the same arm I always use the same anatomical location on the deltoid. Flu in Front and RSV in the Rear portion of the deltoid. The Pt believes it to be the RSV as she receives the Flu every year without issue. She claims that shortly after the injections were given, she began to itch mildly on the bicep area. The next day (Saturday) it was red then became mildly swollen this morning, 9/18.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient reported an allergic reaction: redness, itchiness and warm to the touch on her left arm below injection site- not including injection site.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: After receiving the seasonal flu vaccine around 11:25 am, around 5 pm she developed hives on her chin, she was given Benadryl and she seemed to be okay. On 9/17, around 8 am she was complaining of itching on her great toes, at first glance nothing seemed present, at 8:51 am hives were noticed on her elbows, and knees. Within minutes they continued to spread up and down the arms and legs. Mostly present on the bony prominences. Topical Benadryl was applied. Brought to urgent care, where at this point the hives had spread to the face. Prescribed Dexamethasone. Had that around 3 pm, and around 7:30 pm had a 24hr Zyrtec due to increased itching and some hives re-emerging.  Monday, 9/18, no hives noticed but complaints of itching.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Erythema, Joint stiffness, Swelling
Clinical narrative: Patient reported redness, pain in her wrist,  and swelling  24 hours after receiving vaccine. Patient reported that it was still stiff and sore 2-3 days after
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received a Tdap for ages 7 and older instead of the Dtap recommended for ages 6 and under.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness postural, Loss of consciousness, Rash
Clinical narrative: Patient then reported that she had a lot of side effects from the first dose.. Patient reported that she felt dizzy 15 minutes after receiving the vaccine. Patient stated that when she got home from receiving the vaccine that she "passed out" on the couch for the night.  The next morning, the patient broke out in a rash on her feet and legs.  Patient took benadryl and this seemed to help her rash go away.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Product administration error, Wrong product administered
Clinical narrative: PATIENT RECEIVED TDAP VACCINE INSTEAD OF HPV IN ERROR.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: Swollen, raised, painful, hot to touch
Age: 58.0
Sex: F
Vaccine: FLUR4, PNC20
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: patient reporting redness, hardness on skin around injection site
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: PT RECEIVED PNEMOVAX 23 IMZ IN RIGHT DELTOID AND A FLUCELVAX IMZ IN LEFT DELTOID ON 9/13/23. SHE STOPPED BY PHARMACY ON 9/14/23 WITH HER SISTER. SHE STOPPED BY PHARMACY ON 9/18/23 AND SHOWED ME A LARGE BRUISE ON HER RIGHT ARM. THE BRUISE WAS FROM HER RIGHT SHOULD TO THE ELBOW. THE BRUISE WENT AROUND THE WIDTH OF HER ARM. SHE STATES THERE WAS REDNESS, PAIN, AND A LUMP WHERE SHE RECEIVED THE IMMUNIZATION ON THE RIGHT DELTOID ON 9/14/2023. SHE STATES SHE PUT ICE ON THAT AREA ON 9/14/23. SHE STATES THE PAIN IS GONE TODAY. SHE STOPPED BY THE PHARMACY TO SHOW ME THE BRUISE.
Age: 58.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Bradycardia, Cold sweat, Consciousness fluctuating, Dysstasia, Eye movement disorder
Clinical narrative: PT REFUSED EPI-PEN IF NECESSARY DUE TO A HEART CONDITION SO I EXPLAINED IF ANY SERIOUS REACTION OCCURRED THAT I WOULD HAVE TO CALL EMS. IMMEDIATELY AFTER BOTH IMMUNIZATIONS, PATIENT'S HEAD FELL BACK AND HER EYES ROLLED BACK, HER UPPER BODY AND HANDS TREMBLED. SHE WAS IN AND OUT OF CONSCIOUSNESS FOR ABOUT 5 MINUTES BEFORE EMT AND AMBULANCE ARRIVED TO ACCESS PATIENT. SHE REFUSED TREATMENT DESPITE UNSTABLE HYPOTENSION AND BRADYCARDIA WITH CLAMMY SKIN. SHE WAS RELEASED TO HER SISTER WITH ASSISTANCE BY EMT AS SHE WAS UNABLE TO STAND OR WALK BY HERSELF DUE TO HYPOTENSIVE EVENT. I CALLED HER THE NEXT DAY AT HOME AND SHE STATED SHE WAS FEELIMG BETTER AND WAS SORRY FOR RUINING MY DAY. I EXPLAINED IN NO WAY DID SHE RUIN MY DAY AND THAT I AM ONLY CONCERNED WITH HER AND HER HEALTH AND NOT MYSELF.
Age: 58.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Gait inability, Hypotension, Immediate post-injection reaction, Posture abnormal, Refusal of treatment by patient
Clinical narrative: PT REFUSED EPI-PEN IF NECESSARY DUE TO A HEART CONDITION SO I EXPLAINED IF ANY SERIOUS REACTION OCCURRED THAT I WOULD HAVE TO CALL EMS. IMMEDIATELY AFTER BOTH IMMUNIZATIONS, PATIENT'S HEAD FELL BACK AND HER EYES ROLLED BACK, HER UPPER BODY AND HANDS TREMBLED. SHE WAS IN AND OUT OF CONSCIOUSNESS FOR ABOUT 5 MINUTES BEFORE EMT AND AMBULANCE ARRIVED TO ACCESS PATIENT. SHE REFUSED TREATMENT DESPITE UNSTABLE HYPOTENSION AND BRADYCARDIA WITH CLAMMY SKIN. SHE WAS RELEASED TO HER SISTER WITH ASSISTANCE BY EMT AS SHE WAS UNABLE TO STAND OR WALK BY HERSELF DUE TO HYPOTENSIVE EVENT. I CALLED HER THE NEXT DAY AT HOME AND SHE STATED SHE WAS FEELIMG BETTER AND WAS SORRY FOR RUINING MY DAY. I EXPLAINED IN NO WAY DID SHE RUIN MY DAY AND THAT I AM ONLY CONCERNED WITH HER AND HER HEALTH AND NOT MYSELF.
Age: 58.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Tremor
Clinical narrative: PT REFUSED EPI-PEN IF NECESSARY DUE TO A HEART CONDITION SO I EXPLAINED IF ANY SERIOUS REACTION OCCURRED THAT I WOULD HAVE TO CALL EMS. IMMEDIATELY AFTER BOTH IMMUNIZATIONS, PATIENT'S HEAD FELL BACK AND HER EYES ROLLED BACK, HER UPPER BODY AND HANDS TREMBLED. SHE WAS IN AND OUT OF CONSCIOUSNESS FOR ABOUT 5 MINUTES BEFORE EMT AND AMBULANCE ARRIVED TO ACCESS PATIENT. SHE REFUSED TREATMENT DESPITE UNSTABLE HYPOTENSION AND BRADYCARDIA WITH CLAMMY SKIN. SHE WAS RELEASED TO HER SISTER WITH ASSISTANCE BY EMT AS SHE WAS UNABLE TO STAND OR WALK BY HERSELF DUE TO HYPOTENSIVE EVENT. I CALLED HER THE NEXT DAY AT HOME AND SHE STATED SHE WAS FEELIMG BETTER AND WAS SORRY FOR RUINING MY DAY. I EXPLAINED IN NO WAY DID SHE RUIN MY DAY AND THAT I AM ONLY CONCERNED WITH HER AND HER HEALTH AND NOT MYSELF.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: Patient was given 1 dose of COVID-19 Pfizer (5-11yo) bivalent vaccine on 9/12/23. Notification was issued by Agency to stop all COVID-19 vaccinations after 9/11/23
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Immunisation reaction, Injection site erythema, Injection site warmth
Clinical narrative: inch to an inch and a half wide red spot on the injection site. Red and hot to the touch per patient. Recommened the patient go to the doctor to check for cellulitis. The patient went in today and after seen they told her it was a normal adverse reaction from the vaccine.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: severe headache with 'excruciating left foot pain shooting up her leg.  no swelling : reported at approximately 12pm called patient back at 4pm and she reported the headache feeling much better, eating and zero foot and leg pain at this point.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Dizziness, Fluid retention
Clinical narrative: HUGE pockets/pouches of fluid under both eye. (roughly 1 inch long; 1/2 inch thick); Pt got the Fluzone HD and Arexvy at the same time.  Pt has had the Fluzone HD for at least the last few years (4/2/20; 9/2/21; 10/17/22) and has had no issues.  Vaccines given 9/15/23 @ about 11:15am. No issues until Saturday morning, but it was mild fluid up under the eyes. It was the same on Sunday. Patient woke up at 6am on Monday (9/18/23) and had the severe pockets of fluid. pt said he felt a little "woozie". pt was going to go home and take some benadryl. pt said he has never had any problems with a vaccine before.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, VARCEL
Symptoms: Injection site pruritus
Clinical narrative: Patient was administered vaccine at approximatley 4:30PM on right upper arm. I was talking with gaurdian about 5 min after administration patient stated that the site she received the injection on her right arm was itchy. When asked about the other side patient stated that side was fine. Went to find a provider to make so that they could evaluate patient and patient stated that she was itchy on both arms. Patient was assessed by provider and given 25 mg of benadryl, there was no reports of itching anywhere else on patients body. Proivider reassessed patient later and itching had improved and had not spread anywhere else.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis, Peripheral swelling
Clinical narrative: Patient arm swelled.  doctor diagnosis it as adhesive capsulitis
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Balance disorder, Blood glucose normal, Blood pressure decreased, Chest injury, Dizziness
Clinical narrative: The father stated that the pt began feeling dizzy and looked like he was going to faint several minutes after receiving vaccinations.  Upon leaving the exam room, the patient hit his chest on the doorframe and his father caught him to support him. No LOC. Father called to medical assistant, who had the patient sit down. The patient was examined by FNP and blood pressure and blood sugar were taken. Blood sugar reading was normal. Blood pressure readings were low. The patient was slow to respond to questions asked by FNP. Paramedics were called, and the patient was transported to Hospital.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Slow response to stimuli
Clinical narrative: The father stated that the pt began feeling dizzy and looked like he was going to faint several minutes after receiving vaccinations.  Upon leaving the exam room, the patient hit his chest on the doorframe and his father caught him to support him. No LOC. Father called to medical assistant, who had the patient sit down. The patient was examined by FNP and blood pressure and blood sugar were taken. Blood sugar reading was normal. Blood pressure readings were low. The patient was slow to respond to questions asked by FNP. Paramedics were called, and the patient was transported to Hospital.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Peripheral swelling
Clinical narrative: swelling in left lower leg
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Herpes zoster
Clinical narrative: A few hours after the vaccine, patient reported generalized and sharp pain in the left side of her ribs and chest. Patient went to the urgent care and was told my the healthcare team that she has been diagnosed with internal shingles and that it could've been a result of the flu vaccine. Patient wanted to report the possible side effect  of the vaccine. She reported no physical rash, but sharp pain, tingling, and pins and needles.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: SORENESS IN ARM, PT TAKES IBUPROFEN FOR OTHER PAIN
Age: 81.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Dizziness, Visual impairment
Clinical narrative: Patient had extreme dizziness in the evening seeing checker board. She stated it lasted approximately 5 minutes
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Full blood count normal, Headache, Influenza virus test negative, Myalgia
Clinical narrative: Headache, nausea, fever, muscle ache, chills, sore throat.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Headache, nausea, fever, muscle ache, chills, sore throat.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Streptococcus test negative, White blood cell count increased
Clinical narrative: Headache, nausea, fever, muscle ache, chills, sore throat.
Age: 81.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Body temperature increased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports having a temperature of 104 degrees F. for 2 days, sore left arm with swelling. Symptoms subsided by Monday
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Injection site mass, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: tennis ball size hives on injection site with pain, redness and warmth after 12 hours of vaccination. Low grade fever with chill and body ache, dizziness and fainting after 18 hours. Took Tylenol for fever and Motrin for pain, bedrest and lots of fluids for hydration. Fever goes away after 24 hours but still have pain/lump on injection site.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Pyrexia, Syncope
Clinical narrative: tennis ball size hives on injection site with pain, redness and warmth after 12 hours of vaccination. Low grade fever with chill and body ache, dizziness and fainting after 18 hours. Took Tylenol for fever and Motrin for pain, bedrest and lots of fluids for hydration. Fever goes away after 24 hours but still have pain/lump on injection site.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Paraesthesia
Clinical narrative: Tingling/pins and needs across body
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Diarrhoea, Nausea
Clinical narrative: Nausea, diarrhea, chills since night of vaccine administration, symptoms still ongoing but improving
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 breakthrough Infection
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Heart rate increased, Tinnitus
Clinical narrative: tinnitus; Spikes in heart rates; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) and HEART RATE INCREASED (Spikes in heart rates) in a 52-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 0008B21A and 044A12A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular use) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced TINNITUS (tinnitus) and HEART RATE INCREASED (Spikes in heart rates). At the time of the report, TINNITUS (tinnitus) and HEART RATE INCREASED (Spikes in heart rates) had not resolved.            Concomitant product use was not provided by the reporter. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Tinnitus
Clinical narrative: tinnitus; Spikes in heart rates; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) and HEART RATE INCREASED (Spikes in heart rates) in a 52-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 0008B21A and 044A12A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular use) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced TINNITUS (tinnitus) and HEART RATE INCREASED (Spikes in heart rates). At the time of the report, TINNITUS (tinnitus) and HEART RATE INCREASED (Spikes in heart rates) had not resolved.            Concomitant product use was not provided by the reporter. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.
Age: 68.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Prevnar 13 administered to patient. Will follow up with patient to administer next dose.
Age: 68.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Expired product administered
Clinical narrative: Expired Prevnar 13 administered to patient. Will follow up with patient to administer next dose.
Sex: U
Vaccine: HEP, PPV, TDAP, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reporting that a dose of PNEUMOVAX 23 was given to patient after its expiration date. Date of expiration: 8/18/2023, date of administration: 8/24/2023. Confirmed that the vaccine had never undergone temperature excursion.; This spontaneous report was received from a registered nurse concerning an unknown age and gender patient. The patient's concurrent condition, medical history, and concomitant medications were not provided.  On 24-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection 0.5 mL as prophylaxis (lot#: U035117, expiry date: 18-AUG-2023, route of administration, and anatomical location not provided) (expired product administered). It was confirmed that vaccine had never undergone temperature excursion.
Sex: U
Vaccine: HEP, PPV, TDAP, PPV
Symptoms: Expired product administered
Clinical narrative: Caller reporting that a dose of PNEUMOVAX 23 was given to patient after its expiration date. Date of expiration: 8/18/2023, date of administration: 8/24/2023. Confirmed that the vaccine had never undergone temperature excursion.; This spontaneous report was received from a registered nurse concerning an unknown age and gender patient. The patient's concurrent condition, medical history, and concomitant medications were not provided.  On 24-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection 0.5 mL as prophylaxis (lot#: U035117, expiry date: 18-AUG-2023, route of administration, and anatomical location not provided) (expired product administered). It was confirmed that vaccine had never undergone temperature excursion.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Multiple allergies, SARS-CoV-2 test, Throat tightness
Clinical narrative: positive COVID test result; positive COVID test result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 06Apr2021 at 14:00 as dose 1, single (Lot number: ER8737), in left arm and on 04May2021 at 15:00 as dose 2, single (Lot number: ER8734) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: seafood" (unspecified if ongoing); "Known allergies: dairy" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing); "Known allergies: Beef" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC D. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "positive COVID test result". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (10Jan2022) Positive.  Clinical course: No other vaccine in four weeks. No covid prior vaccination. Patient tested for covid post vaccination. No Other medical history.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300297624 same patient, different dose;
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Nasopharyngeal swab, Vaccination failure
Clinical narrative: positive COVID test result; positive COVID test result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 06Apr2021 at 14:00 as dose 1, single (Lot number: ER8737), in left arm and on 04May2021 at 15:00 as dose 2, single (Lot number: ER8734) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: seafood" (unspecified if ongoing); "Known allergies: dairy" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing); "Known allergies: Beef" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC D. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "positive COVID test result". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (10Jan2022) Positive.  Clinical course: No other vaccine in four weeks. No covid prior vaccination. Patient tested for covid post vaccination. No Other medical history.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300297624 same patient, different dose;
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Pain in extremity
Clinical narrative: reports mild sensation of numbness, coolness and tingling to left arm located below vaccination site down to elbow.  Denies bruising, redness or warmth. Reports able to lift and move arm normally without difficulty. Declines any treatment and states it is better.  Did not initially report to Employee Health and only called becasue she was entering her own VAERS and wanted the lot number.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Vaccination site coldness, Vaccination site hypoaesthesia, Vaccination site paraesthesia
Clinical narrative: reports mild sensation of numbness, coolness and tingling to left arm located below vaccination site down to elbow.  Denies bruising, redness or warmth. Reports able to lift and move arm normally without difficulty. Declines any treatment and states it is better.  Did not initially report to Employee Health and only called becasue she was entering her own VAERS and wanted the lot number.
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: HBP calling to report a patient received their first dose of GARDASIL 9 at the age of 9 years old.  The office just administered  the second dose to the patient at the age of 19 on 9/11/2023.  NO symptoms or side effects reported.  No other AE and no; No adverse event; Information has been received from a pharmacist student referred to a child patient of unknown age and gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On an unknown date in 2013 (also reported as "at the age of 9-years-old"), the patient was vaccinated with her/his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, dose number, frequency, route, anatomical location, lot number and expiratoion date were not reported), as prophylaxis.   On 11-SEP-2023 (also reported as "at the age of 19-years-old"), the patient was vaccinated with her/his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, dose number, frequency, route, anatomical location, lot number and expiratoion date were not reported), as prophylaxis (inappropriate schedule of product administration). No adverse event.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no side effects or symptoms reported; Medical Assistant called to report expired PROQUAD was administered to a patient, no side effects or symptoms reported. PROQUAD that expired on 9/4/2023, was given yesterday 9/11/2023 to one patient. Confirmed no previous temperature excursion. Produ; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 11-SEP-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml), once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W007746, expiration date reported and validated as 04-SEP-2023) as prophylaxis (expired product administered). No side effects or symptoms reported. Confirmed no previous temperature excursion.
Age: 48.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No further AE information available.; HCP called to report that a dose of PROQUAD(MMRV) was administered on 9/13/2023 to a 48-year-old female.; patient should have received MMRII and VARIVAX but instead was given PROQUAD(MMRV).; This spontaneous report has been received from a registered nurse and refers to a 48-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 13-SEP-2023, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, recombinant human albumin (rha) (PROQUAD) injection, 0.5 milliliter (ml) once (valid lot number W035472 [expiration date 06-MAY-2024]) (dose number, frequency, route of administration, vaccination scheme, anatomical location, were not provided), administered for prophylaxis and it was not approved for anyone over the age of 12-year-old (product administered to patient of inappropriate age). The healthcare provider (HCP) reported that the patient should have received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMRII) injection, and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (dose, dose number, frequency, route of administration, vaccination scheme, anatomical location, lot number, expiration date were not provided for both vaccines), but instead was given Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, (PROQUAD) (wrong product administered).   No further adverse event (AE) information available.
Sex: F
Vaccine: COVID19
Symptoms: Colposcopy, Human papilloma virus test, Investigation, Pre-existing condition improved, Smear cervix
Clinical narrative: i no longer have this crud running around and through my body and it has to have been from the vaccines; i no longer have this crud running around and through my body and it has to have been from the vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fibroid tumors" (unspecified if ongoing), notes: I went through when I was pregnant in 1990. And I was carrying a baby and fibroid tumors; "surgery removed my uterus, ovaries, Fallopian tubes, and cervix" (unspecified if ongoing), notes: My tumors grew so painful, surgery removed my uterus, ovaries, Fallopian tubes, and cervix; "Pregnancy", start date: 1990 (unspecified if ongoing), notes: I went through when I was pregnant in 1990. And I was carrying a baby and fibroid tumors; "I had been in an accident" (unspecified if ongoing), notes: I had been in an accident at work and also had severe food poisoning close to this time; "had severe food poisoning close to this time" (unspecified if ongoing), notes: I had been in an accident at work and also had severe food poisoning close to this time. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer unknown), for Covid-19 immunization. The following information was reported: PRE-EXISTING CONDITION IMPROVED (non-serious), THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown" and all described as "i no longer have this crud running around and through my body and it has to have been from the vaccines". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: "I just wanted to let y'all know that y'all may have stumbled upon a way to cure people like me. Maybe prevent theirs from developing into cancer-which is what I was terrified was going to happen to me".  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Ultrasound scan
Clinical narrative: i no longer have this crud running around and through my body and it has to have been from the vaccines; i no longer have this crud running around and through my body and it has to have been from the vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fibroid tumors" (unspecified if ongoing), notes: I went through when I was pregnant in 1990. And I was carrying a baby and fibroid tumors; "surgery removed my uterus, ovaries, Fallopian tubes, and cervix" (unspecified if ongoing), notes: My tumors grew so painful, surgery removed my uterus, ovaries, Fallopian tubes, and cervix; "Pregnancy", start date: 1990 (unspecified if ongoing), notes: I went through when I was pregnant in 1990. And I was carrying a baby and fibroid tumors; "I had been in an accident" (unspecified if ongoing), notes: I had been in an accident at work and also had severe food poisoning close to this time; "had severe food poisoning close to this time" (unspecified if ongoing), notes: I had been in an accident at work and also had severe food poisoning close to this time. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer unknown), for Covid-19 immunization. The following information was reported: PRE-EXISTING CONDITION IMPROVED (non-serious), THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown" and all described as "i no longer have this crud running around and through my body and it has to have been from the vaccines". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: "I just wanted to let y'all know that y'all may have stumbled upon a way to cure people like me. Maybe prevent theirs from developing into cancer-which is what I was terrified was going to happen to me".  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Atrial fibrillation
Clinical narrative: Afib
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Heart rate up to 180 bpm and fever throughout the night. No concurrent shortness of breath,dizziness, or chest pain.