chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.).    No concomitant medications were reported. Patient had taken booster dose 0.25 ml 4/8/22 (lot 002M21A) Patient is not pregnant/breastfeeding. The lot number of the vaccine is AS7173B, the date it was pulled out of the freezer was 24Apr2023. It was reported that patient did not receive additional vaccines at same time. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-726797 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2023: Non-significant follow up On 30-May-2023: Live Significant follow up-( Patient Information received, Past drug history Relevant Medical History and Concurrent received, Dose information and Case narrative updated received); Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726797:Patient 1
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptoms; temperature excursion for multiple products/ PROQUAD being administered to one patient; This spontaneous report was received from an office manager and refers to a 4-year-old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 04-MAY-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 ml / once, lot #W030849, expiration date reported as 04-MAR-2024 but upon internal validation established as 26-MAR-2024, administered subcutaneously for prophylaxis (strength was not provided). No symptoms were reported (no adverse event).  The temperature excursion was 2 and a half hours as recorded by a data logger. There was no previous temperature excursion reported.
Sex: M
Vaccine: HEP
Symptoms: Anti-glomerular basement membrane antibody negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Arthralgia, Asthenia
Clinical narrative: Membranous nephropathy; This literature marketed report has been received from the authors of a published literature article, titled as stated below, concerning a 56-year-old male patient who was referred or a second opinion regarding MN.The patients medical history included colonoscopy and PSA with result of normal levels. Concurrent conditions and concomitant therapies were not reported.   On unknown date (reported as one month prior), the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength, dose, rout of administration, anatomical location, lot number, and expiration date were not reported).  On unknown date, the patient presented with joint pain and bilateral extremity paresthesias. He soon developed marked edema and hypertension, with over 20 lbs weight gain, associated with weakness and unsteady gait. He had taken NSAIDs for pain but no other medications. He was found to have 17 grams of proteinuria/24 hs and was diagnosed with nephrotic syndrome. His renal function was normal. Serological workup including C3/ C4, ANA, RF, ANCA, anti-GBM antibodies, hepatitis panel, SPEP, UPEP was negative. Renal biopsy showed membranous nephropathy (glomerulonephritis membranous). PLA2R was positive (1:40). Concomitantly, he was diagnosed with inflammatory demyelinating polyradiculopathy and was started on prednisone 60 milligram (mg) daily. Over the next several months he showed neurological improvement, and the steroid dose was titrated down. Proteinuria also improved (greater than 1g /24 hrs) and the nephrotic syndrome resolved. Repeat PLA2R levels have been negative.  The causal relationship between the suspect vaccine and the event was related.  Upon internal review, the event glomerulonephritis membranous was determined to be medically significant.  Literature Report.
Sex: M
Vaccine: HEP
Symptoms: Biopsy kidney abnormal, Complement factor C3, Complement factor C4, Electrophoresis protein normal, Gait disturbance
Clinical narrative: Membranous nephropathy; This literature marketed report has been received from the authors of a published literature article, titled as stated below, concerning a 56-year-old male patient who was referred or a second opinion regarding MN.The patients medical history included colonoscopy and PSA with result of normal levels. Concurrent conditions and concomitant therapies were not reported.   On unknown date (reported as one month prior), the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength, dose, rout of administration, anatomical location, lot number, and expiration date were not reported).  On unknown date, the patient presented with joint pain and bilateral extremity paresthesias. He soon developed marked edema and hypertension, with over 20 lbs weight gain, associated with weakness and unsteady gait. He had taken NSAIDs for pain but no other medications. He was found to have 17 grams of proteinuria/24 hs and was diagnosed with nephrotic syndrome. His renal function was normal. Serological workup including C3/ C4, ANA, RF, ANCA, anti-GBM antibodies, hepatitis panel, SPEP, UPEP was negative. Renal biopsy showed membranous nephropathy (glomerulonephritis membranous). PLA2R was positive (1:40). Concomitantly, he was diagnosed with inflammatory demyelinating polyradiculopathy and was started on prednisone 60 milligram (mg) daily. Over the next several months he showed neurological improvement, and the steroid dose was titrated down. Proteinuria also improved (greater than 1g /24 hrs) and the nephrotic syndrome resolved. Repeat PLA2R levels have been negative.  The causal relationship between the suspect vaccine and the event was related.  Upon internal review, the event glomerulonephritis membranous was determined to be medically significant.  Literature Report.
Sex: M
Vaccine: HEP
Symptoms: Glomerulonephritis membranous, Guillain-Barre syndrome, Hepatitis viral test negative, Hypertension, Nephrotic syndrome
Clinical narrative: Membranous nephropathy; This literature marketed report has been received from the authors of a published literature article, titled as stated below, concerning a 56-year-old male patient who was referred or a second opinion regarding MN.The patients medical history included colonoscopy and PSA with result of normal levels. Concurrent conditions and concomitant therapies were not reported.   On unknown date (reported as one month prior), the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength, dose, rout of administration, anatomical location, lot number, and expiration date were not reported).  On unknown date, the patient presented with joint pain and bilateral extremity paresthesias. He soon developed marked edema and hypertension, with over 20 lbs weight gain, associated with weakness and unsteady gait. He had taken NSAIDs for pain but no other medications. He was found to have 17 grams of proteinuria/24 hs and was diagnosed with nephrotic syndrome. His renal function was normal. Serological workup including C3/ C4, ANA, RF, ANCA, anti-GBM antibodies, hepatitis panel, SPEP, UPEP was negative. Renal biopsy showed membranous nephropathy (glomerulonephritis membranous). PLA2R was positive (1:40). Concomitantly, he was diagnosed with inflammatory demyelinating polyradiculopathy and was started on prednisone 60 milligram (mg) daily. Over the next several months he showed neurological improvement, and the steroid dose was titrated down. Proteinuria also improved (greater than 1g /24 hrs) and the nephrotic syndrome resolved. Repeat PLA2R levels have been negative.  The causal relationship between the suspect vaccine and the event was related.  Upon internal review, the event glomerulonephritis membranous was determined to be medically significant.  Literature Report.
Sex: M
Vaccine: HEP
Symptoms: Oedema, Paraesthesia, Phospholipase A2 activity increased, Protein urine, Proteinuria
Clinical narrative: Membranous nephropathy; This literature marketed report has been received from the authors of a published literature article, titled as stated below, concerning a 56-year-old male patient who was referred or a second opinion regarding MN.The patients medical history included colonoscopy and PSA with result of normal levels. Concurrent conditions and concomitant therapies were not reported.   On unknown date (reported as one month prior), the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength, dose, rout of administration, anatomical location, lot number, and expiration date were not reported).  On unknown date, the patient presented with joint pain and bilateral extremity paresthesias. He soon developed marked edema and hypertension, with over 20 lbs weight gain, associated with weakness and unsteady gait. He had taken NSAIDs for pain but no other medications. He was found to have 17 grams of proteinuria/24 hs and was diagnosed with nephrotic syndrome. His renal function was normal. Serological workup including C3/ C4, ANA, RF, ANCA, anti-GBM antibodies, hepatitis panel, SPEP, UPEP was negative. Renal biopsy showed membranous nephropathy (glomerulonephritis membranous). PLA2R was positive (1:40). Concomitantly, he was diagnosed with inflammatory demyelinating polyradiculopathy and was started on prednisone 60 milligram (mg) daily. Over the next several months he showed neurological improvement, and the steroid dose was titrated down. Proteinuria also improved (greater than 1g /24 hrs) and the nephrotic syndrome resolved. Repeat PLA2R levels have been negative.  The causal relationship between the suspect vaccine and the event was related.  Upon internal review, the event glomerulonephritis membranous was determined to be medically significant.  Literature Report.
Sex: M
Vaccine: HEP
Symptoms: Renal function test normal, Rheumatoid factor negative, Serology negative, Weight increased
Clinical narrative: Membranous nephropathy; This literature marketed report has been received from the authors of a published literature article, titled as stated below, concerning a 56-year-old male patient who was referred or a second opinion regarding MN.The patients medical history included colonoscopy and PSA with result of normal levels. Concurrent conditions and concomitant therapies were not reported.   On unknown date (reported as one month prior), the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength, dose, rout of administration, anatomical location, lot number, and expiration date were not reported).  On unknown date, the patient presented with joint pain and bilateral extremity paresthesias. He soon developed marked edema and hypertension, with over 20 lbs weight gain, associated with weakness and unsteady gait. He had taken NSAIDs for pain but no other medications. He was found to have 17 grams of proteinuria/24 hs and was diagnosed with nephrotic syndrome. His renal function was normal. Serological workup including C3/ C4, ANA, RF, ANCA, anti-GBM antibodies, hepatitis panel, SPEP, UPEP was negative. Renal biopsy showed membranous nephropathy (glomerulonephritis membranous). PLA2R was positive (1:40). Concomitantly, he was diagnosed with inflammatory demyelinating polyradiculopathy and was started on prednisone 60 milligram (mg) daily. Over the next several months he showed neurological improvement, and the steroid dose was titrated down. Proteinuria also improved (greater than 1g /24 hrs) and the nephrotic syndrome resolved. Repeat PLA2R levels have been negative.  The causal relationship between the suspect vaccine and the event was related.  Upon internal review, the event glomerulonephritis membranous was determined to be medically significant.  Literature Report.
Age: 38.0
Sex: M
Vaccine: HPV9
Symptoms: Culture negative, Diarrhoea, Oropharyngeal pain, Pain, SARS-CoV-2 test negative
Clinical narrative: Sore throat started two days after and has lasted 2 weeks. Does not seem to get better.  Diarrhea and slight body aches as well.
Age: 38.0
Sex: M
Vaccine: HPV9
Symptoms: Sexually transmitted disease test, Streptococcus test negative
Clinical narrative: Sore throat started two days after and has lasted 2 weeks. Does not seem to get better.  Diarrhea and slight body aches as well.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash pruritic
Clinical narrative: PT DEVELOPED A BLISTER/SMALL RASH ON LEFT BUTTOCK DAY AFTER GETTING SHINGRIX SHOT, DESCRIBED RASH  AS BLISTER WITH RASH, ITCHY, MAYBE THE SIZE OF A DIME.  SHE REPORTS SINCE THEN THERE IS SOME IMPROVEMENT IN RASH BUT IT IS STILL THERE AND STILL ITCHY
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Acute disseminated encephalomyelitis, Albumin CSF normal, Anti-GAD antibody positive, Balance disorder, CSF cell count increased
Clinical narrative: Following 4/14/23 vaccination family reported patient remained more tired than usual thereafter. On 5/3 noted to have low grade temperatures (99s F) and some neck pain. On 5/4 developed unsteadiness/wobbly gate. Seen in ED but had some improvement so discharged to home. However developed fever and seen again in ED on 5/6 with ongoing unsteady gate. LP and MRI performed and findings concerning for ADEM. Treated with 5 days of solumedrol pulse with good clinical improvement.  Infectious and neuro evaluations undertaken with only major finding a positive anti-GAD cell based assay with high titer 1:1000. Patient now near baseline neurologic status.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: CSF culture, CSF glucose normal, CSF lymphocyte count increased, CSF protein normal, Demyelination
Clinical narrative: Following 4/14/23 vaccination family reported patient remained more tired than usual thereafter. On 5/3 noted to have low grade temperatures (99s F) and some neck pain. On 5/4 developed unsteadiness/wobbly gate. Seen in ED but had some improvement so discharged to home. However developed fever and seen again in ED on 5/6 with ongoing unsteady gate. LP and MRI performed and findings concerning for ADEM. Treated with 5 days of solumedrol pulse with good clinical improvement.  Infectious and neuro evaluations undertaken with only major finding a positive anti-GAD cell based assay with high titer 1:1000. Patient now near baseline neurologic status.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Enterovirus test, Fatigue, Gait disturbance, Infection, Inflammation
Clinical narrative: Following 4/14/23 vaccination family reported patient remained more tired than usual thereafter. On 5/3 noted to have low grade temperatures (99s F) and some neck pain. On 5/4 developed unsteadiness/wobbly gate. Seen in ED but had some improvement so discharged to home. However developed fever and seen again in ED on 5/6 with ongoing unsteady gate. LP and MRI performed and findings concerning for ADEM. Treated with 5 days of solumedrol pulse with good clinical improvement.  Infectious and neuro evaluations undertaken with only major finding a positive anti-GAD cell based assay with high titer 1:1000. Patient now near baseline neurologic status.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Lumbar puncture abnormal, Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal, Magnetic resonance imaging spinal abnormal
Clinical narrative: Following 4/14/23 vaccination family reported patient remained more tired than usual thereafter. On 5/3 noted to have low grade temperatures (99s F) and some neck pain. On 5/4 developed unsteadiness/wobbly gate. Seen in ED but had some improvement so discharged to home. However developed fever and seen again in ED on 5/6 with ongoing unsteady gate. LP and MRI performed and findings concerning for ADEM. Treated with 5 days of solumedrol pulse with good clinical improvement.  Infectious and neuro evaluations undertaken with only major finding a positive anti-GAD cell based assay with high titer 1:1000. Patient now near baseline neurologic status.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Neck pain, Pleocytosis, Pyrexia, Spinal cord injury, Viral test negative
Clinical narrative: Following 4/14/23 vaccination family reported patient remained more tired than usual thereafter. On 5/3 noted to have low grade temperatures (99s F) and some neck pain. On 5/4 developed unsteadiness/wobbly gate. Seen in ED but had some improvement so discharged to home. However developed fever and seen again in ED on 5/6 with ongoing unsteady gate. LP and MRI performed and findings concerning for ADEM. Treated with 5 days of solumedrol pulse with good clinical improvement.  Infectious and neuro evaluations undertaken with only major finding a positive anti-GAD cell based assay with high titer 1:1000. Patient now near baseline neurologic status.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: White matter lesion
Clinical narrative: Following 4/14/23 vaccination family reported patient remained more tired than usual thereafter. On 5/3 noted to have low grade temperatures (99s F) and some neck pain. On 5/4 developed unsteadiness/wobbly gate. Seen in ED but had some improvement so discharged to home. However developed fever and seen again in ED on 5/6 with ongoing unsteady gate. LP and MRI performed and findings concerning for ADEM. Treated with 5 days of solumedrol pulse with good clinical improvement.  Infectious and neuro evaluations undertaken with only major finding a positive anti-GAD cell based assay with high titer 1:1000. Patient now near baseline neurologic status.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: I had only slight soreness at the site of the injection on the day of injection. However, I woke up the next morning with sharp heel pain in my right heel. Symptoms were like classic plantar fascitis, but it went away after about 3 days. Now seems normal.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: PT called and reported radiating pain up left arm and back pain specifically in deltoid region which began days after receiving the vaccine. PT will schedule visit with doctor and possibly a neurologist. PT also reports tingling in arm and pinky finger
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Neck pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: PT called and reported radiating pain up left arm and back pain specifically in deltoid region which began days after receiving the vaccine. PT will schedule visit with doctor and possibly a neurologist. PT also reports tingling in arm and pinky finger
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Additional Details: pt called and complained that vaccine was given too high on her arm and she is feeling pain and swelling
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fall, Pallor, Visual impairment
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Pt was pale-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient received Boostrix Vaccine. He was instructed to sit for 15 minutes after the vaccination. After sitting for a few minutes, pt got up and started to walk towards his friend. He felt dizzy and fell, he stated he didnt get hurt. Pt got up, was walked to a chair and sat down. He looked pale and stated he cannot see. EMS was called, by the time EMS arrived pt felt and looked better. Pt was taken out by EMS.
Age: 0.75
Sex: M
Vaccine: FLU4, HEP
Symptoms: Body temperature increased, Febrile convulsion, Food refusal, Rash, Roseola
Clinical narrative: 2 hours after physical exam and 2 vaccines given, flu #2 and Hep B #3, child was at home, refused to feed and proceeded to have a febrile seizure, lasted 2-3 min, EMS arrived and noted T 102, afebrile before vaccines and exam 2 hours prior.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Chronic spontaneous urticaria, Laboratory test
Clinical narrative: Adverse effect:  Chronic Spontaneous Urticaria and Angioedema. (CSU/A).  First informed  it should last 3 months, then 6 months, then it may go into remission by Dr.  As of current day still experiencing CSU/A.   With medication of antihistamines, episode as recent as June 2, 2023, Angioedema episode.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension, Injection site pain, Loss of consciousness, Pain
Clinical narrative: Patient reports intense pain after injection, went to friends home and was having intense pain in shoulder of the injected arm, she "passed out" when trying to stand up from sitting position. Friend called EMS and EMT came to assess. EMT took her to the hospital because her BP was very high. She thinks could be from excitement or getting vaccine or a previous heart condition. Had no issues with first dose. She was assessed at the hospital emergency room and discharged several hours later.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Balance disorder, Chills, Confusional state, Decreased appetite
Clinical narrative: 60 hours of prolonged fever ranging from 100.5 to 102.9.  60 hours of watery diarrhea.  Shivers, aches in joints and muscles, nausea, loss of appetite, lethargy, unsteady on feet, night sweats, confusion, fatigue.  Mostly confined to bed and bathroom for 60 hours.  My fever broke early this morning (June 3, 2023) thus I'm able to complete this form.  I still have watery diarrhea and loss of appetite.  Still fatigued.  Walking short distances in the house wears me out.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Gait disturbance, Lethargy, Mobility decreased
Clinical narrative: 60 hours of prolonged fever ranging from 100.5 to 102.9.  60 hours of watery diarrhea.  Shivers, aches in joints and muscles, nausea, loss of appetite, lethargy, unsteady on feet, night sweats, confusion, fatigue.  Mostly confined to bed and bathroom for 60 hours.  My fever broke early this morning (June 3, 2023) thus I'm able to complete this form.  I still have watery diarrhea and loss of appetite.  Still fatigued.  Walking short distances in the house wears me out.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Night sweats, Pyrexia
Clinical narrative: 60 hours of prolonged fever ranging from 100.5 to 102.9.  60 hours of watery diarrhea.  Shivers, aches in joints and muscles, nausea, loss of appetite, lethargy, unsteady on feet, night sweats, confusion, fatigue.  Mostly confined to bed and bathroom for 60 hours.  My fever broke early this morning (June 3, 2023) thus I'm able to complete this form.  I still have watery diarrhea and loss of appetite.  Still fatigued.  Walking short distances in the house wears me out.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given vaccine that was expired one week. Unknown at time of vaccination. No adverse reaction at time of vaccination.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: Hives
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Developed tinnitus
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: EVERY SINCE I RECEIVED THE SHOT A MONTH LATER KEEP GETTING ITU INFECTIONS STILL UP TO THIS DAY 06/03/2023
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Malaise, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Breakthrough infection with sore throat, runny nose and general malaise, called my doctor and was prescribed Paxlovid, symptoms disappeared by fourth day.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccine breakthrough infection
Clinical narrative: Breakthrough infection with sore throat, runny nose and general malaise, called my doctor and was prescribed Paxlovid, symptoms disappeared by fourth day.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: Very sore upper arm in and around injection site extending 2-3 inches outward. Tired
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: VACCINE WAS GIVEN 1 DAY AFTER BEYOND USE DATE, NO ADVERSE EVENTS REPORTED, FOUND ON DOUBLE CHECK OF FORMS.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Slight fever (100.1), body aches, tiredness
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: The patient reports that 1 week after the administration of the vaccine, she presented redness, itching and swelling in different areas of the body (face, legs, arms and neck).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Anger, Blood glucose normal, Blood pressure decreased, Chills, Echocardiogram normal
Clinical narrative: *3rd IPV and 4th DtaP*  Patient received vaccines and was happy well appearing. He left and then was outside around the office near a playground and mom reported:   "45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called EMS but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. EMS was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since. "   On exam when he came to the office vital signs were stable with some decrease in the BP when he was in deep sleep before the epi was given. There was no rash/hives/wheezing. Did have swelling of his hands feet and some puffiness to his lips. No difficulty breathing. Back to baseline now per mom
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Electrocardiogram normal, Erythema, Feeling of body temperature change, Flushing, Headache
Clinical narrative: *3rd IPV and 4th DtaP*  Patient received vaccines and was happy well appearing. He left and then was outside around the office near a playground and mom reported:   "45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called EMS but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. EMS was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since. "   On exam when he came to the office vital signs were stable with some decrease in the BP when he was in deep sleep before the epi was given. There was no rash/hives/wheezing. Did have swelling of his hands feet and some puffiness to his lips. No difficulty breathing. Back to baseline now per mom
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Hypotonia, Lip swelling, Ocular hyperaemia, Peripheral swelling, Pruritus
Clinical narrative: *3rd IPV and 4th DtaP*  Patient received vaccines and was happy well appearing. He left and then was outside around the office near a playground and mom reported:   "45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called EMS but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. EMS was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since. "   On exam when he came to the office vital signs were stable with some decrease in the BP when he was in deep sleep before the epi was given. There was no rash/hives/wheezing. Did have swelling of his hands feet and some puffiness to his lips. No difficulty breathing. Back to baseline now per mom
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Pupillary disorder, Screaming, Slow speech, Sudden onset of sleep
Clinical narrative: *3rd IPV and 4th DtaP*  Patient received vaccines and was happy well appearing. He left and then was outside around the office near a playground and mom reported:   "45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called EMS but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. EMS was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since. "   On exam when he came to the office vital signs were stable with some decrease in the BP when he was in deep sleep before the epi was given. There was no rash/hives/wheezing. Did have swelling of his hands feet and some puffiness to his lips. No difficulty breathing. Back to baseline now per mom
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Anger, Chills, Consciousness fluctuating, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: *3rd IPV and 4th DtaP*  Patient received vaccines and was happy well appearing. He left and then was outside around the office near a playground and mom reported:   "45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called EMS but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. EMS was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since. "   On exam when he came to the office vital signs were stable with some decrease in the BP when he was in deep sleep before the epi was given. There was no rash/hives/wheezing. Did have swelling of his hands feet and some puffiness to his lips. No difficulty breathing. Back to baseline now per mom
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Feeling cold, Feeling hot, Flushing, Headache, Hyporesponsive to stimuli
Clinical narrative: *3rd IPV and 4th DtaP*  Patient received vaccines and was happy well appearing. He left and then was outside around the office near a playground and mom reported:   "45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called EMS but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. EMS was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since. "   On exam when he came to the office vital signs were stable with some decrease in the BP when he was in deep sleep before the epi was given. There was no rash/hives/wheezing. Did have swelling of his hands feet and some puffiness to his lips. No difficulty breathing. Back to baseline now per mom
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Hypotonia, Injection site erythema, Injection site pruritus, Miosis, Ocular hyperaemia
Clinical narrative: *3rd IPV and 4th DtaP*  Patient received vaccines and was happy well appearing. He left and then was outside around the office near a playground and mom reported:   "45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called EMS but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. EMS was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since. "   On exam when he came to the office vital signs were stable with some decrease in the BP when he was in deep sleep before the epi was given. There was no rash/hives/wheezing. Did have swelling of his hands feet and some puffiness to his lips. No difficulty breathing. Back to baseline now per mom
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Pruritus, Screaming, Slow speech, Snoring, Sudden onset of sleep
Clinical narrative: *3rd IPV and 4th DtaP*  Patient received vaccines and was happy well appearing. He left and then was outside around the office near a playground and mom reported:   "45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called EMS but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. EMS was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since. "   On exam when he came to the office vital signs were stable with some decrease in the BP when he was in deep sleep before the epi was given. There was no rash/hives/wheezing. Did have swelling of his hands feet and some puffiness to his lips. No difficulty breathing. Back to baseline now per mom
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Brain fog, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Severe headache that does not respond to Advil, muscle aches, chills,  fatigue, brain fog
Age: 24.0
Sex: F
Vaccine: COVID19-2, TDAP
Symptoms: Hypoacusis, Pallor, Syncope, Tension, Visual impairment
Clinical narrative: Patient fainted then as she came out of the faint her arms bent and were all tense for a minute she looked straight ahead unseeing, she was very pale. She stated everyone sounded really far away. After a minute she came back around drank some water and waited around for about 20 minutes stated she was fine and left.
Age: 81.0
Sex: F
Vaccine: PNC20, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Rash pustular
Clinical narrative: Patient describes rash, swelling, and tenderness at site of injection within the day after vaccination. Rash spread from injection site down approximately 2/3 of the way to the elbow. Patient also noticed some small bumps/pustules within the borders of the rash a couple of days after vaccination. Patient presented to pharmacy one week after vaccination, at which point rash was improved, but still visible and swelling gone.
Age: 81.0
Sex: F
Vaccine: PNC20, VARZOS, VARZOS
Symptoms: Acne, Chills, Erythema, Pain, Pruritus
Clinical narrative: Patient describes rash, swelling, and tenderness at site of injection within the day after vaccination. Rash spread from injection site down approximately 2/3 of the way to the elbow. Patient also noticed some small bumps/pustules within the borders of the rash a couple of days after vaccination. Patient presented to pharmacy one week after vaccination, at which point rash was improved, but still visible and swelling gone.
Age: 81.0
Sex: F
Vaccine: PNC20, VARZOS, VARZOS
Symptoms: Pustule, Pyrexia, Rash pustular
Clinical narrative: Patient describes rash, swelling, and tenderness at site of injection within the day after vaccination. Rash spread from injection site down approximately 2/3 of the way to the elbow. Patient also noticed some small bumps/pustules within the borders of the rash a couple of days after vaccination. Patient presented to pharmacy one week after vaccination, at which point rash was improved, but still visible and swelling gone.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: After vaccination, the patient explained that she had already received both doses of the Shingrix vaccine so she was mistakenly given a third dose on 6-3-23.  The patient thought that she needed to get the pneumonia and shingles vaccine on a yearly basis like the flu vaccine so she had scheduled the appt for the pneumonia and shingles vaccine for 6-3-23.  The pneumonia vaccine was not administered to the patient and was discarded by the pharmacist immediately after the pharmacist was informed by the patient.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pustule, Injection site rash, Injection site swelling
Clinical narrative: Patient describes rash, swelling, and tenderness at site of injection within the day after vaccination. Rash spread from injection site down approximately 2/3 of the way to the elbow. Patient also noticed some small bumps/pustules within the borders of the rash a couple of days after vaccination. Patient presented to pharmacy one week after vaccination, at which point rash was only slightly visible and swelling gone.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Nothing
Age: 47.0
Sex: F
Vaccine: HEPAB
Symptoms: Dyspnoea, Eye swelling, Lip swelling, Urticaria
Clinical narrative: Hives and slightly swollen lip.  One eye swollen.  Some shortness of breath.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Shivering, fatigue, loss of appetite, feverish
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient stated arm was really sore for a couple of days, and then started to get better, but after a few days started to hurt worse again. Vaccine given approximately 2 weeks ago, patient states it started hurting more recently. Stated no tenderness & no issues with shoulder, but that the muscle is sore.  Advised patient have it checked by his PCP. Unknown what he will do.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-