chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Caller reported PCP inadvertently ordered SHINGRIX that was then administered to a 33 year old patient who should have received VARIVAX.; Caller reported PCP inadvertently ordered SHINGRIX that was then administered to a 33 year old patient who should have received VARIVAX.   VARIVAX has not been administered as of time of call.  No other information reported.  No additional AEs or PQC; PCP inadvertently ordered SHINGRIX that was then administered to a 33 year old patient who should have received VARIVAX.; No additional AEs or PQC; This spontaneous report was received from a pharmacist and refers to a 33-year-old male patient.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  Caller reported that on an unspecified date, primary care physician (PCP) inadvertently ordered varicella zoster vaccine rge (cho) (SHINGRIX), that was then administered to a 33-year-old patient (strength, formulation, exact dose, lot #, expiry date, route of administration, and indication were not provided) who should have received varicella virus vaccine live (oka/merck) (VARIVAX) (strength, exact dose, lot #, expiry date, and route of administration were not provided) as prophylaxis (Product prescribing error; Wrong product administered). VARIVAX had not been administered as of time of call because was confused with SINGRIX (Product confusion). No other information reported. No additional adverse event or product quality complaint reported.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Skin discolouration
Clinical narrative: PT REPORTS SUPERFICIAL PINPOINT PURPLE RASH ON RIGHT UNDERARM; NO PAIN, NO ITCH; STATES RASH HAPPENED SHORTLY AFTER VACCINATION
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Fatigue. Injection became swollen, turgid, and red. Not alarming, but not a normal reaction to vaccine. 7 Pfizer, this is my first Moderna.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Blister, Injection site erythema, Product administered at inappropriate site
Clinical narrative: Tdap was given in the non-recommended site, bleb to the inside of inner right forearm, 9:30am, 2 hour post injection site looks like redness pt states no pain/ discomfort.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Patient reported that last time he had an IMZ administered at the pharmacy, he had pain in his shoulder/arm area that has not resolved since having IMZ injected. Last injection here was approximately 3 months ago and pt states pain is still not resolved. Pt reported he has spoke to his MD about this and was given anti-inflammatory medication (NSAID) to take. Pt stated he took the NSAID but it did not relieve pain and he still has it.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Feeling hot, Pruritus, Rash, Swelling
Clinical narrative: Redness, swelling, itchiness, warmth, rash
Age: 30.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Electrocardiogram, Fatigue, Feeling hot, Laboratory test
Clinical narrative: Donor left facility and around an hour after vaccination donor felt tired, weak, warm, facial swelling in lips, cheeks, and throat.
Age: 30.0
Sex: M
Vaccine: RAB
Symptoms: Lip swelling, Pharyngeal swelling, Swelling face
Clinical narrative: Donor left facility and around an hour after vaccination donor felt tired, weak, warm, facial swelling in lips, cheeks, and throat.
Age: 5.0
Sex: M
Vaccine: DTAP, DTAPIPV, MMR
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: Patient received a dose of Dtap and Dtap+ IPV.  Pt's parents notified 2 days after administration. Parent states patient has low grade fever
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Incorrect dose administered
Clinical narrative: Pt received adult dose instead of pediation dose (1440 EL.U/ml instead of 720 EL.U/mL. Pt's mother states that pt didn't have fever that she was aware of, but noticed she seemed tired.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Injection site rash
Clinical narrative: circular rash at injection site approximately 3" diameter
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram, Tinnitus
Clinical narrative: Ringing in ears-has been llong standing
Age: 80.0
Sex: F
Vaccine: HEPAB
Symptoms: Apathy, Head discomfort
Clinical narrative: Patient reported a feeling of pressure in her head, located at the top of her forehead and radiating all the way to the back of her skull. She also reported a feeling of lost desire to do anything, including move. This was just under 24 hours after receiving the vaccine. When questioned whether it was a headache, she stated no, it feels like constant pressure without any pain.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: patient fainted  for few seconds  while receiving shot. mom  was with the patient, refused  911 call. patient regained consciousness right away.  we had both mom and patient rest and advised if she doesn't feel good, see doctor right away
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Rash
Clinical narrative: Rash started on chest evening after vaccine. Has now spread to her upper arms and cheeks on face.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Mobility decreased
Clinical narrative: 8-10 hours after vaccination was found lying on the floor of his home unable to move.  He was hospitalized the same day and then was transferred about a week later to a long term care facility completely bed ridden.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Parkinson's disease
Clinical narrative: My Parkinsons symptoms increased and have not receded
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling abnormal, Loss of consciousness, Syncope
Clinical narrative: Pt was admitted  Gardasil  and Heplisav-B. During the administration of  Gardasil, Pt spaced out and fainted. Pt was placed on on the floor with both legs elevated and she regained consciousness. Pt declined 911 assistance but stated she would follow-up with her doctor.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Tachycardia
Clinical narrative: Hypertension  noted at home in end of April,  started documenting in early May.   Reached peak in mid May and seen in Urgent when also developed tachycardia.   Now BPs back to baseline without any intervention
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Blood test, Bone scan, Complex regional pain syndrome, Electric shock sensation, Electromyogram
Clinical narrative: Right foot injury on June 15,2021 causing Complex Regional Pain Syndrome (CRPS).  Symptoms have spread/transferred to left foot.  Symptoms  affect both feet to include, pins and needles, tingling, hypersensitivity, temperature changes, sensitivity to hot and cold, swelling, joint stiffness, electrical/lightning sensation, skin texture change, excessive perspiration, cold to the touch, color changes.  Treatment includes lumbar Sympathetic blocks, spinal cord stimulator, multiple medications, physical therapy, and aqua therapy.  Outcome no change in symptoms, confinement to wheelchair, CRPS.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Hyperhidrosis, Hypersensitivity, Joint stiffness, Limb injury, Nerve block
Clinical narrative: Right foot injury on June 15,2021 causing Complex Regional Pain Syndrome (CRPS).  Symptoms have spread/transferred to left foot.  Symptoms  affect both feet to include, pins and needles, tingling, hypersensitivity, temperature changes, sensitivity to hot and cold, swelling, joint stiffness, electrical/lightning sensation, skin texture change, excessive perspiration, cold to the touch, color changes.  Treatment includes lumbar Sympathetic blocks, spinal cord stimulator, multiple medications, physical therapy, and aqua therapy.  Outcome no change in symptoms, confinement to wheelchair, CRPS.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Paraesthesia, Peripheral coldness, Skin discolouration, Skin texture abnormal, Spinal nerve stimulator implantation
Clinical narrative: Right foot injury on June 15,2021 causing Complex Regional Pain Syndrome (CRPS).  Symptoms have spread/transferred to left foot.  Symptoms  affect both feet to include, pins and needles, tingling, hypersensitivity, temperature changes, sensitivity to hot and cold, swelling, joint stiffness, electrical/lightning sensation, skin texture change, excessive perspiration, cold to the touch, color changes.  Treatment includes lumbar Sympathetic blocks, spinal cord stimulator, multiple medications, physical therapy, and aqua therapy.  Outcome no change in symptoms, confinement to wheelchair, CRPS.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Swelling, Temperature intolerance, Wheelchair user, X-ray
Clinical narrative: Right foot injury on June 15,2021 causing Complex Regional Pain Syndrome (CRPS).  Symptoms have spread/transferred to left foot.  Symptoms  affect both feet to include, pins and needles, tingling, hypersensitivity, temperature changes, sensitivity to hot and cold, swelling, joint stiffness, electrical/lightning sensation, skin texture change, excessive perspiration, cold to the touch, color changes.  Treatment includes lumbar Sympathetic blocks, spinal cord stimulator, multiple medications, physical therapy, and aqua therapy.  Outcome no change in symptoms, confinement to wheelchair, CRPS.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: REDNESS, MILD PAIN AND ITCH
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Injection site very swollen, red, and hot in a 10" area for 3 days, receiver feels sick.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary mass, Fatigue, Pain, Pyrexia
Clinical narrative: Patient is experiencing fever, tiredness but more concerned about a lump under armpit that causing throbbing pain
Age: 72.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Abnormal dreams, Bone pain, Musculoskeletal pain, Night sweats, Pain in extremity
Clinical narrative: Patient reports that on the night the vaccines were received, 07/12/2024, he experienced bizarre vivid dreams. He states a similar occurrence transpired the last time that he received two vaccines in the same encounter, but to a lesser degree. He reports the following night, 07/13/2024, he experienced sweating. He reports having no adverse effects the following day and night, 07/14/2024; however, states on 07/15/2024 he experienced pain in his bones. He reports the pain originated in his left shoulder blade and subsequently moved down his arm and across his collar bone. He described it not as muscle pain, but a pain in the bones. He further stated that the pain dissipated from previous areas of effect as it moved to each new area and was gone later on in the day. He claims to have experienced pain in the collarbone area a couple of times since that day when he has a strong cough/sneeze. When asked if he had sought any medical help regarding the matter, patient reported he had not. He states he just recently underwent an echocardiogram and other imaging (as his doctor has previously suspected he may have Atrial Fibrillation or some other kind of arrhythmia). Encouraged patient to notify his doctor about the pone pain he has experienced in case there is some other cause and/or for management if the pain continues to be a burden.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lumbar puncture, Magnetic resonance imaging, Multiple sclerosis
Clinical narrative: Dizziness, vomiting, fatigue - MS diagnosis
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Dizziness, vomiting, fatigue - MS diagnosis
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity
Clinical narrative: Pain in Left , Lower Leg , back side from ankle to calf area.
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: pt reported that the morning after receiving a vaccine her arm was sore and in pain and she could barely use her arm due to the soreness
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Myocarditis
Clinical narrative: Myocarditis, consistent chest pains, dizzyness, fatigue, lightheadednsss. Still occuring. I am managing it with consistent cardio training.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC20, RV5
Symptoms: Computerised tomogram normal, Culture stool positive, Diarrhoea, Haematochezia, Intensive care
Clinical narrative: Fever developed within 2 hours of vaccines then vomiting and diarrhea.  After 6 continuous days of fever patient began to have bloody stools.  He was then found to have Yersinia Entercolitis as well as 5 areas of intussusception found which had to be surgically decompressed.  He was admitted to the hospital after emergency surgery and PICU admit.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC20, RV5
Symptoms: Intestinal operation, Intussusception, Laparotomy, Large intestinal obstruction reduction, Pyrexia
Clinical narrative: Fever developed within 2 hours of vaccines then vomiting and diarrhea.  After 6 continuous days of fever patient began to have bloody stools.  He was then found to have Yersinia Entercolitis as well as 5 areas of intussusception found which had to be surgically decompressed.  He was admitted to the hospital after emergency surgery and PICU admit.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC20, RV5
Symptoms: Ultrasound scan normal, Vomiting, Yersinia infection, Yersinia test positive
Clinical narrative: Fever developed within 2 hours of vaccines then vomiting and diarrhea.  After 6 continuous days of fever patient began to have bloody stools.  He was then found to have Yersinia Entercolitis as well as 5 areas of intussusception found which had to be surgically decompressed.  He was admitted to the hospital after emergency surgery and PICU admit.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Pallor, Retching, Vomiting
Clinical narrative: Patient napped for several hours after vaccine administration. She woke vomiting and dry-heaving, appearing pale.  She had 6 episodes of vomiting, prompting visit to the ED.   Vomiting had resolved at time of ED visit.  She was monitored but no other evaluation was needed. Discharged home with zofran in case vomiting returned.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Alopecia, Digital radiogram, Dizziness, Dyspnoea
Clinical narrative: Immediate right arm parasthesias radial nerve distribution, for 10 mins, light headed, short of breath, extreme fatigue, migraine headache and heart palpitations for remainder of day. Severe burning thoracic and sacral spinal pain and severe fatigue within a week progressing over the next month to full spinal pain/ stiffness, bilateral tennis elbow, tenosynovitis R hamstring and R shoulder, severely enlarged lymph nodes, hot flashes, restless leg syndrome, and psoriasis over 80% of scalp and some torso, moderate hairloss scalp, extreme weight loss
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Epicondylitis, Fatigue, Immediate post-injection reaction, Inflammatory marker increased, Lymphadenopathy
Clinical narrative: Immediate right arm parasthesias radial nerve distribution, for 10 mins, light headed, short of breath, extreme fatigue, migraine headache and heart palpitations for remainder of day. Severe burning thoracic and sacral spinal pain and severe fatigue within a week progressing over the next month to full spinal pain/ stiffness, bilateral tennis elbow, tenosynovitis R hamstring and R shoulder, severely enlarged lymph nodes, hot flashes, restless leg syndrome, and psoriasis over 80% of scalp and some torso, moderate hairloss scalp, extreme weight loss
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging joint, Magnetic resonance imaging spinal, Migraine, Musculoskeletal stiffness, Palpitations
Clinical narrative: Immediate right arm parasthesias radial nerve distribution, for 10 mins, light headed, short of breath, extreme fatigue, migraine headache and heart palpitations for remainder of day. Severe burning thoracic and sacral spinal pain and severe fatigue within a week progressing over the next month to full spinal pain/ stiffness, bilateral tennis elbow, tenosynovitis R hamstring and R shoulder, severely enlarged lymph nodes, hot flashes, restless leg syndrome, and psoriasis over 80% of scalp and some torso, moderate hairloss scalp, extreme weight loss
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Psoriasis, Radial nerve injury, Sacral pain, Spinal pain
Clinical narrative: Immediate right arm parasthesias radial nerve distribution, for 10 mins, light headed, short of breath, extreme fatigue, migraine headache and heart palpitations for remainder of day. Severe burning thoracic and sacral spinal pain and severe fatigue within a week progressing over the next month to full spinal pain/ stiffness, bilateral tennis elbow, tenosynovitis R hamstring and R shoulder, severely enlarged lymph nodes, hot flashes, restless leg syndrome, and psoriasis over 80% of scalp and some torso, moderate hairloss scalp, extreme weight loss
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Flank pain, Herpes zoster
Clinical narrative: Got shingles on the left flank side with excruciating pain, no rash
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Patient came into the pharmacy for her 2nd dose of SHINGRIX and she was experiencing redness, swelling, itchiness, warmth, and inflammation on the right arm UNDER the injection site. The actual injection site had bruising.  PSORIASIS FLARE UP WAS PRESENT AT THE TIME OF THE VACCINATION. VACCINATOR MADE SURE TO NOT ADMINISTER THE VACCINATION AT THE SITES OF THE PSORIASIS FLARES ON THE RIGHT ARM. SEVERAL CIRCULAR PSORIASIS FLARES CAN BE SEEN ON THE PATIENT TODAY WHEN THEY CAME INTO THE PHARMACY TO SHOW THE REDNESS, SWELLING, AND INFLAMMATION AT AND UNDER THE INJECTION SITE. BRUISING IS SEEN AT THE EXACT INJECTION SITE.        07-21-2024 12:00:50 PM SHINGRIX (SECOND DOSE): PATIENT CAME IN ON 7/21 AROUND 11:50 AM AND SHOWED HER RIGHT ARM WHICH IS SWOLLEN, RED, HOT, AND ITCHY, SHE ALSO HAS A BRUSE WHERE THE INJECTION WAS ADMINISTERED. I SUGGESTED TO THE PATIENT TO USE BENADRYL TABLETS FOR ITCHING AND THE REDNESS IF SHE IS GOING TO BE AT HOME BECAUSE IT WILL MAKE HER SLEEPY AND SHE CAN USE HC 1% OTC CREAM AND ALTERNATE WITH BENADRLY CREAM TO GET THE REDNESS AND INFLAMMATION DOWN. TOLD HER IF IT GETS WORSE TO WHERE SHE HAS A FEVER, NOT FELLING WELL, AND IF THE REDNESS AND PAIN ARE SPREADING TOO SEEK MEDICAL ATTENTION TO GET AN ABX.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient came into the pharmacy for her 2nd dose of SHINGRIX and she was experiencing redness, swelling, itchiness, warmth, and inflammation on the right arm UNDER the injection site. The actual injection site had bruising.  PSORIASIS FLARE UP WAS PRESENT AT THE TIME OF THE VACCINATION. VACCINATOR MADE SURE TO NOT ADMINISTER THE VACCINATION AT THE SITES OF THE PSORIASIS FLARES ON THE RIGHT ARM. SEVERAL CIRCULAR PSORIASIS FLARES CAN BE SEEN ON THE PATIENT TODAY WHEN THEY CAME INTO THE PHARMACY TO SHOW THE REDNESS, SWELLING, AND INFLAMMATION AT AND UNDER THE INJECTION SITE. BRUISING IS SEEN AT THE EXACT INJECTION SITE.        07-21-2024 12:00:50 PM SHINGRIX (SECOND DOSE): PATIENT CAME IN ON 7/21 AROUND 11:50 AM AND SHOWED HER RIGHT ARM WHICH IS SWOLLEN, RED, HOT, AND ITCHY, SHE ALSO HAS A BRUSE WHERE THE INJECTION WAS ADMINISTERED. I SUGGESTED TO THE PATIENT TO USE BENADRYL TABLETS FOR ITCHING AND THE REDNESS IF SHE IS GOING TO BE AT HOME BECAUSE IT WILL MAKE HER SLEEPY AND SHE CAN USE HC 1% OTC CREAM AND ALTERNATE WITH BENADRLY CREAM TO GET THE REDNESS AND INFLAMMATION DOWN. TOLD HER IF IT GETS WORSE TO WHERE SHE HAS A FEVER, NOT FELLING WELL, AND IF THE REDNESS AND PAIN ARE SPREADING TOO SEEK MEDICAL ATTENTION TO GET AN ABX.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: Moderately sore left arm, headache  for a week; on day 4 had a large itchy, welt behind left knee; the next day maculopapular rash developed behind left knee, turned vesicular the next day and was extremely itchy; new 'spots' developed approximately every 24 hours on both legs (posterior only); now have numerous vesicular rashes on the backs of both calves, thighs and lower gluteal area; new spots continue to develop but don't seem as severe (so far).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Urticaria
Clinical narrative: Moderately sore left arm, headache  for a week; on day 4 had a large itchy, welt behind left knee; the next day maculopapular rash developed behind left knee, turned vesicular the next day and was extremely itchy; new 'spots' developed approximately every 24 hours on both legs (posterior only); now have numerous vesicular rashes on the backs of both calves, thighs and lower gluteal area; new spots continue to develop but don't seem as severe (so far).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Chest discomfort, Condition aggravated, Wheezing
Clinical narrative: I often get reactions to vaccines (fever, aches, fatigue), but about 14 hours after the vaccination, I woke up wheezing and feeling some chest tightness. I do have mild asthma, so I used my albuterol inhaler. I usually only use it about once a month. It helped, and I was able to go back to sleep. I had to use the inhaler again later in the evening (still July 20th). Today, (the 21st) the chest tightness and wheezing are gone.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Immunisation reaction, Pain, Swelling
Clinical narrative: PATIENT DEVELOPED ADVERSE REACTION THE NEXT DAY AFTER THE SHINGRIX VACCINE 2ND DOSE.IT WAS REDDISH,SWOLLEN AND VERY TENDER AND PAINFUL. FOR 3 DAYS.WENT TO ER AND WAS DIAGNOSED WITH CELLULITIS AND PRESCRIBED ANTIBIOTICS
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: PATIENT DEVELOPED ADVERSE REACTION THE NEXT DAY AFTER THE SHINGRIX VACCINE 2ND DOSE.IT WAS REDDISH,SWOLLEN AND VERY TENDER AND PAINFUL. FOR 3 DAYS.WENT TO ER AND WAS DIAGNOSED WITH CELLULITIS AND PRESCRIBED ANTIBIOTICS
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient had redness and swelling on upper arm.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Cough, Decreased appetite, Nasopharyngitis, Weight decreased
Clinical narrative: Day after: no energy, cold symptoms, cough, and no appetite. Continued for 3 days.  Lost 8 pounds. used Coricedine
Age: 71.0
Sex: F
Vaccine: HEPAB
Symptoms: Device issue, Syringe issue
Clinical narrative: syringe malfunction.   plunger would not move
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of the Right upper arm
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Vaccine caused mild rash/itching around neck which had already started to resolve when patient came in. Recommended benadryl if needed.
Age: 50.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient arrived at the pharmacy today and mentioned she experienced a reaction after being administered two vaccines, Heplisav-b and Shingrix.  Patient stated she feels heat, itching, pain and swelling and redness at/near the injection site.  Both injections were administered into the same arm, left arm.  Patient also stated the affected area started small and grew in size.  Patient stated she has a lot of itching at the site.  patient stated she has an appointment to see her pcp  tomorrow 7/21/24
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fear, Hypoaesthesia, Peripheral coldness
Clinical narrative: Numbness in all 10 toes and cold feet. After second dose numbness and tingling spread to half of my both feet.  Never got the booster doses in fear of having the entire both feet numb. No sigs of color change.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Fatigue, Product administered to patient of inappropriate age
Clinical narrative: feeling a little tired but otherwise nothing out of the ordinary".; decreased appetite; Nurse called and reported that 1 dose of the adult formulation of VAQTA was inadvertently administered to a 12 year old patient instead of the pediatric formulation. Caller stated the provider realized 2 days later and spoke to the patient's mom who; This spontaneous report has been received from a nurse, regarding to a 12-year-old male patient. His concurrent conditions included Food allergy (nuts and shellfish). The patient's pertinent medical history, concomitant medications, and previous drug reactions were not reported.   On 08-JUN-2024, the patient was inadvertently vaccinated with an adult dose (1,0 milliliter) (Incorrect dose administered) of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered intramuscularly (IM), as immunization, lot number X006702 which has been verified to be valid, expiration date reported and validated as 01-OCT-2024.   On 10-JUN-2024, the patient feeling a little tired but otherwise nothing out of the ordinary (fatigue) and experienced decreased appetite. At the time of the report, the patient had not recovered from the aforementioned events.   The causality assessment between the events and the suspect vaccine was not provided.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; PROQUAD was inadvertently administered to 18 year old; This spontaneous report was received from a medical assistant referring to an 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 26-JUN-2024, the patient was inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, single dose, administered by a health professional for prophylaxis (lot # X025093, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 16-APR-2025; strength, route of administration, and anatomical location were not provided) (product administered to patient of inappropriate age). No product confusion. Per reporter, she believed administration was "due to human error, that medical assistant (MA) didn't know it was for ages 12 and under". The patient had no previous measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccination. No other information was provided. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller stated no patient symptoms have been reported.; HBP called and reported a dose of ROTATEQ was administered to a patient after the product was involved in a temperature excursion. Caller stated no patient symptoms have been reported. Caller also provided information for additional patients who rece; This spontaneous report has been received from a health business professional (HBP) an office manager (other) referring to a patient of unknown age and gender.  The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 23-MAY-2024, 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid was administered as prophylaxis (dose, route, vaccine scheme were not reported; lot number 1975783, has been verified to be valid, expiration date reported and established as 12-OCT-2024); the vaccine was administered after it was involved in a temperature excursion at 8.94 degree Celsius (C) for a time frame of hours 30 minutes and 0 seconds (Improper storage of product in use). There was not previous temperature excursions. Caller stated no patient symptoms have been reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2407USA003806: US-009507513-2407USA003825:
Age: 50.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical Assistant has no further AE details; Medical Assistant called to report that a 50 year old female patient received a dose of PROQUAD today 7/8/2024. Medical Assistant gives permission to contact. Medical Assistant has no further AE details. No PQC reported.; This spontaneous report has been received from a medical assistant (Other Health Professional) and refers to a 50-year-old female patient.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 08-JUL-2024, at the age of 50-year-old (Product administered to patient of inappropriate age) the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (rHA) (PROQUAD) injection 0.5 ml once as prophylaxis (route, vaccine scheme were not provided; lot number X020565 has been verified to be valid, expiration reported and established as 03-FEB-2025). No further adverse event (AE details) were provided (no adverse event).
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; patient got a dose last year he missed his second and third dose uh he just got his second dose this year, about a year later and we were wondering about if he should get another dose or another two doses.; This spontaneous report was received from a pharmacist regarding a male patient of unspecified age. His pertinent medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2023 (reported as last year), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided).  However, the patient missed his second and third dose as scheduled, and had just received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided) on an unspecified date in 2024 (reported as about a year later) (Inappropriate schedule of vaccine administered). So the pharmacist was wondering he should get another dose or another two doses. No additional adverse events or product quality complaints reported.
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no AE; Nurse called and reported that a 2-month-old consumer was inadvertently administered PNEUMOVAX 23 instead of PREVNAR 20 as prescribed. No additional AE reported. No PQC reported. No additional information provided.; Nurse called and reported that a 2-month-old consumer was inadvertently administered PNEUMOVAX 23 instead of PREVNAR 20 as prescribed. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report was received from a nurse and referred to a 2-month-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-JUL-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #X014729, expiration date: 22-NOV-2024, administered for prophylaxis (strength, dose and route of administration were not provided) instead of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) as prescribed (Product administered to patient of inappropriate age and Wrong product administered). There was no additional adverse event.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event; Medical Assistant calling to report adverse event regarding VARIVAX administered after the expiration date.  Medical Assistant stated that a dose of VARIVAX with a labeled expiration date of 4/12/2024 was administered on 4/23/2024.  Medical Assistant; This spontaneous report was received from medical assistant and refers to a 7-year-old patient of unknown gender. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On 23-APR-2024, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter/ two doses series, lot #w012167, expiration date: 12-APR-2024, (who had been verified to be a valid lot number) administered for prophylaxis (strength, and anatomical route of administration were not provided) (Expired product administered).   Medical Assistant confirmed that the patient involved had not reported any medical concerns or symptoms after the administration of the expired dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; Improper storage of product in use; This spontaneous report was received from a Physician and a Medical Assistant, referred to a 4-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  From 22-APR-2024, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection (lot #W028734, expiration date: 08-SEP-2024); varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #X018954, expiration date: 13-JUL-2025); and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) (lot # 34MF9, expiration date: 13-FEB-2026) were underwent a temperature excursion. No previous temperature excursion.  On 11-JUN-2024, the improperly stored vaccines were administered to the patient for prophylaxis (measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) at left arm; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) at right arm) (strength, dose and route of administration were not provided) (product storage error). No additional adverse events (AEs).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; Vaccines were adminstered to an unknown number of patients after being exposed to multiple temperature excursions; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient.  The patient's pertinent medical history and drug reactions/ allergies and concomitant medication were not reported.  On 23-APR-2024, the patient  was vaccinated with improper storage first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #w028734, expiration date: 08-SEP-2024, administered in the left thigh for prophylaxis (strength, dose and route of administration were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #x010531, expiration date: 11-APR-2025, administered in the left thigh for prophylaxis (strength, dose and route of administration were not provided); and  diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), lot #5AY2J, expiration date: 10-JUN-2024, administered in the right thigh for prophylaxis (strength, dose, formulation, and route of administration were not provided) at the private doctor's office/hospital (Product storage error). The temperature excursion occurred as a result of a reading from a Digital Data Logger. No prior temperature excursions but multiple current temperature excursions. It was reported that 16 different excursions began on 22-APR-2024 but were identified "last week" between 10-JUN-2024 to 14-JUN-2024. No additional adverse event (AE) was reported (No adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2406USA005882:
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received First Dose of 3 Dose Series in 2012, and Received First Dose of Heplisav-B In 2024; Interchange of vaccine products; Initial report received on 28-Jun-2024.  A medical assistant reported that a 26-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after having received one dose of a three-dose series.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 31-Oct-2012, the patient received the first dose of a three-dose unknown hepatitis B vaccine (lot #, expiration date, and NDC # not reported). On 22-May-2024, the patient received the second dose of a hepatitis B vaccine, HEPLISAV-B (lot # 944608, expiration 27-Jan-2026, and NDC # 43528-002-01) in the left deltoid (route not reported). As of the date of reporting, the patient has not received the next dose of HEPLISAV-B.  No adverse reactions were reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Pharmacist reports a nurse administered a dose of Boostrix to a patient by IV route instead of IM; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 33-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number Z7L7H, expiry date 09-AUG-2026) for prophylaxis.   On 10-JUL-2024, the patient received Boostrix (intravenous). On 10-JUL-2024, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Pharmacist reports a nurse administered a dose of Boostrix to a patient by IV route instead of IM). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 10-JUL-2024 The pharmacist reported that the nurse administered a dose of Boostrix to a patient by intravenous route instead of intramuscular, which led to intramuscular formulation administered by other route. She stated that the patient was fine.  The reporter was unsure of the location of the intravenous site. No product quality complaint was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Myalgia
Clinical narrative: Headache; Upset stomach; Muscle aches; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-JUL-2024, the patient received the 2nd dose of Shingrix (left arm). In JUL-2024, less than a week after receiving Shingrix, the patient experienced headache (Verbatim: Headache), upset stomach (Verbatim: Upset stomach), muscle pain (Verbatim: Muscle aches) and chills (Verbatim: Chills). The outcome of the headache, upset stomach, muscle pain and chills were not resolved.   It was unknown if the reporter considered the headache, upset stomach, muscle pain and chills to be related to Shingrix.     It was unknown if the company considered the headache, upset stomach, muscle pain and chills to be related to Shingrix.   Additional Information: GSK receipt date: 10-JUL-2024 The patient received second dose of Shingrix one day before reporting date and reported in the middle of the last night and he experienced chills, muscle aches, upset stomach and headache. The patient still experiencing all of these adverse events this morning. The patient did not receive any paperwork from the physician's office that administered the vaccine and could not provide lot/expiry/ndc/route of administration for the vaccine.  The patient had reported all that was provided about these adverse events.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: an expired Bexsero was administered to a patient on July 10, 2024 that expired on March 31, 2024.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (expiry date 31-MAR-2024) for prophylaxis.   On 10-JUL-2024, the patient received Bexsero. On 10-JUL-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: an expired Bexsero was administered to a patient on July 10, 2024 that expired on March 31, 2024.). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-JUL-2024 The patient received an expired dose of Bexsero, which led to expired vaccine used. Lot was not available. No patient demographics were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed dose/he has never completed the series for Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in May 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: missed dose/he has never completed the series for Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 10-JUL-2024 Minimal information obtained to file adverse event.  Till the time of reporting,, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix late second dose since it is more than 3 years apart; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received first dose on 24th February 22021 and he did not had any complications after the first dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix late second dose since it is more than 3 years apart). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 10-Jul-2024 The patient's pharmacist told him about a 70 percent of effectiveness. The patient wants to know about effectiveness of Shingrix late second dose since it was more than 3 years apart. Till the time of reporting, the patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: vaccine reconstituted and stored outside recommended conditions; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: vaccine reconstituted and stored outside recommended conditions). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-JUL-2024 The pharmacist reported that they were wondering about the Boostrix vaccine how long it was good for, once it had been out of the refrigerator and drawn up. Medical information agent confirmed with health care professional that any patient had been administered with this vaccine, therefore no patient's data were collected, which led to incorrect storage of drug. Lot number was not provided.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Intramuscular administration of Priorix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 36-year-old female patient who received MMR (Priorix) (batch number BL452, expiry date 17-DEC-2024), (batch number 922S5, expiry date 17-DEC-2024) and (batch number 7D755, expiry date 17-DEC-2024) for prophylaxis.   On 10-JUL-2024, the patient received Priorix (intramuscular). On 10-JUL-2024, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Intramuscular administration of Priorix). The outcome of the subcutaneous injection formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-JUL-2024 The pharmacy officer reported that the administration of a Priorix vaccine intramuscularly to a patient (demographics detail provided in the boxes enlisted above of this report), which led to subcutaneous injection formulation administered by other route.  He knows that as package insert said that it had to be administered subcutaneously, he wants to know if there was any adverse event related, if they have to re vaccinate or there was any guidance about this, and also if there was a decrease in efficacy or something like that. No further detail was provided from the pharmacy officer. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: COVID19
Symptoms: Nonspecific reaction
Clinical narrative: BAD REACTION; This spontaneous report received from a J&J managed social media site concerned a patient of unspecified age and sex, reporting self. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, and dose, start therapy date were not reported (dose series 8) for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Patient was vaccinated about 8 times. On an unspecified date, the patient experienced bad reaction (dose series 8). The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of bad reaction was not reported. This report was non-serious.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ventricular extrasystoles
Clinical narrative: Premature ventricular contractions for 33 days. Continuing.