chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUC3
Symptoms: Anal rash, Haematochezia, Hypersensitivity
Clinical narrative: Microscopic blood in stool; Rashes around anus; Allergic reactions; This spontaneous case was received on 24-Oct-2023 from a other non-healthcare professional (patient's father) (reference number: SEQW23-03709) and concerned a male patient of unreported age.  The patient's concurrent conditions included allergic to potato, corn, and other foods. The patient was not taking any concomitant medication.  On 10-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for influenza immunization. The batch number was not reported.  On an unspecified date in Oct-2023, reported as within a few days of the shot, after receiving Flucelvax Quadrivalent, the patient was having allergic reactions. Microscopic blood was found in the patient's stool and rashes developed around the anus.   The outcome of the events 'blood in stool', 'anal rash' and 'allergic reaction' was not reported.  The reporter did not provide a causality assessment. The patient had prior history of allergy, but it was not sure if the present one was related to the vaccine.  The events of 'blood in stool', 'anal rash' and 'allergic reaction', were considered to be medically significant by a Physician within Pharmacovigilance Department.  This case is linked to 202305513 (the same reporter).  Company comment: A patient was vaccinated with Flucelvax Quadrivalent. As reported, within a few days after vaccination, the patient was having allergic reaction. Microscopic blood was found in the patient's stool and rashes developed around the anus. Information regarding relevant laboratory findings and diagnostic data was not provided. The patient's concurrent conditions included allergic to potato, corn, and other foods. The patient was not taking any concomitant medication. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events hypersensitivity, haematochezia and anal rash with the currently available information and chronological plausibility.; Reporter's Comments: The patient had prior history of allergy, but it was not sure if the present one was related to the vaccine.; Sender's Comments: A patient was vaccinated with Flucelvax Quadrivalent. As reported, within a few days after vaccination, the patient was having allergic reaction. Microscopic blood was found in the patient's stool and rashes developed around the anus. Information regarding relevant laboratory findings and diagnostic data was not provided. The patient's concurrent conditions included allergic to potato, corn, and other foods. The patient was not taking any concomitant medication. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events hypersensitivity, haematochezia and anal rash with the currently available information and chronological plausibility.
Sex: M
Vaccine: FLUC3
Symptoms: Anal rash, Haematochezia, Hypersensitivity
Clinical narrative: Microscopic blood in stool; Rashes around anus; Allergic reactions; This spontaneous case was received on 24-Oct-2023 from a other non-healthcare professional (patient's father) (reference number: SEQW23-03709) and concerned a male patient of unreported age.  The patient's concurrent conditions included allergic to potato, corn, and other foods. The patient was not taking any concomitant medication.  On 18-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for influenza immunization. The batch number was not reported.  On an unspecified date in Oct-2023, reported as within a few days of the shot, after receiving Flucelvax Quadrivalent, the patient was having allergic reactions. Microscopic blood was found in the patient's stool and rashes developed around the anus.   The outcome of the events 'blood in stool', 'anal rash' and 'allergic reaction' was not reported.  The reporter did not provide a causality assessment. The patient had prior history of allergy, but it was not sure if the present one was related to the vaccine.  The events of 'blood in stool', 'anal rash' and 'allergic reaction' were considered to be medically significant by a Physician within Pharmacovigilance Department.  This case is linked to 202305512 (the same reporter).  Company comment: A patient was vaccinated with Flucelvax Quadrivalent. As reported, within a few days after vaccination, the patient was having allergic reaction. Microscopic blood was found in the patient's stool and rashes developed around the anus. Information regarding relevant laboratory findings and diagnostic data was not provided. The patient's concurrent conditions included allergic to potato, corn, and other foods. The patient was not taking any concomitant medication. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events hypersensitivity, haematochezia and anal rash with the currently available information and chronological plausibility.; Reporter's Comments: The patient had prior history of allergy, but it was not sure if the present one was related to the vaccine.; Sender's Comments: A patient was vaccinated with Flucelvax Quadrivalent. As reported, within a few days after vaccination, the patient was having allergic reaction. Microscopic blood was found in the patient's stool and rashes developed around the anus. Information regarding relevant laboratory findings and diagnostic data was not provided. The patient's concurrent conditions included allergic to potato, corn, and other foods. The patient was not taking any concomitant medication. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events hypersensitivity, haematochezia and anal rash with the currently available information and chronological plausibility.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired vaccine. Vaccine expired 10/28/2023. No known adverse effects.
Age: 77.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became swollen, red, and hot to the touch. This developed within a few hours of injection. Redness was present in a large area approximately 4inx4in.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Injection site rash, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: same day-- sore arm-- that nite-- fever, chills--next am-- hives, rash, itchy-- rash from  R shoulder to wrist  -  around R scapula, neck area. 50 mg benedryl q6hrs. for 5 days before s/sy were gone.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Rash, Urticaria
Clinical narrative: same day-- sore arm-- that nite-- fever, chills--next am-- hives, rash, itchy-- rash from  R shoulder to wrist  -  around R scapula, neck area. 50 mg benedryl q6hrs. for 5 days before s/sy were gone.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Product administration error, Wrong product administered
Clinical narrative: No adverse reactions noted. Pt was given Tdap inadvertently, mom reports no side effects other than the common pain at the site of injection. Pt was ordered Dtap and fail to administer.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: On 10/11/2023 another Tdap was inadvertently given as a result of an electronic uploading error. Tdap (Boostrix - GlaxoSmithKline) 9HR72 IM R. Delt.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site plaque, Injection site rash, Injection site warmth
Clinical narrative: Patient developed warm red plaque on left upper arm around injection sites.  One site also had a small 0.75 x 0.75 in bruise.  The red plaque is irregular and 3.5" x 4.5" at its maximum.   There was also a small tender enlarged lymph node in his left axilla.  The initial arm pain had been decreasing and on the day of visit he had developed increased arm pain. He was treated for possible infection with Cephalexin 825 mg BID x 7-10 days.  12 hours later the arm was less tender but rash slightly larger at proximal side but less red at distal part.  By 5 days, his arm was nearly back to normal in appearance, just bruising persisited.   Never had fevers.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Patient developed warm red plaque on left upper arm around injection sites.  One site also had a small 0.75 x 0.75 in bruise.  The red plaque is irregular and 3.5" x 4.5" at its maximum.   There was also a small tender enlarged lymph node in his left axilla.  The initial arm pain had been decreasing and on the day of visit he had developed increased arm pain. He was treated for possible infection with Cephalexin 825 mg BID x 7-10 days.  12 hours later the arm was less tender but rash slightly larger at proximal side but less red at distal part.  By 5 days, his arm was nearly back to normal in appearance, just bruising persisited.   Never had fevers.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Patient described a shooting pain down to her elbow immediately after administration. Patient called the pharmacy the next day to report pain continued intermittently up to 5 times per day since receiving vaccine. RPh advised patient to contact PCP with any concerns. RPh called patient 11/1/23, patient reported issue resolved.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Dysphonia, Dyspnoea, Headache, Injection site discomfort, Injection site erythema
Clinical narrative: Redness, swelling, warmness at injection site for about 4 weeks. Felt lethargic, shortness of breath, headaches, itching in feet and hands, pain in feet, body aches, hoarseness and scratchy throat, and at 4 week mark came down with 101 fever on and off for 72 hours. Shoulder has had increasing pain and discomfort since swelling went down. On October 19th 2023 went back to see Physician about increasing pain in shoulder that was preventing me from normal activities and sleeping well.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Lethargy, Loss of personal independence in daily activities
Clinical narrative: Redness, swelling, warmness at injection site for about 4 weeks. Felt lethargic, shortness of breath, headaches, itching in feet and hands, pain in feet, body aches, hoarseness and scratchy throat, and at 4 week mark came down with 101 fever on and off for 72 hours. Shoulder has had increasing pain and discomfort since swelling went down. On October 19th 2023 went back to see Physician about increasing pain in shoulder that was preventing me from normal activities and sleeping well.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Poor quality sleep, Pruritus, Pyrexia
Clinical narrative: Redness, swelling, warmness at injection site for about 4 weeks. Felt lethargic, shortness of breath, headaches, itching in feet and hands, pain in feet, body aches, hoarseness and scratchy throat, and at 4 week mark came down with 101 fever on and off for 72 hours. Shoulder has had increasing pain and discomfort since swelling went down. On October 19th 2023 went back to see Physician about increasing pain in shoulder that was preventing me from normal activities and sleeping well.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Throat irritation, X-ray limb normal
Clinical narrative: Redness, swelling, warmness at injection site for about 4 weeks. Felt lethargic, shortness of breath, headaches, itching in feet and hands, pain in feet, body aches, hoarseness and scratchy throat, and at 4 week mark came down with 101 fever on and off for 72 hours. Shoulder has had increasing pain and discomfort since swelling went down. On October 19th 2023 went back to see Physician about increasing pain in shoulder that was preventing me from normal activities and sleeping well.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site papule, Subcutaneous haematoma
Clinical narrative: hyperpigmented papule at injection site; ~0.25 cm diameter hematoma under skin
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Disturbance in attention, Echocardiogram, Headache
Clinical narrative: Had numbness weakness on the entire right side head to toe. Head aches , could not concentrate on anything.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hemiparesis, Hypoaesthesia, Laboratory test, Magnetic resonance imaging, Scan myocardial perfusion
Clinical narrative: Had numbness weakness on the entire right side head to toe. Head aches , could not concentrate on anything.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Ear discomfort, Fatigue, Hypoacusis, Insomnia
Clinical narrative: (from notes at the time)- ~ immediate "awareness", but not "pain" Fri night (vax day) 5/7/21 -  restless, no/poor sleep Sat - tired Sat night  5/8/21- muffled hearing Monday AM 5/10/21 - ~dizzy, but not vertigo; stuffy ears - "pressure", muffled hearing Present - symptoms continue to this day
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Poor quality sleep, Restlessness
Clinical narrative: (from notes at the time)- ~ immediate "awareness", but not "pain" Fri night (vax day) 5/7/21 -  restless, no/poor sleep Sat - tired Sat night  5/8/21- muffled hearing Monday AM 5/10/21 - ~dizzy, but not vertigo; stuffy ears - "pressure", muffled hearing Present - symptoms continue to this day
Age: 37.0
Sex: F
Vaccine: JEV1
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, soreness
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Cellulitis, Chills, Discomfort, Erythema, Malaise
Clinical narrative: My arm got hot, red and swollen. I had significant chills and felt very ill. My physical therapist saw my arm and told me to have it checked ASAP. The next morning I told my nurse practitioner that it was still red and swollen on day four and seemed to be getting worse and spreading further down my arm. I was also in a great deal of discomfort. She examined it and explained that I had developed cellulitis .  I was put on a course of antibiotics which appears to have cleared the infection although I am continuing to have pain in the upper arm.  I have a follow up tomorrow.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: My arm got hot, red and swollen. I had significant chills and felt very ill. My physical therapist saw my arm and told me to have it checked ASAP. The next morning I told my nurse practitioner that it was still red and swollen on day four and seemed to be getting worse and spreading further down my arm. I was also in a great deal of discomfort. She examined it and explained that I had developed cellulitis .  I was put on a course of antibiotics which appears to have cleared the infection although I am continuing to have pain in the upper arm.  I have a follow up tomorrow.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Hyperhidrosis, Pallor, Posture abnormal, Presyncope
Clinical narrative: patient felt weak after shot and sat down. was pale and on walking back to exam room, slumped to floor (gently lowered by staff). awake and interactive upon lying down. recovered completely after 30 minutes. had diaphoresis. no diff breathing. had not eating for 9 hours before shot. able to eat and drink. vitals stable. event c/w vasovagal episode
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Chondrocalcinosis, Condition aggravated
Clinical narrative: Acute flare of pseudogout in right wrist (calcium pyrophosphate).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swollen tongue, Throat irritation
Clinical narrative: ITCHING ON BODY, THROAT AND TONGUE SWELLING
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site mass, Pain, Pyrexia
Clinical narrative: Fever, fatigue, red swollen bulge at injection site 2 in diameter, pain. Gave ibuprofen.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Chondropathy, Impaired work ability, Injected limb mobility decreased
Clinical narrative: The vaccine was given at about 9:00 a.m. and the patient developed increasingly severe pain starting at about 5:00 p.m. on the same day.  The patient stated that the injection site was higher than usual on her left lateral arm and shoulder area.  She was awakened at 5:00 a.m. on 09/21/2022 with severe left shoulder pain.  She has had ongoing pain and restricted shoulder range of motion since then .  She had tried to continue working in spite of the shoulder pain, but the condition of the shoulder is worsened and she has had to stop working starting in early September of 2023 because of the inability to work with her left hand.  She works as a certified nursing assistant and the vaccine was given as a part of a requirement for her job at the hospital. she was referred to an orthopedic surgeon, MD who recommended surgery for her shoulder. Surgery has not been accomplished because of insurance issues resulting from the workers' compensation insurance refusing to accept the vaccination as the cause of the shoulder injury.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insurance issue, Magnetic resonance imaging abnormal, Pain, Product administered at inappropriate site
Clinical narrative: The vaccine was given at about 9:00 a.m. and the patient developed increasingly severe pain starting at about 5:00 p.m. on the same day.  The patient stated that the injection site was higher than usual on her left lateral arm and shoulder area.  She was awakened at 5:00 a.m. on 09/21/2022 with severe left shoulder pain.  She has had ongoing pain and restricted shoulder range of motion since then .  She had tried to continue working in spite of the shoulder pain, but the condition of the shoulder is worsened and she has had to stop working starting in early September of 2023 because of the inability to work with her left hand.  She works as a certified nursing assistant and the vaccine was given as a part of a requirement for her job at the hospital. she was referred to an orthopedic surgeon, MD who recommended surgery for her shoulder. Surgery has not been accomplished because of insurance issues resulting from the workers' compensation insurance refusing to accept the vaccination as the cause of the shoulder injury.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Shoulder injury related to vaccine administration, Sleep disorder, Tendon disorder, Tendon rupture
Clinical narrative: The vaccine was given at about 9:00 a.m. and the patient developed increasingly severe pain starting at about 5:00 p.m. on the same day.  The patient stated that the injection site was higher than usual on her left lateral arm and shoulder area.  She was awakened at 5:00 a.m. on 09/21/2022 with severe left shoulder pain.  She has had ongoing pain and restricted shoulder range of motion since then .  She had tried to continue working in spite of the shoulder pain, but the condition of the shoulder is worsened and she has had to stop working starting in early September of 2023 because of the inability to work with her left hand.  She works as a certified nursing assistant and the vaccine was given as a part of a requirement for her job at the hospital. she was referred to an orthopedic surgeon, MD who recommended surgery for her shoulder. Surgery has not been accomplished because of insurance issues resulting from the workers' compensation insurance refusing to accept the vaccination as the cause of the shoulder injury.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site nodule, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Shortly after receiving the vaccine on 10/6/2023, a round knot or bump formed at the injection site in my right arm.  It was a little over one inch in diameter, and by the next day I had a red rash about 2 inches in diameter.  The area was sore and itchy.  It has taken about four weeks for the rash to go away.  Although the knot is not as large as it was most of October, I still have the bump and it is still about an inch in diameter.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Rash erythematous
Clinical narrative: Shortly after receiving the vaccine on 10/6/2023, a round knot or bump formed at the injection site in my right arm.  It was a little over one inch in diameter, and by the next day I had a red rash about 2 inches in diameter.  The area was sore and itchy.  It has taken about four weeks for the rash to go away.  Although the knot is not as large as it was most of October, I still have the bump and it is still about an inch in diameter.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Cough, Injection site pain, Injection site swelling, Rash
Clinical narrative: patient states that on october 28 (3 weeks after injection) she started getting rash all over body, soreness and swelling at perceived injection site and cough/tightness in chest
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Muscle spasms, Vomiting
Clinical narrative: Patient reported vomiting all night the evening after her vaccination. She also experienced muscle cramps.
Age: 76.0
Sex: F
Vaccine: FLUR4
Symptoms: Dysgeusia, Feeling abnormal, Parosmia
Clinical narrative: Pt came back to pharmacy 2 days after receiving a vaccine, stating she had very strong metallic taste/smell as soon as she received the vaccine. Burst in month that went to nose that lasted for few seconds and went away. Pt spoke with her Dr about this symptom and Dr told pt to have pharmacy report to VAERS for possible vaccine effect associated with her symptoms. She said she was feeling under the weather for past couple days but all better now, but wants to report her experience. She did not mention anything to pharmacy staff at the time of vaccination.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Administered Spikevax when she had previously received Pfizer COVID 10/16/23. Patient wanted RSV. We administered that in addition at patient request.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Injection site pain, Rhinorrhoea
Clinical narrative: Tested positive for Covid by Dr. Severe cough, running nose. tired, achy infection site
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid by Dr. Severe cough, running nose. tired, achy infection site
Age: 26.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Fever - 11/01 morning and still ongoing  Chills - 11/01 pm and ongoing Tiredness - 11/01 morning and ongoing  Body aches - 11/01 morning and ongoing  Nausea - 11/01 pm and ongoing
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: The day after my shot, I started experiencing the symptoms of a genital herpes outbreak.It was one of the most severe attacks I've had. Luckily I keep a supply of Valacyclovir on hand so I was able to start treating the outbreak right away. I contacted my primary care physician's office to let them know. They made sure I was not having an allergic reaction and offered to prescribe more antivirals.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Full body hives started at 10pm 10/31 and still going strong  24 hrs later
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: generalized body rash, mainly located on lower stomach and groin, also a little at injection site and around sternum.
Age: 15.0
Sex: F
Vaccine: FLU4, HEP, HPV9, IPV, TD
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Pt. received 5 vaccines with 3 in the left deltoid and 2 vaccines in the right deltoid. After giving the last two vaccines Polio and HPV at 1156am in the right deltoid. The patient began to feel dizzy, nauseated, sweaty, weak. Vitals were taken at 11:57. BP 79/ 57 p- 63 O2 sats 99% temp.  97.8 Vitals were retaken again by provider and she retook them at 12:04 pm 96/63 p- 71, O2 sats 99%. Vitals retaken again at 12:07 pm, BP 99/66, p- 69, O2 sats 99,  temp 97.9. Provider stated patient is at baseline. Her baseline vitals are 99/58. Patient ambulated out of the clinic with mother with the steady gait.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood glucose normal, Fall, Headache, Heart rate increased, Hypotension
Clinical narrative: note: at approximately 430 pm when she was standing on the front desk she  LOST CONSCIOUSNESS Falling BACKWARDS AND might had HIT HEAD (unwitnessed). Medical assistant imediately came to assist her and WITNESSED UPPER EXTREMITY SHAKING FOR FEW SECONDS.  I arrived to evaluate her less than one minute after the episode: HER BP WAS LOW AND HER HR WAS HIGH. She appeared pale and unresponsive for few seconds, EMS was called while we evaluated her. THEN within 5 MIN SHE REGAINED CONSCIOUSNESS AND COMPLAINED OF A HEADACHE IN THE BACK OF HER HEAD. A repeat BP was normal. WE CARRIED HER TO THE EXAM TABLE. A REPEAT BP WAS NORMAL AND HER HR WAS STILL HIGH. She appeared oriented with a SG of 81 MG. SHE WAS ABLE TO SIT
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness, Pallor, Tremor, Unresponsive to stimuli
Clinical narrative: note: at approximately 430 pm when she was standing on the front desk she  LOST CONSCIOUSNESS Falling BACKWARDS AND might had HIT HEAD (unwitnessed). Medical assistant imediately came to assist her and WITNESSED UPPER EXTREMITY SHAKING FOR FEW SECONDS.  I arrived to evaluate her less than one minute after the episode: HER BP WAS LOW AND HER HR WAS HIGH. She appeared pale and unresponsive for few seconds, EMS was called while we evaluated her. THEN within 5 MIN SHE REGAINED CONSCIOUSNESS AND COMPLAINED OF A HEADACHE IN THE BACK OF HER HEAD. A repeat BP was normal. WE CARRIED HER TO THE EXAM TABLE. A REPEAT BP WAS NORMAL AND HER HR WAS STILL HIGH. She appeared oriented with a SG of 81 MG. SHE WAS ABLE TO SIT
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTERED AFTER BUD
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED AFTER BUD
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTERED AFTER BUD
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED AFTER BUD
Age: 17.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Product storage error
Clinical narrative: Received vaccine after experiencing a supported temperature excursion.
Age: 12.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Product storage error
Clinical narrative: Received vaccine after it experienced a supported temperature excursion.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Erythema, Hypersensitivity, Induration, Tenderness, Urticaria
Clinical narrative: Patient came into clinic to receive vaccines; patient was not given vaccine she was only given the diluent. I have reached out to patient's mother but am unable to contact her.  Provider is aware.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Product preparation error
Clinical narrative: Patient came into clinic to receive vaccines; patient was not given vaccine she was only given the diluent. I have reached out to patient's mother but am unable to contact her.  Provider is aware.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored VARIVAX were administered to patients; no additional adverse events were reported; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, an improper storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, anatomical location, and route of administration were not provided; lot number reported and validated as W039294 and expiration date was established as 11-DEC-2024) was administered after temperature excursion to a patient (improper storage of product in use).   The excursion occurred with a temperature of 17.4 Farenheit (F) for 2 hours and 0 minutes and 0 seconds. There was no previous temperature excursion reported. No additional adverse event provided.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event, Wrong patient received product
Clinical narrative: Confirmed no side effects or symptoms reported.; HBP reports PROQUAD was administered accidentally to a patient who already received full dosing schedule of MMR containing vaccines but was administered it incidentally when it was meant for their sibling 10/13/2023.; Patient in question received first dose of PROQUAD on 11/22/2022 and received MMRII dose 1/14/2022; This spontaneous report as received from a health business administrator, and refers to a patient of unknown age and gender.      Information regarding the patient's concurrent conditions and medical history was not provided.  On 14-NOV-2022, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II), then, on 22-NOV-2022, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot#, expirations date, route of administration and anatomical location were not provided for any vaccine) (Inappropriate schedule of product administration). Both for prophylaxis. A sterile diluent was reported to be administered; however, it was not specified if it was used with all the vaccines reported.  On 13-OCT-2023, when the patient had already received full dosing schedule of  Measles, Mumps, and Rubella (MMR) containing vaccines,  the patient was accidentally administered with a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) 0.5 ml, lo# X009130 (Expiration date was not reported, but upon internal validations it was established as 24-SEP-2024) (route of administration and anatomical location were not provided) for prophylaxis. The reporter stated that the vaccine was administered incidentally when it was meant for their sibling  (wrong patient received product). It was confirmed that their sibling received their measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)according to schedule. Confirmed no side effects or symptoms reported.
Age: 1.33
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Product expired 10/7/2023 and was administered 10/16/2023.; This spontaneous report was received from a medical assistant and refers to a 16-month-old. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications were not reported.  On 16-OCT-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, and route of administration were not provided), 0.5 ml, lot # U031361, expiration date reported as 07-OCT-2023, administered for prophylaxis. The vaccine was reconstituted with a sterile diluent, lot # and expiration date were not reported. The patient had not experienced any adverse effect after vaccination.   Albumin status has been verified for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # U031361) to be recombinant human albumin (rHa).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs/symptoms of adverse effects from administered vaccine have been reported; VARIVAX was administered after TE; This spontaneous report was received from a physician referring to a patient of unknown age and gender. No information regarding patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On 23-OCT-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis after temperature excursion (product storage error). No signs or symptoms of adverse effects from administered vaccine were reported.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported. No Additional AE; HCP calling to report AE for supported TE for VARIVAX; This spontaneous report has been received from a medical assistant, concerning an 8-year-old female patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 05-SEP-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, dose frequency: single dose (lot number W018829 was verified to be valid, expiration date reported and confirmed as 14-JUN-2024), administered as prophylaxis (exact dose, route of administration, and anatomical location were not provided). The vaccine administered had been suffered temperature excursions (TE) in which a previous TE was of 5.7 degree Fahrenheit (F) for 1 Hour 30 Minutes, and the current TE was of 10.2F for 4 Hours 0 Minutes (Product storage error).  No adverse effects nor additional adverse events (AE) were reported.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Influenza
Clinical narrative: PATIENT DIED FROM FLU COMPLICATIONS AFTER HAVING BOTH A FLU VACCINATION AND COVID VACCINATION; A spontaneous report has been received from a consumer concerning a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.     On an unknown date,The patient received Flu Vaccine (influenza vaccine live reassort 3v) (batch number Unknown), via nasal route. On an unknown date, The patient received Covid Vaccine (covid-19 vaccine nrvv ad (chadox1 ncov-19)) (batch number Unknown), via intramuscular route.     No malfunction has been reported for FLU VACCINE.    On an unknown date, the patient died from flu complications after having both a flu vaccination and covid vaccination (preferred term: Influenza).     It is unknown if any action was taken with Flu Vaccine and Covid Vaccine.    On an unspecified date,The patient died from the event.    An autopsy was not performed. The cause of death was patient died from flu complications after having both a flu vaccination and covid vaccination .     The reporter assessed the  event  patient died from flu complications after having both a flu vaccination and covid vaccination as serious due to fatal outcome.    Device Information:     Combination Product Report: Yes    Product As Reported: FLU VACCINE  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction on 31-Oct-2023: Reporter Name (Vaccination Facility) in association with the Suspect product was link with reporter Vaccination Facility. Narrative amended.; Sender's Comments: Influenza is not listed in the company data sheet for chadox1 ncov-19 and Q/LAIV. Due to limited information on demographics, conditions surrounding reported events, clinical course and treatment provided, medical history, concomitant medications, exact indication and start date of suspect drug, onset dates of events, detailed etiological and diagnostic workup (Complete blood count ,infectious profile and pulmonary workup), the evaluation did not find reasonable evidence to suggest a causal between relationship between the event and suspect drugs.; Reported Cause(s) of Death: PATIENT DIED FROM FLU COMPLICATIONS AFTER HAVING BOTH A FLU VACCINATION AND COVID VACCINATION
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, Immunisation reaction
Clinical narrative: He felt that she felt okay, like normal side effects; Caller knows there is a double dosing for an immune compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (He felt that she felt okay, like normal side effects) and EXTRA DOSE ADMINISTERED (Caller knows there is a double dosing for an immune compromised) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Dementia.    On an unknown date, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (He felt that she felt okay, like normal side effects) and EXTRA DOSE ADMINISTERED (Caller knows there is a double dosing for an immune compromised). At the time of the report, IMMUNISATION REACTION (He felt that she felt okay, like normal side effects) and EXTRA DOSE ADMINISTERED (Caller knows there is a double dosing for an immune compromised) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient had normal side effects. There was a double dosing for an immune compromised. Patient was not immune compromised but in the late 80's or early 90's age.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her arms and a little on her legs; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash on her arms and a little on her legs) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05422A, 939903, 027L20A and 041L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash on her arms and a little on her legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash on legs & arms, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Rash on legs & arms, at an unspecified dose and frequency. At the time of the report, RASH (rash on her arms and a little on her legs) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  It was reported that after the most recent dose the patient had a rash on her arms and a little on her legs. This continued through the summer, but was no longer bothering her at the time of report.
Sex: U
Vaccine: UNK
Symptoms: Dyspnoea, Fatigue, Rhinorrhoea, Sneezing
Clinical narrative: Caller had the shot 4 hours ago and all they are doing is sneezing; nose running; a little breathing problem; they feel tired; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Caller had the shot 4 hours ago and all they are doing is sneezing), RHINORRHOEA (nose running), DYSPNOEA (a little breathing problem) and FATIGUE (they feel tired) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 31-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced SNEEZING (Caller had the shot 4 hours ago and all they are doing is sneezing), RHINORRHOEA (nose running), DYSPNOEA (a little breathing problem) and FATIGUE (they feel tired). At the time of the report, SNEEZING (Caller had the shot 4 hours ago and all they are doing is sneezing), RHINORRHOEA (nose running), DYSPNOEA (a little breathing problem) and FATIGUE (they feel tired) outcome was unknown.      For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Reported that caller had the shot 4 hours ago and all they are doing is sneezing. 20 sneezing in a row, nose running, they feel tired. Nothing really really bad, a little breathing problem.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: they have given a healthy 59-year-old female patient a dose of FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event; Initial information received on 25-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a healthy 59 years old female patient received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, a healthy 59-year-old female patient received a dose of fluzone high dose quadrivalent with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) (lot number and expiry date not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  It was reported that "Pharmacist wanted to check if there are any reported cases that has adverse events for patients that are under 65 years old. As per pharmacist, patient did not report any adverse events after receiving the FLUZONE HIGH DOSE QUADRIVALENT. No further information provided by the reporter."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.