chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Event happened on 1/17/24. Mistake caught in chart review on 3/18/24. Poison control contacted on 3/18/24. Mother made aware of situation. No signs or symptoms noted, according to mother that she can remember.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling face
Clinical narrative: Patient had facial swelling without any swelling of throat, dyspnea or sob. She did not call regarding this and was not seen anywhere for this.
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Asthenia, Injection site mass, Injection site pain, Injection site reaction, Lipoma
Clinical narrative: She got her vaccine, the next day she had the upper arm pain which only progressed and she thought it would last a few days like the COV ID shot.  It was very painful, and then after some time it was painful to move it, could not sleep on her left arm, it hurt to bend her arm.  She did start feeling things inside her arm like bumps and things.  She made an APT to see her NP.  She felt the bumps and put her on a weeks worth of steroids and ordered an US of her left upper arm.  This confirmed that she had lipomas in her arm and they could not rule out hematoma, and that she would need to get an MRI and then another US was ordered in 3-6 months from that date.  She continues to have pain, she cannot sleep as it forces her to sleep on her back and she not a back sleeper.  She is loosing a lot of strength in that arm, it is very difficult and cannot hold a grocery bag in that arm, hurts to slide her closet door open or close and it's getting weaker.  She was given a prescription for Gabapentin, and started taking that this morning.   They are talking about her going to PT to strengthen her arm, but her hesitancy was that all of this was costing her money and is on insurance which does not cover the cost of PT.
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Muscular weakness, Pain, Sleep disorder, Ultrasound scan abnormal
Clinical narrative: She got her vaccine, the next day she had the upper arm pain which only progressed and she thought it would last a few days like the COV ID shot.  It was very painful, and then after some time it was painful to move it, could not sleep on her left arm, it hurt to bend her arm.  She did start feeling things inside her arm like bumps and things.  She made an APT to see her NP.  She felt the bumps and put her on a weeks worth of steroids and ordered an US of her left upper arm.  This confirmed that she had lipomas in her arm and they could not rule out hematoma, and that she would need to get an MRI and then another US was ordered in 3-6 months from that date.  She continues to have pain, she cannot sleep as it forces her to sleep on her back and she not a back sleeper.  She is loosing a lot of strength in that arm, it is very difficult and cannot hold a grocery bag in that arm, hurts to slide her closet door open or close and it's getting weaker.  She was given a prescription for Gabapentin, and started taking that this morning.   They are talking about her going to PT to strengthen her arm, but her hesitancy was that all of this was costing her money and is on insurance which does not cover the cost of PT.
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Injection site pain
Clinical narrative: She got her vaccine, the next day she had the upper arm pain which only progressed and she thought it would last a few days like the COV ID shot.  It was very painful, and then after some time it was painful to move it, could not sleep on her left arm, it hurt to bend her arm.  She did start feeling things inside her arm like bumps and things.  She made an APT to see her NP.  She felt the bumps and put her on a weeks worth of steroids and ordered an US of her left upper arm.  This confirmed that she had lipomas in her arm and they could not rule out hematoma, and that she would need to get an MRI and then another US was ordered in 3-6 months from that date.  She continues to have pain, she cannot sleep as it forces her to sleep on her back and she not a back sleeper.  She is loosing a lot of strength in that arm, it is very difficult and cannot hold a grocery bag in that arm, hurts to slide her closet door open or close and it's getting weaker.  She was given a prescription for Gabapentin, and started taking that this morning.   They are talking about her going to PT to strengthen her arm, but her hesitancy was that all of this was costing her money and is on insurance which does not cover the cost of PT.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to injection site.  Benadryl administered
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Penile pain, Tenderness
Clinical narrative: Approximately 12-15 hours after vaccine administration, the patient reported noticing a tender "cord-like" area over the midline dorsal aspect of the base of the penis, involving an approximately 1 inch region.  He presented to clinic approximately 20 hours after the symptoms began due to persistent dully aching pain, reportedly 3-4/10 severity.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Influenza, Ultrasound foetal abnormal
Clinical narrative: Miscarriage
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Mom reports child arm swollen, red and warm to touch.  Child complains of pain and itching today worse than yesterday.  Encouraged for her to call hcp.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given less than recommended dosage for age group. Was supposed to be given 5-11yr variation, received 6mos-4yr variation.
Age: 10.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adversea reactions noted. Patient should have received dose appropriate for 10 year old, but instead received dose for 12+. Counseled the father on the inadvertently given dose and to watch for side effects.
Age: 16.0
Sex: M
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine given to patient
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, IPV, TD
Symptoms: Hallucination, auditory, Presyncope, Syncope
Clinical narrative: near syncopal event after vaccination. Reports syncopal events X 2 on 3/16. Auditory hallucinations
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Joint swelling
Clinical narrative: arm swollen around elbow area
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Pt received 3rd dose of Dtap @ age of 7
Age: 35.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pain, Injection site rash
Clinical narrative: Skin reaction: patient presented with darkened spot on upper left arm stating he felt pain in the area and discoloration since receiving Shingrix vaccine on 02/26/2024. Darkened spot appears to be small rash. No other ADR reported. Advised patient to monitor reaction and speak with PCP. Advised patient to get PCP ok to receive second dose and do so in office, if possible, where medical treatment available should another or more severe reaction occur to vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Faeces soft, Fatigue, Frequent bowel movements
Clinical narrative: Patient visited PCP on 02/28/2024 for annual check up and received Shringrix #1 on same day.  Pt called PCP's office next day at 3pm, had televisit with PCP at 3:50pm. As per records: has arm pain and mild erythema on injection site since yesterday night. feverish, fatigue since this morning . dizziness, also poor appetite. vomiting once. soft BM three times. no abd pain. no cough.  PCP office staff called EMS for patient, patient was sent to ER. Nurse called patient on 03/01/2024, as per pt: had IV fluid at ER, was given anti-vomiting and anti-diarrhea meds, then pt got discharged at the same day, was told to discuss with PCP to decide second dose of Shingrix. Pt stated she felt much more better, mo more fever,dizzy ,vomiting or diarrhea.  Will discuss Shingrix #2 with PCP at next visit.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Vomiting
Clinical narrative: Patient visited PCP on 02/28/2024 for annual check up and received Shringrix #1 on same day.  Pt called PCP's office next day at 3pm, had televisit with PCP at 3:50pm. As per records: has arm pain and mild erythema on injection site since yesterday night. feverish, fatigue since this morning . dizziness, also poor appetite. vomiting once. soft BM three times. no abd pain. no cough.  PCP office staff called EMS for patient, patient was sent to ER. Nurse called patient on 03/01/2024, as per pt: had IV fluid at ER, was given anti-vomiting and anti-diarrhea meds, then pt got discharged at the same day, was told to discuss with PCP to decide second dose of Shingrix. Pt stated she felt much more better, mo more fever,dizzy ,vomiting or diarrhea.  Will discuss Shingrix #2 with PCP at next visit.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Painful throbbing pain, stiffness and inability to raise arm with limited range of motion
Age: 5.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: development of large erythematous area around the site of vaccination shortly after (approx 2-3 hours) the injection was given.  Painful to touch, slightly raised, measuring approx 6cm x 5 cm.  No itching.  Given Benadryl and ice under recommendation from on-call physician and did improve, but still with symptoms when seen the day following vaccination.
Age: 1.92
Sex: M
Vaccine: DTAP, IPV
Symptoms: Culture negative, Incisional drainage, Injection site abscess sterile, Injection site induration, Injection site nodule
Clinical narrative: Patient with history of 2 sterile abscesses occurring on the left upper thigh which started after patient got DTaP and IPV in his left thigh in September 2023.  Patient did not have any reaction initially but about 1 month out started to get 2 hard, tender nodules at the injection sites.  Patient was seen multiple times, had an ultrasound and ultimately was seen by plastic surgery who drained the lesions which ultimately grew no organisms.  Lesions still present but continuing to heal well.
Age: 1.92
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site pain, Ultrasound scan abnormal
Clinical narrative: Patient with history of 2 sterile abscesses occurring on the left upper thigh which started after patient got DTaP and IPV in his left thigh in September 2023.  Patient did not have any reaction initially but about 1 month out started to get 2 hard, tender nodules at the injection sites.  Patient was seen multiple times, had an ultrasound and ultimately was seen by plastic surgery who drained the lesions which ultimately grew no organisms.  Lesions still present but continuing to heal well.
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: RN ADMINISTERED THE WRONG VACCINE TO A NEWBORN INFANT. INFANT WAS TO GET HEPATITIS B BUT RN ADMINISTERED TDAP INSTEAD. No adverse reactions as of now.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Abdominal pain, Allergy test, Blood test, Choking, Dysphagia
Clinical narrative: She got her vaccines, went home and she seemed fussy and was told to give her Tylenol.  She was having choking and difficulty swallowing immediately after the vaccine, and told them it was not normal and was told that if she was not better by the next day t bring her back.  She went back in the next day and was told she had oral thrush, fever, and had to use a bulb syrine for the severe congestion that she had.  They gave her a steroid and sent her home, and she had problems with breathing after that, and mother had a new pediatrcian who ran titers and she was negative for any HIB.  She did not have thrush prior to the vaccines.   She was told to take her home and keep an eye on her.  She became very fussy, colicky and just constantly is having so much mucous issues, stomach issues, food sensitivies with rashes around her face when she eats something.  She is 24 and feels that ths vaccine has caused some form of immune problems, and she has battled these symptoms for 24  years, and has had over-excessive muscoue and been on Mucines for 24 years.  She has an appointment with an immunologist tomorrow.  She had been sent to allergist for many years, and was supposed to have a vaccine for her job for MMR and mother said she cannot have that vaccine as she was told that she was not to have vaccines.  Mother linked it to the Hib shot as for the polysacralates, and if she has sugars or carbs her system goes into overdrive and feels that this is from the vaccines.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Dyspnoea, Immediate post-injection reaction, Irritability, Oral candidiasis, Pyrexia
Clinical narrative: She got her vaccines, went home and she seemed fussy and was told to give her Tylenol.  She was having choking and difficulty swallowing immediately after the vaccine, and told them it was not normal and was told that if she was not better by the next day t bring her back.  She went back in the next day and was told she had oral thrush, fever, and had to use a bulb syrine for the severe congestion that she had.  They gave her a steroid and sent her home, and she had problems with breathing after that, and mother had a new pediatrcian who ran titers and she was negative for any HIB.  She did not have thrush prior to the vaccines.   She was told to take her home and keep an eye on her.  She became very fussy, colicky and just constantly is having so much mucous issues, stomach issues, food sensitivies with rashes around her face when she eats something.  She is 24 and feels that ths vaccine has caused some form of immune problems, and she has battled these symptoms for 24  years, and has had over-excessive muscoue and been on Mucines for 24 years.  She has an appointment with an immunologist tomorrow.  She had been sent to allergist for many years, and was supposed to have a vaccine for her job for MMR and mother said she cannot have that vaccine as she was told that she was not to have vaccines.  Mother linked it to the Hib shot as for the polysacralates, and if she has sugars or carbs her system goes into overdrive and feels that this is from the vaccines.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Respiratory tract congestion
Clinical narrative: She got her vaccines, went home and she seemed fussy and was told to give her Tylenol.  She was having choking and difficulty swallowing immediately after the vaccine, and told them it was not normal and was told that if she was not better by the next day t bring her back.  She went back in the next day and was told she had oral thrush, fever, and had to use a bulb syrine for the severe congestion that she had.  They gave her a steroid and sent her home, and she had problems with breathing after that, and mother had a new pediatrcian who ran titers and she was negative for any HIB.  She did not have thrush prior to the vaccines.   She was told to take her home and keep an eye on her.  She became very fussy, colicky and just constantly is having so much mucous issues, stomach issues, food sensitivies with rashes around her face when she eats something.  She is 24 and feels that ths vaccine has caused some form of immune problems, and she has battled these symptoms for 24  years, and has had over-excessive muscoue and been on Mucines for 24 years.  She has an appointment with an immunologist tomorrow.  She had been sent to allergist for many years, and was supposed to have a vaccine for her job for MMR and mother said she cannot have that vaccine as she was told that she was not to have vaccines.  Mother linked it to the Hib shot as for the polysacralates, and if she has sugars or carbs her system goes into overdrive and feels that this is from the vaccines.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Nasopharyngitis, Pruritus, Rash
Clinical narrative: 3/11/2024 at 11:04 she received the vaccine. 3/12/2024 at 11:45a bilateral lower legs rash and itch. 3/13/2024 the rash subsided on its own, but then got "cold like symptoms" and was afebrile.
Age: 34.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Exposure during pregnancy, Hypoaesthesia, Magnetic resonance imaging head normal, Paraesthesia
Clinical narrative: Clinic had us stay for 30 minutes to monitor for adverse events. I felt fine so I left but by the time I got back to my car, about 35 minutes I felt tingling/numbness along my left trigeminal nerve in my face along all nerve branches. I took Benadryl and prednisone 80 mg x 5 days after the shot but it didn't help. The numbness persisted. The numbness persists to this day 3 years later. The tingling and exacerbation of numbness recurred when I went for my subsequent COVID vaccinations 2021-2022 and when I received my flu vaccines as well. Reaction more immediate after vaccine administration. Additional vaccine information: Moderna COVID 1/25/21 Lot 02962CA unknown arm, Pfizer COVID 10/27/21 Lot FF2593 unknown arm, Pfizer Bivalent 9/7/22 Lot HH9694 unknown arm (was pregnant). On 3/13/24 left facial numbness spontaneously worsened with no identifiable trigger, numbness spread to bilateral lower extremity, right face, and left upper extremity.
Age: 48.0
Sex: M
Vaccine: TYP
Symptoms: Impaired work ability, Injection site pain, Insomnia, Muscular weakness, Nausea
Clinical narrative: Injection seemed abnormally initially painful when compared to other injections.   Pain faded quickly and arm was slightly sore for the following days.  Within two days after injection, the arm became very painful though range was not limited.   The pain was a bit confusing as it didn?t seem like muscle or bone or joint pain.  The pain escalated to be nauseating and it would not go away, regardless of positioning of the arm.   At this stage, I had already begun the trip and was not within a framework for any sort of medical treatment. There was no treatment, and typical pain relief was not effective. This continued through the whole trip abroad.  Upon return, I got in to see the Dr. and they prescribed antibiotics (Amoxicillin) to attempt to trouble shoot.   There were no improvements.   The shoulder felt as if it were becoming more weak.  They did mobility testing and sorted out that there was no muscular or structural damage to the shoulder.   They then realized that it could be Parsonage Turner Syndrome.  They prescribed a nerve pain killer (nortriptyline) and this did little for the nerve pain but created a host of side effects.   The pain in the shoulder continued for several months.   During this timeframe, sleep, work, and travel was nearly impossible.  I also lost over 25 pounds. The nerve pain tapered off quickly, but the shoulder is still weak.
Age: 48.0
Sex: M
Vaccine: TYP
Symptoms: Neuralgia, Weight decreased
Clinical narrative: Injection seemed abnormally initially painful when compared to other injections.   Pain faded quickly and arm was slightly sore for the following days.  Within two days after injection, the arm became very painful though range was not limited.   The pain was a bit confusing as it didn?t seem like muscle or bone or joint pain.  The pain escalated to be nauseating and it would not go away, regardless of positioning of the arm.   At this stage, I had already begun the trip and was not within a framework for any sort of medical treatment. There was no treatment, and typical pain relief was not effective. This continued through the whole trip abroad.  Upon return, I got in to see the Dr. and they prescribed antibiotics (Amoxicillin) to attempt to trouble shoot.   There were no improvements.   The shoulder felt as if it were becoming more weak.  They did mobility testing and sorted out that there was no muscular or structural damage to the shoulder.   They then realized that it could be Parsonage Turner Syndrome.  They prescribed a nerve pain killer (nortriptyline) and this did little for the nerve pain but created a host of side effects.   The pain in the shoulder continued for several months.   During this timeframe, sleep, work, and travel was nearly impossible.  I also lost over 25 pounds. The nerve pain tapered off quickly, but the shoulder is still weak.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 1 EPISODE OF VOMITING 20-30 mins after receiving vaccine
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated, Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging head normal
Clinical narrative: Within 24 hours of the second Shingrix shot, , I had an episode of atrial fibrillation and an increase in numbness on the left side of my face and tongue. While this happened previously following COVID boosters, the numbness returned to baseline within 4-5 days. In this case, the numbness was more severe, affected my speech, and still has not fully resolved.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Speech disorder
Clinical narrative: Within 24 hours of the second Shingrix shot, , I had an episode of atrial fibrillation and an increase in numbness on the left side of my face and tongue. While this happened previously following COVID boosters, the numbness returned to baseline within 4-5 days. In this case, the numbness was more severe, affected my speech, and still has not fully resolved.
Age: 70.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Supervisor Conducting peer review on vaccine consent and documentation completion.   Identified a consent for an adult patient with a pediatric dose administered.   Reviewed patient file and the vaccine was documented with the pediatric lot number but the dose was incorrect.  1mL was documented but a 0.5mL was administered to patient.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Alopecia, Anosmia, Anxiety, Brain fog
Clinical narrative: Aggravation of Long Covid symptoms:  Exhaustion, tiredness, inability to control sleep schedule, muscle pain, brain fog, serious cognitive problems, chronic pain, muscle spasms, weird vibrations, loss of smell and taste, my body does not heal like it used to, poor skin, loss of hair and beard.  New symptom after vaccine is my body has been on fire, inflamed constantly for years + hart beating differently.  Dealing with all of these symptoms have cause me anxiety and depression.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Circadian rhythm sleep disorder, Cognitive disorder, Condition aggravated, Depression
Clinical narrative: Aggravation of Long Covid symptoms:  Exhaustion, tiredness, inability to control sleep schedule, muscle pain, brain fog, serious cognitive problems, chronic pain, muscle spasms, weird vibrations, loss of smell and taste, my body does not heal like it used to, poor skin, loss of hair and beard.  New symptom after vaccine is my body has been on fire, inflamed constantly for years + hart beating differently.  Dealing with all of these symptoms have cause me anxiety and depression.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate irregular, Impaired healing, Inflammation, Muscle spasms
Clinical narrative: Aggravation of Long Covid symptoms:  Exhaustion, tiredness, inability to control sleep schedule, muscle pain, brain fog, serious cognitive problems, chronic pain, muscle spasms, weird vibrations, loss of smell and taste, my body does not heal like it used to, poor skin, loss of hair and beard.  New symptom after vaccine is my body has been on fire, inflamed constantly for years + hart beating differently.  Dealing with all of these symptoms have cause me anxiety and depression.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Post-acute COVID-19 syndrome, Refusal of treatment by patient, Skin disorder
Clinical narrative: Aggravation of Long Covid symptoms:  Exhaustion, tiredness, inability to control sleep schedule, muscle pain, brain fog, serious cognitive problems, chronic pain, muscle spasms, weird vibrations, loss of smell and taste, my body does not heal like it used to, poor skin, loss of hair and beard.  New symptom after vaccine is my body has been on fire, inflamed constantly for years + hart beating differently.  Dealing with all of these symptoms have cause me anxiety and depression.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vibratory sense increased
Clinical narrative: Aggravation of Long Covid symptoms:  Exhaustion, tiredness, inability to control sleep schedule, muscle pain, brain fog, serious cognitive problems, chronic pain, muscle spasms, weird vibrations, loss of smell and taste, my body does not heal like it used to, poor skin, loss of hair and beard.  New symptom after vaccine is my body has been on fire, inflamed constantly for years + hart beating differently.  Dealing with all of these symptoms have cause me anxiety and depression.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second doses of Influenza 0.5ml , two weeks apart. No signs or symptoms noted of adverse event at present time.
Age: 49.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Adverse reaction, Headache, Nausea, Vomiting
Clinical narrative: I administered 1 boostrix (left arm) and 1 heplisav-b (right arm) to patient on 3/19/24 around 5:30 pm. Patient called me back on 3/20/24 at around 10:30am and indicated that she was experiencing adverse reactions, headache (no fever), nausea, vomiting, patient does have history of migraine headache. Patient felt better after taking some OTC excedrin medication. I advised patient to best rest for now, and if the symptoms got worse, patient needs to seek medical attention.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood creatine phosphokinase, Electrocardiogram, Full blood count, Metabolic function test, Syncope
Clinical narrative: VACCINES ARE ADMINISTERED AND THE PATIENT PRESENTS WITH VASOVAGAL SYNCOPE.
Age: 67.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Asthenia, Chills, Dyspnoea, Fatigue
Clinical narrative: The day after vaccine I was extremely tired and weak.  I slept most of the day with chills.  I also felt more joint pain in my hips than usual.  Any walking at all caused me to feel out-of-breath as if I were climbing stairs.  The second day was similar, without chills and less sleeping.  Every day has gotten better.
Age: 67.0
Sex: F
Vaccine: MNQ
Symptoms: Somnolence
Clinical narrative: The day after vaccine I was extremely tired and weak.  I slept most of the day with chills.  I also felt more joint pain in my hips than usual.  Any walking at all caused me to feel out-of-breath as if I were climbing stairs.  The second day was similar, without chills and less sleeping.  Every day has gotten better.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid- 19 Breakthrough Infection
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Parent consented for student to receive all three vaccines at student clinic to be up-to-date for 7th grade. Review of students vaccine record showed that he was only due for second HPV vaccine. Nurse mistakenly looked at another form/the form filled out by parent, resulting in unnecessary vaccination of Tdap and Meningococcal. Parent informed of mistake and expressed understanding. Patient tolerated vaccines well without any symptoms.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a 12 month vaccination (Proquad) at 4 month visit in place of Prenvar 20. No adverse reactions had.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient reports on 3/17/2024, when he was picking up his maintenance medication that since his receipt of the vaccine he has been experiencing pain on/ near the vaccine site if he moves his arm up and down. The patient described the pain as "he feels as though he has just received the shot again."  He inquired asking if that was a normal symptom to experience that many weeks post vaccination. I notified the patient that I did not believe that to be a normal symptom for such an extensive period. I asked patient if I could look at the vaccination site and I did not notice visible redness or bruising in the area. At this point I advised the patient to make a follow up appointment with his primary care provider to do further assessment.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Patient reports that after the vaccine for a few days she had, "normal soreness" and that subsided. Starting 3/19 she has had pain in the left arm that is "beyond soreness." She states the pain is her entire upper arm, not localized, and is so painful she is using her other arm to lift the left arm up. She denies redness, swelling at the injection site. Also denies numbness/tingling or the pain radiating. She reports that it feels, "kind of warm" but not 'hot' to her. She states she has never had this feeling/pain before with any of the previous COVID vaccines she has received. She has also reported this to her PCP for follow up care, at time of report no result or outcome to report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Gait disturbance, Muscular weakness, Pollakiuria
Clinical narrative: After injection with Novavax: From 9 pm to 8 a.m., chills. Excessive urine every hour,  uncontrollable when standing. Legs lost strength. Difficulty walking, even with cane. (This happened twice with previous Covid vaccine (Moderna): I ended up on the floor and couldn?t rise. No muscle strength. Primary care advised no more vaccination, but now I have new grandchildren to protect, so I got the shot.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence, Walking aid user
Clinical narrative: After injection with Novavax: From 9 pm to 8 a.m., chills. Excessive urine every hour,  uncontrollable when standing. Legs lost strength. Difficulty walking, even with cane. (This happened twice with previous Covid vaccine (Moderna): I ended up on the floor and couldn?t rise. No muscle strength. Primary care advised no more vaccination, but now I have new grandchildren to protect, so I got the shot.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: Patient experienced fever, body aches, red rash that spread on the right side of her arm. Still has a painful spot on arm where shot was given and still has a reddish rash on arm even 1 week later. The rash is not painful or bothersome.
Age: 1.42
Sex: M
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: NONE  at the time mom was contacted in regards to vaccine error
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Blindness, Blood glucose normal, Dizziness, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Approximately 5 minutes after receiving  MenQuadfi vaccine pt stated, "I feel like I do when I give blood. I feel like I am going to pass out." At approximately 2:32 PM pts body became stiff and he started convulsing. Pt was lowered from the chair to floor by 4 nurses. This episode lasted approximately 10 seconds. Oxygen was applied at 2 L/min BNC. Blood pressure at that time was 120/76, pulse 98, O2 sat  97%. Pt stated, "Before I passed out, I lost my vision." Vitals at 2:36 PM was 130/78, pulse 89, O2 sat 97%.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Seizure
Clinical narrative: Approximately 5 minutes after receiving  MenQuadfi vaccine pt stated, "I feel like I do when I give blood. I feel like I am going to pass out." At approximately 2:32 PM pts body became stiff and he started convulsing. Pt was lowered from the chair to floor by 4 nurses. This episode lasted approximately 10 seconds. Oxygen was applied at 2 L/min BNC. Blood pressure at that time was 120/76, pulse 98, O2 sat  97%. Pt stated, "Before I passed out, I lost my vision." Vitals at 2:36 PM was 130/78, pulse 89, O2 sat 97%.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain, Pain in extremity, Urticaria
Clinical narrative: I had severe pain in my arm.  I was unable to move my arm without being in excruciating pain.  I could not function.  I spent the majority of the following 2 days in bed.  My arm also became very red, hot and had raised welts on it.  This was only the first shot in a series of 2 and I am not sure that I should have the second dose.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Itchy, redness, hot to touch, pea sized spot. Has gotten bigger since the originally given but not a super large area.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Experiencing vertigo since day the vaccine was given.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Pruritus, Swelling
Clinical narrative: swelled, hurt, ocassionally like start burning and itching. COVID Moderna lot number: 027L20A
Age: 76.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received the two vaccines and had no adverse reactions that were apparent
Age: 81.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered
Clinical narrative: Patient given two doses. First dose on 10-16-2023 and a second dose was given on 1-3-2024.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Blood lactic acid, Electroencephalogram, Full blood count, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: seizure 24-36h after vaccine administration.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Metabolic function test, Seizure
Clinical narrative: seizure 24-36h after vaccine administration.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt received a dose of RSV vaccine at the age of 59.  Pt was 5 months shy of being eligible.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: PATIENT CONTACTED HER DERMATOLOGIST, RASH ABOUT 5 INCHES DIAMETER IN BOTH LOWER ARMS NOT ITCHY, ROUND
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Pain
Clinical narrative: Headache and body aches.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is outside of FDA approved age range to have received this vaccine from a pharmacy
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms reported and no additional details provided.  No other AE and no PQC; 16 yo pt received proquad; This spontaneous report was received from a nurse and refers to a p16-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 16-FEB-2024, the patient was vaccinated with an inadvertent dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # X020572, expiration date 03-FEB-2025 (dose, route of administration and anatomical location were not provided) for prophylaxis (inappropriate age at vaccine administration). No adverse events were reported.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: the patient was due for both the MMR II and VARIVAX vaccines; the patient last received the MMR II vaccine on 10/20/2009; the patient received both the VARIVAX and PROQUAD vaccines on 02/23/2024; no adverse event; HCP reported that a 15 years and 4 month old patient received the PROQUAD vaccine on 02/23/2024. HCP reported that the PROQUAD vaccine was administered in error due to the HCP not looking at the age range before administration.; HCP reported that the patient was due for both the MMR II and VARIVAX vaccines. HCP reported that the patient received both the VARIVAX and and PROQUAD vaccines on 02/23/2024; the patient was due for both the MMR II and VARIVAX vaccines; the patient last received the MMR II vaccine on 10/20/2009; the patient received both the VARIVAX and PROQUAD vaccines on 02/23/2024; This spontaneous report was received from a medical assistant, referring to a 15 years and 4 month old patient.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 20-OCT-2009, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) injection, administered for prophylaxis (strength, lot #, expiry date, dose, and route of administration were not provided). On 23-FEB-2024, the patient, who was due for both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/merck) (VARIVAX) vaccines, was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, lot # X021131, expiration date: 12-FEB-2025, administered by health professional for prophylaxis (strength, dose, and route of administration were not provided); and with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered by health professional for prophylaxis (strength, lot #, expiry date, dose, and route of administration were not provided) (product administered to patient of inappropriate age; wrong product administered; inappropriate schedule of vaccine administered; overdose). It was reported that the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine was administered in error due to the health care professional (HCP) not looking at the age range before administration. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP calling to report that patient received MMR II and VARIVAX during temp excursion.  Caller unable to provide time or highest temperatures reached as she states excursion occurred during power outage/transport and was not monitored.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-MAR-2024, the patient was vaccinated with improperly stored (exposed to temperature excursion [TE]) vaccines of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, lot #W030848, expiration date: 27-SEP-2024, 0.5 milliliter, administered for prophylaxis (strength, and route of administration were not provided); and with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X021281, expiration date: 20-AUG-2025, 0.5 ml, administered by health professional for prophylaxis (strength, and route of administration were not provided) (product storage error). It was unable to provide time or highest temperatures reached as it was stated that excursion occurred during power outage/transport and was not monitored. It was unknown if there was previous TE:  No additional adverse event (AE) (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2403USA003136:
Age: 17.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from Nurse Practitioner and refers to a 17-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #W031980, expiration date: 06-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent multiple excursion from 19-OCT-2023 to 22-JAN-2024 for 9 hour 27 minutes in the -14 to -10 degree Celsius range(Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.
Age: 18.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from Nurse Practitioner and refers to a 18-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #W031980, expiration date: 06-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent multiple excursion from 19-OCT-2023 to 22-JAN-2024 for 9 hour 27 minutes in the -14 to -10 degree Celsius range(Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from Nurse Practitioner and refers to a 4-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #X003664, expiration date: 10-NOV-2025 (strength, route of administration, and indication were not provided). This vaccine underwent multiple excursion from 19-OCT-2023 to 22-JAN-2024 for 9 hour 27 minutes in the -14 to -10 degree Celsius range(Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from Nurse Practitioner and refers to a 18-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccie underwent multiple excursion from 19-OCT-2023 to 22-JAN-2024 for 9 hour 27 minutes in the -14 to -10 degree Celsius range(Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from Nurse Practitioner and refers to a 7-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccie underwent multiple excursion from 19-OCT-2023 to 22-JAN-2024 for 9 hour 27 minutes in the -14 to -10 degree Celsius range(Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: HIBV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 4-year-old patient of unknown gender.     The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 01-NOV-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, expiration date: 05-JAN-2025, subcutaneously (exact dose and anatomical location were not provided); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), formulation: intramuscular injection, lot # X003664, expiration date: 10-NOV-2025, intramuscularly (exact dose and anatomical location were not provided) and  for prophylaxis.  Administered doses of vaccines were exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).  This is one of several reports receved from the same reporter.
Age: 4.0
Sex: U
Vaccine: HIBV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 4-year-old patient of unknown gender.     The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 01-NOV-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, expiration date: 05-JAN-2025, subcutaneously (exact dose and anatomical location were not provided); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), formulation: intramuscular injection, lot # X003664, expiration date: 10-NOV-2025, intramuscularly (exact dose and anatomical location were not provided) and  for prophylaxis.  Administered doses of vaccines were exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.