chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of mobility decreased in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced mobility decreased and pain in arm. On an unknown date, the outcome of the mobility decreased and pain in arm were unknown. It was unknown if the reporter considered the mobility decreased and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporting pharmacist noted his pharmacy did not give the vaccine to the patient and it was unknown if it was the 1st or 2nd dose of SHINGRIX.   The patient had trouble getting her arm above her head due to the pain. This case was linked with US2019034282, reported by the same reporter.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of lymphadenopathy in a 35-year-old female patient who received HAB (Hepatitis A and Hepatitis B vaccine) for prophylaxis. On 18th February 2019, the patient received Hepatitis A and Hepatitis B vaccine. In February 2019, less than a day after receiving Hepatitis A and Hepatitis B vaccine, the patient experienced lymphadenopathy and swelling of legs. On an unknown date, the outcome of the lymphadenopathy was not recovered/not resolved and the outcome of the swelling of legs was recovering/resolving. It was unknown if the reporter considered the lymphadenopathy and swelling of legs to be related to Hepatitis A and Hepatitis B vaccine. Additional details were provided as follows: This case was reported by the patient's mother who was also a retired nurse. The patient received a dose of Hepatitis A and Hepatitis B combination vaccine (name unknown) on the left arm. Less than 24 hours after vaccination, the patient experienced swelling in her feet and legs. With 48 hours, the swelling became extreme. The physician office was called and was told that the patient might be suffering from Lymphadenopathy. The patient began wearing support hose and the swelling was reduced slightly as of the day before reporting. The reporter consented to follow up.
Sex: M
Vaccine: PNC13
Symptoms: Cough, Crying, Decreased appetite, Diarrhoea, Dyspnoea
Clinical narrative: PREVNAR 13 vaccination dates: 14Nov2017, 12Dec2017, 09Jan2018 18Feb2018, night: high fever with 38.9, treated with TYLENOL and acetaminophen, recovered 27Feb2018: running nose, cough 28Feb2018: high fever with 38.5 01Mar-04Mar: cough, hard breathing, crying, vomiting, lower appetite 05Mar: diagnosed as pneumonia till now: diarrhea, lower appetite, weight loss treatment from 05Mar to 09Mar: IV drop methylprednisolone, azithromycin, ceftriaxone sodium; oral ZYRTEC, Montelukast (MSD), Levocabastine; aerosol inhalation terbutaline, budesonide and ipratropium bromide Night of 05Mar: serious diarrhea, average 5-10 times/ day till now. Vomiting on 07Mar when receiving azithromycin. Lab test of stool on 06Mar and 11Mar found not infection or virus, probiotics and montmorillonite powder received.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia, Pyrexia, Vomiting, Weight decreased
Clinical narrative: PREVNAR 13 vaccination dates: 14Nov2017, 12Dec2017, 09Jan2018 18Feb2018, night: high fever with 38.9, treated with TYLENOL and acetaminophen, recovered 27Feb2018: running nose, cough 28Feb2018: high fever with 38.5 01Mar-04Mar: cough, hard breathing, crying, vomiting, lower appetite 05Mar: diagnosed as pneumonia till now: diarrhea, lower appetite, weight loss treatment from 05Mar to 09Mar: IV drop methylprednisolone, azithromycin, ceftriaxone sodium; oral ZYRTEC, Montelukast (MSD), Levocabastine; aerosol inhalation terbutaline, budesonide and ipratropium bromide Night of 05Mar: serious diarrhea, average 5-10 times/ day till now. Vomiting on 07Mar when receiving azithromycin. Lab test of stool on 06Mar and 11Mar found not infection or virus, probiotics and montmorillonite powder received.
Sex: M
Vaccine: PNC13
Symptoms: Cough, Pneumonia, Pyrexia
Clinical narrative: The baby was receiving PREVNAR 13 as scheduled. While after vaccination about 1 month, he developed fever, cough, and then pneumonia and admitted in hospital for 1 week treatment. Many friends of mine using PREVNAR 13 and some of them developed pneumonia after that. What a vaccine from Pfizer.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Device failure
Clinical narrative: Product problem. Required intervention to prevent permanent impairment/damage (Devices). See additional page(s) for complete text.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction - local inflammation and swelling the size of a half-dollar coin per patient. Red, swollen and Itchy. Late onset (started a few days after dose administration). Patient calling MD and using cortisone cream & Benadryl to mitigate current reaction. No sign of anaphylaxis per patient report.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: Soreness at injection site, rash, fever, body aches, upset stomach, diarrhea, tiredness, itchy, headache, scratchy throat. I had some reaction after 1st injection almost didn't get 2nd one.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pruritus, Pyrexia, Rash, Throat irritation
Clinical narrative: Soreness at injection site, rash, fever, body aches, upset stomach, diarrhea, tiredness, itchy, headache, scratchy throat. I had some reaction after 1st injection almost didn't get 2nd one.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Syncope
Clinical narrative: Soreness at injection site, rash, fever, body aches, upset stomach, diarrhea, tiredness, itchy, headache, scratchy throat. I had some reaction after 1st injection almost didn't get 2nd one.
Age: 0.75
Sex: M
Vaccine: IPV
Symptoms: Allergy to vaccine, Diarrhoea, Pallor, Retching, Skin test positive
Clinical narrative: Within 30 minutes, the nine month old patient, became very pale in the face. He started to dry heave and began to vomit severely. I (mother) called the doctor's office and they instructed me to come back to the office. Upon returning (approximately 3 pm, a little over an hour after the shot was administered) he vomited again in the waiting room. Upon entering the exam room he had extreme diarrhea in his diaper. The doctor examined him and called it a coincidence and said he could have a stomach virus. When we returned for his one year check up, I was concerned about proceeding with vaccines, so the doctor ordered allergy testing.
Age: 0.75
Sex: M
Vaccine: IPV
Symptoms: Vomiting
Clinical narrative: Within 30 minutes, the nine month old patient, became very pale in the face. He started to dry heave and began to vomit severely. I (mother) called the doctor's office and they instructed me to come back to the office. Upon returning (approximately 3 pm, a little over an hour after the shot was administered) he vomited again in the waiting room. Upon entering the exam room he had extreme diarrhea in his diaper. The doctor examined him and called it a coincidence and said he could have a stomach virus. When we returned for his one year check up, I was concerned about proceeding with vaccines, so the doctor ordered allergy testing.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt had a 5x9mm area of swelling, redness, itching, and warmth at the injection site on the left deltoid. No streaking, or s/s systemic infection.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip pain, Lip swelling
Clinical narrative: PATIENT CALLED PHARMACY COMPLAINING OF LIP SWELLING AND PAIN. HAD RECEIVED SHINGRIX VACCINE LESS THAN 24 HOURS PRIOR. HAD FORWARDED CALL TO NURSE TRIAGE LINE WHERE THEY RECOMMENDED PATENT BE SEEN  RIGHT WAY. PATIENT WAS AMENDABLE TO THIS AS ALLERGIC REACTION CAN PROGRESS QUICKLY, WILL FOLLOW UP.
Age: 56.0
Sex: F
Vaccine: HEPA, JEV1, TYP
Symptoms: Pruritus
Clinical narrative: Patient had complaint of itching no redness no edema, left arm. Vital signs stable, Temp 97.9 R 20  O2 sat 100 P 59.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Neuralgia
Clinical narrative: Well Pt was late to work blaming the pain from inj. She stated immediate pain and swelling which has continued to get worse since then. Pt said she has under-arm nerve pain. She said pain is "oozing into her hand and refuses to move or use her hand and arm so Tdap toxins don't get into the rest of her body".
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Swelling
Clinical narrative: Well Pt was late to work blaming the pain from inj. She stated immediate pain and swelling which has continued to get worse since then. Pt said she has under-arm nerve pain. She said pain is "oozing into her hand and refuses to move or use her hand and arm so Tdap toxins don't get into the rest of her body".
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 19.5 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in July 2018, the patient was inadvertently vaccinated with a first dose pediatric (0.5 ml) instead of adult (1.0 ml) dose with VAQTA lot # R006471, expiration date 02-APR-2019, intramuscularly. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On 02-MAR-2019, the patient was inadvertently vaccinated with an expired dose of M-M-R II lot # R013129, expiration date 03-FEB-2019, intramuscular (dose and anatomical location was not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer (manufacturer control number# 2018100629) regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown date, the patient started therapy with VAQTA (route, frequency, lot#, expiration date unknown) for prophylaxis. On an unknown date, the patient had received the other products (VAQTA) after the same temperature excursion (product storage error). No adverse effect reported.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Addison's disease, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of addison's disease in a 70-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. Concurrent medical conditions included sodium decreased. On 3rd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th January 2019, 1 days after receiving SHINGRIX, the patient experienced feeling unwell and fever. On 16th February 2019, the patient experienced addison's disease (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the addison's disease was unknown and the outcome of the feeling unwell and fever were recovered/resolved. It was unknown if the reporter considered the addison's disease, feeling unwell and fever to be related to SHINGRIX. Additional details reported as follows: The next day after vaccination, the patient did not feel well and had a fever, which was 101 F. The patient felt very sick for 2 weeks prior to the hospitalization and had very low sodium. The patient was treated for low sodium for 18 months at the time of reporting and was sick for a while. The patient was not sure if SHINGRIX was what sent her over the edge and caused her to be hospitalized. The patient thought, the patient had Addison's disease prior to getting SHINGRIX but it just was not diagnosed yet. The emergency room visit required. The reporter did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site reaction, Musculoskeletal stiffness, Myalgia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th February 2019, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 14th February 2019, the patient experienced muscle pain. In February 2019, the patient experienced itchy rash. On an unknown date, the patient experienced blotchy rash. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injected limb mobility decreased and muscle pain were recovered/resolved and the outcome of the itchy rash was recovering/resolving and the outcome of the blotchy rash was unknown. It was unknown if the reporter considered the injected limb mobility decreased, muscle pain, itchy rash and blotchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received her dose of SHINGRIX on an unknown arm and that evening her arm felt stiff at the injection site. The next day all her muscles were achy and that lasted a week. The second week after the injection, the patient developed a rash in a band around her arm that was very itching. The rash was improving, and was at the time of reporting a blotch instead of a band, but it was still very itchy. The patient saw her doctor and was advised to ice the rash. Emergency room visit required. The patient consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th February 2019, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 14th February 2019, the patient experienced muscle pain. In February 2019, the patient experienced itchy rash. On an unknown date, the patient experienced blotchy rash. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injected limb mobility decreased and muscle pain were recovered/resolved and the outcome of the itchy rash was recovering/resolving and the outcome of the blotchy rash was unknown. It was unknown if the reporter considered the injected limb mobility decreased, muscle pain, itchy rash and blotchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received her dose of SHINGRIX on an unknown arm and that evening her arm felt stiff at the injection site. The next day all her muscles were achy and that lasted a week. The second week after the injection, the patient developed a rash in a band around her arm that was very itching. The rash was improving, and was at the time of reporting a blotch instead of a band, but it was still very itchy. The patient saw her doctor and was advised to ice the rash. Emergency room visit required. The patient consented to follow up.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Abnormal behaviour, Condition aggravated, Dementia, Loss of personal independence in daily activities, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife) who reported for himself and his wife. This is the first of two reports. A 76-year-old female patient received PREVNAR 13 , on 18Feb2019 at 10:00 at single dose in Left arm to prevent from ever having Pneumonia. Medical history included ongoing dementia, basically she has Alzheimer's. She took quite a bit of medications (unspecified). The patient experienced an extremely severe reaction: on 18Feb2019 around 6, 6:30 she started trembling and it gradually got worse. On an unknown date  it looked like she was having an epileptic attack, she was just shaking and all of her body was like bouncing around, shaking around. No treatment given. Since an unknown date her dementia took a major setback: she was totally lost in the evening as to what to do next, her husband had to be around her to practically tell her to change into her PJ's to go to bed. Husband had to hand her medication and she would not even take a glass of water to drink. "Patient did not know what she was doing and it was not the way it was before all this; to certain extent it was still there, it was not as bad it was in the first 2 nights but it was like she was lost. Patient still knew her husband, but it was not like she is going to go out the door and wonder and disappear and not find her way home". Trembling was recovering, outcome of the other events was unknown. Information on the batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019089398 Same reporter, product/ different patient, event.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Ear pain, Facial paralysis, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received PREVNAR 13, Solution for injection in pre-filled syringe via an unspecified route of administration on 06Feb2019 at single dose for immunisation. Medical history included coeliac disease. The patient's concomitant medications were reported as none. The patient experienced headaches in Feb2019 for 5 days following the vaccination. On 22Feb2019, the patient had ear ache in left ear and was then hospitalized on 24Feb2019. He was diagnosed with bilateral bel palsy. Diagnosing Neurologist indicated this could be due to inflammation of C7 nerve following vaccination. The outcome of events was unknown. Information on the batch number has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Nausea, Vomiting
Clinical narrative: Patient with nausea and vomiting.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 18 years old and 11 months. He was given the adult dose instead of the pediatric dose.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Right arm swollen from shoulder to elbow, denied any pain but site was hot to touch.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lip swelling, Tenderness
Clinical narrative: There is a significant area of redness around the injection site (about 1" all around the site). The patient has also complained of the injection area being very tender as well as having some swelling and tenderness of the neck, and mild swelling of lips. The patient took 650mg of Acetaminophen for pain with very limited improvement.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: VACCINE EXPIRED ON 2/19/2019 AND IT WAS ADMINISTERED TODAY. NO S/S OCCURED OR HAVE OCCURED SINCE TIME OF VACCINE ADMINISTRATION.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: At 2pm felt arm was hurting a lot at injection site. Pain worsen to the point that couldn't move the arm. It was hurting like if someone had hit the arm with a baseball bat; he couldn't pick up anything. Patient called after-hours nurse who instructed use of ice and TYLENOL. Treatment helped a little bit. The next day, still felt pain but not as severe; could bend arm again. Patient felt very dizzy, weak, and had heart palpitationslike if he was coming down with something. Patient did not take any other medication and he not have a fever. Called nurse who recommended to continue to move arm even if it hurts--up and downand continue with ice and TYELNOL as needed. By night the level of pain was tolerable, area of injection was sore at touch, felt weak and dizzy so it hard to get on wheelchair. Today arm feels a lot better, it is sore at injection site, has more motion, no pain when moving arm, still feels tired and dizzy. Patient did not take medication today, but continues to use ice packs. At the beginning the pain level was 10/10 and now at 0/10 or 8/10 when touched. Nurse comes daily to home for foot ulcer care.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Palpitations
Clinical narrative: At 2pm felt arm was hurting a lot at injection site. Pain worsen to the point that couldn't move the arm. It was hurting like if someone had hit the arm with a baseball bat; he couldn't pick up anything. Patient called after-hours nurse who instructed use of ice and TYLENOL. Treatment helped a little bit. The next day, still felt pain but not as severe; could bend arm again. Patient felt very dizzy, weak, and had heart palpitationslike if he was coming down with something. Patient did not take any other medication and he not have a fever. Called nurse who recommended to continue to move arm even if it hurts--up and downand continue with ice and TYELNOL as needed. By night the level of pain was tolerable, area of injection was sore at touch, felt weak and dizzy so it hard to get on wheelchair. Today arm feels a lot better, it is sore at injection site, has more motion, no pain when moving arm, still feels tired and dizzy. Patient did not take medication today, but continues to use ice packs. At the beginning the pain level was 10/10 and now at 0/10 or 8/10 when touched. Nurse comes daily to home for foot ulcer care.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Erythema, Heart rate increased, Nasopharyngitis, Pain in extremity
Clinical narrative: PT NOTED HAVING A LOT OF PAIN IN HER RIGHT ARM AND FELT "COMMON COLD SYMPTOMS" THE DAY AFTER. NOTED HER HEART RATE AND BP WERE INCREASED, BUT NOTED IT MIGHT HAVE BEEN STRESS AND HER WORKING ALL DAY. SAID NOW SHE FELT BETTER, BUT HER ARM WAS NOW RED AND HOT BUT IT WAS GETTING BETTER. THIS WAS 3 DAYS LATER. RECOMMENDED SHE TAKE AN NSAID/APAP AND USE COLD COMPRESS/ICE FOR PAIN /SWELLING. SAID SHE WOULD CALL IF THINGS DID NOT IMPROVE.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: PT NOTED HAVING A LOT OF PAIN IN HER RIGHT ARM AND FELT "COMMON COLD SYMPTOMS" THE DAY AFTER. NOTED HER HEART RATE AND BP WERE INCREASED, BUT NOTED IT MIGHT HAVE BEEN STRESS AND HER WORKING ALL DAY. SAID NOW SHE FELT BETTER, BUT HER ARM WAS NOW RED AND HOT BUT IT WAS GETTING BETTER. THIS WAS 3 DAYS LATER. RECOMMENDED SHE TAKE AN NSAID/APAP AND USE COLD COMPRESS/ICE FOR PAIN /SWELLING. SAID SHE WOULD CALL IF THINGS DID NOT IMPROVE.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came in to get his second dose forgetting that he had already received it. He has suffered no ill effects from the extra vaccine. Also his doctor was notified.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever, arm sore, arm swelling, chills. Missed day of work on 3/7/19.
Age: 58.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Arthritis, Injected limb mobility decreased, Injection site inflammation, Injection site irritation, Injection site pain
Clinical narrative: Both shoulders  and deltoids painful, irritated and inflamed. Clicking, crepitus, and popping noises at glenohumeral joints bilaterally. Pain occurred over night. Was unable to sleep on shoulders or sidelying. Unable to get dressed or raise arms above head. Used heat to  shoulders. 2 months later saw Ortho who stated rotator cuffs and deltoids inflammed inadditon to arthritis. On or about 11/19. Reported complaint of prolonged pain to Dr and RN who administered vaccines and RN, MSN, BSN who is the supervisor over the Women's Clinic. Dr concluded incident need not to be report dispite Public Law and that the signs and symptons were NOT due to the vaccine, or adminstration technique but was due to arthritis. According to proper protocol a incident report should be filed with Quality Assurance however, RN believe reporting this incident to QA or CDC is NOT warranted. This is in violaton with VAERS and the Law which governs Compensation and Injury.
Age: 58.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Joint noise, Loss of personal independence in daily activities, Pain, Rotator cuff syndrome, Sleep disorder
Clinical narrative: Both shoulders  and deltoids painful, irritated and inflamed. Clicking, crepitus, and popping noises at glenohumeral joints bilaterally. Pain occurred over night. Was unable to sleep on shoulders or sidelying. Unable to get dressed or raise arms above head. Used heat to  shoulders. 2 months later saw Ortho who stated rotator cuffs and deltoids inflammed inadditon to arthritis. On or about 11/19. Reported complaint of prolonged pain to Dr and RN who administered vaccines and RN, MSN, BSN who is the supervisor over the Women's Clinic. Dr concluded incident need not to be report dispite Public Law and that the signs and symptons were NOT due to the vaccine, or adminstration technique but was due to arthritis. According to proper protocol a incident report should be filed with Quality Assurance however, RN believe reporting this incident to QA or CDC is NOT warranted. This is in violaton with VAERS and the Law which governs Compensation and Injury.
Age: 58.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: X-ray limb abnormal
Clinical narrative: Both shoulders  and deltoids painful, irritated and inflamed. Clicking, crepitus, and popping noises at glenohumeral joints bilaterally. Pain occurred over night. Was unable to sleep on shoulders or sidelying. Unable to get dressed or raise arms above head. Used heat to  shoulders. 2 months later saw Ortho who stated rotator cuffs and deltoids inflammed inadditon to arthritis. On or about 11/19. Reported complaint of prolonged pain to Dr and RN who administered vaccines and RN, MSN, BSN who is the supervisor over the Women's Clinic. Dr concluded incident need not to be report dispite Public Law and that the signs and symptons were NOT due to the vaccine, or adminstration technique but was due to arthritis. According to proper protocol a incident report should be filed with Quality Assurance however, RN believe reporting this incident to QA or CDC is NOT warranted. This is in violaton with VAERS and the Law which governs Compensation and Injury.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pruritus, Mobility decreased, Pain, Pruritus
Clinical narrative: Patient felt sore, weak and could hardly move arm. Next day still felt the same. There was induration at site of vaccination. Friday felt the same. Patient reports sleeping more. Patient still has not called doctor. Saturday symptoms started letting up a bit. Sunday started to feel better; it was the first time that went out after vaccination. Patient felt like she recovered completely by Monday. Last night, vaccination site started to get itchy and hard--similar to symptoms after vaccination. It felt for a while like other parts of a body were itchy as well. Patient put cortisone on site and took Acetaminophen 250mg which helped. Last night soreness was at a 10, today still sore but down to 3-4. Today patient feels better and not itching. Patient reports that nothing has changed besides the vaccine and has been homebound. Patient has not taken any meds since 4am this morning.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Vaccination site induration
Clinical narrative: Patient felt sore, weak and could hardly move arm. Next day still felt the same. There was induration at site of vaccination. Friday felt the same. Patient reports sleeping more. Patient still has not called doctor. Saturday symptoms started letting up a bit. Sunday started to feel better; it was the first time that went out after vaccination. Patient felt like she recovered completely by Monday. Last night, vaccination site started to get itchy and hard--similar to symptoms after vaccination. It felt for a while like other parts of a body were itchy as well. Patient put cortisone on site and took Acetaminophen 250mg which helped. Last night soreness was at a 10, today still sore but down to 3-4. Today patient feels better and not itching. Patient reports that nothing has changed besides the vaccine and has been homebound. Patient has not taken any meds since 4am this morning.
Age: 60.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Impaired work ability, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever, chills, sore arm (cannot lift 10 pounds), swollen arm, missed day of work 3/7/19.
Age: 60.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Weight bearing difficulty
Clinical narrative: Fever, chills, sore arm (cannot lift 10 pounds), swollen arm, missed day of work 3/7/19.
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Child had Diarrhea 2 weeks after Rotavirus was given.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt experienced redness, heat and swelling on the arm vaccinated w PNEUMOVAX. Advised to use cool compresses, antihistamines and closely monitor. If worsens to call office back. No signs of cellulitis.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reported an outbreak of SHINGRIX approximately 7-10 days after pharmacy administered the initial dose of SHINGRIX.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Headache, Neck pain, Rash, Scab
Clinical narrative: Patient reported an outbreak of SHINGRIX approximately 7-10 days after pharmacy administered the initial dose of SHINGRIX.
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 25 months (also reported as 2 years) old male patient received a dose of vaccine PENTACEL on 26-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and PREVNAR. On 26-Feb-2019, the patient received a 4th dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Liquid vial: Lot: U6216AA and expiry date: 30-Sep-2019, Lyophilized Powder: Lot: UI989AC Expiry date:30-Sep-2020 and Package: Lot:UI989ACA Expiry date: 30-Sep-2020) via unknown route in right vastus lateralis. It was a case of actual medication error due to extra dose administered. Nurse reported that Pentacel was given to a 2 year old male on 26-Feb-2019 and that he did not need the polio until 2021 and patient got an extra dose of the polio vaccine. No side effects were reported. 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 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. List of documents held by sender: none.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Influenza like illness
Clinical narrative: Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an over 65 years old patient who experienced flu-like symptoms, while he/she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation. In 2017, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a non-serious flu-like symptoms following the administration of INFLUENZA VACCINE. Patient went to the hospital. Lab test not reported. Final diagnosis was flu-like symptoms. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for flu-like symptoms.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case is linked to case 2019SA062342 (for 19 month old child). This case involves an eight-years-old patient who was vaccinated with first dose of vaccine QUADRACEL (lot C5500CA and Exp. Date  16-Aug-2020) via unknown route in the left thigh (left vastus lateralus) on 29-Jan-2019. The patients medical history not reported and no any concomitant vaccinations received at the time of vaccination. It was an actual medication error case due to inappropriate age at vaccine administration. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient of an unknown demographics who was received DAPTACEL instead of ADACEL, via unknown route in unknown administration site, on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a five-months-old male patient who was vaccinated with 0.5 ml second dose of ACT-HIB (lot: UI974AAA, expiry date: 04-Apr-2020, via intramuscular route in right thigh), which was reconstituted in sterile water, on 01-Mar-2019. Concomitant vaccinations included a dose of PEDIARIX for Immunisation; a dose of PREVNAR 13 for Immunisation and a dose of ROTAVIRUS VACCINE orally for Immunisation. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate reconstitution technique. It was reported that a nurse used sterile water instead of the diluent that came with ACTHIB vaccine on Friday 01 Mar 2019. No symptoms were experienced. 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 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. List of documents held by sender: none.
Age: 0.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 27 months old female patient who was vaccinated with 0.5 ml dose of suspect ACT-HIB lot number UI895AAA (Expiry date 21-Feb-2019) via intramuscular route in the left thigh on 05-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was reported that doctor inadvertently gave a ACTHIB to a patient that expired on 21-Feb-2019. It was not reported whether the patent experienced any adverse events. 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 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 42-years-old female patient who received a expired dose of vaccine ADACEL batch number: U5552AA, expiration date: 08-Feb-2019 via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccine was given on same time. It was an actual medication error due to expired vaccine used. A patient was given an expired dose of ADACEL vaccine. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient states soreness and swelling in arm around injection site. She says that this occurred after the injection and never went away.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Per doctor office, pt had rash develop on chest the evening the shot was given. Pt reported to doctor office 2/25/19 and rash had traveled to cover around trunk as well. Rash was bright red and itchy but not painful. Doctor treated with prednisone.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient said has a bump and arm is swollen and has unusually high pain.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac flutter, Dizziness
Clinical narrative: Patient's husband reports having to take patient to emergency department one or two days after receiving vaccine due to dizziness and heart flutter. Patient was admitted for overnight observation and then released the next day. No specific treatment was reported by husband.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Pain
Clinical narrative: Patient reports "not feeling right" for two weeks after vaccines. Reports redness at site for a few days and substantial pain for several weeks.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Rash and Hives for 2 days.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Atrial fibrillation returned the same day that she received the vaccine.
Age: 1.17
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Pyrexia
Clinical narrative: Patient presented with 2cm, deep red, tender firm lesion on left thigh. Also had fever of 100.6 axillary in office. Patient was treated with Keflex 375mg BID for 7 days.
Age: 1.17
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: Patient presented with 2cm, deep red, tender firm lesion on left thigh. Also had fever of 100.6 axillary in office. Patient was treated with Keflex 375mg BID for 7 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site warmth, Rash
Clinical narrative: Patient presented with erythema and injection site warmness starting the day following injection. By 3 days post injection rash was improving.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Diarrhoea, Immediate post-injection reaction, Nausea, Pain in extremity, Vomiting
Clinical narrative: Arm pain immediately after shot; nausea started around 3:30 PM on 3/7/19; vomiting and diarrhea beginning 4 PM on 3/7/19. No fever - tested twice over a span of two hours.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Swelling, Tenderness
Clinical narrative: Per patient, "severe local reaction about 2-3hours after injection. Redness, swelling to tennis ball size. Extreme tenderness. swelling subsided a little after taking 400mg motrin but remained swollen and tender for two days after".
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Influenza virus test negative, Injection site pain, Nausea
Clinical narrative: Patient C/O Pain at site, redness, swelling, mild fever, headache, nausea, vomiting, body aches.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Swelling, Vomiting
Clinical narrative: Patient C/O Pain at site, redness, swelling, mild fever, headache, nausea, vomiting, body aches.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness
Clinical narrative: Patient reported via secure messaging: At the end of my wellness appt yesterday. I was given a pneumonia vaccine. I thought it was strange the nurse/medical assistant put it so high on my arm almost my shoulder, or possibly my shoulder. Then a few hours later I was in such pain and could not more or use my left arm without being quite painful and my arm was weak and very difficult to lift. I had a miserable night with an ice pack and a pain pill, I was not much better this morning and basically am missing a day of work as it is so painful and feels like my shoulder joint/ or rotator whatever, is a mess. I virtually can not use that arm. RN called and spoke with patient the day after immunization, 3/7/19, and patient reports today that ibuprofen is providing some relief, but still has difficulty with range of motion, and continues to have significant pain. Patient denies any redness or swelling to the injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Right arm slighty swollen, red, irritated and hot on site.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Feeling hot, Injection site swelling, Pyrexia
Clinical narrative: Pt describes swelling at injection site at 40 hours after injection, redness and fever, pain in elbow of injection arm, approximately 60 hours post injection, swelling of half the face, opposite the injection arm. Slight temperature, and redness and warmth of half of face.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: Pt describes swelling at injection site at 40 hours after injection, redness and fever, pain in elbow of injection arm, approximately 60 hours post injection, swelling of half the face, opposite the injection arm. Slight temperature, and redness and warmth of half of face.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt describes swelling at injection site at 40 hours after injection, redness and fever, pain in elbow of injection arm, approximately 60 hours post injection, swelling of half the face, opposite the injection arm. Slight temperature, and redness and warmth of half of face.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Pain, Pyrexia, Sjogren's syndrome, Somnolence
Clinical narrative: Pt describes swelling at injection site at 40 hours after injection, redness and fever, pain in elbow of injection arm, approximately 60 hours post injection, swelling of half the face, opposite the injection arm. Slight temperature, and redness and warmth of half of face.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient indicates she has experienced chronic stabbing pain in the arm since her time of immunization. She indicates it is not all the time, but when placed in certain positions.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site extravasation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe reaction around injection site, 8.5 cm in diameter. Bright red, severe swelling, hot to touch and very tender to touch. 3 days later symptoms slowly decreasing, now 7 cm in diameter with treatment. Cause may have been inappropriate administration by pharmacist into subcutaneous tissue instead of muscle. Prior to injection, pharmacist pinched arm to elevate fat layer, did not inject needle completely into muscle layer and when removing needle the vaccine dripped out of injection site. It was also injected too low on the arm to be in the meat of the deltoid muscle.