chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 22nd March 2019, the patient received the 1st dose of SHINGRIX. On 23rd March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain, contusion, muscle pain, fever and fatigue. On 24th March 2019, the patient experienced lymphedema. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the contusion was not recovered/not resolved and the outcome of the muscle pain, fever and fatigue were recovered/resolved and the outcome of the lymphedema was unknown. It was unknown if the reporter considered the injection site pain, contusion, muscle pain, fever, fatigue and lymphedema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX vaccine in left deltoid and had a pretty bad reaction. She had pain at the injection site, bruising, muscle aches, fever, and fatigue, she was really wiped out. These started on 23rd March 2019, and pretty much went away. The fever went away after one dose of TYLENOL, the muscle aches are pretty much gone, the pain at the injection site had gotten less and less. The fatigue was pretty much gone. The bruise was recovered. On 24th March 2019, she developed lymphedema of her arm and by 25th March 2019, the swelling in her armpit was really bad and it was not getting better. The lot number and expiry date was not known.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient) received via a sales representative. A female patient of an unspecified age received the third dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first and second dose of TRUMENBA on an unspecified date for immunization. The received third dose of meningococcal group b rlp2086 vaccine and was in bed for three days with a fever. The outcome of the event was unknown. Information on the lot number has been requested.
Age: 1.67
Sex: M
Vaccine: PNC13
Symptoms: Balance disorder, Bronchitis, Decreased appetite, Fall, Fatigue
Clinical narrative: Was not vaccinated according to Pfizer's product insert and the CDC guidelines/if starting the Prevnar 13 after 1 year of age that the patient should only receive 2 doses, not 4 doses.; rash on his stomach, bath, and mouth; blisters and welts around the injection site that were over 3 inches in length; blisters and welts around the injection site that were over 3 inches in length; Hives on stomach and back; Fever; Instability walking where he would get off balance and fall; Instability walking where he would get off balance and fall; Instability walking where he would get off balance and fall; Redness around the injection site; A little tired; Not eating as much; This is a spontaneous report from a contactable consumer.  A 20-month-old male patient received third dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on 28Jan2019 and fourth dose on 25Mar2019 at single dose for routine vaccination.  The patient medical history and concomitant medications were not reported.  The patient previously took Prevnar 13 on 19Dec2018 and experienced bronchitis. On Jan2019, when he had the third round of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) he ended up with hives on his stomach and back, had a fever, instability walking where he would get off balance and fall. The second day he had a mild fever and redness around the injection site. By the next day he just had a mild fever and was a little tired and not eating as much. On Tuesday, 25Mar2019, he had his fourth dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). He ended up with a rash on his stomach, bath, and mouth. He had a bad fever that lasted through the night. The next day he had a mild fever and blisters and welts around the injection site that were over 3 inches in length. Yesterday, 26Mar2019, it was reported that he was taken to the urgent care where he was given steroids. He again had the instability walking and was running in to things. Her concern is that after he had these reactions she looked at an insert from pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and looked at the CDC guidelines and her son was not vaccinated according to the guidelines. The insert says that if starting the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) after 1 year of age that the patient should only receive 2 doses, not 4 doses. The outcome of the events was unknown.  Information on the batch number has been requested.
Age: 1.67
Sex: M
Vaccine: PNC13
Symptoms: Gait disturbance, Inappropriate schedule of product administration, Injection site erythema, Injection site reaction, Injection site vesicles
Clinical narrative: Was not vaccinated according to Pfizer's product insert and the CDC guidelines/if starting the Prevnar 13 after 1 year of age that the patient should only receive 2 doses, not 4 doses.; rash on his stomach, bath, and mouth; blisters and welts around the injection site that were over 3 inches in length; blisters and welts around the injection site that were over 3 inches in length; Hives on stomach and back; Fever; Instability walking where he would get off balance and fall; Instability walking where he would get off balance and fall; Instability walking where he would get off balance and fall; Redness around the injection site; A little tired; Not eating as much; This is a spontaneous report from a contactable consumer.  A 20-month-old male patient received third dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on 28Jan2019 and fourth dose on 25Mar2019 at single dose for routine vaccination.  The patient medical history and concomitant medications were not reported.  The patient previously took Prevnar 13 on 19Dec2018 and experienced bronchitis. On Jan2019, when he had the third round of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) he ended up with hives on his stomach and back, had a fever, instability walking where he would get off balance and fall. The second day he had a mild fever and redness around the injection site. By the next day he just had a mild fever and was a little tired and not eating as much. On Tuesday, 25Mar2019, he had his fourth dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). He ended up with a rash on his stomach, bath, and mouth. He had a bad fever that lasted through the night. The next day he had a mild fever and blisters and welts around the injection site that were over 3 inches in length. Yesterday, 26Mar2019, it was reported that he was taken to the urgent care where he was given steroids. He again had the instability walking and was running in to things. Her concern is that after he had these reactions she looked at an insert from pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and looked at the CDC guidelines and her son was not vaccinated according to the guidelines. The insert says that if starting the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) after 1 year of age that the patient should only receive 2 doses, not 4 doses. The outcome of the events was unknown.  Information on the batch number has been requested.
Age: 1.67
Sex: M
Vaccine: PNC13
Symptoms: Oral mucosal eruption, Pyrexia, Rash, Urticaria
Clinical narrative: Was not vaccinated according to Pfizer's product insert and the CDC guidelines/if starting the Prevnar 13 after 1 year of age that the patient should only receive 2 doses, not 4 doses.; rash on his stomach, bath, and mouth; blisters and welts around the injection site that were over 3 inches in length; blisters and welts around the injection site that were over 3 inches in length; Hives on stomach and back; Fever; Instability walking where he would get off balance and fall; Instability walking where he would get off balance and fall; Instability walking where he would get off balance and fall; Redness around the injection site; A little tired; Not eating as much; This is a spontaneous report from a contactable consumer.  A 20-month-old male patient received third dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on 28Jan2019 and fourth dose on 25Mar2019 at single dose for routine vaccination.  The patient medical history and concomitant medications were not reported.  The patient previously took Prevnar 13 on 19Dec2018 and experienced bronchitis. On Jan2019, when he had the third round of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) he ended up with hives on his stomach and back, had a fever, instability walking where he would get off balance and fall. The second day he had a mild fever and redness around the injection site. By the next day he just had a mild fever and was a little tired and not eating as much. On Tuesday, 25Mar2019, he had his fourth dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). He ended up with a rash on his stomach, bath, and mouth. He had a bad fever that lasted through the night. The next day he had a mild fever and blisters and welts around the injection site that were over 3 inches in length. Yesterday, 26Mar2019, it was reported that he was taken to the urgent care where he was given steroids. He again had the instability walking and was running in to things. Her concern is that after he had these reactions she looked at an insert from pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and looked at the CDC guidelines and her son was not vaccinated according to the guidelines. The insert says that if starting the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) after 1 year of age that the patient should only receive 2 doses, not 4 doses. The outcome of the events was unknown.  Information on the batch number has been requested.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 4-decade-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date not provided), via an unspecified route of administration in the arm at the physician's office on 14Feb2019 at a single dose since they travel a lot and husband insisted on it. The patient's medical history and concomitant medications were not reported. The patient experienced swollen arm on 14Feb2019. The patient went back to the doctor the next day and got a steroid shot. Outcome of the event was recovered; physician was unsure when it resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching at the injection site; Swelling and itching at the injection site; This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Case Number: 01144534).  The primary reporter is the physician. The primary reporter reported that a 34 year old female was administered a dose of PREVNAR 13 (unknown lot or expiration date) on an unspecified date ''12 years ago.'' The primary reporter reported that on an unknown date after the administration the patient experienced ''Swelling and itching at the injection site.'' No additional information was provided.  Information on lot/batch number has been requested.
Age: 21.0
Sex: M
Vaccine: FLUR4, MMR
Symptoms: Borrelia test negative, Discomfort, Full blood count normal, Gait disturbance, Immunology test abnormal
Clinical narrative: On Sunday, March 17 there was sudden onset swelling of the right knee which later also went into the left knee. As the night went on swelling moved into the ankles, wrists and fingers. By Monday and Tuesday there was an inability to walk correctly due to swelling and discomfort. I contacted the family doctor who suggested taking him to the ER. He is a student and had to get back home from his school so I would accompany him to the ER. The Infectious Disease doctor came in and I explained the family history of adverse effects from vaccines. He contacted the head of ID to discuss possibility of adverse effect which she confirmed could be the rubella portion of the MMR as also listed on CDC website. Several test were taken.
Age: 21.0
Sex: M
Vaccine: FLUR4, MMR
Symptoms: Joint swelling, Laboratory test normal, Peripheral swelling, Urine analysis normal
Clinical narrative: On Sunday, March 17 there was sudden onset swelling of the right knee which later also went into the left knee. As the night went on swelling moved into the ankles, wrists and fingers. By Monday and Tuesday there was an inability to walk correctly due to swelling and discomfort. I contacted the family doctor who suggested taking him to the ER. He is a student and had to get back home from his school so I would accompany him to the ER. The Infectious Disease doctor came in and I explained the family history of adverse effects from vaccines. He contacted the head of ID to discuss possibility of adverse effect which she confirmed could be the rubella portion of the MMR as also listed on CDC website. Several test were taken.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Ear infection, Malaise, Nasopharyngitis, Pyrexia, Somnolence
Clinical narrative: My son had a fever within hours and slept the rest of the day. This wasn't surprising as I had read this would happen. The next two days he still had a fever which led to a cold and an entire month of sickness (child had never been sick before in life), followed by a double ear infection. This put us out for a month having to take off work and lose money for our family. Before receiving vaccines he was healthy, in the 95th or higher percentile and 'thriving' as the doctor described. Now he has received two rounds of vaccines over the last three months. Over the course of this time he has been constantly sick, hasn't gained any weight or grown at all during this time and both series of vaccines have led to colds and double ear infections with the cold/fever starting the same day as the vaccines and the double ear infection setting in within the week.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Injection site swelling, Mouth swelling, Musculoskeletal discomfort, Neck pain
Clinical narrative: RASH AND SWELLING TO AREA OF INJECTION WITH PAIN UP TO THE NECK, TINGLING OF ARM. PATIENT REPORTED NECK DISCOMFORT WITH SWELLING OF HER THROAT AND MOUTH.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Pharyngeal swelling
Clinical narrative: RASH AND SWELLING TO AREA OF INJECTION WITH PAIN UP TO THE NECK, TINGLING OF ARM. PATIENT REPORTED NECK DISCOMFORT WITH SWELLING OF HER THROAT AND MOUTH.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Influenza like illness, Muscular weakness
Clinical narrative: Flu like symptoms- aches/headaches/chills for 36 hours. One and 1/2 week after, diffuse shifting burning pain back. Chills, very cold hands. Tingling in hands and legs, weakness in legs. She went to ER and put on prednisone which helped resolved symptoms.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Peripheral coldness
Clinical narrative: Flu like symptoms- aches/headaches/chills for 36 hours. One and 1/2 week after, diffuse shifting burning pain back. Chills, very cold hands. Tingling in hands and legs, weakness in legs. She went to ER and put on prednisone which helped resolved symptoms.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Blister, Injection site erythema, Injection site papule, Injection site vesicles, Otitis media
Clinical narrative: Immunizations given 3/6/19, developed URI symptoms with fever on 3/13/19, seen in office on 3/18/19 and diagnosed with bilateral otitis media. Started on amoxicillin. Seen in urgent care on 3/24/19 for persistent otitis symptoms and a rash. Switched to azithromycin 3/24/19. Seen again on 3/27/19 for rash. Noted to have a crop of three vesicles on left upper leg at site of injection with a satellite papule at 4 o'clock and surrounding erythema. Also noted to have a vesicle on (R)upper lip, (L) temple, (R) upper abdomen, and a red macular-popular lesion on right labia majora.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash maculo-papular, Upper respiratory tract infection, Vulval disorder
Clinical narrative: Immunizations given 3/6/19, developed URI symptoms with fever on 3/13/19, seen in office on 3/18/19 and diagnosed with bilateral otitis media. Started on amoxicillin. Seen in urgent care on 3/24/19 for persistent otitis symptoms and a rash. Switched to azithromycin 3/24/19. Seen again on 3/27/19 for rash. Noted to have a crop of three vesicles on left upper leg at site of injection with a satellite papule at 4 o'clock and surrounding erythema. Also noted to have a vesicle on (R)upper lip, (L) temple, (R) upper abdomen, and a red macular-popular lesion on right labia majora.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus generalised
Clinical narrative: Itching and burning all over the body specially arms, legs ,shoulder, buttocks, belly, and back.
Age: 56.0
Sex: M
Vaccine: MMR, VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: Patient felt shivering, fever, nausea, joint pain, lightheadedness, and fatigue about 7 hours after getting the vaccine. He also report sciatic pain shortly after receiving the vaccine that lasted until 11pm the same day. His symptoms are subsiding, but, more than 24 hours later he is still experiencing mild nausea, fatigue, aching, and some lightheadedness.
Age: 56.0
Sex: M
Vaccine: MMR, VARZOS
Symptoms: Pyrexia, Sciatica
Clinical narrative: Patient felt shivering, fever, nausea, joint pain, lightheadedness, and fatigue about 7 hours after getting the vaccine. He also report sciatic pain shortly after receiving the vaccine that lasted until 11pm the same day. His symptoms are subsiding, but, more than 24 hours later he is still experiencing mild nausea, fatigue, aching, and some lightheadedness.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Product administered at inappropriate site, Rash erythematous
Clinical narrative: Patient presented to pharmacy 3 days following vaccine administration with a red rash  approximately 3 inches in diameter on mid-upper arm at least 1-2 inches below thickest part of deltoid muscle. Patient reports that this is where vaccine was administered. Although the pharmacist who documented vaccine administration reported it was given IM in left deltoid, by observation 3 days later, it was evidently administered below the deltoid, more likely hitting subQ tissue.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Rash
Clinical narrative: Patient presented to pharmacy 3 days following vaccine administration with a red rash  approximately 3 inches in diameter on mid-upper arm at least 1-2 inches below thickest part of deltoid muscle. Patient reports that this is where vaccine was administered. Although the pharmacist who documented vaccine administration reported it was given IM in left deltoid, by observation 3 days later, it was evidently administered below the deltoid, more likely hitting subQ tissue.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Blood culture negative, C-reactive protein increased, Conjunctivitis, Culture urine negative, Diarrhoea
Clinical narrative: Kawasaki Disease: patient is a 2mo F who presented to the Hospital with 7 days of fever, diarrhea, rash, and decreasing PO(fevers started on 3/28, and was admitted on 4/3). Initially required a modified sepsis workup with blood culture and urine culture drawn. All cultures  negative, but given her persistent fevers, worsening rash, irritability, conjunctivitis as well as lab values that showed elevated CRP, with pediatric rheumatology consultation, it was determined that she met criteria for Kawasaki Disease. She received IVIG and will be on low dose aspirin.  She is still admitted at this time.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Haematocrit decreased, Haemoglobin decreased, Hypophagia, Immunoglobulin therapy, Irritability
Clinical narrative: Kawasaki Disease: patient is a 2mo F who presented to the Hospital with 7 days of fever, diarrhea, rash, and decreasing PO(fevers started on 3/28, and was admitted on 4/3). Initially required a modified sepsis workup with blood culture and urine culture drawn. All cultures  negative, but given her persistent fevers, worsening rash, irritability, conjunctivitis as well as lab values that showed elevated CRP, with pediatric rheumatology consultation, it was determined that she met criteria for Kawasaki Disease. She received IVIG and will be on low dose aspirin.  She is still admitted at this time.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Kawasaki's disease, Procalcitonin increased, Pyrexia, Rash, Septic screen
Clinical narrative: Kawasaki Disease: patient is a 2mo F who presented to the Hospital with 7 days of fever, diarrhea, rash, and decreasing PO(fevers started on 3/28, and was admitted on 4/3). Initially required a modified sepsis workup with blood culture and urine culture drawn. All cultures  negative, but given her persistent fevers, worsening rash, irritability, conjunctivitis as well as lab values that showed elevated CRP, with pediatric rheumatology consultation, it was determined that she met criteria for Kawasaki Disease. She received IVIG and will be on low dose aspirin.  She is still admitted at this time.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: White blood cell count increased
Clinical narrative: Kawasaki Disease: patient is a 2mo F who presented to the Hospital with 7 days of fever, diarrhea, rash, and decreasing PO(fevers started on 3/28, and was admitted on 4/3). Initially required a modified sepsis workup with blood culture and urine culture drawn. All cultures  negative, but given her persistent fevers, worsening rash, irritability, conjunctivitis as well as lab values that showed elevated CRP, with pediatric rheumatology consultation, it was determined that she met criteria for Kawasaki Disease. She received IVIG and will be on low dose aspirin.  She is still admitted at this time.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Disturbance in attention, Epistaxis, Fatigue, Muscular weakness, Nausea
Clinical narrative: Nausea and fatigue. Difficulties with concentration. Epistaxis. Decreased strength in lower extremities. Evaluated at the office again on 3/26/19. Evaluation and testing recommended in the emergency department. Did not go for evaluation.
Age: 1.58
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swollen area with tenderness at site of immunizations.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Aspiration, Gastrointestinal tube insertion, Incomplete course of vaccination, Selective eating disorder, Swallow study abnormal
Clinical narrative: This spontaneous report was received from a physician concerning a 3 months old male patient. The patient's medical history included reflux, and his concurrent conditions were not reported. He had no drug reactions or allergies. His concomitant medications included ranitidine hydrochloride (ZANTAC) and omeprazole. On 06-DEC-2018, the patient was vaccinated with the first dose of ROTATEQ orally (lot # R021069, expiration date: 18-APR-2020) for prevention of rotavirus. On 22-JAN-2019,  during a routine visit to the physician, it was noticed that the patient's weight percentile was trending downward (weight decreased). The physician determined the patient was experiencing difficulty with feeding and as treatment, the physician directed patient's mother to increase the amount of calories the patient was receiving via breastfeeding and formula feeding. Then, on 06-FEB-2019, the patient received the second dose of ROTATEQ orally (lot # R021069, expiration date: 18-APR-2020)  also for prevention of rotavirus. Due to the patient's difficulty with feeding, patient had a swallow study which was performed on an unknown date in 2019, which determined the patient was experiencing "silent aspiration" (also reported as it was unknown whether this meant the patient may have aspirated dose of ROTATEQ). On 14-MAR-2019, as it was scheduled, the patient was admitted in a hospital for placement of a nasogastric tube which was performed on an unspecified date in March 2019 during hospitalization. On 20-MAR-2019, the patient was discharged from the hospital. Since placement of the nasogastric tube, the patient was not permitted to receive anything by mouth and had not received his third dose of ROTATEQ. It was reported that patient was recently switched from ranitidine hydrochloride (ZANTAC) to omeprazole. At the reporting time, the patient had not recovered from the silent aspiration and weight decreased. The causal relationship between the events and ROTATEQ was not reported.  Upon internal review, silent aspiration was determined to be medically significant.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Weight decreased
Clinical narrative: This spontaneous report was received from a physician concerning a 3 months old male patient. The patient's medical history included reflux, and his concurrent conditions were not reported. He had no drug reactions or allergies. His concomitant medications included ranitidine hydrochloride (ZANTAC) and omeprazole. On 06-DEC-2018, the patient was vaccinated with the first dose of ROTATEQ orally (lot # R021069, expiration date: 18-APR-2020) for prevention of rotavirus. On 22-JAN-2019,  during a routine visit to the physician, it was noticed that the patient's weight percentile was trending downward (weight decreased). The physician determined the patient was experiencing difficulty with feeding and as treatment, the physician directed patient's mother to increase the amount of calories the patient was receiving via breastfeeding and formula feeding. Then, on 06-FEB-2019, the patient received the second dose of ROTATEQ orally (lot # R021069, expiration date: 18-APR-2020)  also for prevention of rotavirus. Due to the patient's difficulty with feeding, patient had a swallow study which was performed on an unknown date in 2019, which determined the patient was experiencing "silent aspiration" (also reported as it was unknown whether this meant the patient may have aspirated dose of ROTATEQ). On 14-MAR-2019, as it was scheduled, the patient was admitted in a hospital for placement of a nasogastric tube which was performed on an unspecified date in March 2019 during hospitalization. On 20-MAR-2019, the patient was discharged from the hospital. Since placement of the nasogastric tube, the patient was not permitted to receive anything by mouth and had not received his third dose of ROTATEQ. It was reported that patient was recently switched from ranitidine hydrochloride (ZANTAC) to omeprazole. At the reporting time, the patient had not recovered from the silent aspiration and weight decreased. The causal relationship between the events and ROTATEQ was not reported.  Upon internal review, silent aspiration was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; the patient was inadvertently administered a dose of VAQTA which expired; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported.      On 04-APR-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # N032753 with expiration date on 23-MAR-2019 (strength, dose, route of administration, and anatomical location were not reported) indicated for prophylaxis.        No adverse effects were reported.
Sex: U
Vaccine: ANTH
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered Anthrax the last week of January that expired December 2018; No adverse reactions; Received a spontaneous report on 05MAR2019 from personnel.  Reported that a patient was administered Anthrax the last week of January that expired December 2018. A patient safety report was filled out and the incident was reported to VAERS. Patient displayed no adverse reactions. Policy changes were made to ensure lot numbers and expiration dates are checked prior to administration.  No further information is expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Inflammation, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: HPI from 2/22/19 office visit (ER follow up): Patient had onset of right upper arm pain beginning about 2 hours following administration of PPSV 23 here in our office on 2/18. The pain escalated to the point where it was extremely severe. She was unable to move the arm using the deltoid muscle and really could not even flex the elbow. The pain did not extend below the elbow. It was a deep ache, not a burning pain. She took a hot bath at home to try to relieve the pain and had an episode of syncope while in the tub. Fortunately, her husband was at home and was able to lower her down to a safe area. No head injury or submersion. She then had an episode of vomiting and diarrhea and 911 was called. She was transported to the ER and evaluated. She received 1 L of fluid, a shot of TORADOL and 10 mg of hydrocodone. Pain started to subside, vital signs were stable and she was discharged to home. There was no evidence of respiratory involvement or infection. On 2/19 she was about 50% improved though still had significant pain in her arm with any engagement of the deltoid muscle. She is taking hydrocodone at night and ibuprofen during the day. Today she found to stay she still had pain with muscle movement and it was not really improved from yesterday. HPI from 3/28/19 office visit: Patient was last seen by Dr. on 2/20/19 for pain in upper right arm after receiving PPSV 23 injection on 2/18/19. Last office visit was noted "Likely inflammatory reaction to the PPSV 23 injection. She is improving slowly.  Encouraged her to continue with heat application as it helps relieve pain. Gentle range of motion exercises as tolerated, Ibuprofen. She will watch closely for redness, increasing warmth, fever, worsening pain. Will come in or call for any of these symptoms." Patient called in on 3/6/19 requesting referral to physical therapy. This was generated and one progress report scanned in on 3/11/19 from Physical Therapy. Today patient states she has been getting PT twice a week for the last couple of weeks. States that it feels good but has on going pain and feels she has pain with some movements. Lateral raises will cause an achiness with a pain scale fo 3-4. Does not stop her from moving and is able to raise her arm laterally. At night will "bug her" and at times will have a dull ache to the deltoid muscle. She just wants to make sure that there is no abscess or fluid pocket that should be lanced, and that this is not related to the joint.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Syncope, Vomiting
Clinical narrative: HPI from 2/22/19 office visit (ER follow up): Patient had onset of right upper arm pain beginning about 2 hours following administration of PPSV 23 here in our office on 2/18. The pain escalated to the point where it was extremely severe. She was unable to move the arm using the deltoid muscle and really could not even flex the elbow. The pain did not extend below the elbow. It was a deep ache, not a burning pain. She took a hot bath at home to try to relieve the pain and had an episode of syncope while in the tub. Fortunately, her husband was at home and was able to lower her down to a safe area. No head injury or submersion. She then had an episode of vomiting and diarrhea and 911 was called. She was transported to the ER and evaluated. She received 1 L of fluid, a shot of TORADOL and 10 mg of hydrocodone. Pain started to subside, vital signs were stable and she was discharged to home. There was no evidence of respiratory involvement or infection. On 2/19 she was about 50% improved though still had significant pain in her arm with any engagement of the deltoid muscle. She is taking hydrocodone at night and ibuprofen during the day. Today she found to stay she still had pain with muscle movement and it was not really improved from yesterday. HPI from 3/28/19 office visit: Patient was last seen by Dr. on 2/20/19 for pain in upper right arm after receiving PPSV 23 injection on 2/18/19. Last office visit was noted "Likely inflammatory reaction to the PPSV 23 injection. She is improving slowly.  Encouraged her to continue with heat application as it helps relieve pain. Gentle range of motion exercises as tolerated, Ibuprofen. She will watch closely for redness, increasing warmth, fever, worsening pain. Will come in or call for any of these symptoms." Patient called in on 3/6/19 requesting referral to physical therapy. This was generated and one progress report scanned in on 3/11/19 from Physical Therapy. Today patient states she has been getting PT twice a week for the last couple of weeks. States that it feels good but has on going pain and feels she has pain with some movements. Lateral raises will cause an achiness with a pain scale fo 3-4. Does not stop her from moving and is able to raise her arm laterally. At night will "bug her" and at times will have a dull ache to the deltoid muscle. She just wants to make sure that there is no abscess or fluid pocket that should be lanced, and that this is not related to the joint.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Chills, Fatigue, Myalgia
Clinical narrative: Upset stomach, abdominal pain, fever, chills, muscle aches, fatigue all during night and day after vaccination.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Upset stomach, abdominal pain, fever, chills, muscle aches, fatigue all during night and day after vaccination.
Sex: F
Vaccine: UNK
Symptoms: Dry skin, Erythema
Clinical narrative: Facial cheeks get very red and dry looking. This happened after her first shots but I found excuses for it, but it happened again this time.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Dizziness, fever of 102.3 degrees Farenheit, swelling and redness in arm at injection site. Began the in the afternoon after receiving injection in the morning.
Age: 8.0
Sex: F
Vaccine: FLU4, HEPA, VARCEL
Symptoms: Loss of personal independence in daily activities, Pruritus, Pyrexia, Rash generalised, Skin lesion
Clinical narrative: Vaccines given on 3/27/2019 per child got 2 shots in right arm and 1 in left.  Went to school on Monday and Tuesday and was feeling fine. Missed on Wed and Thur. Today tried to go but sent home due to rash.  Tuesday evening had tactile fever.  Wednesday rash started on trunk, then spread to face and full body. Sparing feet and palms of hands. 1 lesion on tongue. 1 lesion near right eye. Very itchy. Eating and drinking well. No decreased UOP. Continues to be in good spirits but is a little itchy. Tactile fever has continued until now. Relieved by Tylenol. Last dose of Tylenol was at 730am. No motrin given.   No contacts with same rash Several new products on skin in past 1m Arrived from country 1 m ago Previously well child. No admissions.  No family history immunosuppression.
Age: 8.0
Sex: F
Vaccine: FLU4, HEPA, VARCEL
Symptoms: Tongue disorder
Clinical narrative: Vaccines given on 3/27/2019 per child got 2 shots in right arm and 1 in left.  Went to school on Monday and Tuesday and was feeling fine. Missed on Wed and Thur. Today tried to go but sent home due to rash.  Tuesday evening had tactile fever.  Wednesday rash started on trunk, then spread to face and full body. Sparing feet and palms of hands. 1 lesion on tongue. 1 lesion near right eye. Very itchy. Eating and drinking well. No decreased UOP. Continues to be in good spirits but is a little itchy. Tactile fever has continued until now. Relieved by Tylenol. Last dose of Tylenol was at 730am. No motrin given.   No contacts with same rash Several new products on skin in past 1m Arrived from country 1 m ago Previously well child. No admissions.  No family history immunosuppression.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Muscle tightness, Pain
Clinical narrative: Muscle tightness, burning and swelling at the site of the injection, radiating pain from shoulder to elbow, flu-like symptoms, light rash.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Muscle tightness, burning and swelling at the site of the injection, radiating pain from shoulder to elbow, flu-like symptoms, light rash.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: Heavy vomiting
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: Pruritic rash on down rt arm shortly after administration of vaccine, this resolved after 2hrs.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Nausea, Night sweats, Pain
Clinical narrative: aching of entire body night sweats nausea some chills every day since vaccine was given began the evening of the vaccine.
Age: 36.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Patient states broke out in a rash on 04/01/2019 on her face and arms, and the next day it spread to her legs and torso. Patient was advised to stay away from unvaccinated individuals, and pregnant woman. Patient was advised to seek a health care provider if new symptoms appeared.  On 04/05/2019 Patient states her rash is getting better mostly on her face and arms. Patient denied any other new symptoms at this time.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Fever, injection site soreness, injection site rash (non-itchy), injection site swelling.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: He developed shingles less than 1 month after 1st dose of SHINGRIX.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Morbillivirus test positive, Polymerase chain reaction positive, Pyrexia, Rash generalised
Clinical narrative: Patient became symptomatic on 3/22/2019 with rash around head and had a fever of around 100F.  Rash spread to trunk on 3/23 and then the rest of the body on 3/24.  His fever disapated after 3/22.   Patient was seen at Urgent Care on 3/24 where he was tested for measles.    Rash had mostly disapeared by 3/26.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient complains of dull achy pain lasting more than 8 weeks after the injection. Onset was at the time of injection and comes and goes. It is worst when she sleeps on that particular arm or does yoga.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Loss of consciousness, Transient ischaemic attack
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around May of 2012, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. In or around April 2017, the patient was diagnosed with shingles by her primary care physician. The shingles lasted for approximately two months. In October of 2017, the patient passed out and was subsequently diagnosed as having a transient ischemic attack. Finally, in or around May of 2018 and August of 2018, the patient was again diagnosed with shingles by her primary care physician. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Three events of shingles and transient ischemic attack were reported as disabling. Upon internal review transient ischemic attack was considered medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect; Inadvertantly administered one dose of PROQUAD and one Dose of VARIVAX; This spontaneous report was received from a health professional refers to a patient of age and gender. The patient's medical history, concomitant and historical drugs were unknown. On 29-MAR-2019, the patient was inadvertently vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX),(strength, frequency, route of administration, lot number, batch number, expiration date was unknown) and one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)(strength, frequency, route of administration, lot number, batch number, expiration date was unknown) (inappropriate schedule of product administration). No adverse event was reported.
Sex: F
Vaccine: MMR
Symptoms: Thalassaemia, Transfusion
Clinical narrative: This spontaneous report was received from a pharmacist regarding to a female patient of unknown age. The patient's medical history, concurrent condition, concomitant medications and drug allergies were not reported. On an unknown date, as a child the patient was vaccinated with M-M-R II (albumin status, dose, frequency, strength, lot/batch # and expiry date were unknown) as vaccine. On an unspecified date the patient was diagnosed with thalassemia and since unspecified dates, received blood transfusions every 3 weeks. The reporter refused to answer if any medical attention was sought, if any intervention was made to prevent serious criteria, if there was hospitalization or prolonged hospitalization and if the event was life threatening. The outcome of event thalassaemia was reported as not recovered. The causality of the event thalassaemia was not reported. Upon internal review the event thalassaemia was considered to be serious (medically significant).
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: About 10:30 AM 4/4/19 the day after I received the vaccine, I started to feel achy, tired, and 'flu-ish'. These symptoms continue to worsen throughout the day, although I never got a headache. My nose also began running mid-afternoon. I had a fever of about 99.6 by 12:30 PM; by 6:30 it was 100.9. I then took 2 acetaminophen and soon began to feel better. By 10:00 I no longer had a fever. I took 2 ibuprofen about 10:30 before going to bed. I feel pretty much recovered today, 4/5/19, have not had a fever. I am a little more tired than usual.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Peripheral swelling, Pyrexia, Skin warm, Swollen tongue
Clinical narrative: Swollen tongue, left arm swelling, warm to touch, difficult breathing, SOB, fever.
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Cough, Fatigue, Headache
Clinical narrative: 04/10/2019: Follow up received from patient: I forgot to include that I felt a very slight nausea when the headache started (evening of 4/3) and had no appetite the following morning.   9:30 PM beginning of a mild dull head ache;  11:00 PM -10-15 minute coughing spell bringing up generous amounts of clear mucus;   1:30 AM awakened with body wracking chills which lasted 3 hours; at 2:30 AM I took 2 Tylenol and added more blankets.  The following morning (4/4) , I was extremely tired and a bit weak but by noon time I felt able to eat and felt better as the day went by.
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Productive cough
Clinical narrative: 04/10/2019: Follow up received from patient: I forgot to include that I felt a very slight nausea when the headache started (evening of 4/3) and had no appetite the following morning.   9:30 PM beginning of a mild dull head ache;  11:00 PM -10-15 minute coughing spell bringing up generous amounts of clear mucus;   1:30 AM awakened with body wracking chills which lasted 3 hours; at 2:30 AM I took 2 Tylenol and added more blankets.  The following morning (4/4) , I was extremely tired and a bit weak but by noon time I felt able to eat and felt better as the day went by.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Lethargy, Myalgia, Pyrexia
Clinical narrative: I am flat on my back in bed. I feel like I have a massive case of the flu. Aching joints, feverish, lethargic, muscle pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Injection site swelling, Myalgia, Nausea
Clinical narrative: Muscle pain, severe exhaustion, swelling at injection site, nausea/upset stomach. Went to sleep for 2 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia, Swelling
Clinical narrative: Pain, swelling, tired, low-grade fever. 99.5
Age: 17.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Seizure, Syncope
Clinical narrative: Tunnel vision, dizziness, fainting, convulsions, sweating. Low blood pressure.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Tunnel vision
Clinical narrative: Tunnel vision, dizziness, fainting, convulsions, sweating. Low blood pressure.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Immediate post-injection reaction, Memory impairment, Seizure
Clinical narrative: Tunnel vision, dizziness, fainting, convulsions, sweating. Low blood pressure.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Seizure, Syncope
Clinical narrative: Immediately after brief "episode" which involved some brief convulsions. Patient reported that he did not remember what happened. Patient reported not eaten breakfast.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Tunnel vision
Clinical narrative: Immediately after brief "episode" which involved some brief convulsions. Patient reported that he did not remember what happened. Patient reported not eaten breakfast.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Immediate post-injection reaction, Memory impairment, Seizure
Clinical narrative: Immediately after brief "episode" which involved some brief convulsions. Patient reported that he did not remember what happened. Patient reported not eaten breakfast.