chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient describes gradual onset of bilat LE weakness and "sore muscle pain" that progressed into bilat UE. These symptoms started axially and progressed into the feet and then hands. He also developed frontal HAs. He denies that there was any difficulty with breathing or swallowing. There also was no proceeding symptoms C/W viral or bacterial infection. He went to the ER for care and had a full W/U to include multiple spinal taps, blood work, and CT - all of which were non-diagnostic. He was sent home with medication for symptomatic relief. The symptoms slowly resolved over the course of two weeks. He now denies any residual symptoms and has a normal physical examination.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: Patient had redness and swelling around the injection site.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Balance disorder, Clumsiness, Constipation, Cough, Crying
Clinical narrative: Screaming, non stop crying, fever, lose of appetite, all within the night following the vaccination and some. Continued in the course of a month and a half, wheezing, dry coughing, runny nose, rash, constipation, insecure, clumsy and unable to keep balance. Prior to vaccination he was already walking, he has now stopped.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Decreased appetite, Fear, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Screaming, non stop crying, fever, lose of appetite, all within the night following the vaccination and some. Continued in the course of a month and a half, wheezing, dry coughing, runny nose, rash, constipation, insecure, clumsy and unable to keep balance. Prior to vaccination he was already walking, he has now stopped.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Screaming, Wheezing
Clinical narrative: Screaming, non stop crying, fever, lose of appetite, all within the night following the vaccination and some. Continued in the course of a month and a half, wheezing, dry coughing, runny nose, rash, constipation, insecure, clumsy and unable to keep balance. Prior to vaccination he was already walking, he has now stopped.
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was inadvertently given a zoster vaccine instead of a varicella vaccine. Patient reports no untoward effects.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product preparation error
Clinical narrative: Information has been received from a physician via Poison and Drug Center (PDC) referring to a baby patient of unknown age and gender. The patient's medical history and concurrent condition were unknown. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, lot# and route unknown) and a dose of VARIVAX (Merck) (dose, lot # and route unknown). The physician reported that the vaccines were administered using potentially tainted diluent, which was extra diluent in the physician's office (lot #LO28090 with expiration date of 26-MAR-2018), but was not provided with the vaccines. At the time of reporting, it was unknown if the patient continued to receive M-M-R II and VARIVAX (Merck). Additional information been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner regarding a female patient of unknown age. No concomitant medication was reported. On 22-DEC-2015, the patient was vaccinated with GARDASIL dose and it has been over 1 year since she received the 1st dose of GARDASIL. No adverse event was reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 31-DEC-2015, the patient was vaccinated with expired dose of VARIVAX (Merck) lot # J012210 with expiry date of 28-SEP-2015. No adverse effects were reported. Additional information is not expected as the reporter denied consent for further contact.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. Past medical history and concurrent conditions were not reported. On unspecified dates in 2013, the patient received complete set of 3 doses of GARDASIL 1 vial of 1. intramuscular route (dose, strength, vaccination site. #lot, expiry date unspecified). Concomitant medications were not provided. On 31-DEC-2015, the patient received another dose of GARDASIL 1 vial of 1, intramuscular route (dose, strength, vaccination site, #lot, expiry date unspecified). No product quality complaint (PQC) was reported. There was no known adverse effects. No further information was provided. Additional information has been requested.
Age: 92.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Pleural effusion, Productive cough, Respiratory tract congestion
Clinical narrative: CHEST CONGESTION, COUGH, PRODUCTIVE COUGH, FLUID IN LUNGS. SEEN IN OUR OFFICE 12/18/2015. SYMPTOMS FOR 10+ DAYS.
Age: 28.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Pruritus
Clinical narrative: A few minutes after administration, the patient started getting itchy on the left hand.  I gave her 10 ml of liquid Benadryl as well as an ice pack.  Minutes later, the symptoms went away and she was fine.  We continued to monitor and she had no complaints.  She then went home and I did a follow-up phone call to check on her and she reports no symptoms.
Age: 0.34
Sex: F
Vaccine: IPV
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Rash erythematous, Rash generalised
Clinical narrative: Broke out in a red blotchy rash covering the whole body including the injection site.
Age: 0.34
Sex: F
Vaccine: IPV
Symptoms: Rash macular
Clinical narrative: Broke out in a red blotchy rash covering the whole body including the injection site.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MMR, TD
Symptoms: Hyperventilation, Hypoaesthesia, Muscle spasms, Rash
Clinical narrative: After vaccines were administered to patient at 11:50 AM, patient was advised to wait 30 minutes for monitoring. Patient was speaking to the nurse for about 5 minutes and the patient started hyperventilating and complaining of numbness to both arms and cramping on both hands. Patient remained alert and oriented x3. Nurse remained with patient and measures were done to attempt to calm patient down. Patient calmed down and was breathing normally, and minutes later started hyperventilating again and rashes were observed on patient's upper chest. Telephone call made to 911 for emergency intervention.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching at site as well as redness and swelling of upper arm.  Eventually upper arm became all red and swollen the entire way around my arm.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Presyncope, Pyrexia, Vomiting
Clinical narrative: Patient developed a fever. This am he vomited x1 and had a near syncopal event.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Neck pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Pain in upper right arm and neck. Started out with mild pain and progressed into severe pain in arm and neck. I finally went to a doctor and in treatment now. MRI has been done, awaiting results.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: The day after shot upper arm was hot, swollen (about the size of palm was swollen) and red.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Pain, Skin warm
Clinical narrative: Bruise, occasional throbbing and warm to touch, redness.
Age: 37.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pt had initial swelling and pain to injected arm.  Now continues to complain of continued soreness, particularly with exercising.
Age: 1.28
Sex: F
Vaccine: DTAP, FLUX, HIBV, VARCEL, FLUX, HIBV, TDAP, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and fever.
Age: 1.3
Sex: F
Vaccine: HEPA, MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: 12/22 - Received MMR vaccine. 8 days later developed fever to 104 F. On 12/31/2015, had complex febrile seizure.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal distension, Cough, Diarrhoea, Dysuria, Food aversion
Clinical narrative: 11/3/15 - Got 2 mos immunizations. 11/10/15 - ER - cough, congestion, diarrhea, decreased PO - viral gastro. 11/11/15 clinic little better - diarrhea each feed - viral gast. 11/19/2015 - ER admit - decreased PO intake, decreased void -> TPN, rectal, NG feeds. 12/01/15 - Discharged. 12/11 - GI clinic appt. - feeding aversion, abd distention - BM only with saline rectal irrigations and stimulation. 12/11/15 - Readmit to hospital - NPO/TPN or NG feeds - still only stool with irrigations and stimulations. 12/21/15 - G-tube placed in OR. 12/22/15 - Discharged home NPO (aspiration risk with D.S.) on GT feedings, irrigations and stimulation.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Gastroenteritis viral, Gastrointestinal tube insertion, Gastrostomy, Hypophagia, Parenteral nutrition
Clinical narrative: 11/3/15 - Got 2 mos immunizations. 11/10/15 - ER - cough, congestion, diarrhea, decreased PO - viral gastro. 11/11/15 clinic little better - diarrhea each feed - viral gast. 11/19/2015 - ER admit - decreased PO intake, decreased void -> TPN, rectal, NG feeds. 12/01/15 - Discharged. 12/11 - GI clinic appt. - feeding aversion, abd distention - BM only with saline rectal irrigations and stimulation. 12/11/15 - Readmit to hospital - NPO/TPN or NG feeds - still only stool with irrigations and stimulations. 12/21/15 - G-tube placed in OR. 12/22/15 - Discharged home NPO (aspiration risk with D.S.) on GT feedings, irrigations and stimulation.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Respiratory tract congestion
Clinical narrative: 11/3/15 - Got 2 mos immunizations. 11/10/15 - ER - cough, congestion, diarrhea, decreased PO - viral gastro. 11/11/15 clinic little better - diarrhea each feed - viral gast. 11/19/2015 - ER admit - decreased PO intake, decreased void -> TPN, rectal, NG feeds. 12/01/15 - Discharged. 12/11 - GI clinic appt. - feeding aversion, abd distention - BM only with saline rectal irrigations and stimulation. 12/11/15 - Readmit to hospital - NPO/TPN or NG feeds - still only stool with irrigations and stimulations. 12/21/15 - G-tube placed in OR. 12/22/15 - Discharged home NPO (aspiration risk with D.S.) on GT feedings, irrigations and stimulation.
Age: 61.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Accidental exposure to product, Erythema, Eye disorder, Eye pruritus, Pruritus
Clinical narrative: This spontaneous report as received from a 61-year-old male patient, who was also a pharmacist and refers to himself. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient administered ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). The pharmacist stated that he did not wear gloves when he reconstituted the ZOSTAVAX. Sometimes after reconstituting, while he was trying to get the air out of the syringe, a small droplet formed at the end of the needle. Event though the droplet had no contact with his skin, it was possible that the droplet fell on the work surface. On 10-DEC-2015, pharmacist noticed the skin of outside edge of his left eye was itchy, not intense but was felt. He thought maybe he was contacting conjunctivitis, which did not develop. Another time, he felt a twinge at the same site of left eye (date unspecified). The patient stated that the night before the onset, he ate chili and was wondering if he somehow touched that area of his eye. Pharmacist stated all symptoms of the left eye resolved on approximately 14-DEC-2015. On 15-DEC-2015, he had itching on the left side of his lower ribs to the middle of back going around toward the front. He stated he had no rash, no papules, no shingles, only redness, which could have been from scratching. The patient mentioned he did yard work the day before and that could have been the cause. The outcome of itching on the left side of his lower ribs to the middle of back going around toward the front and redness was not reported. Causality assessment was not provided. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (LVN) refers to a 4 month old female patient. Patient's concurrent condition and medical history was not known. On 05-DEC-2015, the 4  month old patient was vaccinated with PNEUMOVAX 23 (lot # L027732, expiry date: 23-FEB-2017). No adverse effects were reported. No product quality complaints (PQC) was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L002310, expiration date 08-JUL-2016 or lot # L012215, expiration date 13-JAN-2017 (doses and routes of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On an unknown date, since 26-OCT-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # L016427 expiration date: 13-APR-2017 and lot# "K022265" expiration date: 22-OCT-2016  (administration route was not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a 62 year old female patient, reporting on herself. The patient's pertinent medical history included breast cancer and knee replacement. It was reported that the patient had no drug reactions or allergies. On 29-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 one shot, (lot #, expiration date, exact dose and route of administration were not reported). Concomitant therapies included influenza virus vaccine (unspecified) (reported as unspecified flu shot). On approximately 06-OCT-2015 (reported as about one week after receiving PNEUMOVAX 23), the patient developed hives. She sought medical attention, had an office visit and an unspecified steroid shot was given for the adverse event. No lab diagnostic studies were performed. No PQC (product quality complaint) was involved. The outcome of the event was reported as not recovered. At the time of report the patient continued to experience hives. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a multiple unspecified patients. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L008664, expiration date 03-NOV-2016) doses, routes, anatomical locations were not reported. No concomitant medications were reported. No adverse effects were reported. No further information was provided. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Neuropathy peripheral
Clinical narrative: Information has been received from a currently 80 years old female patient via Pfizer (Company No. 2015457004). In 2002, when the patient was approximately 67 years old, she was vaccinated with a dose of PNEUMOVAX 23 (dose, site and route not reported). In 2004, when the patient was approximately 69 years old, she developed neuropathy The outcome of neuropathy peripheral was not reported. The relationship between neuropathy and therapy with PNEUMOVAX 23 was not reported. This report is linked to MARRS 1601USA000869 from the same patient. Additional information is not expected as the patient did not want to be contacted for follow up.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Abasia, Blood glucose normal, Head injury, Hypopnoea, Lethargy
Clinical narrative: Information has been received from a registered nurse referring to an 11 year old male patient with asthma and allergy to amoxicillin. On 21-DEC-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot # L020015 with expired date 16-AUG-2017, dose and route were unknown) along with MENACTRA and Tdap. Concomitant therapy also included albuterol sulfate inhaler (manufacturer unknown). The patient was observed for 10-15 minutes in the office following administration and he was doing fine with no issues so he was sent home. As the patient was leaving and walking out of the office with his mom, he fainted and hit his head on the ground. The reporter stated that fainting lasted less than a minute and the patient was conscious again. But the patient was very lethargic, was not responding on his own when the reporter asked what his name was and could not get up and walk on his own so the reporter and the patient's mom had to help him get up and they carried him back to exam room. The patient was laid down in the exam room. The patient was given GLUCOLA and some water because the patient did not eat anything this morning prior to receiving vaccines. The reporter checked the patient's blood sugar and pulse oximetry. Both of them were fine. The reporter noticed that the patient's respiration was little shallow and rough. But the patient was slowly coming back. In about 20 minutes, the patient was able to sit up by himself and able to respond to questions. The patient was asked to walk back and forth after he was fully sitting up and he was able to walk on his own without any problem. The patient's vital signs were checked and everything was good. So the patient was sent home. The patient's mother called the office back about 10 minutes after leaving the office to inform the patient was all better and was doing fine. The outcome of the event "head injury" was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Mobility decreased, Respiration abnormal, Syncope, Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse referring to an 11 year old male patient with asthma and allergy to amoxicillin. On 21-DEC-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot # L020015 with expired date 16-AUG-2017, dose and route were unknown) along with MENACTRA and Tdap. Concomitant therapy also included albuterol sulfate inhaler (manufacturer unknown). The patient was observed for 10-15 minutes in the office following administration and he was doing fine with no issues so he was sent home. As the patient was leaving and walking out of the office with his mom, he fainted and hit his head on the ground. The reporter stated that fainting lasted less than a minute and the patient was conscious again. But the patient was very lethargic, was not responding on his own when the reporter asked what his name was and could not get up and walk on his own so the reporter and the patient's mom had to help him get up and they carried him back to exam room. The patient was laid down in the exam room. The patient was given GLUCOLA and some water because the patient did not eat anything this morning prior to receiving vaccines. The reporter checked the patient's blood sugar and pulse oximetry. Both of them were fine. The reporter noticed that the patient's respiration was little shallow and rough. But the patient was slowly coming back. In about 20 minutes, the patient was able to sit up by himself and able to respond to questions. The patient was asked to walk back and forth after he was fully sitting up and he was able to walk on his own without any problem. The patient's vital signs were checked and everything was good. So the patient was sent home. The patient's mother called the office back about 10 minutes after leaving the office to inform the patient was all better and was doing fine. The outcome of the event "head injury" was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Breath sounds abnormal, Communication disorder, Head injury, Hypopnoea
Clinical narrative: Information has been received from a registered nurse referring to an 11 year old male patient with asthma and allergy to amoxicillin. On 21-DEC-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot # L020015 with expired date 16-AUG-2017, dose and route were unknown) along with MENACTRA and Tdap. Concomitant therapy also included albuterol sulfate inhaler (manufacturer unknown). The patient was observed for 10-15 minutes in the office following administration and he was doing fine with no issues so he was sent home. As the patient was leaving and walking out of the office with his mom, he fainted and hit his head on the ground. The reporter stated that fainting lasted less than a minute and the patient was conscious again. But the patient was very lethargic, was not responding on his own when the reporter asked what his name was and could not get up and walk on his own so the reporter and the patient's mom had to help him get up and they carried him back to exam room. The patient was laid down in the exam room. The patient was given GLUCOLA and some water because the patient did not eat anything this morning prior to receiving vaccines. The reporter checked the patient's blood sugar and pulse oximetry. Both of them were fine. The reporter noticed that the patient's respiration was little shallow and rough. But the patient was slowly coming back. In about 20 minutes, the patient was able to sit up by himself and able to respond to questions. The patient was asked to walk back and forth after he was fully sitting up and he was able to walk on his own without any problem. The patient's vital signs were checked and everything was good. So the patient was sent home. The patient's mother called the office back about 10 minutes after leaving the office to inform the patient was all better and was doing fine. The outcome of the event "head injury" was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Lethargy, Syncope
Clinical narrative: Information has been received from a registered nurse referring to an 11 year old male patient with asthma and allergy to amoxicillin. On 21-DEC-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot # L020015 with expired date 16-AUG-2017, dose and route were unknown) along with MENACTRA and Tdap. Concomitant therapy also included albuterol sulfate inhaler (manufacturer unknown). The patient was observed for 10-15 minutes in the office following administration and he was doing fine with no issues so he was sent home. As the patient was leaving and walking out of the office with his mom, he fainted and hit his head on the ground. The reporter stated that fainting lasted less than a minute and the patient was conscious again. But the patient was very lethargic, was not responding on his own when the reporter asked what his name was and could not get up and walk on his own so the reporter and the patient's mom had to help him get up and they carried him back to exam room. The patient was laid down in the exam room. The patient was given GLUCOLA and some water because the patient did not eat anything this morning prior to receiving vaccines. The reporter checked the patient's blood sugar and pulse oximetry. Both of them were fine. The reporter noticed that the patient's respiration was little shallow and rough. But the patient was slowly coming back. In about 20 minutes, the patient was able to sit up by himself and able to respond to questions. The patient was asked to walk back and forth after he was fully sitting up and he was able to walk on his own without any problem. The patient's vital signs were checked and everything was good. So the patient was sent home. The patient's mother called the office back about 10 minutes after leaving the office to inform the patient was all better and was doing fine. The outcome of the event "head injury" was unknown. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: HEPA, PNC, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 9 week old infant. Patient's medical history or concurrent conditions were not reported. On 07-OCT-2015, the patient was vaccinated in error with a dose of VAQTA (lot # L002717, expiry date 02-JUN-2017). The infant also received doses of PREVNAR and ROTATEQ, oral (manufacturer unknown). The infant had not demonstrated any adverse effects at the time of this report. Follow up information has been received from a registered nurse on 29-DEC-2015. Patient demographics updated. It was reported that VAQTA was ordered and given intramuscularly, instead of Hepatitis B vaccine. The patient also received Oral, ROTATEQ and PREVNAR concomitantly. Additional information is not expected as all correspondence was received. Reporter, patient, product information and narrative updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated orally with improperly stored doses of ROTATEQ lot # K015843, expiration date 04-MAY-2016, lot # K022995, expiration date 22-JUL-2016 (doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a multiple unspecified patients. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, (Lot # L006181, expiration date 13-DEC-2016), doses were not specified. No concomitant medications were reported. No adverse effects were reported. No further information was provided. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a multiple unspecified patients. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (Lot # L029631, expiration date 14-AUG-2017) doses, routes, anatomical locations were not reported. No concomitant medications were reported. No adverse effects were reported. No further information was provided. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a multiple unspecified patients. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA, (Lot # L004734, expiration date 01-JUN-2017) doses, routes, anatomical locations were not reported. No concomitant medications were reported. No adverse effects were reported. No further information was provided. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K010216, expiration date 17-SEP-2016, lot # K014190, expiration date 24-OCT-2016, lot # K007263, expiration date 09-JUN-2016 or lot # L007558, expiration date 10-NOV-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Musculoskeletal discomfort
Clinical narrative: This spontaneous report was received from a 60 year old female consumer, reporting on herself, with unspecified hypersensitivity to MIGRANAL. There was not pertinent medical history. On 21-DEC-2015, the patient was vaccinated without prescription from a physician, with ZOSTAVAX, (dosage, route, lot# and expiration date were not reported). There was not concomitant therapy. On approximately 22-DEC-2015, (reported as "after one or two days") the patient experienced musculoskeletal discomfort, reported as "constant pressure on her back", then on approximately 24-DEC-2015, (reported as "on Thursday or Friday"), the patient experienced herpes zoster, reported as "shingles". The patient sought medical attention by a physician visit and VALTREX was prescribed. There were not laboratories studies performed. The outcome of herpes zoster and musculoskeletal discomfort was reported as recovering at the time of this report, as the patient just started medication on 30-DEC-2015. Additional information is not expected because the reporter did not provided details to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On an unknown date, since 26-OCT-2015, the patients were vaccinated with improperly stored doses of ROTATEQ lot # reported as : L008054 expiration date: 30-NOV-2016 (administration route was not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Hello, My 9-week-old went in for his two month vaccines this past Friday, November 20. When I returned to work after his appointment I received a call from his doctor's office saying that the nurse mistakenly gave my son two injections of sterile water and no vaccines. After further questioning, it now appears that they were wrong and that my son received all vaccines except for the powdered Hib mix in that should have been added to his PENTACEL injection. I'm still trying to get written documentation and clarification from his doctor's office to determine exactly what he did and didn't receive - did he receive saline or did he receive all but Hib? And until he goes back in, he's still vulnerable to meningitis and, should be happen to develop a fever between now and the time he receives his Hib vaccines, he'll be admitted to the hospital and require a spinal tap to rule out meningitis all because of the negligence of the nurse. He was seen at the office.
Age: 0.3
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 31-DEC-2015, the patient was inadvertently vaccinated with a dose of GARDASIL 9 injection (strength, dose, route of administration, lot number and expiration date were not reported). The reporter confirmed that the vaccine administered was not GARDASIL. There was no adverse effect reported. Additional information is not expected as no consent for correspondence contact was reported.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a multiple unspecified patients. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL (Lot # L010596, expiration date 06-APR-2017) doses. routes, anatomical locations were not reported. No concomitant medications were reported. No adverse effects were reported. No further information was provided. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Developed a large hot red area on arm after receiving the current 2015/2016 influenza vaccination.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of an unknown age and gender. No historical, concurrent conditions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (Lot#L013063 and expiry: 14-APR-2017; Lot#L017142 and expiry: 13-MAY-2017; Lot#L025207 and expiry: 07-JUL-2017) (incorrect product storage). No adverse effects were reported. No Product Quality Complaint (PQC) was reported. This is one of the two reports received from the same reporter. Additional information is not expected as consent for contact was denied.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L004014, expiration date 04-MAR-2017 (doses and routes of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site pain
Clinical narrative: Pain at injection site.
Age: 53.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Rash
Clinical narrative: Rash. Triamcinolone 40 mg once, diphenhydramine 50 mg once.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of ROTATEQ, lot # L008054, expiration date 30-NOV-2016 (dose was not reported) were given to unspecified patients on unspecified dates. No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: TYP
Symptoms: Blood test normal, Diplopia, IVth nerve paralysis, Neurological examination normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Re VIVOTIF Berna EC Capsules- live oral vaccine for typhoid Ty21a: 59 year old man developed acute onset diplopia in all visual fields after taking the second of four oral doses of this attenuated vaccine. The diplopia was primarily vertical. Past medical history notable only for controlled hypertension, on metoprolol, diltiazem, and losartan. There was no history of prior neurological abnormalities, visual disturbances, head trauma, or intercurrent or recent illnesses. Neurology and neuro-ophthalmology consults were obtained. Neurological exam was normal apart from diplopia. Brain MRI was unremarkable. Blood tests were unremarkable. Diagnosis by neuro-ophthalmologist was fourth cranial nerve palsy. After two weeks the patient (a physician) self-prescribed a 6-day steroid taper. Diplopia began to slowly improve after this, although it is uncertain to what extent steroids contributed. After two months the diplopia was restricted to far right gaze, and by 3.5 months the diplopia had completely resolved. The temporal relationship to taking this oral vaccine strongly suggests an adverse immunological response to the medication.
Age: 1.2
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 14 month old patient of unknown gender. Medical history and concurrent conditions were not provided. On 22-DEC-2015 (reported as yesterday), the patient was vaccinated with a dose of ZOSTAVAX instead of VARIVAX (dose, route, lot number and expiration date were not reported). No adverse effects reported at this time. There was no concomitant medication provided and no Product Quality Complaint (PQC) involved. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and unknown gender. No medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L020015 and expiry date 16-AUG-2017, and lot # L028083 and expiry date 03-SEP-2017) (dosage, frequency and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling, Wrong drug administered
Clinical narrative: I have 2 sons ages 15 and 12 that are on a modified vaccine schedule to accommodate severe allergies. They were to receive Tdap doses and instead received 2 consecutive doses (2-weeks apart) of D-Tap vaccine instead. They both experienced extreme tenderness and moderate swelling at the injection sites. It was even more pronounced after the 2nd dose that we now understand was not even needed as well as wrong.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Pain
Clinical narrative: Swelling (R) upper arm from elbow to shoulder. Horizontal red streak above (R) antecubital. Pain with raising arm. Ice and elevation.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Approximately 10 hrs post given vaccine had temp approximately 102 and felt nauseated w/headache. Fever lasted 2 days.
Age: 16.0
Sex: F
Vaccine: FLU4, MEN, MENB
Symptoms: Headache
Clinical narrative: This case was reported by a nurse via licensee and described the occurrence of headache in a 16-year-old female patient who received Influenza vaccine Quadrivalent. Co-suspect products included Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and Meningitis B vaccine. On 29th October 2015, the patient received Influenza vaccine Quadrivalent, the 2nd dose of Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and the 1st dose of Meningitis B vaccine. In 2015, less than a month after receiving Influenza vaccine Quadrivalent and Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, the patient experienced headache. In 2015, the outcome of the headache was recovered/resolved. The reporter considered the headache to be related to Influenza vaccine Quadrivalent and Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. Additional details were provided as follows: On Thursday, 29th October 2015, the patient received 1st dose of TRUMENBA and 2nd dose of Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine in her left arm. On the same day, the patient received Influenza vaccine Quadrivalent in her right arm. The patient then complained of experiencing a bad headache for two and half days and this was reported by patient's mother at the office. The patient's mother began some sort of medication at home for the patient's headache but she did not say what the medication was. The sales representative of other manufacturer reported that he did not have any patient details including name, medical history and other details and added that the doctor's office will be happy to share other information. The reporter mentioned that the doctor did not know but he suspect that the adverse event was related to the vaccines. The doctor also did not know if it was combination of the vaccines or a single vaccine and they were actually calling to find out that and the reporter told them to call Medical Affairs to find the information. The sales representative called back to confirm the reporter of the adverse event and nurse as confirmed as reporter who had same address and contact as of doctor and added that he did not have the email address of the doctor. Limited information was available to the sales representative. It was unknown if the reporter considered the headache to be related to TRUMENBA. This case has been linked to case US2015GSK172261, reported by the same reporter.
Age: 1.82
Sex: F
Vaccine: FLU3
Symptoms: Clumsiness, Gait disturbance
Clinical narrative: Received Flu shot 0.25 mg IM on 12/24/15 at 11 am. By evening patient started becoming clumsy. Next day daycare teacher noted clumsiness and tripping. Improved in 1 week.
Age: 1.76
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Hypersensitivity, Rash generalised
Clinical narrative: Parent stated shortly after returning home the child broke out in a raised rash. On 1-5-16 the child had a generalized rash (hives ?). The parent took the child to the doctor and steroids were prescribed for an allergic reaction.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Urticaria
Clinical narrative: Hives or rash covered entire body (except face, hand and feet) starting the morning after receiving shot. Took Diphenhydramine HD 25 mg every 6 hours. As of 12/26/15 most of rash has diminished.
Age: 46.0
Sex: F
Vaccine: FLUC3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Skin rash and urticaria pruritus.
Age: 16.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Headache, Hyperaesthesia, Influenza like illness, Myalgia
Clinical narrative: Case number PHEH2015US021296 is an initial spontaneous report from a nurse received on 16 Oct 2015. This report refers to a 16-year-old female patient. Concomitant drug included LO LOESTRIN FE. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported) on 08 Oct 2015 in the left deltoid. On 15 Oct 2015, the patient was vaccinated with RABAVERT (batch number: 578011A, expiry date: 30 Sep 2018) intramuscularly in the left deltoid. On the same date, 9 hours after RABAVERT vaccination the patient experienced severe myalgia, she felt like she was getting the flu, her skin sensitive to touch, had chills, nausea, feverish, severe headache and her arm hurt a lot. The outcome of the events reported as recovered on 16 Oct 2015. The seriousness of the events was not reported. The causality of the events reported as probable. Following an internal review on 22 Oct 2015, a significant case correction was performed for the information received on 16 Oct 2015: event skin sensitive to touch was recoded to increased skin sensitivity.
Age: 16.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Case number PHEH2015US021296 is an initial spontaneous report from a nurse received on 16 Oct 2015. This report refers to a 16-year-old female patient. Concomitant drug included LO LOESTRIN FE. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported) on 08 Oct 2015 in the left deltoid. On 15 Oct 2015, the patient was vaccinated with RABAVERT (batch number: 578011A, expiry date: 30 Sep 2018) intramuscularly in the left deltoid. On the same date, 9 hours after RABAVERT vaccination the patient experienced severe myalgia, she felt like she was getting the flu, her skin sensitive to touch, had chills, nausea, feverish, severe headache and her arm hurt a lot. The outcome of the events reported as recovered on 16 Oct 2015. The seriousness of the events was not reported. The causality of the events reported as probable. Following an internal review on 22 Oct 2015, a significant case correction was performed for the information received on 16 Oct 2015: event skin sensitive to touch was recoded to increased skin sensitivity.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US017809, is an initial spontaneous report received form a nurse on 09 Sep 2015. This report refers to a 16 year female patient. Past medical history and concomitant medications were not reported. She was vaccinated with expired Men A lyophilized conjugate (batch number: A14057 and expiry date: Aug 2015) component of MENVEO (batch number and expiry date: not reported) on 03 Sep 2015. It was reported that, MENVEO was prepared with both portion of the vaccine correctly mixed and administered. No adverse event was reported following this administration error. No other information was reported at the time of this report. Follow-up information received on 13 November 2015: Previously administered products included meningococcal vaccine, administered on 30 Aug 2010. On 3rd September 2015, the patient received MENVEO (intramuscular) .5 ml. Diluent was expired since August 2015. On 10 September 2015, the patient returned to office and was re-vaccinated with MENACTRA.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Physician referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # reported as: L002042 expiration date: 28-JUL-2016 (administration route was not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.