chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not provided. it was reported that since 17-JAN-2017, the patient have been administered doses of improperly stored GARDASIL 9 injection (lot # reported as M037770, expiration date 01-JUN-2019) for prophylaxis (strength, dose and route were unknown). On an unknown date, the vaccine was stored to a temperature excursion between 0 Celsius degrees and 2 celsius degrees for 48 hours. There was no previous temperature excursion. The call was made because of a digital data logger. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA013818: US-009507513-1701USA013819: US-009507513-1701USA013820: US-009507513-1701USA013631:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M034893, expiration date: 26-MAY-2017, via intramuscular, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 46 and 77 Fahrenheit degrees for 24 hours and between 32 and 36 Fahrenheit degrees for 419 hours and 30 minutes. There were no previous temperature excursions. Digital data logger was not involved. It was also reported that the patients were vaccinated with improperly stored doses of VAQTA via intramuscular as prophylaxis (Strength, lot #, expiration date and dose were not reported), which experienced an unknown temperature excursion for an unknown time frame. There were no previous temperature excursions. Digital data logger was not involved. No adverse effects were reported.   A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA014312:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with an improperly stored dose GARDASIL 9, lot number M021407, expiration date 30-APR-2018, intramuscularly (dose, and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of 46 Fahrenheit (F) (7,7 Celsius(C)) and to the highest recorded temperature of 77 F (25C) during 240 hours. No storage type "data logger" was reported. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: DTOX
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: Initial unsolicited misuse report received from (LPN) Register Nurse on 24 January 2017. This case involves a 57 years old female patient who was inadvertently vaccinated intradermally with 0.1 milliliter dose of DIPHTHERIA AND TETANUS TOXOIDS (DT) (lot number, expiration date unknown) instead of TUBERCULIN PPD (lot number, expiration date and dose unknown) in the left forearm on an unknown date of December 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none and Illness at the time of vaccination were reported as unknown. On an unknown date, unspecified time following the vaccination patient had developed a lesion in left forearm which was not nodular and erythema. This was a case of Wrong drug administered, Drug administered at inappropriate site. The patient had emergency visit on an unknown date. Lab data and corrective treatment was not reported. The patient was recovered from the events on an unknown date. List of the documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: DTOX
Symptoms: Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from (LPN) Register Nurse on 24 January 2017. This case involves a 57 years old female patient who was inadvertently vaccinated intradermally with 0.1 milliliter dose of DIPHTHERIA AND TETANUS TOXOIDS (DT) (lot number, expiration date unknown) instead of TUBERCULIN PPD (lot number, expiration date and dose unknown) in the left forearm on an unknown date of December 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none and Illness at the time of vaccination were reported as unknown. On an unknown date, unspecified time following the vaccination patient had developed a lesion in left forearm which was not nodular and erythema. This was a case of Wrong drug administered, Drug administered at inappropriate site. The patient had emergency visit on an unknown date. Lab data and corrective treatment was not reported. The patient was recovered from the events on an unknown date. List of the documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Decreased appetite, Dyskinesia, Eye movement disorder, Glassy eyes, Insomnia
Clinical narrative: About an hour after the vaccines, she started jerking her arms and legs, and her eyes became glassy, then her body went stiff and her eyes rolled up. This lasted about a minute or two. She barely ate or slept the next weeks, and screamed like she was in pain for hours at a time.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Musculoskeletal stiffness, Pain, Screaming
Clinical narrative: About an hour after the vaccines, she started jerking her arms and legs, and her eyes became glassy, then her body went stiff and her eyes rolled up. This lasted about a minute or two. She barely ate or slept the next weeks, and screamed like she was in pain for hours at a time.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13, UNK
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-01-30.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Crying, Diet refusal, Food aversion, Hyperacusis, Hyperaesthesia
Clinical narrative: She began to have a fever within a few hours. Her fever went up to 104. She then broke out in a rash head to toe. She refused to eat and could not sleep, she withdrew and just cried all the time. I called her Dr's office, they said to not bring her in because she could be contagious. She did not want to eat or sleep for the next few days. After about two weeks, when these symptoms subsided, we began to notice that she developed an aversion to most foods, especially foods with texture like mushy, soft, etc. She became sensitive to temperatures, her food, drink, bath water had to be very specific and she cried it if wasn't the right temperature. She started speaking too loud or too quiet and couldn't seem to regulate her volume, while other loud noises bothered her. She cried that clothes and socks hurt her body. We discussed these issues at her next doctors visit, but he did not seem to think they were serious. These issues got better over the 1st year, but have not completely gone away. She is still very sensitive to touch, temperature, noise, etc.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Insomnia, Pyrexia, Rash generalised, Social avoidant behaviour, Speech disorder
Clinical narrative: She began to have a fever within a few hours. Her fever went up to 104. She then broke out in a rash head to toe. She refused to eat and could not sleep, she withdrew and just cried all the time. I called her Dr's office, they said to not bring her in because she could be contagious. She did not want to eat or sleep for the next few days. After about two weeks, when these symptoms subsided, we began to notice that she developed an aversion to most foods, especially foods with texture like mushy, soft, etc. She became sensitive to temperatures, her food, drink, bath water had to be very specific and she cried it if wasn't the right temperature. She started speaking too loud or too quiet and couldn't seem to regulate her volume, while other loud noises bothered her. She cried that clothes and socks hurt her body. We discussed these issues at her next doctors visit, but he did not seem to think they were serious. These issues got better over the 1st year, but have not completely gone away. She is still very sensitive to touch, temperature, noise, etc.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Temperature intolerance
Clinical narrative: She began to have a fever within a few hours. Her fever went up to 104. She then broke out in a rash head to toe. She refused to eat and could not sleep, she withdrew and just cried all the time. I called her Dr's office, they said to not bring her in because she could be contagious. She did not want to eat or sleep for the next few days. After about two weeks, when these symptoms subsided, we began to notice that she developed an aversion to most foods, especially foods with texture like mushy, soft, etc. She became sensitive to temperatures, her food, drink, bath water had to be very specific and she cried it if wasn't the right temperature. She started speaking too loud or too quiet and couldn't seem to regulate her volume, while other loud noises bothered her. She cried that clothes and socks hurt her body. We discussed these issues at her next doctors visit, but he did not seem to think they were serious. These issues got better over the 1st year, but have not completely gone away. She is still very sensitive to touch, temperature, noise, etc.
Age: 0.75
Sex: M
Vaccine: FLU4, HIBV
Symptoms: Excoriation, Papule, Rash, Rash papular
Clinical narrative: Rash: Cheeks red and red papular rash with excoriation. Trunk: red rash with scattered papules. Treatment: Prednisolone solution for 4 days.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Chest discomfort, Injection site erythema, Skin warm
Clinical narrative: Patient described red circle at injection site and arm was warm. She also stated she had chest tightness.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 24 year old female patient. There was no information about the patient's pertinent medical history and concomitant medication. The patient had an allergy to penicillin. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly (site of administration, lot # and expiration date were not reported) for Human Papillomavirus (HPV). On an unknown date (1 month after first dose), the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly (site of administration, lot # and expiration date were not reported) for HPV. On an unknown date (6 months after first dose), the patient was vaccinated with the third dose of GARDASIL 0.5 ml, intramuscularly (site of administration, lot # and expiration date were not reported) for HPV. On unknown date in September 2015 and on unknown date in 2016, the patient had PAP smear tests with positive result for HPV 16 (it was also reported that there were no adverse events from administered vaccines). The treatment was not given to the event. The outcome of the event was unknown. The causality between the event and the vaccine was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 57 year old patient. On 06-JAN-2017 the patient was vaccinated with a pediatric dose of VAQTA lot # M022531, expiration 23-FEB-2018 intramuscular for prophylaxis.  No adverse effect was reported. This is one of several reports from the same reporter.   Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 26-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot # L027282, dose, route and site of administration and expiry date were not reported). On 27-MAY-2016 and 28-JUN-2016, the patient was vaccinated with the second and the third dose of GARDASIL 9 respectively (lot # L02782; lot # M007728). No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 26-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot # L027282, dose, route and site of administration and expiry date were not reported). On 27-MAY-2016 and 28-JUN-2016, the patient was vaccinated with the second and the third dose of GARDASIL 9 respectively (lot # L02782; lot # M007728). No adverse effects were reported. 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 licensed practical nurse and refers to 26 patients of unknown age and gender. The patients' concurrent conditions or medical history were not reported. On unspecified dates since 11-JAN-2017, improperly stored doses of ROTATEQ oral liquid (lot # M031650, expiry date 16-MAR-2018, or lot # M033338, expiry date 15-APR-2018; exact dose was not reported) were administered to the patients. The vaccine was stored over 46 degrees Fahrenheit but under 77 degrees Fahrenheit for 1 hour and 6 minutes. There was previous temperature excursion of over 46 degrees Fahrenheit but under 77 degrees Fahrenheit for 1 hour and 30 minutes. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007854: US-009507513-1701USA007856: US-009507513-1701USA007855.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an adult patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JAN-2017, the patient was vaccinated with two pediatric doses of VAQTA, strength reported as 25/0.5 (no unit was provided), lot # M031806, expiration date 30-MAR-2018, intramuscularly (dose was not reported). There was no adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Polymyalgia rheumatica
Clinical narrative: This spontaneous report was received from a medical assistant via company representative, referring to a 60 year old male patient. Information about the patient's medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On 29-DEC-2016, the patient was vaccinated with the first dose of ZOSTAVAX subcutaneously for prevention of shingles (dose, lot # and expiration date were not provided). On an unknown date, after being vaccinated with ZOSTAVAX. Furthermore, the reporter stated that the patient's wife thought her husband the patient had polymyalgia rheumatica (PMR). At the time of this report, the outcome of polymyalgia rheumatica and pain was reported as not recovered. The reporter did not assess the relationship between ZOSTAVAX) and polymyalgia rheumatica. Upon internal review, polymyalgia rheumatica was considered to be medically significant. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a 36 year old nurse prescriber (also reported as a nurse practitioner) who is also the patient via a company representative. The patient's concurrent conditions included an immunodeficiency. Other pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the immunocompromised patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming units (PFU), as prophylaxis (Strength, dose, frequency, lot # and expiration date were not reported). No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 57 year old patient. On 06-JAN-2017 the patient was vaccinated with a pediatric dose of RECOMBIVAX HB lot # M010212, expiration date 21-JAN-2019.   No adverse effect was reported. This is one of several reports from the same reporter.  Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Neck pain
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist.  A 71-year-old female patient of an unspecified ethnicity received PREVENAR 13 (Lot. R45377, Expiration date: Dec2017, NDC number: 00005197101) at 0.5 ml, single dose, on an unknown date, in 2016, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced neck pain. Clinical outcome of the adverse event was unknown. The reporter believed that the neck pain was related to the pneumococcal 13-val conj vac (dipht crm197 protein).
Age: 0.67
Sex: F
Vaccine: HEP
Symptoms: Coeliac disease, Hepatitis B antibody negative, Inappropriate schedule of drug administration, Therapy non-responder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of celiac disease in a 23-year-old female patient who received Hepatitis B vaccine (batch number 1154B2 ?, expiry date unknown). GSK note: the reported lot number did not match with any GSK lot number. Clarification has been requested. Co-suspect products included Hepatitis B vaccine (batch number 1115B2 ?, expiry date unknown) and Hepatitis B vaccine (batch number 1309B2 ?, expiry date unknown). On 9th July 1993, the patient received the 1st dose of Hepatitis B vaccine. On 6th August 1993, the patient received the 2nd dose of Hepatitis B vaccine. On 9th March 1994, the patient received the 3rd dose of Hepatitis B vaccine. On 9th March 1994, not applicable after receiving Hepatitis B vaccine and Hepatitis B vaccine, not applicable after receiving Hepatitis B vaccine and Hepatitis B vaccine, and an  unknown time after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long. On 21st December 2016, the patient experienced therapy non-responder. On an unknown date, the patient experienced celiac disease (serious criteria GSK medically significant). On an unknown date, the outcome of the celiac disease, therapy non-responder and drug dose administration interval too long were unknown. The reporter considered the celiac disease to be unrelated to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: This case was reported by the patient's father. The patient had received the hepatitis B vaccine series when she was an infant. On 21st December 2016, the patient was tested for hepatitis B antibodies and it showed she had no antibodies. Thus, leading the patient to be a therapy non-responder. The pediatrician's office was able to provide the lot numbers, but did not know what company's vaccine it was. The patient was diagnosed with celiac disease and her gastroenterologist had proposed her to get 2 ml doses of ENGERIX-B so she would develop antibodies against the virus. She went to a pharmacy to receive the 2 ml dose, but the pharmacy refused to administer it. The patient would be seeing her gastroenterologist at the time of reporting to further discuss the vaccination. The patient's father was not concerned about the celiac, since the patient also had the disease, he was only calling with questions about the dosing of ENGERIX-B vaccine.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA, FLU4, HEPA
Symptoms: Abasia, Bladder dysfunction, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness
Clinical narrative: A few days after receiving his vaccines, patient began to show signs of head cold/upper respiratory infection. 20 days post vaccines, patient woke up unable to walk or put any weight on his legs and was admitted to hospital. The illness spread weakening upper body muscles, facial muscles, and shutting down his bladder functions. Patient was treated with IVIG and steroids. He was diagnosed w/Guillain Barre syndrome. As of 12/5, he is in inpatient rehab, still unable to sit up or use his legs at all.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA, FLU4, HEPA
Symptoms: Nasopharyngitis, Posture abnormal, Upper respiratory tract infection, Weight bearing difficulty
Clinical narrative: A few days after receiving his vaccines, patient began to show signs of head cold/upper respiratory infection. 20 days post vaccines, patient woke up unable to walk or put any weight on his legs and was admitted to hospital. The illness spread weakening upper body muscles, facial muscles, and shutting down his bladder functions. Patient was treated with IVIG and steroids. He was diagnosed w/Guillain Barre syndrome. As of 12/5, he is in inpatient rehab, still unable to sit up or use his legs at all.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA, FLU4, HEPA
Symptoms: Upper respiratory tract infection, Viral upper respiratory tract infection, Weight bearing difficulty
Clinical narrative: A few days after receiving his vaccines, patient began to show signs of head cold/upper respiratory infection. 20 days post vaccines, patient woke up unable to walk or put any weight on his legs and was admitted to hospital. The illness spread weakening upper body muscles, facial muscles, and shutting down his bladder functions. Patient was treated with IVIG and steroids. He was diagnosed w/Guillain Barre syndrome. As of 12/5, he is in inpatient rehab, still unable to sit up or use his legs at all.
Age: 53.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Somnolence
Clinical narrative: I had my eyes checked at 9:30 am. 9-25-16. Then went and got my flu shot around 11:00 a.m. Went home and watched TV and relaxed. Woke up the next day tired and wore out. Can sleep no problem can't wake up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Pt received zoster vaccine and had cellulitis as an adverse RXN.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray, Computerised tomogram head, Dizziness, Electrocardiogram, Full blood count normal
Clinical narrative: Pt. got Pneumonia vaccine yesterday (1-25-17) and Flu vaccine 2 weeks ago. This morning at 05:45 he says he suddenly became dizzy and his vision "went white". Vertigo-like dizziness continues with nausea and blurry vision in (L) eye.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test normal, Nausea, Nuclear magnetic resonance imaging, Prothrombin time prolonged, Vision blurred
Clinical narrative: Pt. got Pneumonia vaccine yesterday (1-25-17) and Flu vaccine 2 weeks ago. This morning at 05:45 he says he suddenly became dizzy and his vision "went white". Vertigo-like dizziness continues with nausea and blurry vision in (L) eye.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Visual impairment
Clinical narrative: Pt. got Pneumonia vaccine yesterday (1-25-17) and Flu vaccine 2 weeks ago. This morning at 05:45 he says he suddenly became dizzy and his vision "went white". Vertigo-like dizziness continues with nausea and blurry vision in (L) eye.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Localized rash that itches, patient has had for several days.
Age: 1.17
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Pain, Rash erythematous, Rash vesicular
Clinical narrative: Mom states child woke up with a rash on his Rt. Abd. States rash is bright red, blistered, and he acts like it hurts (walking around holding shirt off of body and holding hand on rash.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Burning sensation, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red raised bumps on arms, chest, back, buttox, and thighs.  Itchy, burning feeling on bumps.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Abdominal pain upper, Biopsy kidney, C-reactive protein, Creatinine urine, Full blood count
Clinical narrative: Six (6) days following vaccination at school, my son complained of stomach pain. 10 days post-vaccination he complained of scrotal/groin pain, pain in lower limbs, left hand and a raised palpable purpuric rashes were noticed on his lower limbs by me and the doctor at ER, where I took him that Friday evening. Diagnosis of Henoch-Schonlein purpura (HSP) was made at 2nd hospital, where he was transferred to. Case has progressed to HSP nephritis in the nephrotic range and was just placed on Immunosuppressor drugs- Prednisolone, Cyclosporine; Lisinopril, ZANTAC and Fish oil by a Nephrologist at 3rd hospital.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Groin pain, Henoch-Schonlein purpura, Henoch-Schonlein purpura nephritis, Pain in extremity, Palpable purpura
Clinical narrative: Six (6) days following vaccination at school, my son complained of stomach pain. 10 days post-vaccination he complained of scrotal/groin pain, pain in lower limbs, left hand and a raised palpable purpuric rashes were noticed on his lower limbs by me and the doctor at ER, where I took him that Friday evening. Diagnosis of Henoch-Schonlein purpura (HSP) was made at 2nd hospital, where he was transferred to. Case has progressed to HSP nephritis in the nephrotic range and was just placed on Immunosuppressor drugs- Prednisolone, Cyclosporine; Lisinopril, ZANTAC and Fish oil by a Nephrologist at 3rd hospital.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Purpura, Scrotal pain, Urine analysis
Clinical narrative: Six (6) days following vaccination at school, my son complained of stomach pain. 10 days post-vaccination he complained of scrotal/groin pain, pain in lower limbs, left hand and a raised palpable purpuric rashes were noticed on his lower limbs by me and the doctor at ER, where I took him that Friday evening. Diagnosis of Henoch-Schonlein purpura (HSP) was made at 2nd hospital, where he was transferred to. Case has progressed to HSP nephritis in the nephrotic range and was just placed on Immunosuppressor drugs- Prednisolone, Cyclosporine; Lisinopril, ZANTAC and Fish oil by a Nephrologist at 3rd hospital.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pain, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # M020521, expiration date 17-NOV-2017, intramuscular, dose not specified) for prophylaxis. "The next day" (date not specified), the patient was seen at the pharmacy, complaining of "redness, swelling, pain, and inflammation". The pharmacist recommended the patient to take TYLENOL and use an ice pack. No lab diagnostics studies were performed. The patient was recovered on an unknown date. The pharmacist requested a lot check for this lot of PNEUMOVAX 23. This is one of three reports received from the same source involving same events and same lot #. Additional information has been requested. Sender's Comments: US-009507513-1701USA003778: US-009507513-1701USA003855.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-JAN-2017, the patient was vaccinated with an expired dose of VARIVAX subcutaneously (lot # L000453 with expiry date of 06-JAN-2017, site of administration was not reported). No adverse effects were reported.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient's husband had called and reported this information to the pharmacist. The patient's concurrent conditions included sulfa and penicillin allergy. There was no information about the patient's concomitant therapies or medical history provided. On 13-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035694, expiration date 07-NOV-2017, in her upper arm (dose and route of administration were not reported). On 15-JAN-2017, the patient experienced injection site inflammation about the size of a baseball. The patient did not receive any treatment. There were no lab diagnostic studies performed. The outcome of injection site inflammation was unknown. The pharmacist stated that the patient never called back to report on her recovery. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 16 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-JAN-2017, the patient was vaccinated with her second dose of GARDASIL 9 intramuscularly for human papillomavirus (HPV) infection prevention (dose, lot # and expiration date were not reported). Other suspect therapies included MENACTRA, administered on the same day. On 18-JAN-2017, the nurse received test results of the patient being 3 weeks pregnant. Her last menstrual period (LMP) was on 28-DEC-2016 and her estimated date of delivery (EDD) was 04-OCT-2017 (calculation based on being 3 weeks pregnant on 18-JAN-2017). Initial exposure to GARDASIL 9 was at 2 weeks. The pregnancy outcome was pending. The nurse would tell the patient and her parents about the pregnancy on 19-JAN-2017, as they were unaware of it at the time of the report. The patient did not receive any treatment. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 23-JAN-2017 (on the same visit), the patient had inadvertently administered a dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported) and a dose of PROQUAD (dose, route of administration, lot # and expiration date were not reported), both for prophylaxis. There were no adverse events reported. No product quality complaint (PQC) was involved.    Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Adverse reaction, Drug administered at inappropriate site
Clinical narrative: This spontaneous report was received from an unspecified health care worker via company representative referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with M-M-R II(strength, dose, lot # and expiration date were not provided) subcutaneously into the abdomen for prophylaxis. On an unknown date, the patient experienced a "severe reaction". At the reporting time the outcome of a "severe reaction" was unknown. The relationship between the event and M-M-R II was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 13-JAN-2017, the patient received RECOMBIVAX HB strength 10/1.0 microgram/ml, at a dose of 1.0 mcrg/ml (lot # M039642 with expiration date of 30-JUL-2019) intramuscularly for prophylaxis. On 24-JAN-2017, the patient  inadvertently received RECOMBIVAX HB strength 10/1.0 microgram/ml, at a dose of 1.0 mcrg/ml (lot# M036156 with expiration date of 23-FEB-2019) intramuscularly for prophylaxis. No adverse effects reported. Furthermore, no product quality complaint was involved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Hives over entire body.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: NONE THAT AWARE OF PATIENT WAS GIVEN MMR IM WHICH SHOULD HAVE BEEN SUB Q.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper leg has approx. 6 cm in diameter red swollen area.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nausea, Neck pain, Pain, Pyrexia
Clinical narrative: Child developed body aches, nausea, vomiting, head pain, neck pain and fever within 24 hours of vaccine administration. No preceding sick symptoms.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Child developed body aches, nausea, vomiting, head pain, neck pain and fever within 24 hours of vaccine administration. No preceding sick symptoms.
Age: 32.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Asthma, Cellulitis, Condition aggravated, Headache, Leukocytosis
Clinical narrative: Fever 101.6 on ibuprofen, severe headache, arm pain, cellulitis skin changes, mild asthma exacerbation.
Age: 32.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Pyrexia, Skin disorder, White blood cell count increased
Clinical narrative: Fever 101.6 on ibuprofen, severe headache, arm pain, cellulitis skin changes, mild asthma exacerbation.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Inflammation, Injection site pain, Muscular weakness, Musculoskeletal pain
Clinical narrative: VACCINE GIVEN ON 11/14/16. PAIN AT SITE OF INJECTION LEFT ARM PROGRESSIVELY WORSENED. EXCRUCIATING PAIN FROM SITE DOWN THE ARM IN THE BACK OF THE UPPER ARM AND SHOULDER BLADE. UNABLE TO SLEEP ON THAT SIDE. DOCTOR SAID HE SEES THIS OFTEN AFTER FLU VACCINE. INFLAMMATION. HE SAID THE VACCINE WENT TO THE BURSA INSTEAD OF THE MUSCLE. GAVE ME A CORTISONE SHOT. ABLE TO SLEEP. PAIN A LITTLE BETTER BUT ARM WEAK. FINGERS TINGLY. SLEEP INTERRUPTED BY PAIN. JUST STARTED PHYSICAL THERAPY. THERAPIST SAID NERVE DAMAGE CAUSING EXCRUCIATING PAIN AT NIGHT. MY LEFT ARM IS SHOT! THERAPIST JUST SAID IT WILL TAKE TIME TO FEEL BETTER.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve injury, Nerve stimulation test, Paraesthesia, Sleep disorder, X-ray
Clinical narrative: VACCINE GIVEN ON 11/14/16. PAIN AT SITE OF INJECTION LEFT ARM PROGRESSIVELY WORSENED. EXCRUCIATING PAIN FROM SITE DOWN THE ARM IN THE BACK OF THE UPPER ARM AND SHOULDER BLADE. UNABLE TO SLEEP ON THAT SIDE. DOCTOR SAID HE SEES THIS OFTEN AFTER FLU VACCINE. INFLAMMATION. HE SAID THE VACCINE WENT TO THE BURSA INSTEAD OF THE MUSCLE. GAVE ME A CORTISONE SHOT. ABLE TO SLEEP. PAIN A LITTLE BETTER BUT ARM WEAK. FINGERS TINGLY. SLEEP INTERRUPTED BY PAIN. JUST STARTED PHYSICAL THERAPY. THERAPIST SAID NERVE DAMAGE CAUSING EXCRUCIATING PAIN AT NIGHT. MY LEFT ARM IS SHOT! THERAPIST JUST SAID IT WILL TAKE TIME TO FEEL BETTER.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Erythema, Injection site urticaria, Swelling
Clinical narrative: INJESTION SITE UPPER LEFT ARM- HIVES RAISED TO .25 INCH TALL X 3.0 INCHES LONG X 1.0 INCH WIDE. CHIN - SHOWS TO HAVE TWO OCCURENCES OF RED RAISED AREAS WITH ONE WHITE BLISTER LIKE SPOT IN EACH OCCURENCE. LOCATED UNDER BOTTOM LIP CENTER OF CHIN.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received on 10-JAN-2017 from a nurse regarding an male patient (age not reported). Medical history/concurrent conditions included hypertension, degenerative joint disease, arthritis and hearing loss.  Concomitant medications included aspirin, amlodipine, omega-3 acid ethyl esters (LOVAZA) and losartan potassium (+) hydrochlorothiazide (HYZAAR). No allergies were reported. On 18-MAR-2016 the patient was administered ZOSTAVAX (lot # M000555 expiration date 27-MAR-2017). On 29-DEC-2016 the patient came to the office with shingles to the right upper leg and groin area and right hip and back which started on 25-DEC-2016. Shingles was not resolved and the patient continued to be treated. The nurse did not rate the causal relationship. No further information was provided. The nurse asked to have the VZV packet to be faxed. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (an office manager) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-JAN-2017, the patient was vaccinated with an expired dose of VARIVAX subcutaneously (lot # K007976 with expiry date of 03-JUN-2017, site of administration was not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 25-JAN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number M023169, expiration date 13-JUN-2018, dose, route and anatomical application were not reported) for prophylaxis. No adverse event was reported.  The temperature of storage was 32 °F, and the time frame was 8 hours 30 minutes. Previous temperature excursion was not reported and a data logger was involved. A product quality complaint was not involved. Additional information is not expected as there is no consent to contact the reporter.
Sex: F
Vaccine: FLUN3
Symptoms: Hypersensitivity
Clinical narrative: A spontaneous report was received from a consumer concerning a female patient. On an unknown date, the patient received nasal FLUMIST(intranasal). It was reported that the patient had FLUMIST a few years ago and had allergies (preferred term: hypersensitivity) ever since. The outcome of allergies was unknown. The reporter considered allergies to be non-serious.
Age: 67.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Pain in extremity
Clinical narrative: Persistent pain in right arm since vaccination was administered. Pain lasting > 2 mo.
Age: 67.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Persistent pain in right arm since vaccination was administered. Pain lasting > 2 mo.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient returned to room about 15 minutes after vaccines administered. Noted red raised lump on (L) thigh. Patient did not have any difficulty breathing.
Age: 66.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Pain
Clinical narrative: She has pain from her elbow down since she received shot.
Age: 66.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: She has pain from her elbow down since she received shot.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: ARM SORENESS CONTINUING FOR 1 MONTH AFTER IMMUNIZATION. NO RELIEF FROM OTC PRODUCTS.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient called clinic. Stated she began having pain in her shoulder radiating to her elbow shortly after she left our clinic. Went to an urgent care facility. Was told to go to the ER.
Age: 0.17
Sex: M
Vaccine: DTAP, RV1
Symptoms: Abdominal pain, Crying, Diarrhoea, Fatigue, Influenza virus test negative
Clinical narrative: He got the DTAP and rotavirus about 12:30pm and went to sleep after a bath and Tylenol when we got home. He woke about 4:30-5:00pm that evening screaming. He screamed for about 2-2.5 hours straight followed by 20-30 minutes of exhausted but restless whimpering followed by another round of screaming and that continued all night until around 8:30-9:00am the following morning. He then went to sleep so deeply I couldn't wake him enough to nurse. He was barely rousable. I was told he wouldn't want to nurse as much so I assumed it was ok and just watched him carefully. He didn't rouse to nurse until 5:00pm or so that evening and wouldn't nurse more than 5 minutes at a time then. He also developed persistent and explosive diarrhea lasting for almost a week. He developed a colicky type cry for two weeks and a hard lump about the size of a marble at the injection site for three weeks. He also had a rash on his cheeks, between his eyebrows, and under his lip that have mostly resolved. He also developed what appeared to be a severe child starting about midnight following the vaccinations. That has improved some but still persists.
Age: 0.17
Sex: M
Vaccine: DTAP, RV1
Symptoms: Injection site induration, Injection site mass, Nasopharyngitis, Rash, Respiratory syncytial virus test negative
Clinical narrative: He got the DTAP and rotavirus about 12:30pm and went to sleep after a bath and Tylenol when we got home. He woke about 4:30-5:00pm that evening screaming. He screamed for about 2-2.5 hours straight followed by 20-30 minutes of exhausted but restless whimpering followed by another round of screaming and that continued all night until around 8:30-9:00am the following morning. He then went to sleep so deeply I couldn't wake him enough to nurse. He was barely rousable. I was told he wouldn't want to nurse as much so I assumed it was ok and just watched him carefully. He didn't rouse to nurse until 5:00pm or so that evening and wouldn't nurse more than 5 minutes at a time then. He also developed persistent and explosive diarrhea lasting for almost a week. He developed a colicky type cry for two weeks and a hard lump about the size of a marble at the injection site for three weeks. He also had a rash on his cheeks, between his eyebrows, and under his lip that have mostly resolved. He also developed what appeared to be a severe child starting about midnight following the vaccinations. That has improved some but still persists.
Age: 0.17
Sex: M
Vaccine: DTAP, RV1
Symptoms: Restlessness, Screaming, Somnolence
Clinical narrative: He got the DTAP and rotavirus about 12:30pm and went to sleep after a bath and Tylenol when we got home. He woke about 4:30-5:00pm that evening screaming. He screamed for about 2-2.5 hours straight followed by 20-30 minutes of exhausted but restless whimpering followed by another round of screaming and that continued all night until around 8:30-9:00am the following morning. He then went to sleep so deeply I couldn't wake him enough to nurse. He was barely rousable. I was told he wouldn't want to nurse as much so I assumed it was ok and just watched him carefully. He didn't rouse to nurse until 5:00pm or so that evening and wouldn't nurse more than 5 minutes at a time then. He also developed persistent and explosive diarrhea lasting for almost a week. He developed a colicky type cry for two weeks and a hard lump about the size of a marble at the injection site for three weeks. He also had a rash on his cheeks, between his eyebrows, and under his lip that have mostly resolved. He also developed what appeared to be a severe child starting about midnight following the vaccinations. That has improved some but still persists.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Red and warm to touch.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site discharge, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Red and warm to touch.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Left upper arm warm. edematous/ erythematous in a 7 x 3 cm area shoulder to just above olecrenon, oozinf serosanguinois fluid from site of injection.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site discharge, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left upper arm warm. edematous/ erythematous in a 7 x 3 cm area shoulder to just above olecrenon, oozinf serosanguinois fluid from site of injection.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Respiratory tract congestion, Rhinorrhoea, Urticaria
Clinical narrative: Severe itching and swelling at injection site, followed by upper airway congestion and rhinorrhea that continued for weeks. 4 days following vaccine she required an inhaler for wheezing. 5 days after vaccine she developed generalized hives. She has been treated by her personal physician with antihistamines, inhalers and steroids.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Severe itching and swelling at injection site, followed by upper airway congestion and rhinorrhea that continued for weeks. 4 days following vaccine she required an inhaler for wheezing. 5 days after vaccine she developed generalized hives. She has been treated by her personal physician with antihistamines, inhalers and steroids.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Lethargy, Ultrasound abdomen
Clinical narrative: Intussusception; lethargy, hematochezia, vomiting.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Intussusception; lethargy, hematochezia, vomiting.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Redness at the site worsened 2 days after vaccine, treated for suspected cellulitis.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Autism spectrum disorder, Encephalitis
Clinical narrative: Encephalitis (unknown at time). Autism Spectrum Disorder.
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site pain, Swelling
Clinical narrative: SWELLING AT RIGHT ARM FOLLOWED BY INCREASING SEVERE PAIN OF RIGHT SHOULDER. UNABLE TO LIFT ARM ABOVE SHOULDER FOR 2 WEEKS +.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Pain in extremity, Pyrexia, Swelling
Clinical narrative: SORE ARM, REDNESS, SWELLING FIRST FEW HOURS..THEN FEVER & CHILL AT NIGHT.. SYMPTOMS SUBSIDED AND WENT AWAY NEXT DAY..BUT SORENESS STAY X1 WK.