chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse, via a company representative, referring to a patient of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated wit an expired dose of PNEUMOVAX 23. Dose, route, lot # and expiration date were not reported. No adverse effect was reported. It was not a product quality complaint involved. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Headache, Malaise, Pyrexia
Clinical narrative: Vaccination at 4pm 8/21. At 4:30 am 8/22 pt reports she woke up in a cold sweat, fever, headache, and was dizzy. After self-administration of Ibuprofen patient felt better but continued to suffer with malaise.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient is presenting with redness at the injection site. She is 2 days post injection. Site is firm, red, and tender. Patient does not have fever.
Age: 77.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Injection site inflammation, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pain in right deltoid, swelling, inflammation, rash, warmth down to elbow.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant referring to multiple unknown patients of unknown age and gender. Patient's concurrent conditions and medical history were not reported. On an unspecific date the patients were vaccinated with improperly stored VAQTA (lot # M021124, expiry date 02-FEB-2018) concentration, dose and route of administration were not reported. It was reported that the temperature excursion was for 46 minutes at 1.7 degrees C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Mother called stating child had redness, hardness, warmth on injection site (R) leg, advised to consult MD.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Throat tightness, Urticaria
Clinical narrative: Redness to face, hives to body, thickness to throat.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Headache, Injection site pain, Injection site warmth, Myalgia
Clinical narrative: Pain at injection site, warmth at injection site, joint pain, myalgia, headache, fever 101.9.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Pain at injection site, warmth at injection site, joint pain, myalgia, headache, fever 101.9.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule, Pain, Swelling
Clinical narrative: Red, swollen, painful knot 24hrs after admin lasting approximately 9 days.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Feeling abnormal, Syncope, Vomiting
Clinical narrative: Patient states 2 hrs after receiving vaccine-she was dizzy, fainted, fell to the floor and had to call the rescue squad to help her up. She vomited and has not felt right since.
Age: 88.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Severe nightly pain in anterolateral (L) shoulder, at site of injection, After 5 wks the pain is still there, no palpable mass to suggest a hematoma or abscess.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient given MENVEO 8/16/16 and presented to after hours 8/18 for (R) deltoid swelling, warm to touch.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Pyrexia
Clinical narrative: 10PM day of vaccines had chills, fever; took ALKA SELTZER for fever and 1/4 of a "sleeping pill". Symptoms recurred at 3AM. By 11AM next day, still feels "bad"  but better (PT. concerned about receiving both vaccines at the same time).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant referring to multiple unknown patients of unknown age and gender. Patient's concurrent conditions and medical history were not reported. On an unspecific date the patients were vaccinated with improperly stored ROTATEQ (lot # L037924, expiry date 22-JUN-2017) concentration, dose and route of administration were not reported. It was reported that the temperature excursion was for 46 minutes at 1.7 degrees C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. 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 Medical assistant referring to multiple unknown patients of unknown age and gender. Patient's concurrent conditions and medical history were not reported. On an unspecific date the patients were vaccinated with improperly stored GARDASIL 9, lot #,expiry date, concentration, dose and route of administration were not reported. It was reported that the temperature excursion was for 46 minutes at 1.7 degrees C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Decreased appetite, Hypersomnia, Weight decreased
Clinical narrative: This spontaneous report as received from a consumer who refers to a male patient, her husband of unknown age. The patient's concurrent conditions and medical history were unknown. On 07-JUL-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # and Expiration date not provided), (dose and route unknown). There was no concomitant medication reported. The consumer states her husband received the PNEUMOVAX 23 injection on 07-JUL-2016 and has been sleeping a lot and not eating since that same evening. The consumer states that her husband has lost 10 pounds since 07-JUL-2016. The consumer states she contacted her husbands physician but cannot get an appointment until 12-JUL-2016. The consumer stated, she did not know if the PNEUMOVAX 23 injection was given by her husband's primary physician. Lab diagnostics studies were reported as unknown by the consumer. The outcome of hypersomnia, weight decreased and eating disorder was reported as not recovered/not resolved. The reported did not assess the causal relationship between the adverse events. The consumer did not want to give any other information regarding this situation. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, current conditions, drug reactions/allergies and concomitant medications information were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (lot # L038503, expiry date: 18-DEC-2017) via intramuscular route. Nurse reported that the vaccine underwent a temperature excursion at 35 degree Fahrenheit for 21 minutes. There were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Hypersensitivity, Swelling, Urticaria, Vaccination complication
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N), reporting on her son, a 12 month old male infant. The patient had no pertinent medical history or concomitant medications. Drug allergies/reactions were not reported. On 18-JAN-2015, the patient was vaccinated with VARIVAX. Dose, route, lot #, expiration date and anatomical location were not provided. On 18-JAN-2015, after vaccination, the patient had an allergic reaction to VARIVAX injection including: swelling, hives and trouble breathing at the time of injection .The infant required an unspecified medical attention and received treatment for the events. It was not a product quality complaint involved. At the time of reporting the outcome of the events was unknown. The reporter considered the events to be related to VARIVAX. Additional information has been requested.
Sex: F
Vaccine: RAB
Symptoms: Exposure during pregnancy, Hypersensitivity
Clinical narrative: Initial unsolicited pregnancy report received from literature on 10-Aug-2016. This case is linked to 2016SA148381, 2016SA148766, 2016SA148776, 2016SA148787, 2016SA148792, 2016SA148885, 2016SA148897 AND 2016SA148890 (Same literature). The following is verbatim from the article: Background: In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use. Objective: To assess adverse events (AEs) after HDCV reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods: We searched VAERS for reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using Med- DRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions: This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. This case involves a female patient who was vaccinated with a dose of RABIES (HDC) VACCINE (batch number, expiry date, route and site of administration: not reported) on an unspecified date while she was pregnant. The patients last menstrual period date and pregnancy trimester was not reported. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unknown date, following the vaccination patient experienced hypersensitivity. This case considered as serious because of medically significant. Documents held by sender: none. Sender's Comments: Hypersensitivity may occur after administration of RABIES (HDC) VACCINE. In this literature case vaccine administered during pregnancy. This case is insufficiently documented however investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 02-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU), subcutaneously, lot# reported as M011746, expiry date 07-APR-2017 (strength and dose were not reported). Concomitant therapies included cyclobenzaprine hydrochloride, naproxen, pramipexole and hydrochlorothiazide (+) lisinopril. On 03-AUG-2016, the patient called the pharmacy stating that on an unknown date in August 2016, injection site had "a red circle that was swollen and warm to the touch". Warm compresses and ibuprofen were given as a treatment, for the events. The outcome of the events was reported as not recovered. No lab diagnostic studies were performed. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 02-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU), subcutaneously, lot# reported as M011746, expiry date 07-APR-2017 (strength and dose were not reported). Concomitant therapies included cyclobenzaprine hydrochloride, naproxen, pramipexole and hydrochlorothiazide (+) lisinopril. On 03-AUG-2016, the patient called the pharmacy stating that on an unknown date in August 2016, injection site had "a red circle that was swollen and warm to the touch". Warm compresses and ibuprofen were given as a treatment, for the events. The outcome of the events was reported as not recovered. No lab diagnostic studies were performed. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Arthropod bite, Blister, Burning sensation, Erythema, Pruritus
Clinical narrative: This spontaneous case initially received on 19-Aug-2016, was reported by a non health professional and concerns a male patient. Past medical history included asthma and eczema. Concomitant medication include albuterol. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On 06-Jul-2016, the patient received the first dose of GARDASIL (batch not provided) for HPV prevention. Dose number: 1. Site of administration: Right arm. Adverse reactions/events and outcomes: On an unknown date following GARDASIL vaccination, the patient experienced an adverse reaction (outcome: recovered / resolved). The reaction started out as a "small red spot" on his foot "just like if someone took a marker and just tapped it on the skin" (outcome: recovered / resolved). Then the reaction spread from the feet to the ankles, to the lower arms, to the chest and then to the back (outcome: recovered / resolved). It then turned into "blisters with a crust on top of them" (outcome: recovered / resolved). The reaction itched and burned (outcome: recovered / resolved). On 10-Jul-2016, the patient was taken to the emergency room (ER). On an unspecified date, the reporter took the patient to their primary physician. The reporter also stated that the patient had a "bad reaction" with a flu vaccine (outcome: not reported). Treatment was not given. Reporter's Comments: Reporter's assessment: The "medics" at the ER felt that the reaction was caused by "bug bites", however, the reporter felt that the reaction was related to GARDASIL. The patient's primary physician felt that it might be "hoof and mouth disease". Sender's Comments: Company comments: Listedness: Unlisted. Brand of Influenza vaccine not specified. Assessment according to the agency for CSL's Influenza Virus Vaccine, all events are unlisted listed except rash macular and pruritus which are listed. Causality: Unassessable. Temporal relationship with Influenza vaccination cannot be established. Of note, patient received GARDASIL vaccination which is co-suspect. Causality is unassessable due to insufficient information.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Scab
Clinical narrative: This spontaneous case initially received on 19-Aug-2016, was reported by a non health professional and concerns a male patient. Past medical history included asthma and eczema. Concomitant medication include albuterol. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On 06-Jul-2016, the patient received the first dose of GARDASIL (batch not provided) for HPV prevention. Dose number: 1. Site of administration: Right arm. Adverse reactions/events and outcomes: On an unknown date following GARDASIL vaccination, the patient experienced an adverse reaction (outcome: recovered / resolved). The reaction started out as a "small red spot" on his foot "just like if someone took a marker and just tapped it on the skin" (outcome: recovered / resolved). Then the reaction spread from the feet to the ankles, to the lower arms, to the chest and then to the back (outcome: recovered / resolved). It then turned into "blisters with a crust on top of them" (outcome: recovered / resolved). The reaction itched and burned (outcome: recovered / resolved). On 10-Jul-2016, the patient was taken to the emergency room (ER). On an unspecified date, the reporter took the patient to their primary physician. The reporter also stated that the patient had a "bad reaction" with a flu vaccine (outcome: not reported). Treatment was not given. Reporter's Comments: Reporter's assessment: The "medics" at the ER felt that the reaction was caused by "bug bites", however, the reporter felt that the reaction was related to GARDASIL. The patient's primary physician felt that it might be "hoof and mouth disease". Sender's Comments: Company comments: Listedness: Unlisted. Brand of Influenza vaccine not specified. Assessment according to the agency for CSL's Influenza Virus Vaccine, all events are unlisted listed except rash macular and pruritus which are listed. Causality: Unassessable. Temporal relationship with Influenza vaccination cannot be established. Of note, patient received GARDASIL vaccination which is co-suspect. Causality is unassessable due to insufficient information.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blister, Burning sensation, Erythema, Pruritus, Scab
Clinical narrative: This spontaneous case initially received on 19-Aug-2016, was reported by a non health professional and concerns a male patient. Past medical history included asthma and eczema. Concomitant medication include albuterol. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On 06-Jul-2016, the patient received the first dose of GARDASIL (batch not provided) for HPV prevention. Dose number: 1. Site of administration: Right arm. Adverse reactions/events and outcomes: On an unknown date following GARDASIL vaccination, the patient experienced an adverse reaction (outcome: recovered / resolved). The reaction started out as a "small red spot" on his foot "just like if someone took a marker and just tapped it on the skin" (outcome: recovered / resolved). Then the reaction spread from the feet to the ankles, to the lower arms, to the chest and then to the back (outcome: recovered / resolved). It then turned into "blisters with a crust on top of them" (outcome: recovered / resolved). The reaction itched and burned (outcome: recovered / resolved). On 10-Jul-2016, the patient was taken to the emergency room (ER). On an unspecified date, the reporter took the patient to their primary physician. The reporter also stated that the patient had a "bad reaction" with a flu vaccine (outcome: not reported). Treatment was not given. Reporter's Comments: Reporter's assessment: The "medics" at the ER felt that the reaction was caused by "bug bites", however, the reporter felt that the reaction was related to GARDASIL. The patient's primary physician felt that it might be "hoof and mouth disease". Sender's Comments: Company comments: Listedness: Unlisted. Brand of Influenza vaccine not specified. Assessment according to the agency for CSL's Influenza Virus Vaccine, all events are unlisted listed except rash macular and pruritus which are listed. Causality: Unassessable. Temporal relationship with Influenza vaccination cannot be established. Of note, patient received GARDASIL vaccination which is co-suspect. Causality is unassessable due to insufficient information.
Age: 67.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Insomnia, Pain in extremity
Clinical narrative: Redness, Pain, Swelling at Injection Site - in Left Deltoid.
Age: 67.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, Pain, Swelling at Injection Site - in Left Deltoid.
Age: 5.0
Sex: M
Vaccine: DTPIHI
Symptoms: Crying, Headache, Pain, Pyrexia, Screaming
Clinical narrative: Shakes. Fevers. Puking. Headaches. Screaming crying in pain. Doctors said it was normal vaccine aftermath. I'm outraged this happened to my son. I had no help at the emergency room.
Age: 5.0
Sex: M
Vaccine: DTPIHI
Symptoms: Tremor, Vomiting
Clinical narrative: Shakes. Fevers. Puking. Headaches. Screaming crying in pain. Doctors said it was normal vaccine aftermath. I'm outraged this happened to my son. I had no help at the emergency room.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report as received from a medical student, refers to an unspecified children patients of unknown age and gender. No information on patients' concurrent conditions, medical history and concomitant therapies was reported. On an unknown dates, the children patients were vaccinated with M-M-R II (dose, route, lot # and expiration date were not reported) and with other unspecified vaccines. The reporter stated that he had read many different unspecified articles and books and watched a movie, which were telling that M-M-R II and other unspecified vaccines were causing autism in children. The outcome of autism was unknown. Upon internal review, the autism was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Hyperhidrosis, Lymphadenopathy, Nausea
Clinical narrative: Initial unsolicited report received from a health care professional (daughter of patient and Physician's assistant) on 11-Aug-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of ADACEL (batch number: unknown, expiry date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date following vaccination the reporter stated that the patient experienced reaction, swollen lymph nodes above the left clavicle with swelling upwards to face, redness of swollen area, headache, nausea and sweating. Lab test and corrective treatment were not reported. The outcome of the events was unknown. List of documents held by the sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Initial unsolicited report received from a health care professional (daughter of patient and Physician's assistant) on 11-Aug-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of ADACEL (batch number: unknown, expiry date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date following vaccination the reporter stated that the patient experienced reaction, swollen lymph nodes above the left clavicle with swelling upwards to face, redness of swollen area, headache, nausea and sweating. Lab test and corrective treatment were not reported. The outcome of the events was unknown. List of documents held by the sender: None.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspepsia, Malaise, Muscle spasms, Sensation of foreign body, Throat irritation
Clinical narrative: Initial unsolicited report received from a consumer on 17 Aug 2016. This case involves a 64-year female patient who was vaccinated with a dose of TDAP (batch number, expiry date, dose, dose in series, route and site of administration were not reported) and a first dose of ADACEL (batch number: U5467AC, expiry date: 08 Oct 2018, dose and route of administration was not reported) in the left arm on 06 Aug 2016. It was reported that the patient did not have any problems in the past with regular Tetanus vaccine. Patient's Illness at time of vaccination was not reported. The patient had a heart attack at the end of April 2016 and almost died twice. Patient had a history of hypertension, Irritable Bowel Syndrome with Diarrhea, and Fibromyalgia in the past. Patient's concomitant medications were not reported. On 06 Aug 2016, same day following the vaccination, the patient had to clear the throat, feeling like there is something in the throat/ feeling as if something is stuck in the throat, getting cramps in all of the muscles, It was worse in the hands and fingers, but also in the feet/toes. The patient was having some cramps in the arms and legs as well/ Patient had severe muscle cramps in arms, hands, legs and feet, can't rub the cramp out, and just doesn't feel right in general. The patient thought that she had heartburn and was concerned about the ADACEL affecting her heart muscle. Lab data and corrective treatment was not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Erythema, Myalgia, Neck pain, Pain
Clinical narrative: Area in arm was red, swollen with fever. Then on Monday the redness had spread down to my elbow. Tingling in fingers, sharp pain would radiate too my elbow and up to my neck. Muscle and body aches with fever.
Age: 42.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Paraesthesia, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Area in arm was red, swollen with fever. Then on Monday the redness had spread down to my elbow. Tingling in fingers, sharp pain would radiate too my elbow and up to my neck. Muscle and body aches with fever.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema multiforme, Pyrexia, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Red bumps that were very itchy that continued to spread from head to toe, first noticed at 8 pm 8/18/16. Prior to this, the day before he thought he had been bitten by mosquitos. He was given Benadryl 8/19/16 at 7:30 AM with no relief and continued worsening of rash. He was taken to pediatrician at 11 AM, unknown diagnosis, given prednisone, Zantac and hydrocortisone cream 2.5%. By 5 PM, the rash had continued to worsen and he was taken to local emergency room. He was then transferred to Hospital believed to have Stevens Johnson Syndrome. Given more Benadryl with no relief. Infectious Disease doctor diagnosed as Erythema Multiforme on 8/20/16. He was then given Atarax at 2 PM with mild relief. He then developed a fever of 101. He was released from hospital that night and given a prescription for Atarax and told to follow up with pediatrician. On 8/21/16, he had a fever 103.2 and was given Advil. His fever has continued around 103 since. He is taking Advil prn. His rash is now almost all connected and he is almost completely red. He is very itchy and continues to run a fever.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse (clinic coordinator) concerning unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients received doses of improperly stored PNEUMOVAX 23 (lot # L014420 with expiration date 23-FEB-2017, dose and route were not reported). The doses of PNEUMOVAX 23 underwent temperature excursions at 34.8 F for 6 hour 25 minutes and 14.6 F for 5 hours 45 minutes respectively. Previous temperature excursion was as followings: 47 F for 45 min, 48 F for 45 min, 49 F for 30 min, 50 F for 45 min and 50 F for 3 hour 15 min. Data logger was involved. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: TD
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) on 17 August 2016. Manufacturer Report Number: 2016380448. This case involves a female patient (age not reported) who was vaccinated with a dose of DIPHTHERIA AND TETANUS TOXOIDS (DT) (manufacturer: unknown, batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had rare reaction. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In August 2016, reported as dates starting on or after 04-AUG-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M010212, expiry date 02-JAN-2019 (strength, dose, route and site of administration were not reported). No adverse effect was reported. Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 6 hours and 25 minutes and 47 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
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 gender and age. Information regarding patients' medical history, current conditions, drug reactions/allergies and concomitant medications information were not provided. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L042257, expiry date: 17-AUG-2018) (incorrect product storage). Medical assistant reported that the vaccine reached 32 F for 28 hours and 30 minutes. A data logger was used and the vaccines were back in range. There were no prior excursions. No adverse experiences were reported. This is one of the two 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 as received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, current conditions, drug reactions/allergies and concomitant medications information were not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L039638, expiry date: 23-AUG-2017) (incorrect product storage). Medical assistant reported that the vaccine reached 32F for 28 hours and 30 minutes. A data logger was used and the vaccines were back in range. There were no prior excursions. No adverse experiences were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Malaise, Pyrexia
Clinical narrative: Fever, malaise, swelling at site of injection.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Bedridden, Chills, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: Chills, fever, severe headache, nausea, severe body aches, injection sight soreness, at injection site 12" by 4" bright red inflamed area, sweats. Bedridden for 2 days.  NO food or water intake for 24 hours.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site inflammation, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever, severe headache, nausea, severe body aches, injection sight soreness, at injection site 12" by 4" bright red inflamed area, sweats. Bedridden for 2 days.  NO food or water intake for 24 hours.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache; Fever; Body Aches.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Confusional state, Injection site pain, Muscular weakness, Nuclear magnetic resonance imaging brain
Clinical narrative: Severe pain at the injection site however she was also having trouble with weakness in her left lower extremity and some speech problems.  She was slightly confused couldn't work her garage door opener.  According the daughter the patient is extremely sharp and very active for her age.  Speech was very slow and purposeful instead of free fluid and fast like her normal speech pattern is.  Also noted that she was having trouble with her left lower extremity.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Slow speech, Speech disorder, Ultrasound scan
Clinical narrative: Severe pain at the injection site however she was also having trouble with weakness in her left lower extremity and some speech problems.  She was slightly confused couldn't work her garage door opener.  According the daughter the patient is extremely sharp and very active for her age.  Speech was very slow and purposeful instead of free fluid and fast like her normal speech pattern is.  Also noted that she was having trouble with her left lower extremity.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Coeliac disease
Clinical narrative: This spontaneous report was received from a registered nurse via company representative and refers to a 9 year old female patient with gluten allergy. The patient's pertinent medical history was not known by the reporter. On 12-JUN-2001, "at the age of three years old", the patient received the first dose of VARIVAX (dose, route of administration, lot # and expiration date were not provided). It was unknown if the patient took any concomitant medication. On an unspecified date (reported as "at the age of nine years old"), the patient was diagnosed with celiac disease. It was unknown if any treatment was given for the event. The outcome of celiac disease was unknown at the time of this report. The relatedness between event of celiac disease and VARIVAX was not specified by the reporter. Upon internal review, the event of celiac disease was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In August 2016, reported as dates starting on or after 04-AUG-2016, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II lot # L028273, expiry date 28-JUL-2017 and lot # M006544, expiry date 03-FEB-2018 (strength, dose, route and site of administration were not reported). No adverse effect was reported. Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 6 hours and 25 minutes and 47 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. 2 inches in diameter.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Stiff neck, neck pain, shoulder pain.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Cardiac failure, Intensive care, Respiratory arrest, Vaccination error
Clinical narrative: Heart Failure, Breathing Stopped. Spent 14 days in Intensive care to recover.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown ages and genders. On unknown dates, the patients received improperly stored dose of PROQUAD (Lot# L044055, Expiry date: 02-MAY-2017) (Lot# L046510, Expiry date: 19-MAY-2017) (Lot# L051101, Expiry date: 17-JUN-2017) (route of administration: subcutaneous) (incorrect product storage). No adverse effect reported. The outcome of the events was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB which had lot # L014426, expiry date: 09-MAR-2018, (strength, dose, and route not reported). No adverse effect reported. No product quality complaint (PQC) involved. No further information provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L050907 with expiration date 14-JUL-2017 or lot # M011664 with expiration date 08-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 11.5 degrees Fahrenheit for 3 hours and 54 minutes. Data logger was involved. The temperature was back in range. The previous excursions were the following: 15 degrees Fahrenheit during one hour and 20 minutes, 7 degrees Fahrenheit during two hours and 24.1 unspecified degrees during five hours and 41 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were unknown. On 17-AUG-2016, the patient was vaccinated with M-M-R II (lot number and expiry date were not reported) (dosing regimen and frequency unknown), which was inadvertently administered with sodium chloride rather than the sterile diluent that was supplied (product preparation error). No concomitant medications were reported. There were no adverse effects reported. There was no product quality complaint (PQC) involved. Additional information is not expected as the reporter did not want to provide his demographics nor participate in the report.
Age: 1.33
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a physician and refers to a 1 year old male patient. The patient did not have any pertinent medical history, drug reactions, allergies or concomitant therapies. On 23-JUN-2016, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L049534, expiration date, exact dose and route of administration were not reported). On 08-JUL-2016, the patient developed a persistent generalized rash following administration of (Oka/Merck) VARIVIAX. The physician stated that the rash was continuing to evolve. The patient sought medical attention, he visited physician, but no treatment was given for the event. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between the event and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse refers to a 18 year old patient of unknown gender. Patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 27-JUL-2016, the patient was inadvertently vaccinated with ZOSTAVAX (lot number/expiry date unknown by reporter), instead of VARIVAX. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored GARDASIL 9 (lot# L018351, expiry date: 11-AUG-2017; lot # L037554, expiry date: 25-DEC-2017) (incorrect product storage). The vaccine was stored at a temperature of 53.3 F for a time of 3 hours and 23 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This spontaneous report was received a 67 year old female patient reporting on herself. The patient stated that, on an unknown date, she was diagnosed with the chicken pox by a doctor before ZOSTAVAX vaccination. The chicken pox was at a very small area and therefore she was able to get the shot. On an unknown date, the patient was vaccinated with ZOSTAVAX injection, route reported as "vaccine" (dose, anatomical location, lot # and expiry date were not specified). On 09-AUG-2016 (reported as "today"), about an hour before she called, the patient found a blister like circle in her chin. She was not sure what it was but the patient stated that she would seek medical attention. The outcome of the event was unknown. The reporter did not provide the causality assessment between the event and ZOSTAVAX. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also an office manager) refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L048237, expiry date 15-MAY-2017; dose and route were not reported). These doses were exposed to 56 F for 798 hours and 33 F for 273 hours. There were no previous excursions. Data logger was not involved. No adverse effects were reported This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately August 2016 (reported as "on or after 04-AUG-2016"), the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection, subcutaneously (exact dose, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines were stored in refrigerator for 24 hours upon arrival, before being moved to freezer at that correct storage temperature. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to patient of unknown age and gender. The Patient's pertinent medical history and drug reactions or allergies were not reported. On 27-JUN-2016, the patient was vaccinated with improperly stored doses of VARIVAX (lot number: M002061 and expiration date 12-JAN-2018 (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. Information regarding patient's medical history, concurrent conditions or concomitant therapies were not provided. On unspecified dates, unspecified number of patients were vaccinated with one dose of improperly stored RECOMBIVAX HB lot #L027733 expiry date 13-SEP-2017 or lot # L040458 expiry date 04-FEB-2018 (dose number, dose units, route and anatomical location were not reported). Concomitant medications were not reported. No symptoms were reported. The reporting nurse was not sure which lot numbers were administered but the lot numbers mentioned were the ones possible involved. It was reported that the administered vaccines were exposed to temperatures of 46.9 Fahrenheit degrees for 15 minutes and 34.9 Fahrenheit degrees for 2 hours. This is one of the several reports from the same reporter. Follow up information has been received from Registered Nurse on 09-AUG-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Cold sweat, Injected limb mobility decreased, Injection site pain, Injection site warmth
Clinical narrative: Pain at injection site located high on left hip. Pain continued throughout the evening and resulted in inability for child to sleep through the night, basically awake in pain all night. The following morning, painful to move/bend her leg at the hip joint and not able to walk. Warm skin at the injection point and clammy skin throughout the evening. Have given Tylenol AM of 8/24/16. Tried cold compresses. Have been advised to bring child to clinic if condition worsens or is still the same on 8/25/16.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Pain
Clinical narrative: Pain at injection site located high on left hip. Pain continued throughout the evening and resulted in inability for child to sleep through the night, basically awake in pain all night. The following morning, painful to move/bend her leg at the hip joint and not able to walk. Warm skin at the injection point and clammy skin throughout the evening. Have given Tylenol AM of 8/24/16. Tried cold compresses. Have been advised to bring child to clinic if condition worsens or is still the same on 8/25/16.
Age: 40.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Rash
Clinical narrative: Rash on left and right arms from shoulders to wrist area.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Basophil percentage, Cyanosis, Differential white blood cell count
Clinical narrative: Fatigue, weakness, dizziness, headache, pains down left side of body, stomach pains, and lips turned blue.