chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 22-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular, Trigeminal neuralgia
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 20-JAN-2015, the patient was inoculated at clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-NOV-2015, the patient was treated by a Nurse Practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as trigeminal shingles, a condition of nerve pain and damage affecting the trigeminal nerve of the face, neck, and ear secondary to a herpes zoster infection. The patient has been prescribed valacyclovir (VALTREX)  for management of his perisitent and painful symptoms. As a direct and proximate result of these malfunctions, he has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses. and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 06-NOV-2017 from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender (The patient's first name could be a male or female name). Medical history, concurrent conditions, and concomitant medications were not provided. On or about 25-JUL-2012, the patient was inoculated (by an unspecified person) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-AUG-2016, the patient was treated by an unspecified health care professional at a home health service facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 63 year old female patient with no pertinent medical history, concomitant therapies or drug reactions or allergies. On 31-OCT-2017, the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU, for prophylaxis, lot # M039453 with expiration date of 19-DEC-2017 (dose, route and frequency were not reported). Other suspect therapies included sterile diluent (manufacturer unknown). On 03-NOV-2017, the patient experienced a raised six inch wide area around injection site and was warm to touch after being vaccinated with ZOSTAVAX. The patient did not perform laboratory diagnostic studies, she did not present significant disability or incapacity, she did not need hospitalization and the events were not life threatening. The outcome of injection site mass and injection site warmth was unknown. The causality between injection site mass and injection site warmth with ZOSTAVAX was not reported.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received PREVNAR 13, (lot#: R49358, expiry date: Apr2018, NDC #: 00006197102), intramuscular in left deltoid on 31Oct2017 at 0.5 ml, single for immunisation. Vaccination was done in a pharmacy/drug store. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patent experienced arm was red and inflamed, sore to the touch although not as sore today as it's been since she got the shot, it was swollen and red about 3 to 4 inches in diameter it's itchy, she said she was not running a fever and she wanted to find out if she should go to the doctor or if this would be considered normal. The outcome of the event sore to the touch although not as sore was recovering while the outcome of the remaining events was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received PREVNAR 13, (lot#: R49358, expiry date: Apr2018, NDC #: 00006197102), intramuscular in left deltoid on 31Oct2017 at 0.5 ml, single for immunisation. Vaccination was done in a pharmacy/drug store. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patent experienced arm was red and inflamed, sore to the touch although not as sore today as it's been since she got the shot, it was swollen and red about 3 to 4 inches in diameter it's itchy, she said she was not running a fever and she wanted to find out if she should go to the doctor or if this would be considered normal. The outcome of the event sore to the touch although not as sore was recovering while the outcome of the remaining events was unknown.
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (parent, reporting for her sons). This consumer reported similar events for 2 patients. This is the 1st of 2 reports. A male patient of an unspecified age and ethnicity received first dose of TRUMENBA, via an unspecified route of administration on an unspecified date in Jul2017 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue and headache, which lasted two days. The patient also stated that the pediatrician office does not seem to know what was going on with the dose schedule. The outcome of the events was recovered. The patient will be getting the second shot at the end of Nov2017, which would be 4 months after the first dose. Sender's Comments: Linked Report(s): US-PFIZER INC-2017479987 same drug and event/ different patient.
Sex: M
Vaccine: MENB
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A 15-year-old male patient (reporters son) received first dose of TRUMENBA at single dose in Jul2017 for immunization. Medical history and concomitant medications were not reported. In Jul2017, patient received the first dose and he played tennis after receiving the vaccine. He was really sick and got a fever that lasted two days. He had sore muscles in the arm he was injected in (consumer thinks it was the left arm) and the sore muscles lasted three days. Outcome of event sickness was unknown, outcome of other events was recovered.
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache
Clinical narrative: This is a spontaneous report received from a Pfizer sponsored program, via a contactable consumer (reporting for her sons). This consumer reported similar events for 2 patients. This is for the 2nd of two reports. A male patient of an unspecified age and ethnicity received first dose of TRUMENBA, via an unspecified route of administration on Jul2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue and headache, but it only lasted two days. The reported also stated that the pediatrician office does not seem to know what was going on with the dose schedule. The outcome of the event was recovered. The patient will be getting the second shot at the end of Nov2017, which would be 4 months after the first dose. Sender's Comments: Linked Report(s): US-PFIZER INC-2017479958 Same drug/AE for different patients.
Sex: U
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a patient of unspecified age, gender and ethnicity received PREVNAR 13 via unspecified route of administration on unspecified date at single dose for immunization. Patient medical history and concomitant medications were not reported. The patient stated, "Those shots freaking hurt" on unspecified date. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rash generalised, Urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse. An infant male patient of an unspecified ethnicity received PREVNAR 13, at single dose, and PENTACEL, at unknown dose; both were administered on the same date (unspecified) at the primary pediatrician's office, via an unspecified route of administration for immunization. The patient's medical history and concomitant medications were not reported. The reporting nurse worked at an allergy and immunology office and was requesting on information regarding ingredients of the vaccines so she could do the skin test to the patient. The patient experienced total body rash with hives which began 24 hours after the vaccines were administered. The nurse was requesting for the specific ingredients in the product and to get those separate ingredients to test patient for allergies. The nurse stated that they were possibly performing a skin test. The patient had recovered completely from the events.
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 06Nov2017 at single dose for pneumonia. The patient's medical history and concomitant medications were not reported. The patient had swelling that was the size of a baseball, at the site on unspecified date. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 65-year-old  female patient received PREVNAR 13, intramuscular in the right arm on 31Oct2017 at 0.5 ml, single to prevent pneumonia, and FLUZONE, intramuscular injection in the left arm on 31Oct2017 at unknown dose for immunization. Medical history included ongoing Hashimoto's disease diagnosed in 1998, double pneumonia about 12 years ago and heart palpitations. Her gastroenterologist wanted her to get the flu and pneumonia shot. Concomitant medication included ongoing atenolol since 1998 for heart palpitations. The patient had no family history. The patient previously received FLUZONE for immunization, which she gets every year, and after having double pneumonia she had the first pneumonia shot, but not PREVNAR 13. The patient also had a shingle vaccine that was hard. This was 4 or five years ago. She had redness and stuff. The patient did not have the current symptoms and did not last as long for the shingle vaccine. The patient reported that she got the the pneumonia shot last Tuesday and began to have some problems a little bit after and is still having some. Two days after on 01Nov2017 around 14:00, she got the chills and almost a 103 degree fever clarified as she got the chills and her fever was at 102.5 degrees Fahrenheit. In the late afternoon on 02Nov2017, reported as about 48 hours later it was so swollen, she had redness and swelling that was about 6 inches long from the injection site and 5 inches wide and itching. It is no longer all hard, but it was still red and had all the itchy bumps. She clarified that she had itchy bumps to the injection site area but that the itching is getting worse and has spread to her whole right arm and lower part of arm, top of her neck area, and back on an unspecified date. The itchy bumps are just to the injection site area that is red and swollen. The itching has been more in the last few days.  It is still red, but the mobility is better than it was, the swelling is not as intense. She stated that she can raise her arm up but it was so swollen and painful to raise it up or lay on it on an unspecified date. This has improved, she can lift it. Neck stiffness happened, Friday, 03Nov2017, around 12:30. It was further reported that maybe on Saturday she had a 100 degrees Fahrenheit fever, but has not had a fever since. The patient did not undergo any relevant tests. The patient wanted to know how much longer could the reaction be. The events did not require emergency room or physician office visit. The outcome of the fever was recovered on 04Nov2017 while the itching/itchy bumps at injection site was not recovered. The outcome of itching getting worse and has spread to her whole right arm and lower part of arm, top of her neck area, and back was unknown, while the outcome of the remaining events was recovering.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site rash, Injection site swelling, Pyrexia, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 65-year-old  female patient received PREVNAR 13, intramuscular in the right arm on 31Oct2017 at 0.5 ml, single to prevent pneumonia, and FLUZONE, intramuscular injection in the left arm on 31Oct2017 at unknown dose for immunization. Medical history included ongoing Hashimoto's disease diagnosed in 1998, double pneumonia about 12 years ago and heart palpitations. Her gastroenterologist wanted her to get the flu and pneumonia shot. Concomitant medication included ongoing atenolol since 1998 for heart palpitations. The patient had no family history. The patient previously received FLUZONE for immunization, which she gets every year, and after having double pneumonia she had the first pneumonia shot, but not PREVNAR 13. The patient also had a shingle vaccine that was hard. This was 4 or five years ago. She had redness and stuff. The patient did not have the current symptoms and did not last as long for the shingle vaccine. The patient reported that she got the the pneumonia shot last Tuesday and began to have some problems a little bit after and is still having some. Two days after on 01Nov2017 around 14:00, she got the chills and almost a 103 degree fever clarified as she got the chills and her fever was at 102.5 degrees Fahrenheit. In the late afternoon on 02Nov2017, reported as about 48 hours later it was so swollen, she had redness and swelling that was about 6 inches long from the injection site and 5 inches wide and itching. It is no longer all hard, but it was still red and had all the itchy bumps. She clarified that she had itchy bumps to the injection site area but that the itching is getting worse and has spread to her whole right arm and lower part of arm, top of her neck area, and back on an unspecified date. The itchy bumps are just to the injection site area that is red and swollen. The itching has been more in the last few days.  It is still red, but the mobility is better than it was, the swelling is not as intense. She stated that she can raise her arm up but it was so swollen and painful to raise it up or lay on it on an unspecified date. This has improved, she can lift it. Neck stiffness happened, Friday, 03Nov2017, around 12:30. It was further reported that maybe on Saturday she had a 100 degrees Fahrenheit fever, but has not had a fever since. The patient did not undergo any relevant tests. The patient wanted to know how much longer could the reaction be. The events did not require emergency room or physician office visit. The outcome of the fever was recovered on 04Nov2017 while the itching/itchy bumps at injection site was not recovered. The outcome of itching getting worse and has spread to her whole right arm and lower part of arm, top of her neck area, and back was unknown, while the outcome of the remaining events was recovering.
Sex: U
Vaccine: PPV
Symptoms: Feeling abnormal
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a patient of an unspecified age, race/ethnicity received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) at single dose for immunization. Relevant medical history and concomitant medication were not specified. On unknown date the patient experienced Feeling abnormal. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 16-year-old patient of an unspecified ethnicity and gender received the 1st dose TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced body aches, headaches, chills, fever, nausea, and vomiting on an unspecified date lasted 2 days, with outcome of recovered. The patient went to the emergency room.
Sex: U
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 16-year-old patient of an unspecified ethnicity and gender received the 1st dose TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced body aches, headaches, chills, fever, nausea, and vomiting on an unspecified date lasted 2 days, with outcome of recovered. The patient went to the emergency room.
Sex: U
Vaccine: UNK
Symptoms: Drug ineffective, Pneumonia, Quality of life decreased
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for self, from a Pfizer sponsored program. A patient of unspecified age, ethnicity, and gender received the PREVNAR 13, via an unspecified route of administration in 2015 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. As reported, the patient was in excellent health prior to the immunization. On an unspecified date, four days after the immunization, the patient experienced drug ineffective and pneumonia. As reported, this ruined the quality of the health. The clinical outcome of the events, drug ineffective and pneumonia, was unknown. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: FLU4
Symptoms: Eye swelling
Clinical narrative: This case was reported by a other health professional and described the occurrence of eye swelling in a child patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced eye swelling. On an unknown date, the outcome of the eye swelling was unknown. It was unknown if the reporter considered the eye swelling to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that, the patient received flu shot then the patient eyes swelled up. The reporter did not know this patient, only heard from people talking about the incident. The reporter did not provide anymore information.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Crying, Foaming at mouth, Skin warm, Somnolence, Tremor
Clinical narrative: Felt warm prior to diaper changed at 9:30 PM when began to have whole body shaking with frothing at mouth. Lasted approx. 5 mins. Was sleepy and whimpening in ambulance then back to baseline once reached ER.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discomfort, Injection site erythema, Injection site mass
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a adult female patient who received BEXERO. On 16th December 2016, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site erythema, injection site lump and injection site discomfort. On an unknown date, the outcome of the injection site erythema, injection site lump and injection site discomfort were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site lump and injection site discomfort to be related to BEXSERO. Additional details were provided as follows: The patient's mother called to the reporter in concerned about getting the second shot in the serious for BEXSERO. The patient's mother stated to the reporter that, after the first shot the patient experienced a red knot that formed at the injection site and it was sensitive till the time of reporting. The reporter did not know if this was related to BEXSERO but she had doubts (In her own words).
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Patient's parent reported a large raised reddened area approximately 4 inches in diameter. Area was warm and hard to the touch. Steroid and antibiotic injection given to reduce inflammation and treat possible cellulitis at injection site on 11/10/17. Instructed to return to clinic if not improved or worsens within next day or two.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a female patient who received BEXSERO. On 1st November 2017, the patient received BEXSERO. In November 2017, 1 day after receiving BEXSERO, the patient experienced injection site erythema, injection site pain and injection site induration. The patient was treated with ibuprofen, BENADRYL and medication unknown (Ice Pack (NOS)). On an unknown date, the outcome of the injection site erythema, injection site pain and injection site induration were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site induration to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient was given BEXSERO vaccine 24 hours ago and was complaining of pain at injection site. The patient was seen today for pain and redness at the injection site with a harden area measuring four and a half by six centimeters. The reporter also mentioned that a second patient experienced the same symptoms 2 weeks ago. There were no additional details regarding that patient. The reporter had limited details and also attempted to file this adverse event online but got a message to call the Governance risk compliance. All questions asked and details provided were documented.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Sluggishness, Swelling face
Clinical narrative: This am fever of 102.4, body aches, face looked "puffy" this am but has improved seems sluggish but not confused.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discharge, Injection site extravasation, Injection site injury, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 20-year-old female patient who received FLUARIX QUADRIVALENT. On 1st November 2017, the patient received FLUARIX QUADRIVALENT (intramuscular). On 1st November 2017, 45 min after receiving FLUARIX QUADRIVALENT, the patient experienced injection site itching, injection site extravasation and injection site injury. On an unknown date, the outcome of the injection site itching, injection site extravasation and injection site injury were unknown. It was unknown if the reporter considered the injection site itching, injection site extravasation and injection site injury to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient called the pharmacist to report that, 45 minutes after vaccination, she started to experience itchiness at the injection site. After she scratched it, there was oozing of clear to colorless liquid from the injection site.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient was vaccinated in school-based mass clinic setting by Public Health. She reported feeling well prior to being vaccinated and tolerated vaccine administration well. Per review of consent form completed by child's mother, child does not have any allergies to medications, food, a vaccine component or latex. She has not had any serious reaction to vaccines in the past, and she does not have any brain or other nervous systems problems or history of problems. Patient's mom phoned the school nurse the following morning (11/17/17). School nurse in turn phoned Public Health to discuss. Patient's mom reports that child started with symptoms last night (day of vaccination). States that left arm was red and swollen, also itchy. She reports that the redness is approximately soft-ball sized. Mom had been in touch with the child's doctor who advised on home care remedies. It should be noted that child had a very similar reaction to the vaccine last year (2016) given also by Public Health in the school-based mass clinic setting. Mom stated to school nurse that next year she is going to request that child receive a preservative-free vaccine. Many attempts were made by PH to get in contact with child's mother to explain that child did receive preservative-free vaccine from PH last year and this year. Unable to connect with patient's mom to discuss. Followed up with child's school nurse who reported that she will explain to child's mother and will advise mom to complete the consent form next year indicating that child has had a reaction to the vaccine in the past and may want to consider having the vaccine administered by her HCP.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood thyroid stimulating hormone, Dyspnoea, Fall, Hypoaesthesia
Clinical narrative: GENERALIZED SORENESS, WEAKNESS, STIFFNESS NUMBNESS AND TINGLING IN TOES AND FINGERS THAT IS GRADUALLY MOVING UP SOME DIFFICULTY BREATHING AT TIMES NOT ASSOCIATED WITH URI SEVERE WEAKNESS IN LEGS, FALLING PAIN IN NECK, STIFFNESS I WENT TO OCCUPATIONAL HEALTH CLINIC ON 10/27/2017 AND NP ADVISED ME TO GO SEE MY PCP BECAUSE IT WAS DUE TO MY "THYROID", TO HAVE MY TSH CHECKED AGAIN.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Musculoskeletal stiffness, Neck pain, Pain, Paraesthesia
Clinical narrative: GENERALIZED SORENESS, WEAKNESS, STIFFNESS NUMBNESS AND TINGLING IN TOES AND FINGERS THAT IS GRADUALLY MOVING UP SOME DIFFICULTY BREATHING AT TIMES NOT ASSOCIATED WITH URI SEVERE WEAKNESS IN LEGS, FALLING PAIN IN NECK, STIFFNESS I WENT TO OCCUPATIONAL HEALTH CLINIC ON 10/27/2017 AND NP ADVISED ME TO GO SEE MY PCP BECAUSE IT WAS DUE TO MY "THYROID", TO HAVE MY TSH CHECKED AGAIN.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Upper respiratory tract infection
Clinical narrative: GENERALIZED SORENESS, WEAKNESS, STIFFNESS NUMBNESS AND TINGLING IN TOES AND FINGERS THAT IS GRADUALLY MOVING UP SOME DIFFICULTY BREATHING AT TIMES NOT ASSOCIATED WITH URI SEVERE WEAKNESS IN LEGS, FALLING PAIN IN NECK, STIFFNESS I WENT TO OCCUPATIONAL HEALTH CLINIC ON 10/27/2017 AND NP ADVISED ME TO GO SEE MY PCP BECAUSE IT WAS DUE TO MY "THYROID", TO HAVE MY TSH CHECKED AGAIN.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site injury, Rotator cuff syndrome, Ultrasound scan
Clinical narrative: Right arm/Right Shoulder, patient stating rotator-cuff tear.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Feeling abnormal, Headache, Hypersomnia, Injected limb mobility decreased
Clinical narrative: A few hours after the vaccination, I developed pain and swelling in my left arm around the shot location (deltoid ms). Then the pain spread to my whole posterior upper arm (triceps). 12 hours after the shot, I developed a headache, 102 fever and chills, and severe pain trying to move my arm. That all lasted several hours. The next day, I felt awful, had a headache, slept most of the day, still couldn't move my arm.  By the 2nd day, I felt pretty much back to normal except the pain persisted in my posterior arm (triceps). Today (the third day) the pain is isolated to the distal triceps, and tolerable.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: A few hours after the vaccination, I developed pain and swelling in my left arm around the shot location (deltoid ms). Then the pain spread to my whole posterior upper arm (triceps). 12 hours after the shot, I developed a headache, 102 fever and chills, and severe pain trying to move my arm. That all lasted several hours. The next day, I felt awful, had a headache, slept most of the day, still couldn't move my arm.  By the 2nd day, I felt pretty much back to normal except the pain persisted in my posterior arm (triceps). Today (the third day) the pain is isolated to the distal triceps, and tolerable.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Emotional distress, Injection site erythema, Injection site scar, Screaming
Clinical narrative: Child screaming very hard to calm after. Shot turned into a red mark that scarred and never went away. Child was 100% breastfed. Vaccines are not needed when mother's antibodies transfers to a newborn. This same child went on to later have more severe vaccine reactions that could have ultimately been prevented.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Heart rate increased, Hypersensitivity, Pain, Pharyngeal oedema, Skin warm
Clinical narrative: Pt had an allergic reaction (Swelling, large painful bump, hot to the touch, throat swelling, increased heart rate). Pt went to the Emergency Room via ambulance where she was treated with EpiPen, Benadryl and Pepcid and stayed a while for observation. Pt was sent home from ER. She came to the pharmacy the following day to get those same meds filled that she had in the ER and her condition was fine.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling
Clinical narrative: Pt had an allergic reaction (Swelling, large painful bump, hot to the touch, throat swelling, increased heart rate). Pt went to the Emergency Room via ambulance where she was treated with EpiPen, Benadryl and Pepcid and stayed a while for observation. Pt was sent home from ER. She came to the pharmacy the following day to get those same meds filled that she had in the ER and her condition was fine.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt received flu vaccine on Wednesday and on Thursday night mom noticed redness/swelling and itching at injection site - warm to touch, BENADRYL given for 2 nights and slow improvement noted.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced redness, sorness and swelling at injection site.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Swollen at injection site, intense itching.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Presyncope
Clinical narrative: Patient appeared to have vaso-vagal response several minutes after administration of vaccine.  Supportive care given until ems arrived.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: Pt complains of itching spots on body, hands were swollen.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Eye swelling, Flushing, Headache
Clinical narrative: Difficulty swallowing, headache, felt flushed, about 2 hours after vaccination. Denies struggle to breathe. Sought treatment at ED. Woke up the next morning with swollen eyes. I'm not informed of the treatments provided at the ED.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: ITCH CONFLUENT, ERYTHEMATOUS RASH TO TRUNK, ARMS  AND LEGS INTERMITTANTLY X 2 DAYS.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Called later the same day of vaccination reporting swelling from shoulder to elbow of arm of administration. Did not improve following day. Pt seeking medical attention.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dysgeusia, Dysphagia, Headache, Musculoskeletal stiffness
Clinical narrative: Copper taste in mouth, increased mucus making it difficult to swallow, neck/back/shoulder stiffness, fuzzy vision, dull headache, left-sided chest ache.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea, Vision blurred
Clinical narrative: Copper taste in mouth, increased mucus making it difficult to swallow, neck/back/shoulder stiffness, fuzzy vision, dull headache, left-sided chest ache.
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Chest discomfort
Clinical narrative: Pt called today stating that it feels like someone is sitting on his chest. I told him to go to the emergency room. He agreed.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Red and swollen down arm thru elbow with pain. Fever on Tuesday 11/7.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia, Myositis
Clinical narrative: Muscle aches, joint pain and myositis that lasted 10 days.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Patient was supposed to get FLUZONE-QUAD but was given FLUZONE-HD, he is not of indicated age to receive the HD. Patient said he reported no adverse effects and felt fine. Counseled him that increased risk of injection site reaction, low grade fever, or malaise were the most common things he would have been at risk for.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from an office worker refers to a patient of unknown age and gender. The patient's historical drugs, medical history and concurrent conditions were not reported. The patient's concomitant therapies included MERCK STERILE DILUENT. On 12-OCT-2017, the patient was vaccinated with an expired dose of PROQUAD rHA, lot # M017336, expiration date 12-OCT-2017, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effect reported. Lot number M017336 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 18-OCT-2017, the patient was vaccinated with improperly stored doses of ROTATEQ lot # N005619, expiration date 29-OCT-2018, orally, for prophylaxis (strength, dose and frequency were not reported) and RECOMBIVAX HB lot # N020613, expiration date 05-MAY-2020, for prophylaxis (strength, dose, route and frequency were not reported). The temperature/Time frame was 34.8°F for 8 hours 23 minutes and 34.8°F for 8 hours 15 minutes The previous temperature excursion was 47.6°F for 5 minutes There was a data logger involved. No adverse effects reported. This is one of several cases from the same source; Sender's Comments: US-009507513-1710USA010653: US-009507513-1710USA010654: US-009507513-1710USA010655: US-009507513-1710USA010656:
Sex: F
Vaccine: PPV
Symptoms: Soft tissue necrosis
Clinical narrative: This spontaneous report was received from a physician assistant, via company representative, and refers to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, 1 dosage form (reported as: vaccine dose) for prophylaxis (route of administration, lot number and expiration date were not reported). On an unspecified date, after receiving the vaccine, the patient was diagnosed with necrotic tissue. The patient received treatment for the event, and recovered on an unspecified date. It was reported that the patient seek medical attention contacting the primary reporter. Upon internal review the event of soft tissue necrosis was considered to be medically significant.
Sex: M
Vaccine: HPVX
Symptoms: Abnormal behaviour
Clinical narrative: This spontaneous report was received from a registered nurse referring to male patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with GARDASIL or GARDASIL 9 for prophylaxis (strength, dose, units and lot number were not reported). The nurse stated that she knew a coworker's grandson that became more laid back and had behavior changes after being vaccinated. It was unknown by the reporter which of the two vaccines were administered to the patient. The outcome of the events was unknown. Causality assessment was not provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA007114.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV9, MENB
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative, and refers to a 16 year old female patient with no medical history, current conditions or historical drugs reported. The physician stated that the patient had not eaten anything prior to the office visit on 04-NOV-2017, where the patient was vaccinated with an unspecified dose of GARDASIL 9, intramuscular for prevention of Human Papilloma Virus (HPV) (lot# and expiration date were unknown); BEXSERO, for prophylaxis (route of administration, lot# and expiration date were unknown); and influenza virus vaccine (manufacturer unknown) for prophylaxis (route of administration, lot# and expiration date were unknown). It was also mentioned that during the patient's visit a tuberculine test was performed, test results unknown. Shortly after vaccinations on the same date, she began to feel lightheaded and dizzy, fainted, and then fell off of the exam table and hit their head on the blood pressure machine, the patient was unconscious for 5-10 minutes. The physician also documented the events as sudden and moderate. The patient had a follow up visit to the physician's office on 06-NOV-2017, and everything was OK. The patient did not receive any treatment and no laboratory diagnostic studies were performed. The patient recovered from syncope, loss of consciousness and dizziness on the same date of vaccination, and recovered from head injury in November 2016. Upon internal review the event Loss of consciousness was considered as medically significant.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV9, MENB
Symptoms: Tuberculin test
Clinical narrative: This spontaneous report was received from a physician via company representative, and refers to a 16 year old female patient with no medical history, current conditions or historical drugs reported. The physician stated that the patient had not eaten anything prior to the office visit on 04-NOV-2017, where the patient was vaccinated with an unspecified dose of GARDASIL 9, intramuscular for prevention of Human Papilloma Virus (HPV) (lot# and expiration date were unknown); BEXSERO, for prophylaxis (route of administration, lot# and expiration date were unknown); and influenza virus vaccine (manufacturer unknown) for prophylaxis (route of administration, lot# and expiration date were unknown). It was also mentioned that during the patient's visit a tuberculine test was performed, test results unknown. Shortly after vaccinations on the same date, she began to feel lightheaded and dizzy, fainted, and then fell off of the exam table and hit their head on the blood pressure machine, the patient was unconscious for 5-10 minutes. The physician also documented the events as sudden and moderate. The patient had a follow up visit to the physician's office on 06-NOV-2017, and everything was OK. The patient did not receive any treatment and no laboratory diagnostic studies were performed. The patient recovered from syncope, loss of consciousness and dizziness on the same date of vaccination, and recovered from head injury in November 2016. Upon internal review the event Loss of consciousness was considered as medically significant.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: This spontaneous report was received from a male patient of unknown age via a company representative concerning on himself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot number N022303, expiration date 03-MAR-2019 (strength, dose and route of administration were not reported) to prevent pneumonia. On the same date, later that evening, the injection site was warm to the touch and the area was blotchy and red. At the time of the report, the patient had not recovered from the events. The causality assessment between the events and therapy with PNEUMOVAX 23 was not reported. This is one of two cases from the same reporter.; Sender's Comments: US-009507513-1711USA004606:
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender via a company representative concerning on  theirself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot number M043987, expiration date 30-JUN-2018 (strength, dose and route of administration were not reported) to prevent pneumonia. On the same date, later that evening, the injection site was warm to the touch and the area was blotchy and red. At the time of the report, the patient had not recovered from the events. The causality assessment between the events and therapy with PNEUMOVAX 23 was not reported. This is one of two cases from the same reporter.; Sender's Comments: US-009507513-1711USA003938:
Age: 49.0
Sex: F
Vaccine: PNC13
Symptoms: Depression, Dyspnoea, Fatigue, Upper respiratory tract infection
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, by a contactable consumer. A 49-year-old female patient of an unspecified race/ethnicity received the first dose of PREVNAR 13, via an unspecified route of administration at single dose on 01Jan2017 for immunisation. Medical history included pneumonia pneumococcal in 2016. Concomitant medications were not reported. The patient experienced upper respiratory infections/diagnosed with URI about every 6-8 weeks since February (2017), being tired all the time, getting winded easily/breathing so hard, depression on an unspecified date. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, 8 days after administration of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), the patient experienced redness and swelling on the injection site. The patient asked if this is an expected adverse event.
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable physician. A 74-year-old female patient received the PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 31Oct2017, the patient experienced raised and erythematous rash near the injection site, which was assessed as medically significant. The clinical outcome of the event, raised and erythematous rash near the injection site, was not recovered. Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of vaccination site reaction cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Left shoulder pain, painful ROM of left shoulder since vaccine was administered on 10/23/2017.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Left shoulder and left deltoid tenderness and discomfort since vaccine was given on 10/23/2017.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: Erythema and pain results in cellulitis. Tx with NSAIDs and KEFLEX.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Abnormal behaviour, Hyperacusis, Injection site erythema, Injection site swelling
Clinical narrative: Patient has some behavior changes, redness and swelling to the site. Patient was also complaining that all sounds were "too loud". Symptoms resolved in about 24 hours.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal discomfort, Ammonia increased, Dehydration, Delirium, Disorientation
Clinical narrative: WOKE UP NEXT DAY NAUSEOUS AND UPSET STOMACH, FOLLOWED BY DRY HEAVES NEXT DAY, DAY 3 TOOK TO ER AS I WAS CONCERNED ABOUT DEHYDRATION. BECAME DISORIENTED, DELIRIOUS, BREATHING COMPROMISED, INTUBATED, AMONIA LEVEL 188, UNCONSCIOUS FOR 5 DAYS ON VENTILATOR.