chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Mitogen stimulation test, Otorrhoea, Purulence, Pyrexia, Rash generalised
Clinical narrative: This literature marketed report was received from a physician refers to a 2 year old female patient with Wolf-Hirschhorn syndrome. The patient's medical history included transient hypogammaglobulinaemia of infancy, routine viral illness and recurrent otitis media, but no other recurrent viral, bacteria, fungal or autoimmune diseases. The patient's drug history included oral rotavirus live virus vaccine with demonstrated adequate humoral response noted at 1 year of age with tetanus and diphtheria antibodies present at appropriate levels. On an unspecified date patient was vaccinated with VARIVAX (Merck) (manufacture unknown). Concomitant medications were not reported. On an unspecified date (3 days after vaccination) the patient developed fever to 100.4 degree F associated with bilateral otorrhea. The patient was treated with acetaminophen and ofloxacin drops. On day 3 of fever the patient was presented to outpatient clinic for initial evaluation. On examination the patient had purulent drainage from the ears with debris preventing effective drop administration and the patient external auditory canals were cleared and the treatment with otic antibiotic drops was recommended. The otorrhea was resolved. On day 10 of fever the patient had rash, the rash started at left thigh near the vaccine administration and the rash spread by the initial onset of lesions to the abdomen, back, neck, face, extremities and it was diagnosed as atypical varicella (varicella post vaccine and vaccination failure) and the patient was admitted to the inpatient pediatric ward, the patient was treated with intravenous acyclovir therapy. Laboratory test were performed to evaluate current immunologic functions included complete blood count, immunoglobulin levels, mitogen and antigen lymphocyte studies. On hospital day 1, the patient was removed from the intravenous access and treated with oral acyclovir until the lesion to resolve. The following day the patient appeared well, maintaining adequate oral intake and fever had decreased so the patient was discharged from the hospital. The outcome of the event atypical varicella (varicella post vaccine) was reported as recovering. The reporter assessed the events atypical varicella (varicella post vaccine and vaccination failure) to be related to the suspect therapy. The event atypical varicella (varicella post vaccine) was considered serious due to hospitalization. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure, Vaccination site rash, Varicella post vaccine
Clinical narrative: This literature marketed report was received from a physician refers to a 2 year old female patient with Wolf-Hirschhorn syndrome. The patient's medical history included transient hypogammaglobulinaemia of infancy, routine viral illness and recurrent otitis media, but no other recurrent viral, bacteria, fungal or autoimmune diseases. The patient's drug history included oral rotavirus live virus vaccine with demonstrated adequate humoral response noted at 1 year of age with tetanus and diphtheria antibodies present at appropriate levels. On an unspecified date patient was vaccinated with VARIVAX (Merck) (manufacture unknown). Concomitant medications were not reported. On an unspecified date (3 days after vaccination) the patient developed fever to 100.4 degree F associated with bilateral otorrhea. The patient was treated with acetaminophen and ofloxacin drops. On day 3 of fever the patient was presented to outpatient clinic for initial evaluation. On examination the patient had purulent drainage from the ears with debris preventing effective drop administration and the patient external auditory canals were cleared and the treatment with otic antibiotic drops was recommended. The otorrhea was resolved. On day 10 of fever the patient had rash, the rash started at left thigh near the vaccine administration and the rash spread by the initial onset of lesions to the abdomen, back, neck, face, extremities and it was diagnosed as atypical varicella (varicella post vaccine and vaccination failure) and the patient was admitted to the inpatient pediatric ward, the patient was treated with intravenous acyclovir therapy. Laboratory test were performed to evaluate current immunologic functions included complete blood count, immunoglobulin levels, mitogen and antigen lymphocyte studies. On hospital day 1, the patient was removed from the intravenous access and treated with oral acyclovir until the lesion to resolve. The following day the patient appeared well, maintaining adequate oral intake and fever had decreased so the patient was discharged from the hospital. The outcome of the event atypical varicella (varicella post vaccine) was reported as recovering. The reporter assessed the events atypical varicella (varicella post vaccine and vaccination failure) to be related to the suspect therapy. The event atypical varicella (varicella post vaccine) was considered serious due to hospitalization. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: Severe pain in right shoulder (same side as injection) with certain movements; Limited mobility without inducing extreme pain. Any minimal movement while sleeping woke me up. This just happened within 24hr of reporting so it is unknown as yet what the outcome will be.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Severe pain in right shoulder (same side as injection) with certain movements; Limited mobility without inducing extreme pain. Any minimal movement while sleeping woke me up. This just happened within 24hr of reporting so it is unknown as yet what the outcome will be.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Oedema peripheral
Clinical narrative: Father noticed increased redness and swelling of RIGHT arm the afternoon of the day after the vaccinations.  Dad called our office and we told him to come in.  Redness of right upper outer extremity noted along with edema of right arm including wrist, hand.  There is noted a small area of darker redness at the apparent site of injection.  Redness measures for 6.25" down the upper arm.  The upper outer right arm is warm to touch and hardened.  ROM is unaffected. Child denies pain.  Father req report as, according to father, child had worse reaction with first HPV vaccine.  Father states at that vaccination, child had more redness, more swelling, lots of pain and decreased ROM.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ
Symptoms: Peripheral swelling
Clinical narrative: Father noticed increased redness and swelling of RIGHT arm the afternoon of the day after the vaccinations.  Dad called our office and we told him to come in.  Redness of right upper outer extremity noted along with edema of right arm including wrist, hand.  There is noted a small area of darker redness at the apparent site of injection.  Redness measures for 6.25" down the upper arm.  The upper outer right arm is warm to touch and hardened.  ROM is unaffected. Child denies pain.  Father req report as, according to father, child had worse reaction with first HPV vaccine.  Father states at that vaccination, child had more redness, more swelling, lots of pain and decreased ROM.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Impaired driving ability, Impaired work ability, Vertigo
Clinical narrative: Light dizziness to begin with for a few days off and on with headache, by 9/24 vertigo started antivert 25 tid, some relief then by 9/27 sustained vertigo and went to Dr. recieved 4mg Decadron and started steroid dose pack. Vertigo continues on 2nd day of dose pack.  Missing work unable to drive. Very concerned that I am not getting better, interfering with work. Took the Fluarix Quad 0.5.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Autopsy, Peripheral coldness, Respiratory arrest, Resuscitation
Clinical narrative: Awoke to find baby not breathing and skin cool to touch. Called 911. Administered CPR until EMS arrived. They took over and transported her to the hospital ER.
Age: 1.16
Sex: F
Vaccine: MMR
Symptoms: Diet refusal, Gingival erythema, Gingival pain, Herpangina, Pyrexia
Clinical narrative: High fever for three days up to 102F controlled with OTC medication. On the fourth day a rash appeared and lasted a day. On the fifth day the child's gums looked red and irritated and the child refused solid food. This lasted several days. The doctor diagnosed herpangina.
Age: 1.16
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: High fever for three days up to 102F controlled with OTC medication. On the fourth day a rash appeared and lasted a day. On the fifth day the child's gums looked red and irritated and the child refused solid food. This lasted several days. The doctor diagnosed herpangina.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Skin warm
Clinical narrative: Patient concerned that pain did not go away within a couple of days. Still warm to the touch and sore. These symptoms are getting better and not worse.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 2 days after Fluzone HD, pt woke with mild redness 5-6 inches in diameter around injection spot.  It is slightly itch, but not sore or warm to touch.  He has no fever. He took a Zyrtec that morning and applied hydrocortisone cream.
Age: 55.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Dizziness, Erythema, Fatigue, Injection site warmth, Myalgia
Clinical narrative: REDNESS, SWELLING, MUSCLE ACHES, DIZZINESS, WARM FEELING AT INJECTION SITE, FATIGUE.
Age: 55.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Swelling
Clinical narrative: REDNESS, SWELLING, MUSCLE ACHES, DIZZINESS, WARM FEELING AT INJECTION SITE, FATIGUE.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Tingling down right arm.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Tenderness at PPSV injection site, slight swelling, no erythema c/o headache, nausea, fatigue.
Age: 83.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Rt. arm swelling with red line from Rt. shoulder to Rt. fingertips on Fri. day after shot and went to ER on Sat. Rx. with Doxycycline and Prednisone x one week.
Age: 83.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site hypersensitivity, Injection site swelling
Clinical narrative: Rt. arm swelling with red line from Rt. shoulder to Rt. fingertips on Fri. day after shot and went to ER on Sat. Rx. with Doxycycline and Prednisone x one week.
Age: 83.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Rt. arm swelling with red line from Rt. shoulder to Rt. fingertips on Fri. day after shot and went to ER on Sat. Rx. with Doxycycline and Prednisone x one week.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Electroencephalogram abnormal, Intensive care, Seizure, Status epilepticus
Clinical narrative: Pneumovax was administered to patient on 8/13/15 at 1040.  Patient had new onset seizure on 8/14/15 at 2020 and again on 8/15/15 at 0320. Transferred to ICU, hooked up to EEG. EEG showed status epilepticus.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Depression, Dizziness, Electroencephalogram, Epidural blood patch
Clinical narrative: Body rash appeared within a few days lasted about a week then on 8/31/14 extreme fatigue set in so bad that he had to quit sports and be on 504 plan at school. Neurologist did sleep study and said he has Idiopathic Hypersomnia hypothesizing by the HPV vaccine. He also has dizziness, muscle malaise, and depression.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Fatigue, Hypersomnia, Ligament sprain, Lumbar puncture
Clinical narrative: Body rash appeared within a few days lasted about a week then on 8/31/14 extreme fatigue set in so bad that he had to quit sports and be on 504 plan at school. Neurologist did sleep study and said he has Idiopathic Hypersomnia hypothesizing by the HPV vaccine. He also has dizziness, muscle malaise, and depression.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Malaise, Rash generalised, Sleep study abnormal
Clinical narrative: Body rash appeared within a few days lasted about a week then on 8/31/14 extreme fatigue set in so bad that he had to quit sports and be on 504 plan at school. Neurologist did sleep study and said he has Idiopathic Hypersomnia hypothesizing by the HPV vaccine. He also has dizziness, muscle malaise, and depression.
Age: 0.83
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives, called HD nurse. Mother took baby to ER. Benadryl given and prescribed for 24 hours at home.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site pain, Injection site rash, Myalgia
Clinical narrative: Rash, burning at injection site, fatigue, slight nausea, swelling in armpit, joint/muscle pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Oedema peripheral
Clinical narrative: Rash, burning at injection site, fatigue, slight nausea, swelling in armpit, joint/muscle pain.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac failure congestive, Pneumonia
Clinical narrative: 2 weeks after receiving vaccine patient was hospitalized due to congestive heart failure and pneumonia.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of anaphylactic reaction in a adult patient who received FLUARIX QUADRIVALENT. In September 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown. It was unknown if the reporter considered the anaphylactic reaction to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The pharmacist reported to the sales representative that many employees recently received the FLUARIX QUADRIVALENT injection at their facility, and seven 7 experienced events. This case is for one of the 2 patients who experienced an anaphylactic shock (Refer case US2015137455 for the 2nd patient who experienced anaphylactic shock).
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Per grandfather pt. woke up with the left arm vaccine area, red and swollen.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left upper arm swelling and pain.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain in extremity, Paraesthesia, Pruritus, Skin wrinkling
Clinical narrative: Hands hurting and itching severely, like a burning, deep itch that could not be scratched and not helped with lotion. Also, skin on tips of fingers were wrinkly like I soaked in a tub, but I didn't. Hands also burning, tingling especially fingers. I have never felt such a thing before.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain
Clinical narrative: Left shoulder pain, persistent -rates 4/10 at rest and 8/10 with movement.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypersomnia, Lymphadenopathy, Myalgia, Oropharyngeal pain
Clinical narrative: Sore throat, rash on the back, swollen lymph nodes in the right axilla, muscle aches, joint pain, slept for 12-14 hours the night post flu vaccination.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Sore throat, rash on the back, swollen lymph nodes in the right axilla, muscle aches, joint pain, slept for 12-14 hours the night post flu vaccination.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fall, Hyperhidrosis, Loss of consciousness, Pyrexia
Clinical narrative: Fever and chills at 9pm, at 2am 01Oct2015 walked to bathroom to urinate and passed out collapsing to floor, passed out again two minutes later returning to bed, in both cases regained consciousness immediately, in second case began to perspire freely immediately afterwards, slept until 7am and woke with no fever, sweats, or other problems.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dysphagia, Dyspnoea, Hypersensitivity, Throat tightness, Wheezing
Clinical narrative: Throat closing, difficulty swallowing, wheezing, breathing problems.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Nasopharyngitis, Pyrexia, Rhinorrhoea
Clinical narrative: Patient called back stating she experienced dizziness, headache, runny nose and fever, "like a cold". Symptoms resolved 9/30/15. Patient states she did not see a physician and received no treatment or medications for her symptoms.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Fatigue, Pyrexia, Vomiting
Clinical narrative: Grandmother called back 9/29/2015 stating patient complained of vomiting, diarrhea, dizziness, fever and fatigue the evening of 9/28/15 and all day 9/29/15. Symptoms resolved by 9/30/15.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Eye pain, Eye swelling, Headache, Insomnia
Clinical narrative: Throat pain/cramping and difficulty swallowing; sore eyes and very bloodshot and swollen and pus filled; headachey; sleepless. Took 2 Benadryl at advice of pharmacist and doctor 12:30 on 10/01/2015.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Ocular hyperaemia, Oropharyngeal pain, Purulence
Clinical narrative: Throat pain/cramping and difficulty swallowing; sore eyes and very bloodshot and swollen and pus filled; headachey; sleepless. Took 2 Benadryl at advice of pharmacist and doctor 12:30 on 10/01/2015.
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster, Varicella
Clinical narrative: Patient has both chicken pox and the shingles.  She acquired both post vaccination.  She stated that after initially believing she had the chicken pox as a child, her mother communicated to her post vaccination that now she wasn't sure if the patient had chicken pox as a child. She hasn't recovered yet.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Dizzy, light headedness, nausea, fatigue.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Joint range of motion decreased, Loss of consciousness, Nausea, Peripheral swelling
Clinical narrative: Husband called this morning 9:38am. Reports pt has Right arm swelling, weakness, limited ROM, Nausea, blacked out. Treatment -rest. Spoke to pt at 10am, pt reports feeling better, denies any SOB, some nausea and swelling. Instructed to go to urgent care but pt did not go. Pt was instructed to come in this afternoon to see Dr., 10/1/15, at 2PM. Pt was advised to take Benadryl 25mg as needed but hold until she sees Dr. for evaluation.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Chills, Diarrhoea, Dyspepsia, Hypoacusis
Clinical narrative: Patient awakened about midnight with nausea. She took a tums and went to bed. This morning when she woke up she had diarrhea, abdominal cramps, nausea but no vomiting. Muffled hearing. Her whole body went numb and she felt like she had heart burn. They symptoms lasted about 5 minutes. The symptoms have resolved except for the heartburn and chills with waves of mild nausea.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Middle insomnia, Nausea
Clinical narrative: Patient awakened about midnight with nausea. She took a tums and went to bed. This morning when she woke up she had diarrhea, abdominal cramps, nausea but no vomiting. Muffled hearing. Her whole body went numb and she felt like she had heart burn. They symptoms lasted about 5 minutes. The symptoms have resolved except for the heartburn and chills with waves of mild nausea.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient called on 9/30/2015 and stated that she had a rash on her neck and nothing had changed in past couple of days other than getting a flu shot. No reaction at injection site.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Burning sensation, Hypoaesthesia, Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: This spontaneous report has been received from a female patient of unknown age, who was reporting on herself. The patient had no pertinent medical history. The patient's concurrent conditions included multiple unspecified allergies to unspecified pain medications (she could take only TYLENOL). In 2012 (reported as "3 years ago"), the patient was vaccinated with an unspecified pneumococcal vaccine and she was advised that an updated version of the pneumococcal vaccine was required. On 28-SEP-2015 at 12:00, the patient was vaccinated intramuscularly in the arm with an unknown dose of PNEUMOVAX 23 (lot# and expiry date were not reported). Concomitant therapies included influenza virus vaccine (unspecified), also administered on 28-SEP-2015 at 12:00, in the other arm, and TYLENOL, which the patient took as premedication thirty minutes before and post vaccination. On 28-SEP-2015 at 18:00, 6 hours after vaccination, the patient experienced swelling and burning of her fingers and her shoulder started hurting. She took another TYLENOL, but it did not work. On 28-SEP-2015 at 20:00, 8 hours after vaccination, the patient was not able to move her arm. She tried using a cold pack on her arm, which helped, but her hand was still swollen. In the night of 28-SEP-2015, she did not sleep well, and "could not move in bed". She also used alternating "cold water bottles and hot", but only slept for 2 hours. On 29-SEP-2015, when she woke up, she could only feel the first bend on her fingers, and her hand was still swollen and sore. On 29-SEP-2015 at 14:00, 26 hours post vaccination, she can lift her arm, but it was still sore, "but getting better". The patient did not seek medical attention, because she considered that the physician would tell her to go to the emergency room and she did not want to pay so much money, because her arm seemed to be getting better. No lab diagnostics studies were performed. The patient reported that inability to move her arm lasted for 24 hours (resolved on approximately 29-SEP-2015 at 20:00). At the time of report, the patient was recovering from the events of swelling and burning of her fingers, hurting shoulder, sleeping unwell, movement disorder, sleep decreased, hypoaesthesia of fingers, hand swollen and sore. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information is not expected as no contact details were provided and the reporter did not wish contact the physician.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Peripheral swelling, Poor quality sleep
Clinical narrative: This spontaneous report has been received from a female patient of unknown age, who was reporting on herself. The patient had no pertinent medical history. The patient's concurrent conditions included multiple unspecified allergies to unspecified pain medications (she could take only TYLENOL). In 2012 (reported as "3 years ago"), the patient was vaccinated with an unspecified pneumococcal vaccine and she was advised that an updated version of the pneumococcal vaccine was required. On 28-SEP-2015 at 12:00, the patient was vaccinated intramuscularly in the arm with an unknown dose of PNEUMOVAX 23 (lot# and expiry date were not reported). Concomitant therapies included influenza virus vaccine (unspecified), also administered on 28-SEP-2015 at 12:00, in the other arm, and TYLENOL, which the patient took as premedication thirty minutes before and post vaccination. On 28-SEP-2015 at 18:00, 6 hours after vaccination, the patient experienced swelling and burning of her fingers and her shoulder started hurting. She took another TYLENOL, but it did not work. On 28-SEP-2015 at 20:00, 8 hours after vaccination, the patient was not able to move her arm. She tried using a cold pack on her arm, which helped, but her hand was still swollen. In the night of 28-SEP-2015, she did not sleep well, and "could not move in bed". She also used alternating "cold water bottles and hot", but only slept for 2 hours. On 29-SEP-2015, when she woke up, she could only feel the first bend on her fingers, and her hand was still swollen and sore. On 29-SEP-2015 at 14:00, 26 hours post vaccination, she can lift her arm, but it was still sore, "but getting better". The patient did not seek medical attention, because she considered that the physician would tell her to go to the emergency room and she did not want to pay so much money, because her arm seemed to be getting better. No lab diagnostics studies were performed. The patient reported that inability to move her arm lasted for 24 hours (resolved on approximately 29-SEP-2015 at 20:00). At the time of report, the patient was recovering from the events of swelling and burning of her fingers, hurting shoulder, sleeping unwell, movement disorder, sleep decreased, hypoaesthesia of fingers, hand swollen and sore. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information is not expected as no contact details were provided and the reporter did not wish contact the physician.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling and erythema of left upper arm following immunization.
Age: 17.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Anxiety, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: The patient is a 17 year, 2 month old female who presents with worries. Note for "Worries": Patient's mom states the patient had a reaction to the flu shot given on 09/24/2015. C/o warmth, and redness at injection site (right deltoid). Patient is in today for evaluation of a reaction to an immunization that was given last Wednesday. Mom called me more than once this weekend. Review with the nurses reveals that the site that is reacting is the site of her flu immunization. Mom states that the reactive area started on Thursday and on Friday was only the size of a fifty cent piece. Child had a massage on Friday. I don't know if that could have affected but mom states that by Saturday the reactive area was "huge, bright red and very hot, although it did not seem tender." Patient at no time has developed any fever but she is on round the clock ibuprofen for her chronic pain condition. Mom states that it was swollen down to the elbow on Saturday and started to be visible below the elbow yesterday, which was Sunday. She has had no cough, rhinorrhea, vomiting or diarrhea, and is otherwise in her usual state (tube fed, trached, non-verbal, severe developmental delay and spastic CP).
Age: 17.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vaccination complication
Clinical narrative: The patient is a 17 year, 2 month old female who presents with worries. Note for "Worries": Patient's mom states the patient had a reaction to the flu shot given on 09/24/2015. C/o warmth, and redness at injection site (right deltoid). Patient is in today for evaluation of a reaction to an immunization that was given last Wednesday. Mom called me more than once this weekend. Review with the nurses reveals that the site that is reacting is the site of her flu immunization. Mom states that the reactive area started on Thursday and on Friday was only the size of a fifty cent piece. Child had a massage on Friday. I don't know if that could have affected but mom states that by Saturday the reactive area was "huge, bright red and very hot, although it did not seem tender." Patient at no time has developed any fever but she is on round the clock ibuprofen for her chronic pain condition. Mom states that it was swollen down to the elbow on Saturday and started to be visible below the elbow yesterday, which was Sunday. She has had no cough, rhinorrhea, vomiting or diarrhea, and is otherwise in her usual state (tube fed, trached, non-verbal, severe developmental delay and spastic CP).
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: (R) shoulder/prox arm pain causing decreased ROM. Vaccine (R) arm at 3:30 9/29/15-sx 7:30 9/29 a lot better 9/30/15.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Swelling, Urticaria
Clinical narrative: Lt arm red swollen, itching shoulder to elbow. welt swelling 9/26/15 the symptoms started.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: White blood cell count normal
Clinical narrative: Lt arm red swollen, itching shoulder to elbow. welt swelling 9/26/15 the symptoms started.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Influenza like illness, Pain
Clinical narrative: Patient called 9-21-15 and said received shot FLUZONE HD 9-20-15 woke up feeling achy and weak all over, flu-like symptoms. Felt like going to faint in shower. She said she did not feel well the night of 9-20-15 either and woke up worse.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Six hours after administration, site became swollen and two small hives 70mm x 60mm developed which after 30 minutes joined swelling.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Fatigue, Injection site erythema, Injection site induration
Clinical narrative: 9/22/15 01:00: Fever of 102 degrees F, chills, muscle aches, fatigue, congestion all began less than 12 hours after vaccination. Red, hard, warm area at injection site of approximately 6 cm. Also had sore throat, cough, laryngitis, pain swallowing. Was seen in urgent care and by primary care. Treated with albuterol and prednisone, and TYLENOL. Primary care felt reaction to vaccine.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Laryngitis, Myalgia, Odynophagia, Oropharyngeal pain
Clinical narrative: 9/22/15 01:00: Fever of 102 degrees F, chills, muscle aches, fatigue, congestion all began less than 12 hours after vaccination. Red, hard, warm area at injection site of approximately 6 cm. Also had sore throat, cough, laryngitis, pain swallowing. Was seen in urgent care and by primary care. Treated with albuterol and prednisone, and TYLENOL. Primary care felt reaction to vaccine.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory tract congestion, Streptococcus test negative
Clinical narrative: 9/22/15 01:00: Fever of 102 degrees F, chills, muscle aches, fatigue, congestion all began less than 12 hours after vaccination. Red, hard, warm area at injection site of approximately 6 cm. Also had sore throat, cough, laryngitis, pain swallowing. Was seen in urgent care and by primary care. Treated with albuterol and prednisone, and TYLENOL. Primary care felt reaction to vaccine.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dysphagia, Feeling hot, Palpitations, Pruritus
Clinical narrative: Heart racing, itchy and hot feeling on throat trouble swallowing. Chest pain when taking a deep breath, body rash.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Heart racing, itchy and hot feeling on throat trouble swallowing. Chest pain when taking a deep breath, body rash.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Malaise, Nausea, Skin warm
Clinical narrative: Erythema shoulder to elbow, hot to touch, nausea, malaise x2 days.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site pain
Clinical narrative: Pt recieved Fluzone HD immunization on 09/22/15. Pt returned on 9/28/15 complaining of soreness and quarter sized bruise at injection site. Pt did bleed upon injection and sterile gauze was held in place for 30 seconds and then covered with band-aid.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient felt that her arm was getting itchy that night.  In the morning when she took of her nightgown she saw that her arm was very swollen and red.  Patient placed a cold pack on the injection site and came to see a NP at the office.  The NP advised her to place hydrocortisone cream on the site and to call if it does not improve.  I talked to the patient on 10/1/15, the site is still red but improving.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception
Clinical narrative: Intussusception.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness at injection site. Soreness, Hot to the touch. NO Itching. Referred patient to their medical provider. instructed to use cold compress and Benadryl.
Age: 4.0
Sex: F
Vaccine: FLU4, FLUN4
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Patient received the first half of a Flumist (quadrivalent) and then blew out a lot of snot immediately, she tried biting, kicking, and we were unable to give her the 2nd half of the Flumist.  To make sure she was given a full dose we gave her an influenza; injectable, quadrivalent, preservative free. Patient was fine after receiving the injectable flu vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm swelling and redness all around arm.  Warm to touch.  Very sore.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Chills, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: She developed fever, chills. The next morning she had left supraclavicular swelling and pain and tenderness and fatigue. She also had extreme pain to the injection site in left deltoid. She was treated with ice, Tylenol.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Swelling, Tenderness
Clinical narrative: She developed fever, chills. The next morning she had left supraclavicular swelling and pain and tenderness and fatigue. She also had extreme pain to the injection site in left deltoid. She was treated with ice, Tylenol.
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itchy and red at injection site.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Condition aggravated, Musculoskeletal stiffness, Neck pain
Clinical narrative: PATIENT STATES SHE WOKE UP WITH A VERY PAINFUL/STIFF NECK, ESPECIALLY ON THE RIGHT SIDE.  LASTED ALL DAY, THEN WAS GONE THE NEXT DAY. ACCORDING TO THE PATIENT, SHE DOES HAVE A HISTORY OF CHRONIC NECK PAIN.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Limb discomfort, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Awoke with left arm pain and discomfort, stiffness to left side of neck. At 1700 same day noted redness to shoulder with swelling to last two fingers of left hand. Self treated with Motrin on both days and Benadryl on 1 Oct 2015.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Oedema, Rash erythematous, Sensory disturbance
Clinical narrative: Awoke with left arm pain and discomfort, stiffness to left side of neck. At 1700 same day noted redness to shoulder with swelling to last two fingers of left hand. Self treated with Motrin on both days and Benadryl on 1 Oct 2015.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Impaired work ability, Injection site erythema, Injection site infection, Injection site pain
Clinical narrative: Scalp and left shoulder infection site red, hot, burning, itching. Throat sore burning, headache same evening. Next day sneezing, runny nose, body ache. Lasting still today, 10/01/2015. Out of work on sick leave.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site warmth, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Scalp and left shoulder infection site red, hot, burning, itching. Throat sore burning, headache same evening. Next day sneezing, runny nose, body ache. Lasting still today, 10/01/2015. Out of work on sick leave.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Skin disorder, Sneezing, Throat irritation
Clinical narrative: Scalp and left shoulder infection site red, hot, burning, itching. Throat sore burning, headache same evening. Next day sneezing, runny nose, body ache. Lasting still today, 10/01/2015. Out of work on sick leave.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea
Clinical narrative: headache and sever nausea
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Red, swollen, knot at site of injection. Patien took Benadryl, ibuprofen. Patient saw physician and now ok.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: I vomited a few hours after the flu shot was administered. Very violent emesis episode. I'm not sure when the vaccine was administered but it was in Nov or Dec of 2014.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itching and pain near injection site. Redness and swelling extended to entire upper arm and down to elbow. Pt treated with Benadryl.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid margin crusting, Ocular hyperaemia, Throat irritation
Clinical narrative: Pt c/o red crusty eyes and a "funny feeling" in her throat.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Ear pain, Fatigue, Laboratory test, VIIth nerve paralysis
Clinical narrative: Extreme fatigue, followed by ear pain in right ear on 09/22/2015 in the afternoon. On 09/26/2016 loss of taste in early evening. On 09/27/2015 facial paralysis by PM diagnosed as Bell's Palsy. Treatment is Valtrex and prednisone.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Blister, Herpes zoster
Clinical narrative: Blister on on back and side.  Diagnosed shingles.
Age: 33.0
Sex: F
Vaccine: FLUC3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt states arm has been painful since receiving flu shot. Presented to health center, painful, limited movement of Left arm. Physical Therapy and anti-inflammatory prescribed by provider.
Age: 74.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given pediatric dose of Vaqta.
Age: 0.49
Sex: M
Vaccine: DTPIHI, MER, TDAP
Symptoms: Decreased eye contact
Clinical narrative: Lost eye contact.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Ear pain, VIIth nerve paralysis
Clinical narrative: Pain in ear, progressed to severe Bell's Palsy on 09/01/2015.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Significant swelling and redness below the injection site.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Throat tightness
Clinical narrative: SOB AND FELT LIKE THROAT WAS CLOSING-REDNESS AND PAIN AT INJECTION SITE.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Injection site erythema, Injection site swelling, Injection site warmth, Somnolence
Clinical narrative: 8 cm x 7 cm slightly raised and red area that is warm to touch on the left deltoid. Left quadrant is tender to touch. Patient states she started w/(L) side/abdominal pain and fall asleep after work. When she woke up this morning is when she noted this red raised area on (L) deltoid-states it has not changed in size or color, currently 1320.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: 8 cm x 7 cm slightly raised and red area that is warm to touch on the left deltoid. Left quadrant is tender to touch. Patient states she started w/(L) side/abdominal pain and fall asleep after work. When she woke up this morning is when she noted this red raised area on (L) deltoid-states it has not changed in size or color, currently 1320.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site streaking, Lymph node pain, Lymphadenopathy
Clinical narrative: Enlarge lymph node in axillary area of left arm, red streaks around injection site. Lymph nodes swollen and tender to touch.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Developed large amount of swelling, itchiness, redness, and erythema Kw/in 5 minutes of injection. 2 1/2 hours stated she felt short of breath and lightheaded, even after she took 2 tabs of BENADRYL 15 min. after her injection when she felt her arm swell. (Swelling had decreased). Went to E.D.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Developed large amount of swelling, itchiness, redness, and erythema Kw/in 5 minutes of injection. 2 1/2 hours stated she felt short of breath and lightheaded, even after she took 2 tabs of BENADRYL 15 min. after her injection when she felt her arm swell. (Swelling had decreased). Went to E.D.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Dizziness, Nausea
Clinical narrative: 3-4 hours post shot=chills, shivering uncontrollable dizziness mild nausea-went to bed. No appetite only H2O. Now: OK relieved.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The evening that the patient received the injection of Fluzone HD, she developed swelling and pain in the shoulder that received the injection. The pain and swelling has remained constant until this was reported to us on 10/1/15 at approx. 415pm.  She is taking anti-inflammatories and is going to speak to her physician if necessary.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Face injury, Fall, Haemorrhage, Loss of consciousness
Clinical narrative: Family member reports patient had gone back to his office, was sitting when he stated his hand felt tingly and then he slumped over his desk and fell face first onto the floor. Patient came to quickly and was bleeding.  Taken to hospital by family member where they performed a CT scan and gave 3 stitches to head.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Suture insertion
Clinical narrative: Family member reports patient had gone back to his office, was sitting when he stated his hand felt tingly and then he slumped over his desk and fell face first onto the floor. Patient came to quickly and was bleeding.  Taken to hospital by family member where they performed a CT scan and gave 3 stitches to head.
Age: 79.0
Sex: M
Vaccine: PNC
Symptoms: Blood culture negative, Cellulitis, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Patient admitted to the hospital with redness, swelling, and pain on left upper arm two days after receiving Pneumovax at the patients PCP.  Patient was afebrile with a WBC of 11 and was diagnosed with cellulitis.  Patient was started on cefazolin and then was switched to vancomycin after no improvement was seen.  Patient's reaction spread to below the elbow and became more swollen and red after 2 days of antibiotic use.  It was determined that the patient had an extensive reaction to Pneumovax vaccine as opposed to a true infection since it didn't respond to antibiotics.
Age: 79.0
Sex: M
Vaccine: PNC
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling, Vaccination complication, White blood cell count increased
Clinical narrative: Patient admitted to the hospital with redness, swelling, and pain on left upper arm two days after receiving Pneumovax at the patients PCP.  Patient was afebrile with a WBC of 11 and was diagnosed with cellulitis.  Patient was started on cefazolin and then was switched to vancomycin after no improvement was seen.  Patient's reaction spread to below the elbow and became more swollen and red after 2 days of antibiotic use.  It was determined that the patient had an extensive reaction to Pneumovax vaccine as opposed to a true infection since it didn't respond to antibiotics.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Audiogram abnormal, Deafness neurosensory, Deafness unilateral, Dizziness, Labyrinthitis
Clinical narrative: Vertigo, vomiting, dizziness, labyrinthitis, and subsequent hearing loss of right ear.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Vertigo, Vomiting
Clinical narrative: Vertigo, vomiting, dizziness, labyrinthitis, and subsequent hearing loss of right ear.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction, Pruritus, Swelling
Clinical narrative: Local reaction with swelling and pruritis. Ongoing location reaction.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Local swelling, Neck pain
Clinical narrative: Severe pain and continued swelling at the injection site. Worsening pain and swelling on day 2, with a 4" swelling and pain radiating into the neck and shoulder.
Age: 0.24
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test, Eyelid oedema, Swelling face, Urine analysis, Vomiting
Clinical narrative: Pt. vomited after receiving rotavirus vaccine, then vomited again 2 hrs. later, and didn't want to eat. When pt. woke up from his nap at 4pm, his eyes were swollen shut, his face was swollen, he had a temp of 100.5, & he vomited again. Mom took him to the ER where he received Benadryl & IV fluids, & had blood & urine tests.
Age: 91.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Six inch wide red slightly swollen area at injection site, warm to the touch, did not appear until several days after injection.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Patient has red inflamed patch around the site of injection.  She says it is hot to the touch.  It measures 3.5 inches by 2.5 inches.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The customer came to the pharmacy and showed me her arm where the immuniztion was given, it was swollen and red and hot to the touch. She had been using ice on it. She did not have any issues moving her arm. After the 3rd contact, I called her doctor, and she went to see her doctor. The doctor prescribed antibiotics.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Mononucleosis heterophile test positive, Rash, Rash erythematous
Clinical narrative: Red bumps resembling bites on both arms, worse on arm that was not used for vaccine administration.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: The patient came to the pharmacy with a swollen red spot around the injection site. The inflamed area itched and was hot to the touch. I instructed the patient to take Benadryl and see a doctor. The doctor confirmed that the patient did have an allergic reaction and prescribed an anti-histamine to reduce the swelling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: The patient came to the pharmacy with a swollen red spot around the injection site. The inflamed area itched and was hot to the touch. I instructed the patient to take Benadryl and see a doctor. The doctor confirmed that the patient did have an allergic reaction and prescribed an anti-histamine to reduce the swelling.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Vertigo
Clinical narrative: Dizziness, slight vertigo, weakness. Checked patient's BP: 140/90, temp: 98.2 F, Pulse: 97. Advised patient to lay down (made her feel worse); sitting up was better for her. She also had a little candy and water from her employer. After 15 minutes she was escorted to the nearest clinic. The next day, I followed up with her and she says she was discharged from clinic with just needing some rest. They were unsure whether it's vertigo or if she may have the flu.