chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist obtained via a Pfizer sales Representative. A 70 years old patient of unspecified race/ethnicity and gender received PREVNAR 13 on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. On the vaccination day the patient experienced redness and swelling at the injection site. Next day the patient noticed that the redness had darkened closer to a blackish color. At that point the patient went to see the physician. The reporting pharmacist was unaware if any medication was administered, but none was filled at that pharmacy. Events outcome was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: DTAP
Symptoms: Vaccination complication
Clinical narrative: Initial report received from a consumer (the patient) through social media on 21 January 2014. A patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (Manufacturer unknown, batch number, dose number, route and site of administration not reported) on an unspecified date. It was reported that the patient experienced bad reaction to tetanus. Lab investigations and corrective treatments were not reported. At the time of this report, outcome was unknown. List of documents held by sender: None Addendum on 29 Jan 2018: Upon second medical examination of case at time of internal review the following has been modified in this case: Suspect product code changed to DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) from 015 (DIPHTHERIA/TETANUS/WHOLE CELL PERTUSSIS ADSORBED VACCINE).
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Infection, Swelling
Clinical narrative: Red, swollen, infected per nurse practitioner, currently taking minocycline.
Age: 1.33
Sex: M
Vaccine: FLU4, MMRV, PNC13
Symptoms: Cyanosis, Injection site cellulitis, Injection site erythema, Injection site reaction, Injection site vesicles
Clinical narrative: Redness on Rt thigh, with blistering and looks blue. Spreading as well. Dx Cellulitis of thigh. Treated with Amoxicillin-Pot Clavulanate 600-42.9 mg/5mL. Pt to take 3ml BID x 10 days.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: CHILD RECEIVED 2 VACCINES OF TDAP. LAST ONE RECEIVED WAS 01/27/2017. NO ISSUES AT THIS TIME.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: CHILD RECEIVED 2 VACCINES OF MCV4. LAST ONE RECEIVED WAS 01/27/2017. NO ISSUES AT THIS TIME.
Age: 65.0
Sex: F
Vaccine: FLU3, TDAP, FLU3
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt received FLUZONE HD on 1.11.18. 7 days later pt returned to pharmacy with pain in arm. She said she could hardly lift her arm and certain movements were painful. She had used OTC NSAIDs with no relief.
Age: 65.0
Sex: F
Vaccine: FLU3, TDAP, FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pt received FLUZONE HD on 1.11.18. 7 days later pt returned to pharmacy with pain in arm. She said she could hardly lift her arm and certain movements were painful. She had used OTC NSAIDs with no relief.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Cough, Influenza virus test, Malaise, Pyrexia
Clinical narrative: Received flu vaccine injection 9/25/17. Contracted influenza virus 12/10/17 - confirmed at urgent care clinic by swab sample. Severely ill with fever greater than 102 degrees, severe cough, chills, x 5 days. Ineffective vaccine.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, Liothyronine, omeprazole and REGLAN. On 17th January 2018 11:00, the patient received SHINGRIX 50 mcg/mg. On 17th January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. In January 2018, the outcome of the injection site pain and injection site erythema were recovered/resolved. The reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. After receiving SHINGRIX, the patient experienced redness and soreness at the injection site and red circle approximately one inch in diameter and spread to one and half inches after a day or two. The symptoms were resolved after 4 days. Treatment was provided by the pharmacy.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, Liothyronine, omeprazole and REGLAN. On 17th January 2018 11:00, the patient received SHINGRIX 50 mcg/mg. On 17th January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. In January 2018, the outcome of the injection site pain and injection site erythema were recovered/resolved. The reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. After receiving SHINGRIX, the patient experienced redness and soreness at the injection site and red circle approximately one inch in diameter and spread to one and half inches after a day or two. The symptoms were resolved after 4 days. Treatment was provided by the pharmacy.
Age: 0.42
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Hypotonia, Injection site movement impairment, Injection site pain, Pyrexia
Clinical narrative: Patient had fever 101, leg pain and went limp after vaccine given with fever, refused to move legs.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Redness, fevered, swelling, pain mother advised to take child to Emergency room.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Cervical spinal stenosis, Electromyogram normal, Muscular weakness, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity
Clinical narrative: Patient C/O arm pain/weakness following influenza vaccine administration.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Spinal osteoarthritis, Vertebral foraminal stenosis, Vertebral osteophyte
Clinical narrative: Patient C/O arm pain/weakness following influenza vaccine administration.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Adult vaccine given to pediatric patient. No adverse effects reported.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Middle insomnia, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Muscle pain and weakness that has been ongoing since receiving the vaccination in October. Pt sometimes cannot use that arm to the extent that she could previously, even when getting dressed, and sometimes wakes in the middle of the night with arm pain.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Paralysis
Clinical narrative: Patient called into office on 12/20/17 and reported that she had been paralyzed from the flu shot we gave her, and stated she went to the hospital for 2 weeks.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Minutes after the vaccine was administered Dr. re-entered the exam room to speak to the parents. He exited the room and asked us to mark a raised bump that had formed on the patients right thigh. It measure 3/4in wide and 1in long. Patient stayed in the office for 30 minutes longer and upon leaving the office the bump was gone but the leg was still red.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Nephropathy
Clinical narrative: This spontaneous report was received from a nurse and refers to a 18 year old female patient. There were no concurrent conditions and medical history. The patient's concomitant therapies includes unspecified immunosuppressive medications. On an unknown date (reported as in "childhood"), the patient was vaccinated with a series of VARIVAX (dose, route, anatomical place of vaccination, lot# and expiration date were not provided), for varicella prevention. Approximately in 2017 (reported as "in the past year"), the patient developed an unspecified kidney disease (nephropathy) which now required a kidney transplant. On 08-JAN-2018, varicella titers were drawn and results showed negative (antibody test negative). Per nurse, treatment for this was to vaccinate with VARIVAX, however, it was unknown if the patient received another dose. The reporter stated that the patient had been managed as an outpatient and not yet been hospitalized but condition was potentially life threatening and disabling. The reporter did not know if patient had required dialysis. At the time of reporting, the patient did not recover from nephropathy and the outcome of antibody test negative was unknown. The reporter did not provide a causality assessment between nephropathy and antibody test negative and VARIVAX.
Age: 15.0
Sex: U
Vaccine: PNC13, PPV
Symptoms: Antibody test positive, Inappropriate schedule of drug administration, Thrombocytopenia
Clinical narrative: This spontaneous report was received from an unspecified reporter via Pfizer refers to a 15 year old patient. The patient was immunodeficient. The patient's medical history, concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, dose number, frequency, lot #, expiry date, route and site of administration were not reported) for prophylaxis. Other suspect therapy which was given on the same time included PREVNAR 13 (dose, dose number, frequency, lot #, expiry date, route and site of administration were not reported) for prophylaxis (inappropriate schedule of drug administration). On an unknown date, the patient experienced thrombocytopenia and increased antibody titer (antibody test positive). Outcome of thrombocytopenia and antibody test positive was unknown. The reporter's causality assessment between the event and the suspect therapy was not reported. The patient was claiming for reimbursement from insurance company. Upon internal review, the event of thrombocytopenia was determined to be medically significant.
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Influenza, Malaise, Vaccination failure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. The reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was reported by a receptionist from physician's office. The age at vaccination was not reported. The reporter advised that, the physician was out sick with Influenza A and B even though she had received the flu vaccine, inferring the flu vaccine (brand unknown) the patient received was ineffective. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule and lab test confirmation for targeted disease was unknown. No other details were available at the time of call. The sales representative did not know the reporter's contact information. This case is 1 of the 3 cases reported by the same reporter.
Age: 0.33
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient received PEDIARIX, PREVNAR and a accidental TDAP dose instead of Hib dose given by LPN. Patient had no adverse effects.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Similar reaction on previous exposure to drug, Syncope
Clinical narrative: Pt fainted few minutes after the shot. Though has a history of fainting before after shots.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: On January 27th noticed itching, erythema, warm to touch at site of injection. Applied topical anti-itch cream and took BENADRYL. States condition gets worse over time.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Chest X-ray normal, Chills, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: 2 year old female was fine prior to immunization, she was eating dinner and slumped over. Mom thought she was choking. Patient was clearing her throat and mom states she felt warm. Mom gave MOTRIN, then she began to shivering. Mom put her into the car and mom states she began to seizing.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Posture abnormal, Respiratory syncytial virus test negative, Seizure, Skin warm, Streptococcus test negative
Clinical narrative: 2 year old female was fine prior to immunization, she was eating dinner and slumped over. Mom thought she was choking. Patient was clearing her throat and mom states she felt warm. Mom gave MOTRIN, then she began to shivering. Mom put her into the car and mom states she began to seizing.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Urine analysis normal
Clinical narrative: 2 year old female was fine prior to immunization, she was eating dinner and slumped over. Mom thought she was choking. Patient was clearing her throat and mom states she felt warm. Mom gave MOTRIN, then she began to shivering. Mom put her into the car and mom states she began to seizing.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2008, the patient was vaccinated with the first dose of GARDASIL injection for prophylaxis (route, anatomical location, lot# and expiration date were not provided). On 09-JAN-2018, the patient was vaccinated with the first dose (second dose in HPV immunization series) of GARDASIL 9 injection for prophylaxis (route, anatomical location, lot# and expiration date were not provided). No adverse effects reported.
Sex: U
Vaccine: HPV9, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report as received from a licensed practical nurse and a director refers to an unspecified number of patients of unknown ages and genders. No information was provided regarding the patients' concomitant medications, pertinent medical history, drug reactions or allergies. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (exact dose, dose number, route of administration were not reported; lot # N003703 with the expiration date of 29-OCT-2019) for prophylaxis. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (exact dose, dose number, route of administration were not reported; lot # N029303 with the expiration date of 21-APR-2019) for prophylaxis. No adverse effects were reported. The administered doses of vaccines underwent a temperature excursion between 32 Fahrenheit degrees (°F) and 35°F for 87 hours (also reported as "slightly out of range (34°F)"). The reporter stated that she went through all the proper reporting channels and was advised that the vaccines were still stable, since it was only 2°F outside the normal range (36-46°F). There were no previous temperature excursions reported. Digital data logger was involved to capture the temperature excursion. Product quality complaint (PQC) was not filed. Follow-up has been received on 29-JAN-2018. On unknown date, the patients were also vaccinated with improperly stored doses of PNEUMOVAX 23 (exact dose, dose number, route of administration were not reported; lot # N025656 with the expiration date of 19-APR-2019). Reporter stated that, fridge temperature was dropped to 34°F at some point over night and contacted to manufacturer to determine if product was still viable and confirmed that the product was good and nothing needed to disposed of. Patient did not experience any adverse events and was not administered with immunization before stability was confirmed. It was reported that this adverse experience was previously reported to manufacturer and temperature excursion as a result of a reading from a digital data logger.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a consumer referring to her husband, a 72 year old male patient. The patient had no relevant medical history, drug reactions/allergies or concomitant medications. On 28-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 lot number: N019983 (expiration date: 03-MAR-2019), for prophylaxis (strength, route and dosage schedule were not reported). On 29-JAN-2018, the patient's arm was swollen to the extent that the bicep was below the elbow. The patient also had some light pain but no fever. The patient did not seek medical attention but was advised to take BENADRYL. No studies or diagnostic tests were carried out. The outcome of swollen arm and pain was reported as not recovered. Causality assessment was not provided.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Flu Seasonal QIV Dresden. Co-suspect products included VENTOLIN HFA inhaler for asthma and chronic obstructive pulmonary disease. Concurrent medical conditions included glaucoma. Concomitant products included LEVOTHYROXINE, SINGULAIR, omeprazole, Ropinirole, amlodipine, LOSARTAN, Aspirin, Vitamin D3, TRAVATAN and metoprolol. In October 2017, the patient received Influenza Quadrivalent. On an unknown date, the patient started VENTOLIN HFA (inhaled) 2 puff(s) as needed. In November 2017, less than a year after receiving Influenza vaccine Quadrivalent and unknown after starting VENTOLIN HFA, the patient experienced influenza. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant). VENTOLIN HFA was continued with no change. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovering/resolving.  The reporter considered the vaccination failure and influenza to be unrelated to Influenza vaccine Quadrivalent. The reporter considered the influenza to be unrelated to VENTOLIN Hfa. Additional information was provided as follows: The patient's spouse reported this case. The age at vaccination was not reported. Concomitant medication included ZOLAMIDE. In October 2017, the patient received a flu shot of unknown brand. In November 2017, the patient got sick with the flu. On 11th November 2017, the patient went to the physician. The patient required emergency room visit. The patient was still recovering from the illness. This case was considered a suspected vaccination failure case, as the details regarding the exact time to onset were unknown.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 20th January 2020). On 19th January 2018, the patient received SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site pain and injection site erythema. On an unknown date, the outcome of the influenza-like symptoms, injection site pain and injection site erythema were recovering/resolving. It was unknown if the reporter considered the influenza-like symptoms, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that a patient experienced an adverse reaction after receiving SHINGRIX and was unsure of what specific reaction that the patient was experienced. The patient did not required a doctor's visit, hospitalization, or other intervention and the reaction was not believed to be life threatening or disabling.
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved. The reporter considered the vaccination failure and influenza to be related to Flu trivalent vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient stated that he got flu vaccine 20 to 30 years ago and got the flu after getting it. The patient did not know any specifics about the product, believed it must have been a live vaccine since he got the flu. This case has been considered as suspected vaccination failure since the laboratory test confirmation and time to onset for influenza was unknown. The patient had denied permission to contact their physician.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Feeling abnormal, Muscle twitching, Vomiting
Clinical narrative: Mom reported witnessing patient state suddenly that he didn't feel right. Knees buckled, hands and cheeks "twitched". No LOC. Positive vomit. Then felt better. Episode lasted 15 seconds, estimated. Was back to himself next morning.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dyspnoea, Hypersensitivity, Pharyngeal oedema, Tonsillar hypertrophy
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of anaphylactic reaction in a 16-year-old female patient who received FLULAVAL QUADRIVALENT. Previously administered products included Influenza vaccine (yearly without difficulty or reaction). Concurrent medical conditions included multiple allergies (has number of basic allergies) and egg allergy (unknown reaction). On an unknown date, the patient received the 1st dose of FLULAVAL QUADRIVALENT. On an unknown date, 1 day after receiving FLULAVAL QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), tonsillar hypertrophy, difficulty breathing, throat swelling and documented hypersensitivity to administered product. On an unknown date, the outcome of the anaphylactic reaction, tonsillar hypertrophy, difficulty breathing and throat swelling were recovering/resolving and the outcome of the documented hypersensitivity to administered product was unknown. The reporter considered the anaphylactic reaction, tonsillar hypertrophy, difficulty breathing and throat swelling to be possibly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient's concomitant medication was unknown. The physician reported that day after vaccination the patient was picked up from the school and reported to have difficulty breathing, swollen throat and tonsils. The patient was going to be taken to be seen, however it was reported back to the physician that the patient was doing better and treatment was not required. The physician did not see the patient. The physician noted that she did not plan to use FLULAVAL for this patient in the future. It was noted to the account manager that the physician was going to file a report, but the representative was unaware if that was to GSK or VAERS.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. It was unknown if the reporter considered the chills to be related to SHINRIX. Additional details were provided as follows: The patient received their 1st dose of SHINGRIX last Friday. The patient experienced symptoms of chills and shivers since the administration of the vaccine. The patient called because they are concerned about how long was expected that symptoms would be remain and what was the recommendation on receiving the 2nd dose in series. Remote disconnected from the patient during warm transfer, however the GSK360 request had been opened and placed in the patient call back folder for follow-up. The patient did not want to provide the health care professional name for follow up but could send her the letter. No further information was reported regarding the event.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Skin exfoliation
Clinical narrative: Patient experienced peeling skin on face within 24 hours of receiving influenza vaccine. Treated with Dandruff cream and resolved within 6 days. Has had influenza vaccine in past without any problems.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: 3 days after, fever 102 which lasted 3 days. Then rash broke out on day after fever resolved.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Confusional state, Fatigue, Muscular weakness, Rash
Clinical narrative: On 1/12/2018 patient reports a rash starting on her ears, neck and shoulders that spread to her lower back. Also complains of confusion, increased anxiety, increased fatigue, and muscle weakness. Rash resolved after treatment with steroids but is now returning.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Disorientation, Pyrexia, Vomiting
Clinical narrative: Fever, chills, disoriented, vomit.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Feeling hot, Immediate post-injection reaction, Muscular weakness, Musculoskeletal pain
Clinical narrative: Immediate sharp pain shortly after injection when moving arm to put on coat. Over the next few days there was what seemed to be typical soreness/tenderness after a flu shot and then over the next weeks the shoulder hurt more and more with sharp pains whenlifting arm above head or twisting arm. Weakness is arm and feeling of heat in the shoulder. Pain in shoulder when lying on left side and pain down the arm into the elbow after waking up.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Osteoarthritis, Pain, Pain in extremity, Tenderness, X-ray abnormal
Clinical narrative: Immediate sharp pain shortly after injection when moving arm to put on coat. Over the next few days there was what seemed to be typical soreness/tenderness after a flu shot and then over the next weeks the shoulder hurt more and more with sharp pains whenlifting arm above head or twisting arm. Weakness is arm and feeling of heat in the shoulder. Pain in shoulder when lying on left side and pain down the arm into the elbow after waking up.
Age: 29.0
Sex: F
Vaccine: SMALL
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in left anterior side of neck.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: We have 5 patients that received PENTACEL. Out of the 5 patients one patient didn't receive the reconstitute ACTHIB.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: We had five ped patients that received the PENTACEL. Out of the 5 patients one patient didn't receive the reconstitute ACTHHIB.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Fatigue, Heart rate increased, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient developed fever/ swelling to face & neck the day after her 3rd HPV9 vaccine. Also had fever/chills, fatigue, & rapid heart rate. In office the next day c/o sore throat & congestion.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Respiratory tract congestion, Swelling, Swelling face
Clinical narrative: Patient developed fever/ swelling to face & neck the day after her 3rd HPV9 vaccine. Also had fever/chills, fatigue, & rapid heart rate. In office the next day c/o sore throat & congestion.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Hypertension, Palpitations
Clinical narrative: Pt had chills in the evening, very dizzy and heart beating fast/racing. The pt was still very dizzy and blood pressure was high the next day when he came in. I told the patient to take some acetaminophen and rest and give it another day and to call md if symptoms got worse or did not improve in another day.
Age: 0.92
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: We had five ped patients that received the PENTACEL . Out of the 5 patients one patient didn't receive the reconstitute ACTHIB.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Red, swollen, and hot to touch injection site. Pt. is also fussy.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient is a 66 yo female with a CC of inflammation of injection site s/p PNEUMOVAX 23 25 mcg/0.5 mL vaccination on 1 /30/18. HPI: Pt received injection in the left deltoid during the afternoon, pain and swelling worsened over the course of the evening. Pain is described as a 7/10 and as hot, tight and swollen. Patient tried acetaminophen and benadryl in an attempt to alleviate symptoms, which didn't help. Patient was afebrile overnight.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Muscle tightness
Clinical narrative: Patient is a 66 yo female with a CC of inflammation of injection site s/p PNEUMOVAX 23 25 mcg/0.5 mL vaccination on 1 /30/18. HPI: Pt received injection in the left deltoid during the afternoon, pain and swelling worsened over the course of the evening. Pain is described as a 7/10 and as hot, tight and swollen. Patient tried acetaminophen and benadryl in an attempt to alleviate symptoms, which didn't help. Patient was afebrile overnight.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: We had five ped patients that received the PENTACEL. Out of the 5 patients one patient didn't receive the reconstitute ACTHIB.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture urine positive, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Mom took child to the ED 1/11/18 for redness ~12mm per ED report, heat, pain and swelling (larger than the area of redness) in right thigh and fever of 102 (at home, 101.2 at the ED).  Provider at ED felt thigh symptoms were a vaccine reaction but did not think the fever was related to this so checked a U/A which was suggestive of a urinary tract infection and the patient was started on Keflex. The child was seen in the office 1/12/18 for follow-up. Thigh symptoms were noted to be better, still somewhat hard and red,"~ 1 cm subcutaneous mass with erythema, no warmth R upper thigh. NO: discharge". Temp was 98.5 in the office. Parent was advised to continue Keflex as prescribed and return to the office with worsening or persistent symptoms or any other concerns. There was no further follow-up after that.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site warmth, Pyrexia, Urinary tract infection, Urine analysis abnormal
Clinical narrative: Mom took child to the ED 1/11/18 for redness ~12mm per ED report, heat, pain and swelling (larger than the area of redness) in right thigh and fever of 102 (at home, 101.2 at the ED).  Provider at ED felt thigh symptoms were a vaccine reaction but did not think the fever was related to this so checked a U/A which was suggestive of a urinary tract infection and the patient was started on Keflex. The child was seen in the office 1/12/18 for follow-up. Thigh symptoms were noted to be better, still somewhat hard and red,"~ 1 cm subcutaneous mass with erythema, no warmth R upper thigh. NO: discharge". Temp was 98.5 in the office. Parent was advised to continue Keflex as prescribed and return to the office with worsening or persistent symptoms or any other concerns. There was no further follow-up after that.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: We had five ped patients that received the PENTACEL. Out of the 5 patients one patient didn't receive the reconstitute ACTHIB.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: The immunizations were given just 3 weeks after first series; making them 1 week too soon. All immunizations cannot be counted and will be repeated in 1 month.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Passed out five minutes after vaccine, hit his head on the floor.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 4 month old came in for well visit and immunizations. 2 mo immunizations given just 3 weeks prior. The vaccines cannot be counted and will be repeated within the next 4 weeks.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, MMR, VARCEL
Symptoms: Erythema, Pruritus, Urticaria, Vomiting
Clinical narrative: Approximately 1 hr. after vaccines child's face became red, started itching, and had 2 episodes of emesis. Seen in office approximately 1 hr. later, redness improved. No additional episodes of emesis. Noted to have erythema on face and pink with wheals on abd. Given 120 mg BENADRYL PO.
Age: 63.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient developed puritic rash on neck and upper torso the evening of administration. Pt. given KENALOG 40 mg 1/30/18.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a nurse vial call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX. On 23rd January 2018, the patient received SHINGRIX. On 24th January 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site itching. The patient was treated with VASELINE. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site itching were recovering/resolving. The reporter considered the injection site pain, injection site erythema, injection site swelling and injection site itching to be almost certainly related to SHINGRIX. Additional details were provided as follows: The case was reported by a nurse practitioner who was the patient. There was no other medical history or medication history or concomitant vaccines reported by caller. The patient received SHINGRIX in left deltoid. The reporter stated that symptoms were getting better and no other medical treatment besides VASELINE at site had occurred. She did not have batch number or expiration. There was no address was provided for facility. The reporting nurse practitioner stated that she was not calling to report adverse event.
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dysphagia, Facial paralysis, Guillain-Barre syndrome, Influenza
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a adult male patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, Guillain Barre Syndrome (serious criteria hospitalization and GSK medically significant), monoplegia (serious criteria GSK medically significant), facial paralysis (serious criteria GSK medically significant), swallowing difficult and weakness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza, Guillain Barre Syndrome, monoplegia, facial paralysis, swallowing difficult and weakness were not reported. It was unknown if the reporter considered the vaccination failure, influenza, Guillain Barre Syndrome, monoplegia, facial paralysis, swallowing difficult and weakness to be related to Flu trivalent vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient was 60 years old at the time of reporting. In 2002, the patient received seasonal influenza vaccine (pharmacist did not know which Flu vaccine). In 2002, the patient was sick with flu, was weak, became paralyzed in the right leg, arm and face and had difficulty in swallowing. The patient was hospitalized and diagnosed with Guillain Barre Syndrome. This case has been considered as suspected vaccination failure case since the time to onset and laboratory test confirmation was unknown. No further information was provided. No consent to follow up required.
Sex: M
Vaccine: FLU3
Symptoms: Monoplegia, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a adult male patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, Guillain Barre Syndrome (serious criteria hospitalization and GSK medically significant), monoplegia (serious criteria GSK medically significant), facial paralysis (serious criteria GSK medically significant), swallowing difficult and weakness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza, Guillain Barre Syndrome, monoplegia, facial paralysis, swallowing difficult and weakness were not reported. It was unknown if the reporter considered the vaccination failure, influenza, Guillain Barre Syndrome, monoplegia, facial paralysis, swallowing difficult and weakness to be related to Flu trivalent vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient was 60 years old at the time of reporting. In 2002, the patient received seasonal influenza vaccine (pharmacist did not know which Flu vaccine). In 2002, the patient was sick with flu, was weak, became paralyzed in the right leg, arm and face and had difficulty in swallowing. The patient was hospitalized and diagnosed with Guillain Barre Syndrome. This case has been considered as suspected vaccination failure case since the time to onset and laboratory test confirmation was unknown. No further information was provided. No consent to follow up required.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 39 year old woman with lymphangioleiomyomatosis and tuberous sclerosis complex. Patient received flu vaccine to right deltoid at 12:50 on 11/14/17. Nursing noted right deltoid flu vaccine site has approx 3cm diam of erythema, swelling, and slight tenderness area of erythema, swelling to the site at 13:20 on 11/15/17. NP and attending were notified. Pt evaluated by NP who recommended cold compresses to site. Pt instructed to follow up with local MD upon discharge if any worsening of condition.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia, Muscle disorder, Paraesthesia
Clinical narrative: Loss of muscle control, tingling, numbness.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Feeling hot, Rash, Rash erythematous
Clinical narrative: Student complaint of feeling hot inside. Red patches noted to forhead, cheeks, chest and back approximately 15 minutes after vaccination. Vital signs as follows; T 96.9, P 106, R 18  B/P  120/100. Benadryl 50 mg/ml injected IM to her Lt. deltoid. Tolerated well. Rash was cleared one minute after Benadryl injection. Mother was notifed and student pick ed up from school.  Instructions given to parent.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Left arm is somewhat sore and possibly swollen at the site of injection, Injection site is slightly warm to the touch.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Nausea, Rash, Vertigo
Clinical narrative: Rash, fatigue, vertigo, nausea for approximately a day and a half.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash generalised
Clinical narrative: Wide spread rash, itching, patient given antihistamines, felt rash was stable at 36 hours after onset of symptoms, main concern at visit today wash itching.
Age: 76.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Pain in extremity
Clinical narrative: Patient reported very sore arm and sought medical treatment.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Lethargy, Pain, Pallor, Vomiting
Clinical narrative: Unable to move arm without severe pain, intense vomiting, pale, lethargic.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest pain, Pain in extremity
Clinical narrative: About an hour after the shot, I started getting pain coming from my arm over into my chest area. At first I didn't realize what it was and had forgotten that I'd gotten the flu shot; however when I realized it at about 7 pm, I took an 800 mg ibuprofen which seemed to help with the pain. After I arrived home from dinner, I called the pharmacy and was told to go ahead an keep taking the ibuprofen because sometimes inflammation can be caused due to an injection, etc. I took ibuprofen the following day (Thursday) but then stopped. The pain had not gone away but was not as intense. It continued throughout the day on Friday; however early Saturday am (approx 3 am on 10/21/17), I was awoken with pain and throbbing going down into my hand. Because no doctor offices were open, I went to the ER (based on advice given on the online nursing hotline) and was given a muscle relaxer and anti-inflammatory -- diagnosis, maybe muscle spasm. I only took that medication for 1-2 days -- it helped greatly but I did not want to take those rx drugs for a longer length of time. Since then, my arm pain has continued -- intensity varies, there is limited range of motion, sometimes hurts higher on the arm, other times into the top half of my arm and often extends into my elbow. I've tried creams, ibuprofen, etc.
Age: 19.0
Sex: M
Vaccine: FLUC4
Symptoms: Facial paralysis, Paralysis
Clinical narrative: PATIENT EXPERIENCE PARALYSIS LIKE SYMPTOMS ON LEFT SIDE THE NIGHT AFTER RECEIVING FLU SHOT. HE WENT TO OFFICE WHO DIAGNOSED HIM WITH BELL'S PALSY AND WAS GIVEN A PRESCRIPTION ON 1/8/18. HE THEN WENT TO HOSPITAL AND THEY TOO DIAGNOSE HIM WITH BELL'S PALSY. THEY GAVE A PRESCRIPTION ON 1/8/18 TO TREAT HIS SYMTPOMS. PATIENT STILL HAS SOME SYMPTOMS TIL TODAY. HE IS GETTING INSURANCE AND WILL FOLLOW UP WITH A DOCTOR.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Endotracheal intubation
Clinical narrative: I received the flu shot at around 3:30 and by 10:30, I had a problem breathing. It became so severe that 911 was called and I was taken to the hospital. A breathing tube was inserted to correct the problem.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted a few minutes after receiving vaccine. Not injured in the faint.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Allergy to vaccine, Cough, Dyspnoea, Hypersensitivity, Throat tightness
Clinical narrative: Pt had allergic reaction about 3 hours after taking PREVNAR with FLUZONE HD. She stated that she has had the flu vaccine before so she and her dr. believe it was an allergy to the PREVNAR. She couldn't breath, her throat was closing, and she couldn't stop coughing. She went to urgent care and dr gave her benadryl and a steroid shot. She was then prescribed prednisone 50mg and xyzal 5mg which she filled here.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema
Clinical narrative: Child has a red spot on left arm. Appeared morning after vaccine. DX; Cellulitis. RX: Augmentin 600mg TID x10 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat, and patient says it feels like a rock at the injection site. Patients is taking tylenol and using a cold pack. We suggusted on 1/31/18 that the patient go to the doctor if no improvement.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Swelling
Clinical narrative: Redness/bump. No treatment needed.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Eye pain, Eye pruritus, Headache
Clinical narrative: Started to have bad headaches the next day and also sore, itchy eyes.
Age: 74.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Identified an adult patient received an adolescent dose of HEP B. Incident reported to our risk manager and patient's PCP informed. Reviewed consequences and next steps with our risk management team and pharmacy consultant. Reported event on VAERS, contacted patient and scheduled patient for appointment for the last HEP B dose.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Identified an adult patient received an adolescent dose of HEP B. Incident reported to our organization's risk manager and patient's PCP informed. Reviewed consequences and next steps with our risk management team and pharmacy consultant. Reported event on VAERS, contacted patient and scheduled patient for appointment for the second HEP B dose.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Headache, Nausea, Neck pain
Clinical narrative: Headache, nausea, fever, rash, hives, full body ache, neck pain, back pain, weakness (especially in legs).
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Rash, Urticaria
Clinical narrative: Headache, nausea, fever, rash, hives, full body ache, neck pain, back pain, weakness (especially in legs).
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Head injury, Headache, Nausea, Syncope
Clinical narrative: As PT was leaving she fainted in the front of the store as she was walking out. She fainted/fell into her mother's arms and fell to the floor. When she hit her head. Upon notification, she was attended to and after several minutes, she was able to get up and walk out. At the time of incident, she was asked if she would like us to call for an ambulance - she declined. After leaving about 20 minutes later the mother phoned to say the PT was nauseous and her head hurt and they were going to the hospital.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Hypersensitivity, Rash, Wheezing
Clinical narrative: Typical delayed allergic reaction - rash on chest and wheezing/labored breathing.