chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reaction or allergies were not reported. On 02-NOV-2018, the patient was inadvertently vaccinated with M-M-R II, lot # N014483, expiration date 10-MAY-2019 (strength, exact dose were not reported), intramuscularly, for prophylaxis (unspecified dose in series of vaccination). Nurse stated that the M-M-R II was administered intramuscularly instead of subcutaneously. M-M-R II was reconstituted with sterile diluent (lot# M036841, expiration date 14-APR-2019). No adverse effects were reported. The outcome of inappropriate route of vaccination and no adverse event was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2016, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date in 2016, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On 12-DEC-2016, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 22-DEC-2008, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 30-NOV-2017, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 18-APR-2013, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 14-DEC-2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: TD
Symptoms: Product administered at inappropriate site
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a male patient who received vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications not reported. On 26-Oct-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported in the left gluteus medius. It was a case of actual medication error due to Vaccine administered at inappropriate site. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 95 years old male patient who received 2 doses of FLUZONE, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route. 1 other doses were administered on unknown dates for suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was a case of actual medication error due to extra dose administered. The patient outcome is reported as Not Applicable for 95 year old male, received 2 doses of FLUZONE. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Vertigo
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves female patient who experienced dizzy and vertigo, while she received vaccine FLUBLOK QIV. The patient's past vaccination(s) included Flu vaccine. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route. The patient developed a non-serious dizzy following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The patient developed a non-serious vertigo following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included No lab test). Final diagnosis was vertigo and dizzy. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for dizzy and as Unknown for vertigo.
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA308762, 2018SA308765, 2018SA308766 and 2018SA308767 (same reporter). This case involves a 56 years old patient (gender unspecified) who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE lot UJ029AB via intramuscular route instead of FLUZONE QUADRIVALENT on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and accidental overdose. It was not reported whether the patient experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Feeling abnormal, Headache, Oral pain, Pain in jaw, Toothache
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 73 years old male patient who experienced felt a little bit different the next day, a headache off and on since then, on the right side of his head, the right side of his mouth feels sensitive and painful and his right upper jaw and back right molar have been aching and painful, while he received vaccine INFLUENZA VACCINE. The patient's past medical history included Cardiac failure with in 2006, and a quadruple bypass surgery, and now has a defibrillator and pacemaker. The patient's past vaccination(s) included flu shots in the past and never had a reaction. The patient's past medical treatment(s) and family history were not provided. Concomitant medication was not reported. On 24-Sep-2018, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a non-serious felt a little bit different the next day (feeling abnormal) following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious a headache off and on since then, on the right side of his head (headache) following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious the right side of his mouth feels sensitive and painful (oral pain) following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious his right upper jaw and back right molar have been aching and painful (pain in jaw) following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab data.) Final diagnosis was his right upper jaw and back right molar have been aching and painful, the right side of his mouth feels sensitive and painful, a headache off and on since then, on the right side of his head and felt a little bit different the next day. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for a headache off and on since then, on the right side of his head, as Unknown for the right side of his mouth feels sensitive and painful, as Unknown for his right upper jaw and back right molar have been aching and painful and as Unknown for felt a little bit different the next day. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 91 years old female patient who was vaccinated with 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AC, expiry date- 30-Jun-2019, via intramuscular in unknown site on 20-Oct-2018 and 07-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered. It was reported that Caller wanting to know any potential side effects, because of this, and asking if this be considered equivalent to her receiving a FLUZONE HIGH-DOSE injection. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Injection site rash, Rash, Urticaria
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 months old patient (gender not reported) who experienced a rash on both legs and hives, while he/she received vaccine ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date (reported as possibly on Oct-2017), the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot number: UI764AA, expiry date, dose in series not reported) via intramuscular route in the left thigh. On an unknown date, the patient developed a non-serious a rash on both legs following the administration of HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious hives following the administration of HIB (PRP/T) VACCINE. Other relevant tests included No Lab data was reported. Final diagnosis was hives and a rash on both legs. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for a rash on both legs and as Unknown for hives. Documents held by the sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a male child patient (age was not reported) was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UJ000AB, expiry date: 28-Mar-2019) the left deltoid instead of who FLUZONE QUADRIVALENT on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was also a case of accidental overdose. It was not reported whether the patient experienced any adverse events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Influenza like illness, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Extremely sore and swollen injection site. I took TYLENOL about two hours after the injection. It wasn't until I went to bed about 10:00 PM, that my entire body began to ache - as if I had the flu. My face ached, my arms, legs, and back ached. Even my neck ached. I also had moderate nausea. Not enough to throw up, but extremely uncomfortable. As I was in bed sleeping, my first thought was that it must have been something that I had eaten for dinner, but I believe it was the vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Extremely sore and swollen injection site. I took TYLENOL about two hours after the injection. It wasn't until I went to bed about 10:00 PM, that my entire body began to ache - as if I had the flu. My face ached, my arms, legs, and back ached. Even my neck ached. I also had moderate nausea. Not enough to throw up, but extremely uncomfortable. As I was in bed sleeping, my first thought was that it must have been something that I had eaten for dinner, but I believe it was the vaccine.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Patient's wife called at 12:30 pm on 11/25 and stated that patient had a rash that started in the underarm and traveled a little down the arm. She stated the rash looked like little pimples with minor itching. I recommended that he take some BENADRYL. I spoke with them again at 1:20 pm.  She stated that the rash was not spreading and itch had decreased. Spoke with her again and 4:40 pm and she stated that the rash was going away. Spoke with them again at 9:30 am on 11/26 and wife stated that rash was almost completely gone and he was not having any symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Warmth, redness and swelling. Cool compress, Ibuprofen as needed.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Hyperhidrosis, Myalgia, Peripheral swelling
Clinical narrative: Injection arm swelling, myalgia, erythema/redness radiating down entire arm. Sweats and chills without identified fever.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had redness, discomfort and mild swelling at injection site. Swelling improved and nearly resolved while examined in clinic. Redness and discomfort with palpation still present during examination. Pt given oral BENADRYL and instructed to cotinue with oral BENADRYL as prescribed and apply ice.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Day after vaccination she had right arm pain radiating from upper arm down to wrist from 1 injection site. No redness or swelling. She visited he doctor for regular appointment that week. When doctor touched spot patient said it was painful. I then had no contact with patient until this past Sunday November 18th. She never came in the store to show us her painful spot, but on Nov 18th felt she would let me know the pain was bothering her, but she has not had any treatment done.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Chest X-ray, Computerised tomogram, Dizziness, Dyspnoea
Clinical narrative: Soon after the shot I had swelling of my lips. I took an ALLEGRA and it subsided. The next morning I was dizzy upon waking. It got better and I went to lunch. At lunch I started to get severe vertigo and was also pale and short of breath. Went home and lay down and it subsided. The next day I felt ok and went to an evening meeting. The severe vertigo returned and lasted for eleven hours. I went to the Emergency Department at Hospital. They diagnosed me with vertigo. My ENT performed a series of tests and said it was Vestibular Neuritis. He believed that it could have been a result of the SHINGRIX vaccine. I am taking PT to help restore by balance.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram, Lip swelling, Nuclear magnetic resonance imaging, Pallor, Scan with contrast
Clinical narrative: Soon after the shot I had swelling of my lips. I took an ALLEGRA and it subsided. The next morning I was dizzy upon waking. It got better and I went to lunch. At lunch I started to get severe vertigo and was also pale and short of breath. Went home and lay down and it subsided. The next day I felt ok and went to an evening meeting. The severe vertigo returned and lasted for eleven hours. I went to the Emergency Department at Hospital. They diagnosed me with vertigo. My ENT performed a series of tests and said it was Vestibular Neuritis. He believed that it could have been a result of the SHINGRIX vaccine. I am taking PT to help restore by balance.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Tympanometry, Vertigo, Vestibular function test, Vestibular neuronitis
Clinical narrative: Soon after the shot I had swelling of my lips. I took an ALLEGRA and it subsided. The next morning I was dizzy upon waking. It got better and I went to lunch. At lunch I started to get severe vertigo and was also pale and short of breath. Went home and lay down and it subsided. The next day I felt ok and went to an evening meeting. The severe vertigo returned and lasted for eleven hours. I went to the Emergency Department at Hospital. They diagnosed me with vertigo. My ENT performed a series of tests and said it was Vestibular Neuritis. He believed that it could have been a result of the SHINGRIX vaccine. I am taking PT to help restore by balance.
Age: 86.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Axillary pain, Chest pain, Injection site pain, Pain
Clinical narrative: Pain in left arm around injection site; radiated into chest/underarm area and down arm a bit. Patient reports she couldn't lay on it for 4 days and each day it felt a little bit better. She said the pain was much more severe than previous immunizations and had no trouble with the PNEUMOVAX shot in right arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased activity, Pain, Pyrexia
Clinical narrative: Received vaccine at a pharmacy. Fever, full body muscle aches, pain lasting 24 hours or more. Unable to do normal level of activity. Some relief with ibuprofen.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin tightness, Swelling face
Clinical narrative: Patient reports swelling/tightness of forehead that appeared one day after vaccine and lasted 1.5 days.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Axillary pain, Breast pain, Headache, Influenza like illness
Clinical narrative: Severe stabbing pains and aches all over body; cramping of both feet; severe headache; loss of use of R arm (arm that was injected) for several hours; loss of energy; general malaise. Started about 7:30 PM after morning injection. Better now, but still have some overall body aches and pains,  headache, overall feeling like I'm getting over the flu. Continued pain in R armpit, R breast.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Muscle spasms, Musculoskeletal disorder, Pain
Clinical narrative: Severe stabbing pains and aches all over body; cramping of both feet; severe headache; loss of use of R arm (arm that was injected) for several hours; loss of energy; general malaise. Started about 7:30 PM after morning injection. Better now, but still have some overall body aches and pains,  headache, overall feeling like I'm getting over the flu. Continued pain in R armpit, R breast.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Dry skin, Headache, Herpes zoster, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Injection site on left detoid was slightly sore for 2 days. Then 9 days post injection, dry skin with itchy rash began on upper left back and shoulder area. 19 days post injection, red itchy spots  noted on upper left shoulder and down bicep of left arm, initially to elbow joint. Pulsing muscle pain, level 4 on pain scale at site of vaccination in deltoid muscle that extended down through bicep to elbow area. No problems on tricep muscle. Slight headache with achy body and malaise. Body temperature normal. Difficulty sleeping due to pain. Painful left shoulder joint. Limited motion due to pain. Pulsing muscle pain up left side of neck to ear. Diagnosed as shingles on 11/06/2018.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site joint pain, Injection site pain, Injection site reaction, Insomnia, Malaise
Clinical narrative: Injection site on left detoid was slightly sore for 2 days. Then 9 days post injection, dry skin with itchy rash began on upper left back and shoulder area. 19 days post injection, red itchy spots  noted on upper left shoulder and down bicep of left arm, initially to elbow joint. Pulsing muscle pain, level 4 on pain scale at site of vaccination in deltoid muscle that extended down through bicep to elbow area. No problems on tricep muscle. Slight headache with achy body and malaise. Body temperature normal. Difficulty sleeping due to pain. Painful left shoulder joint. Limited motion due to pain. Pulsing muscle pain up left side of neck to ear. Diagnosed as shingles on 11/06/2018.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain, Rash pruritic
Clinical narrative: Injection site on left detoid was slightly sore for 2 days. Then 9 days post injection, dry skin with itchy rash began on upper left back and shoulder area. 19 days post injection, red itchy spots  noted on upper left shoulder and down bicep of left arm, initially to elbow joint. Pulsing muscle pain, level 4 on pain scale at site of vaccination in deltoid muscle that extended down through bicep to elbow area. No problems on tricep muscle. Slight headache with achy body and malaise. Body temperature normal. Difficulty sleeping due to pain. Painful left shoulder joint. Limited motion due to pain. Pulsing muscle pain up left side of neck to ear. Diagnosed as shingles on 11/06/2018.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Tiny red itchy bumps all over palms of hands for about 16 hours. They were gone the next day.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 11/10/18 at injection plus 27 hrs onset of slight headache, tiredness. By nightfall (inj plus 30 hrs) went to bed with severe headache, chills and body aches. By next morning (inj plus 48 hrs) noted formation of raised rash like a C-shape with a bar through it, starting about 3 inches below the injection site on R arm. It looked like a large cattle brand about 3 inches wide. I was unable to lift R arm to open cupboards or perform tasks. Felt feverish during the night but too ill to take temperature. By injection plus 56 hours, the rash also expanded along lower part of R bicep. Began to feel better by injection plus 60 hrs. Rash faded over the next 48 hours and all other symptoms subsided. More post-marketing data is needed!!
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: 11/10/18 at injection plus 27 hrs onset of slight headache, tiredness. By nightfall (inj plus 30 hrs) went to bed with severe headache, chills and body aches. By next morning (inj plus 48 hrs) noted formation of raised rash like a C-shape with a bar through it, starting about 3 inches below the injection site on R arm. It looked like a large cattle brand about 3 inches wide. I was unable to lift R arm to open cupboards or perform tasks. Felt feverish during the night but too ill to take temperature. By injection plus 56 hours, the rash also expanded along lower part of R bicep. Began to feel better by injection plus 60 hrs. Rash faded over the next 48 hours and all other symptoms subsided. More post-marketing data is needed!!
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Nausea, Pruritus generalised, Swelling face, Urticaria
Clinical narrative: Face (particularly eye/nose area) became extremely swollen and covered in small welts, itching from head to toe, skin became flush, and mild nausea. Breathing was not labored so she was given BENADRYL and placed in a cool bath. Itching and welts subsided within approximately 3 hours while the swelling remained for 3 days.
Age: 81.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient reports pain and extreme weakness in all 4 extremities; starting 2 days after vaccination and lasting for approximately 1 week. She required assistance to move about her home. However, she did not seek medical assistance.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: Patient received a total of 4 doses of BEXSERO. 1st dose- 7/1/2016 2nd dose- 7/11/17 3rd dose- 8/15/17 4th dose - 11/2/18.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: Patient reports swelling of eyelids that occured the day after the vaccination and lasted for about 1.5 days.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: PREVNAR administered to patient on 11/12/2018 by certified pharmacy intern. Patient had already received Flu shot in same arm. At time of administration, patient reported that she felt a lot of pain in her shoulder. Intern reported he administered the shot above Band-Aid where she received flu shot and was wondering if he administered the shot too high in deltoid area. Patient's husband reported to pharmacy on November 21st and said his wife was having so much pain in the area where the shot was administered that she could not lift any items and experienced a lot of pain to move her arm. She had reported to her physician on an unknown date after the shot for alternate problem and she described the pain in her arm and the approximate area that the shot was administered. The nurse confirmed that she thought the shot was administered above the area of the deltoid that the shot is usually given. The patient had her husband report this incident to our pharmacy, because she was too embarrassed. The husband said she was slowly improving, by using TYLENOL and heat to ease the pain. He just wanted to report the incident, so it did not happen again. I reassured him that I would discuss with staff and report incident to VAERS and our own reporting system. I listed as adverse drug reaction, however, I feel that the administration was more to blame than a reaction to the medication itself in this incidence.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Electrocardiogram normal, Muscular weakness, X-ray normal
Clinical narrative: 15 mins. after pt rec'd vaccine: took elevator from 3rd to 1st floor experienced weak legs, faintness. Pt was taken to ER for F/U. Mother stated he was released from ER after EKG; Xray results normal along with vitals. Mother states he's resting but feeling "fine".
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Pallor, Sensory disturbance, Visual impairment
Clinical narrative: Patient received their Flu shot at facility, after sitting for a few minutes the whole Family walked to the elevator to go down to the car. While in the elevator the patient said he couldn't see and was feeling like his legs were going to give out. His parents held on to him and brought him back up to the Flu Shot Spot. The patient was conscious and able to answer questions, but the patient was quickly losing coloring and complaining he couldn't feel his hands and feet. When I arrived, the patient was able to tell my his name where he was and he could move all his limbs. His coloring was not good. He was laying down on the floor with his feet elevated on a chair. After drinking 3 juices and continued blow by the patient's color and vitals had returned to normal. F/U call at 11/21/18 at 1625 but no answer, RN.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Very little arm pain. Extreme chills and fatigue after each shot - about 4-6 hrs. - more after second shot. Didn't want to bother doctor. Chills lasted about 1 1/2 days. Just thought someone should know. Read warnings - my choice to proceed with these shots.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Biliary colic, Herpes zoster, Rash
Clinical narrative: Gallbladder pain, Shingles rash appearance 10-12-18. 10-18-18 prescribed valacyclovir (1000mg) 3x/day. 10-23-18 prescribed Gabapentin 300mg.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient lost consciousness following influenza shot (FLUZONE 18-19).
Age: 0.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 3 month old patient of unknown gender. The patient's concurrent, historical and concomitant medications were not reported. On 16-NOV-2018, the patient was vaccinated with VARIVAX lot number R012531 and expiration date of 01-MAY-2020 (dosage, frequency, strength, route of administration were not reported) for prophylaxis. The patient's vaccination was outside the recommended age according to the prescribing information. No adverse events was reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 21-NOV-2018, the patient was inadvertently vaccinated with expired RECOMBIVAX HB lot # L045117 with expiration date 06-OCT-2018, intramuscularly, for prophylaxis (dose was not reported). No adverse effects were reported.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received DTPa (Reduced antigen) for prophylaxis. Co-suspect products included DIPHTHERIA TETANUS VACCINE (NON-GSK) for prophylaxis. On an unknown date, the patient received dTpa vaccine and DIPHTHERIA TETANUS VACCINE (NON-GSK) at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. It was unknown if the reporter considered the vaccination failure and whooping cough to be related to dTpa vaccine. Additional information received as follows: The age at vaccination was not reported. The patient got the DTP (every 5-7 years needed it for travel), then they started just giving the DT. The DTP was recommended every 10 years and after 5 years received another if a wound. The patient got the whooping cough despite all that. This case was considered as a suspected vaccination failure case as the time to onset and the lab test confirmation for pertussis were unknown.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 17th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced blister, tingling of extremity, wakefulness and pruritus. On 17th September 2018, the patient experienced erythema of extremities, injection site burning and extensive swelling of vaccinated limb. SHINGRIX was discontinued. On an unknown date, the outcome of the erythema of extremities, injection site burning, extensive swelling of vaccinated limb, blister, tingling of extremity, wakefulness and pruritus were unknown. It was unknown if the reporter considered the erythema of extremities, injection site burning, extensive swelling of vaccinated limb, blister, tingling of extremity, wakefulness and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient reported that vaccine burnt as it was being administered. At the afternoon, less than a day after receiving the SHINGRIX, the patient noted that the injection site was becoming red and swollen. The redness and swelling increased until it extended almost fully around her right arm. She went to her physician's office and was evaluated by the physician assistant. She went back to and saw her physician a couple of days later and was told that she should not get the second dose. Her physician filled out a report at the time she was seen related to her symptoms. She described that red blisters began to appear on the area from her knuckles to her fingertips within a few days after receiving the vaccine. She went to her physician again (the fourth visit), approximately a week after being told by her not to get the second dose of the product, to have the blisters evaluated. She was given a cream but the cream made the blisters worse. She had more blisters on her fingers. She did not have very many on her pinky finger but her ring, middle and index fingers are covered with blisters on the top. The ring finger has one blister underneath that was itchy. The tips of her fingers tingle almost continuously. This tingling has caused her to wake up several times during the night. She reported that we can still see a faint pink outline of where the redness and swelling at the injection site occurred. Emergency room visit was required. The reporter gave permission for her physician to be contacted. The reporter was unable to obtain additional information. Counseled reporter to contact the manufacturer of the cream to report her experience.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Paraesthesia, Poor quality sleep, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 17th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced blister, tingling of extremity, wakefulness and pruritus. On 17th September 2018, the patient experienced erythema of extremities, injection site burning and extensive swelling of vaccinated limb. SHINGRIX was discontinued. On an unknown date, the outcome of the erythema of extremities, injection site burning, extensive swelling of vaccinated limb, blister, tingling of extremity, wakefulness and pruritus were unknown. It was unknown if the reporter considered the erythema of extremities, injection site burning, extensive swelling of vaccinated limb, blister, tingling of extremity, wakefulness and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient reported that vaccine burnt as it was being administered. At the afternoon, less than a day after receiving the SHINGRIX, the patient noted that the injection site was becoming red and swollen. The redness and swelling increased until it extended almost fully around her right arm. She went to her physician's office and was evaluated by the physician assistant. She went back to and saw her physician a couple of days later and was told that she should not get the second dose. Her physician filled out a report at the time she was seen related to her symptoms. She described that red blisters began to appear on the area from her knuckles to her fingertips within a few days after receiving the vaccine. She went to her physician again (the fourth visit), approximately a week after being told by her not to get the second dose of the product, to have the blisters evaluated. She was given a cream but the cream made the blisters worse. She had more blisters on her fingers. She did not have very many on her pinky finger but her ring, middle and index fingers are covered with blisters on the top. The ring finger has one blister underneath that was itchy. The tips of her fingers tingle almost continuously. This tingling has caused her to wake up several times during the night. She reported that we can still see a faint pink outline of where the redness and swelling at the injection site occurred. Emergency room visit was required. The reporter gave permission for her physician to be contacted. The reporter was unable to obtain additional information. Counseled reporter to contact the manufacturer of the cream to report her experience.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Neuralgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of back pain in a 84-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included neuralgia. On 19th August 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced back pain, neuralgia and condition aggravated. On an unknown date, the outcome of the back pain, neuralgia and condition aggravated were not recovered/not resolved. It was unknown if the reporter considered the back pain, neuralgia and condition aggravated to be related to SHINGRIX. Additional information was received as follows: The batch number and expiry date for SHINGRIX was not reported. The patient experienced rash, that she referenced as shingles rash, experienced by her years ago before vaccination with SHINGRIX, however the patient did not experience any rash after vaccination with SHINGRIX. The patient received the vaccine on the left arm. The patient usually experienced two episodes of post hepatic neuralgia pain in a year but after vaccination with SHINGRIX she had experienced an increase in the frequency of her post hepatic neuralgia episodes that leaded to aggravated condition. The patient stated that she did not remember when the first episode of post hepatic neuralgia started but could have been in late August or September. The patient also experienced intermittent pain in her back, where the patient rated the pain as 7 out of 10 on a pain scale to a 10 out of 10. The patient also added that the pain increased with activity and usually lasted around for four days per episode. On 4th October 2018, the patient saw her doctor for the pain experienced by her. Emergency room visit was required for the patient. The patient provided permission to contact her pharmacist. Consent to follow-up was provided.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 3-year-old female patient who received FLULAVAL QUADRIVALENT 2017-2018 season) (batch number 7PL77, expiry date 31st May 2018) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2017-2018 season. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT 2017-2018 season, the patient experienced injection site swelling, injection site warmth, injection site erythema and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site swelling, injection site warmth and vaccine administered at inappropriate site were unknown and the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to FLULAVAL QUADRIVALENT 2017-2018 season. Additional details were reported as follows: This case was reported by patient's father. The patient received flu vaccine on left thigh, which led to vaccine administered at inappropriate site. The patient got the flu vaccine last year (2017) and she had a severe reaction of a large red spot, swelling and warmth at the injection site. The reporter described the size of redness as that of a softball size and it lasted for 4 days. The reporter consented to follow up. The reporter didn't have the Healthcare Professional (HCP) information at time of the call, but was open to receiving the authorization form.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Intercepted product administration error
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (On an unknown date 1st dose received). On an unknown date, the patient received the 2nd dose of SHINGRIX and the 3rd dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and intercepted drug administration error. On an unknown date, the outcome of the injection site pain and intercepted drug administration error were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated the patient was given dose of SHINGRIX and complained that the vaccine hurt when it was administered. The reporter also stated that the patient did not believe she got 2 doses of SHINGRIX (even though MD had documentation of 2 doses being given to patient) and the patient wanted the reporter to get a 3rd dose of SHINGRIX. The reporter said she was not going to give the patient a 3rd dose of SHINGRIX since they already had documentation of 2 doses being given to this patient. This led to intercepted (averted) drug administration error. The reporter did not consent to follow-up.