chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient. The patient did not have any medical history or drug reaction/ allergy to report. On 19-OCT-2015, the patient was vaccinated subcutaneously in the right arm with a dose of ZOSTAVAX 0.65 ml, once, lot # reported as K016323, expiration date 24-DEC-2015. Concomitant therapies included morphine sulfate (manufacturer unknown), PERCOCET and fentanyl. On an unspecified date in October 2015 (reported as on or after 19-OCT-2015), the patient developed redness at the injection site in her right arm after receiving the ZOSTAVAX dose. No treatment was given to the patient. No laboratory diagnostic studies were performed. The patient sought medical attention by visiting the pharmacist. At the time of the report, the outcome of injection site erythema was reported as not recovered. The relatedness between injection site erythema and ZOSTAVAX was not provided. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified dates, the patients were vaccinated with an unspecified improperly stored doses of PEDVAXHIB, injection, lot # L002867 and expiration date 11-NOV-2017, (routes of administration and anatomical location were not provided). No adverse symptoms were reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Influenza in a adult female patient who received FLUARIX. Previously administered products included seasonal Influenza vaccine (the patient has received the Flu vaccine pretty much every year). Concurrent medical conditions included fibromyalgia. Concomitant products included simvastatin, BENADRYL, calcium, CENTRUM Silver and Vitamin D. In October 2013, the patient received Influenza vaccine unspecified. On an unknown date, 91 days after receiving Influenza vaccine, the patient experienced Influenza. On an unknown date, the outcome of the Influenza was recovered/resolved. The reporter considered the Influenza to be related to Influenza vaccine unspecified. Additional details provided were as follows: This case was previously reported to a doctor. This case was reported by the patient herself. The patient has received the Flu vaccine pretty much every year. Two years ago, in October 2013, the patient received a dose of trivalent Flu vaccine (unknown manufacturer). In January 2014, approximately 3 months later, the patient experienced the Flu. The patient stated, that she got the senior dose, one shot, but noted it was stronger than the quadrivalent vaccine. She also stated that, she was told the trivalent was stronger and better for seniors so that was what she was referring to when she noted senior dose. The patient stated that, she cannot recall that her physician was aware she got the Flu.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified number of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (lot # reported as L013826, expiration date: 21-APR-2017) (dose, anatomical location, route of administration and frequency were unspecified). No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site rash in a adult patient who received FLULAVAL quadrivalent (batch number 99LN2, expiry date May 2016). In 2015, the patient received FLULAVAL quadrivalent. On an unknown date, an unknown time after receiving FLULAVAL quadrivalent, the patient experienced injection site rash, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site rash, injection site warmth and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site warmth and injection site swelling to be related to FLULAVAL quadrivalent. Additional details were provided as follows: This case was reported by a pharmacy director. This case was 1 of the 2 cases reported for the employees of the pharmacy who experienced an adverse reaction after the vaccination. The two patients received the FLULAVAL QIV vaccine from different vials purchased at the same time. In 2015, the patient experienced large red rash,warm and puffy (swelling) surrounding the injection site of FLULAVAL QIV vaccine. The reactions lasted for few days. The reporter was not aware of any other issues regarding either of the vials containing the vaccine. This case has been linked to case US2015GSK155180, reported by the same reporter.
Sex: F
Vaccine: DTAP
Symptoms: Cough, Respiratory tract congestion
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of respiratory tract congestion in a female patient who received DTPa vaccine. In July 2015, the patient received DTPa vaccine. On an unknown date, less than a month after receiving DTPa vaccine, the patient experienced respiratory tract congestion and cough. On an unknown date, the outcome of the respiratory tract congestion and cough were unknown. It was unknown if the reporter considered the respiratory tract congestion and cough to be related to DTPa vaccine. Additional details were provided as follows: In the last week before the reporting time, the patient received the tdap booster. In July 2015, the patient experienced chest congestion and cough. The patient was wondering if the symptoms were a slight side effect of the vaccine. The patient's doctor did not inform her of the possible side effects after the vaccination.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Ageusia
Clinical narrative: This case was reported by a physician and described the occurrence of taste loss in a 31-year-old male patient who received Influenza vaccine quadrivalent. On 30th September 2015, the patient received influenza vaccine quadrivalent. On an unknown date, 10 days after receiving influenza vaccine quadrivalent, the patient experienced taste loss. On an unknown date, the outcome of the taste loss was recovering/resolving. It was unknown if the reporter considered the taste loss to be related to influenza vaccine quadrivalent. Additional details were received as follows: The patient received influenza vaccine quadrivalent and after 10 days he experienced acute loss of taste. The sense of taste was gradually improving over subsequent 2 weeks. The patient denied of having any sinus or nasal congestion, post nasal drip and fever. The patient was asking if ageussia or hypogeusia were reported response to flu quadrivalent vaccine.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Chills, Condition aggravated, Cough, Nausea
Clinical narrative: This case, manufacturer control number 2015-0179629, received via Gilead, is a non-serious case of a patient who experienced: coughing and wheezing due to asthma, fever, chills and nausea.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Wheezing
Clinical narrative: This case, manufacturer control number 2015-0179629, received via Gilead, is a non-serious case of a patient who experienced: coughing and wheezing due to asthma, fever, chills and nausea.
Sex: F
Vaccine: FLU4
Symptoms: Laceration, Product quality issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of laceration of finger in a adult female patient who received FLULAVAL QUADRIVALENT (batch number AT3CC, expiry date 31st May 2016). On 22nd October 2015, the patient received FLULAVAL QUADRIVALENT. On 22nd October 2015, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced laceration of finger. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger was recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the laceration of finger to be related to FLULAVAL QUADRIVALENT. Additional details provided were as follows: This case was associated to the pharmaceutical product complaint. The reporter stated that, the FLULAVAL QUADRIVALENT vaccine arrived on 9th September 2015 and was stored in a refrigerator. On 22nd October 2015, the another nurse (patient) opened the box and saw that one vial was broken on its side and the patient cut her finger due to this broken glass inside the box.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, Neurological examination normal, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 year old male patient. The patient has had no significant intercurrent illnesses over the past couple of months. Patient has myopia and currently wore glasses. The patient was pleasant, alert and active. Neurological examination was normal with CNs 2-12 intact, normal sensation and strength, motor strength-5/5 upper and lower extremities. The patient's medical history included heart surgery at the age of 5. The patient was allergic to ketamine (developed rash). The patient had one chicken pox vaccination on an unspecified date. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) 0.5, lot number L008273.on the left deltoid. Concomitant medications were not reported. The outcome of the incorrect product storage was not known. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Incorrect product storage, Neurological examination abnormal, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 month 8 day, old female patient. The patient had esotropia on the left eye and a small hemangioma over right eye. Upon general examination, the patient was found to be pleasant, alert and orientated, in no apparent distress, well developed and well nourished. The patient had no known drug allergies. The patient had had no intercurrent illness recently. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose (incorrect product storage) of (Merck) VARIVAX 0.5 ml, lot number L008273, on the left vastus lateralis. Patient was concomitantly vaccinated with PREVNAR 13, M-M-R II and HAVRIX. The outcome of the incorrect product storage was not known. There were no adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to four patients of unknown age and gender. The patients concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K010222, expiration date: 12-MAY-2016 or lot K019370, expiration date: 16-JUL-2016, dose and route were unknown). No adverse effect reported. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Incorrect product storage, Neurological examination normal, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner and refers to a 14 months 7 days female patient. The patient has had lot of intercurrent respiratory type problems and was also treated recently for a sinus infection. Patient's purulent rhinitis was improved but still had mild cold symptoms. Patient had a sickle cell trait. The patient was pleasant, alert and oriented in no apparent distress. The patient's neurologic examination showed ant fontanelle closing and normal sutures. Patient's mother was asthmatic. The patient had no known drug allergies. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) 0.5, dose 1 lot number L008273, on left vastus lateralis. Patient had no adverse effects. Patient had no adverse effects. Patient was concomitantly vaccinated with PREVNAR 13, M-M-R II and HAVIRX. The patient's other medications included CODITUSS DH, cefdinir, amoxicillin, POLYTRIM. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 26-OCT-2015 the patient was vaccinated with expired dose of M-M-R II lot # J010208, expiration date 23-AUG-2015, .5 ml, subcutaneous in the Anterolateral Left thigh (expired product administered). No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of VARIVAX (Merck) (dose and route were not reported, lot # L004650 with expiration date 11-FEB-2017) that had been improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter (other linked case # 1511USA003344). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 5 year, 6 month old female patient. The patient had no known drug allergies. Upon general examination, the patient was found to be alert and active and in no distress. All examinations were normal. The patient has never had chicken pox. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose (improper product storage) of VARIVAX (Merck) 0.5 ml, lot number L008273, on the right vastus lateralis. Patient was concomitant vaccinated with M-M-R II. The patient's other medications included multivitamins. Outocme of the incorrect product storage was not known. There were no other adverse effects. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 14-JUL-2014, the patient was vaccinated with a dose of GARDASIL, then on 10-OCT-2014, received other dose of GARDASIL (Lot numbers, dose and anatomical location of administration were not reported) intramuscular. On 27-OCT-2015, the patient would receive another dose. No known adverse effects. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of PROQUAD (Merck) (dose and route were not reported, lot # L007230 with expiration date 03-SEP-2016) that had been improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter (other linked case # 1511USA003443). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 month 18 days old male patient. The patient had no known drug allergies. Upon general examination, it was found that the patient was pleasant and well developed, well nourished, alert and active. Patient had normal muscle tone and strength, normal sensations, no ataxia and no abnormal reflexes. The patient was born with some jaundice. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose (incorrect product storage) of VARIVAX (Merck) 0.5, dose 1, lot number L008273, on the left vastus lateralis. Patient was concomitantly vaccinated with HAVRIX and M-M-R II. The patient's other medication included ZYRTEC. Outcome of incorrect product storage was not known. This is one of the several reports received from the same source. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Incorrect product storage, Neurological examination normal
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 13 month 15 days old male patient. Upon general examination, it was found that the patient was pleasant with normal appearance, was alert and oriented in no apparent distress. The patient's neurologic examination was CNs 2-12 intact, 3, motor strength -5/5 upper and lower extremities, DTRs-2+ bilaterally and symmetric. The patient had no known drug allergies and not had any intercurrent illnesses. Patient was not on any medications. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) 0.5, dose 1, lot number L008273, on left vastus lateralis. Patient was concomitantly vaccinated with PREVNAR-13, M-M-R II and HAVRIX. Outcome of the incorrect product storage was not known. This is one of the several reports received from the same source. Additional information has been requested.
Age: 1.45
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 17 month old male patient. No relevant medical history or concurrent conditions were reported. On 28-JUL-2015 the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported; lot# reported as K002939 which was verified as invalid, expiration date 11-DEC-2016) and improperly stored VARIVAX (Merck) (dose and route not reported; lot # reported as L00827 which was verified as invalid, expiration date 11-MAR-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 58 year old male patient. No information regarding the patients pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 28-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L003227, expiration date 13-OCT-2016 (strength, dose and route of administration were not provided). On 30-OCT-2015 (reported as "for 2 days afterwards"), the patient experienced erythema and swelling at the injection site. The patient sought treatment from an unspecified physician on an unspecified date in 2015 and was prescribed KEFLEX. The patient sought medical attention via visiting the physician. The outcome of the events (the patient's present status) was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. The patient's medical history and concurrent condition were unknown. On 02-OCT-2015, the patient was vaccinated with a dose of influenza virus vaccine (unspecified) (dose and route unknown) and PREVNAR (dose and route unknown). On 07-OCT-2015, at a local pharmacy, the patient was vaccinated with a dose of ZOSTAVAX in the "far back" of her left arm "near her axilla" (dose and route unknown) (drug administered at inappropriate site). Concomitant therapy was not reported. On an unspecified date in October 2015, the patient developed redness and itchiness at her ZOSTAVAX injection site. The outcome of the events were unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. The patient's medical history and concurrent condition were unknown. On 02-OCT-2015, the patient was vaccinated with a dose of influenza virus vaccine (unspecified) (dose and route unknown) and PREVNAR (dose and route unknown). On 07-OCT-2015, at a local pharmacy, the patient was vaccinated with a dose of ZOSTAVAX in the "far back" of her left arm "near her axilla" (dose and route unknown) (drug administered at inappropriate site). Concomitant therapy was not reported. On an unspecified date in October 2015, the patient developed redness and itchiness at her ZOSTAVAX injection site. The outcome of the events were unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: The patient is a 61 yo with a history of rheumatoid arthritis, and COPD who presents to office for evaluation of vaccine reaction to IIV (SKB Lot # 7AJ5J) on October 14, 2015. She reports she received vaccine to her right arm without adverse event. She states approximately 24 hours later she developed severe pain to her right shoulder which progressed and spread distally down her arm to included her fingers. She states the pain was very severe aching in character and she recalls mild numbness to her fingers. Range of motion was limited only due to pain. She had no neurologic weakness, loss of grasp, paresis or paralysis. She denies any local reaction at the injection site of erythema, edema, pruritus or dermatitis. She reports she was seen by her provider in an ER and was given a sling and to continue her pain medications. She states the pain continued intermittently for 5 days and then resolve spontaneously. She's had no further signs or symptoms. She treated it additionally with heat.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Hypoaesthesia, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: The patient is a 61 yo with a history of rheumatoid arthritis, and COPD who presents to office for evaluation of vaccine reaction to IIV (SKB Lot # 7AJ5J) on October 14, 2015. She reports she received vaccine to her right arm without adverse event. She states approximately 24 hours later she developed severe pain to her right shoulder which progressed and spread distally down her arm to included her fingers. She states the pain was very severe aching in character and she recalls mild numbness to her fingers. Range of motion was limited only due to pain. She had no neurologic weakness, loss of grasp, paresis or paralysis. She denies any local reaction at the injection site of erythema, edema, pruritus or dermatitis. She reports she was seen by her provider in an ER and was given a sling and to continue her pain medications. She states the pain continued intermittently for 5 days and then resolve spontaneously. She's had no further signs or symptoms. She treated it additionally with heat.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, VARZOS
Symptoms: Infection, Lymphadenopathy, Pain, Pruritus, Swelling
Clinical narrative: "Infection" of arm (tricep area) saw MD -> given antibiotics. Sterile procedure used however.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, VARZOS
Symptoms: Localised infection
Clinical narrative: "Infection" of arm (tricep area) saw MD -> given antibiotics. Sterile procedure used however.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, VARZOS
Symptoms: Erythema, Headache, Herpes virus infection, Infection, Lymphadenopathy
Clinical narrative: "Infection" of arm (tricep area) saw MD -> given antibiotics. Sterile procedure used however.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, VARZOS
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: "Infection" of arm (tricep area) saw MD -> given antibiotics. Sterile procedure used however.
Age: 10.0
Sex: M
Vaccine: FLUN4, HPV9, TDAP, FLUN4, HPV9, TDAP
Symptoms: Anxiety, Dyspnoea, Erythema, Erythema multiforme, Induration
Clinical narrative: A case has been received from physician concerning a 10 years 8 weeks 3 days old male patient. No information was provided regarding the concomitant medications, concurrent diseases and medical history of the patient. Patient received FLUMIST (intranasal) started on 06-Oct-2015. Report provided no information about the influenza vaccine manufacturer, brand, lot, or route of administration. On 16-Oct-2015, patient experienced rash/rash indurated itchy/rash on palms of hands, soles on feet, also on thighs, on exterior elbows, knees, left eyelid/immune mediated skin rash. On unspecified date, erythema multiforme minor, shortness of breath, SOB was anxiety based and painful. Action taken with FLUMIST was unknown. At the time of reporting, erythema multiforme minor, rash/rash indurated itchy/rash on palms of hands, soles on feet, also on thighs, on exterior elbows, knees, left eyelid/immune mediated skin rash and painful was ongoing and the outcome of shortness of breath and SOB was anxiety based was unknown. The company physician considered erythema multiforme minor as serious with the seriousness of important medical event and rest all were non serious.
Age: 10.0
Sex: M
Vaccine: FLUN4, HPV9, TDAP, FLUN4, HPV9, TDAP
Symptoms: Pain, Palmar-plantar erythrodysaesthesia syndrome, Purpura, Rash pruritic
Clinical narrative: A case has been received from physician concerning a 10 years 8 weeks 3 days old male patient. No information was provided regarding the concomitant medications, concurrent diseases and medical history of the patient. Patient received FLUMIST (intranasal) started on 06-Oct-2015. Report provided no information about the influenza vaccine manufacturer, brand, lot, or route of administration. On 16-Oct-2015, patient experienced rash/rash indurated itchy/rash on palms of hands, soles on feet, also on thighs, on exterior elbows, knees, left eyelid/immune mediated skin rash. On unspecified date, erythema multiforme minor, shortness of breath, SOB was anxiety based and painful. Action taken with FLUMIST was unknown. At the time of reporting, erythema multiforme minor, rash/rash indurated itchy/rash on palms of hands, soles on feet, also on thighs, on exterior elbows, knees, left eyelid/immune mediated skin rash and painful was ongoing and the outcome of shortness of breath and SOB was anxiety based was unknown. The company physician considered erythema multiforme minor as serious with the seriousness of important medical event and rest all were non serious.
Age: 10.0
Sex: M
Vaccine: FLUN4, HPV9, TDAP, FLUN4, HPV9, TDAP
Symptoms: Anxiety, Dyspnoea, Erythema multiforme, Induration, Pain
Clinical narrative: A case has been received from physician concerning a 10 years 8 weeks 3 days old male patient. No information was provided regarding the concomitant medications, concurrent diseases and medical history of the patient. Patient received FLUMIST (intranasal) started on 06-Oct-2015. Report provided no information about the influenza vaccine manufacturer, brand, lot, or route of administration. On 16-Oct-2015, patient experienced rash/rash indurated itchy/rash on palms of hands, soles on feet, also on thighs, on exterior elbows, knees, left eyelid/immune mediated skin rash. On unspecified date, erythema multiforme minor, shortness of breath, SOB was anxiety based and painful. Action taken with FLUMIST was unknown. At the time of reporting, erythema multiforme minor, rash/rash indurated itchy/rash on palms of hands, soles on feet, also on thighs, on exterior elbows, knees, left eyelid/immune mediated skin rash and painful was ongoing and the outcome of shortness of breath and SOB was anxiety based was unknown. The company physician considered erythema multiforme minor as serious with the seriousness of important medical event and rest all were non serious.
Age: 10.0
Sex: M
Vaccine: FLUN4, HPV9, TDAP, FLUN4, HPV9, TDAP
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: A case has been received from physician concerning a 10 years 8 weeks 3 days old male patient. No information was provided regarding the concomitant medications, concurrent diseases and medical history of the patient. Patient received FLUMIST (intranasal) started on 06-Oct-2015. Report provided no information about the influenza vaccine manufacturer, brand, lot, or route of administration. On 16-Oct-2015, patient experienced rash/rash indurated itchy/rash on palms of hands, soles on feet, also on thighs, on exterior elbows, knees, left eyelid/immune mediated skin rash. On unspecified date, erythema multiforme minor, shortness of breath, SOB was anxiety based and painful. Action taken with FLUMIST was unknown. At the time of reporting, erythema multiforme minor, rash/rash indurated itchy/rash on palms of hands, soles on feet, also on thighs, on exterior elbows, knees, left eyelid/immune mediated skin rash and painful was ongoing and the outcome of shortness of breath and SOB was anxiety based was unknown. The company physician considered erythema multiforme minor as serious with the seriousness of important medical event and rest all were non serious.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 23-Oct-2015) concerns a 45 year-old female patient who had an episode of atrial fibrillation two years ago. On the 21-Oct-2015, the patient received Afluria (influenza virus vaccine polyvalent, batch number U58508) via the intramuscular route for the protection against the influenza virus. On the 21-Oct-2015, 30 minutes after vaccination ('with' two hours of receiving the vaccine) the patient experienced atrial fibrillation. The patient saw her primary care physician on 22-Oct-2015 and may need cardio conversion next week. The outcome was reported as not yet recovered. Reporter's Comments: N/A. Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, atrial fibrillation is unlisted. Causality: Possible. Time to onset is within 2 hours of vaccination. It is plausible that systemic reaction resulting from vaccination triggered event especially in individual who was pre-disposed. Past history is considered to be significant risk factor specifically for requiring cardioversion.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Arm sore at injection site. Pain progressively worsens and stays for rest of month. Methylprednisolone dose pack 4 mg started 10/26/2015 with no affect. Physical therapy started 11/04/2015 which continues 2/3 times per week.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain, Pain in extremity
Clinical narrative: Vaccination given too far up and to the right of deltoid. Severe arm and shoulder pain lasting for 2 months despite anti-inflammatories and stretching.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dysstasia, Gait disturbance, Pain, Pain in extremity
Clinical narrative: I began to have generalized body aches and lower back pain. Body aches are a normal reaction for me from the vaccine. By 10/31/15 my body aches were gone but back pain remained and increased in intensity. On 11/02/2015 I could hardly walk or rise from sitting to standing. My pain radiated into anterior thighs as well. I iced my back, took ibuprofen and stay in a jacuzzi got tub on and off for the next few days. The back pain is tolerable at this time but has not fully dissipated. I went through events/activities that I had done that could've harmed my back besides the vaccine but could not recall anything.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Guillain-Barre syndrome (severe weakness, numbness in all 4 extremities, worst in legs, hospitalized, given 5 d IVIG).
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Chest pain, Dyspnoea, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16-year-old female patient. The patient's pertinent medical history was not reported. The patient had no drug reactions or allergies. On 31-OCT-2015, the patient was vaccinated with GARDASIL or GARDASIL 9 (dose, route of administration, frequency and lot# were not reported). Concomitant therapies included influenza virus vaccine (unspecified), fluoxetine, albuterol sulfate (manufacturer unknown), fluticasone and ondansetron (manufacturer unknown). On 01-NOV-2015, the patient was admitted to the hospital because she experienced vomiting, shortness of breath and chest pain after she received two vaccines. Prior being admitted to the hospital, the patient self-administered EPIPEN to herself. At the time of the report, the patient was stable and recovering after receiving unspecified treatment in the hospital. The causality between the events and the suspect vaccines was not reported. The reporter considered the events to be life threatening and medically significant. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: FLUX
Symptoms: Muscle injury, Muscular weakness, Pain in extremity, Wrong technique in product usage process, X-ray
Clinical narrative: A report has been received from Regulatory Authority via consumer concerning a 79 year old male patient, height: 182.0 centimeters; weight: 76.2 kilograms. Concomitant medications included aspirin, atenolol and statin. The patient's concomitant diseases were not reported. During Oct-2013 the patient started to receiving parenteral influenza virus vaccine. The patient experienced pain and weakness in right arm, weakness of arms which started during Oct-2013. Slowly getting worse over the last 18 months. The injection caused muscle damage which started during  Oct-2013 by being incorrectly administered. The patient was referred to clinic at hospital. He had 7 x-rays over a 6 month period. Was also referred to physiotherapy, but this was ineffective. He still had to attend hospital again. At the time of reporting, the event of pain and weakness in right arm, weakness of arms and muscle damage was ongoing and the outcome of the event of wrong injection technique was unknown. All the events were considered as serious with the serious criteria of important medical event by company physician.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Paraesthesia
Clinical narrative: Patient said she went to her doctor 9/18/15 with facial tingling left side of her face which she claims started after receiving varivax vaccine in Feb/March of 2015.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Fluzone Quad 15-16 vaccine manufactured by Sanofi Pasteur, was given to patient in the right arm in the afternoon of 11/03/2015 and immediately the after the vaccine was administered, the site began to swell. An Ice pak was immediately administered to the site and held on for about 10 minutes, after which the swelling went down. Patient was observed for a few minutes and given permission to leave. A follow up call was done to patient's home twice but we were unable to reach patient.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Middle insomnia, Pyrexia
Clinical narrative: Patient woke in middle of night with fever of 101. Mom treated with Tylenol and patient went back to sleep. Awoke 6AM perfectly fine and eager to go to school.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Redness at injection site with small blisters. Itching, warm to touch. Swelling 3-4 inches in diameter.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood urine present, Decreased appetite, Dyspnoea, Hypoaesthesia, Influenza
Clinical narrative: Muscle pain in back and shoulders, difficulty breathing, numbness in hands, no appetite, blood in urine, flu symptoms - symptoms lasted up to 2-3 weeks after vaccine.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle pain in back and shoulders, difficulty breathing, numbness in hands, no appetite, blood in urine, flu symptoms - symptoms lasted up to 2-3 weeks after vaccine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Mouth ulceration, Oral mucosal blistering, Oral pain
Clinical narrative: Ulcers and blisters in mouth oral pain.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test negative, Urticaria
Clinical narrative: Flu vaccine administered on 10/31/15 at 11:00PM. Employee developed hives over neck, chest and abdomen within 48 hours of administration. Called PCP and told to take BENADRYL.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Patient complains of right arm hurting.  Upon assessment arm found to be red and hot to touch from shoulder to elbow.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash
Clinical narrative: Redness under chin and around mouth.  Rash noted on arms and trunk.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: HA, body aches, low grade fever on 10/12/2015 and development of 2" wide band of giant hives, redness, itching and pain approx. 4" below injection site on right deltoid.  This band finally resolved approx. 10 days later with slight residual rash remaining.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site urticaria, Pain, Pyrexia
Clinical narrative: HA, body aches, low grade fever on 10/12/2015 and development of 2" wide band of giant hives, redness, itching and pain approx. 4" below injection site on right deltoid.  This band finally resolved approx. 10 days later with slight residual rash remaining.
Age: 33.0
Sex: F
Vaccine: ANTH, IPV, PPV, TYP
Symptoms: Headache, Injection site induration, Pyrexia, Urticaria, Vaccination complication
Clinical narrative: Fever geographical tongue induration at site as well as anterior, posterior lateral and medial adjacent areas hives vomiting headache.
Age: 33.0
Sex: F
Vaccine: ANTH, IPV, PPV, TYP
Symptoms: Vomiting
Clinical narrative: Fever geographical tongue induration at site as well as anterior, posterior lateral and medial adjacent areas hives vomiting headache.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: I could not lift my arm at all.  Now, TWO MONTHS later, while it is better, I still have difficulty lifting my elbow above my shoulder.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm with 10 x 12 cm raised, warm, erythematous, indurated. Patient was treated for a cellulitis with AUGMENTIN, warm compress.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Headache, Hypothyroidism, Local swelling, Tenderness
Clinical narrative: Flu vaccine given 11/4/15 right arm 11/5/15 right neck became swollen and tender to touch. C/O headache.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Breast pain, Culture negative, Erythema, Hyperaesthesia
Clinical narrative: The patient is a 46 yo female professional emergency room registered nurse with a history of hypothyroidism and cosmetic breast implants in 1998 with revision in 2012, who required drainage of a seroma and removal of a left breast implant with symptoms onset temporarily associated with receipt of employer mandated IIV FLUARIX (lot # 7AJ5J) to her left deltoid. She states the vaccine was given at approximately 10 om on 23 Sept 2015. She states she experienced immediate pain during injection and felt that it was incorrect technique (needle placed against skin then pushed in rather than smooth motion) but appropriate placement in her deltoid. She states the pain is localized to the upper arm, sensitive to pressure and had a continuous ache of sufficient intensity to wake her from sleep. She states the shoulder was not affected and had normal range of motion. She states several days later she noted mild edema to her axilla and her left breast experienced intermittent sharp pains, but denies lymphadenopathy. On October 3 she noted a continuous ache on her left breast and it was slightly hard and erythematous. Within 12 hours she had severe pain and was seen in the emergency room at hospital. Ultrasound was normal and she was treated with KEFLEX and released. She had no fever chills malaise arthralgias or myalgias. She states she had no fever on arrival to ER, but self checked because she felt hot while she was there and registered a temperature of 101.7. In 24 hours she developed erythema on the outer aspect of her left breast and was again seen by her surgeon and received IM ROCEPHIN and prescription for SEPTRA and AUGMENTIN. She was scheduled for surgical exploration and possible I and D on Thursday, October 8. On Tuesday, October 6 she woke with 'angioedema' described as edema to her upper lip and puffiness to her chin and mild pruritus to her lower extremities. She denies urticarial lesions, oral lesions, throat edema, conjunctivitis, rhinorrhea, dyspnea. Wheezing, chest pain cough, nausea, or emesis. She stated had mild anxiety but attributes to concerns for her health. She felt generalized malaise. She was seen in ER and again ultrasound did not demonstrate abnormalities. On Wednesday, October 7 the surgery center performed I and D and reported she had a sterile seroma. The culture was negative,  and the implant was intact but they remove the implant anyway. She reports the surgeon stated he has seen seromas secondary to vaccine receipt.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Incisional drainage, Induration, Injection site pain, Lip oedema, Malaise
Clinical narrative: The patient is a 46 yo female professional emergency room registered nurse with a history of hypothyroidism and cosmetic breast implants in 1998 with revision in 2012, who required drainage of a seroma and removal of a left breast implant with symptoms onset temporarily associated with receipt of employer mandated IIV FLUARIX (lot # 7AJ5J) to her left deltoid. She states the vaccine was given at approximately 10 om on 23 Sept 2015. She states she experienced immediate pain during injection and felt that it was incorrect technique (needle placed against skin then pushed in rather than smooth motion) but appropriate placement in her deltoid. She states the pain is localized to the upper arm, sensitive to pressure and had a continuous ache of sufficient intensity to wake her from sleep. She states the shoulder was not affected and had normal range of motion. She states several days later she noted mild edema to her axilla and her left breast experienced intermittent sharp pains, but denies lymphadenopathy. On October 3 she noted a continuous ache on her left breast and it was slightly hard and erythematous. Within 12 hours she had severe pain and was seen in the emergency room at hospital. Ultrasound was normal and she was treated with KEFLEX and released. She had no fever chills malaise arthralgias or myalgias. She states she had no fever on arrival to ER, but self checked because she felt hot while she was there and registered a temperature of 101.7. In 24 hours she developed erythema on the outer aspect of her left breast and was again seen by her surgeon and received IM ROCEPHIN and prescription for SEPTRA and AUGMENTIN. She was scheduled for surgical exploration and possible I and D on Thursday, October 8. On Tuesday, October 6 she woke with 'angioedema' described as edema to her upper lip and puffiness to her chin and mild pruritus to her lower extremities. She denies urticarial lesions, oral lesions, throat edema, conjunctivitis, rhinorrhea, dyspnea. Wheezing, chest pain cough, nausea, or emesis. She stated had mild anxiety but attributes to concerns for her health. She felt generalized malaise. She was seen in ER and again ultrasound did not demonstrate abnormalities. On Wednesday, October 7 the surgery center performed I and D and reported she had a sterile seroma. The culture was negative,  and the implant was intact but they remove the implant anyway. She reports the surgeon stated he has seen seromas secondary to vaccine receipt.