chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Condition aggravated, Cough, Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 57-year-old female patient who received Influenza vaccine. The patient's past medical history included ovarian cancer (at the age of 29 years), lymph node excision (all infected parts as well as 66 percent of lymph glands removed), loss of voice (woke up last Monday with no voice) and walking pneumonia (10 years ago). Previously administered products included Influenza vaccine (Annually during 25 years). Concurrent medical conditions included cough (aggravated at the time of reporting). In 2015, the patient received Influenza vaccine. On an unknown date, less than a month after receiving Influenza vaccine, the patient experienced joint pain and cough aggravated. On an unknown date, the outcome of the joint pain and cough aggravated were unknown. It was unknown if the reporter considered the joint pain and cough aggravated to be related to Influenza vaccine. Additional details were received as follows: The patient was receiving Flu vaccine for last 25 years. In the end of September or in the start of October, the patient received Flu vaccine. By Thursday, less than a week after receiving Flu vaccine, the patient experienced pain in joints and muscles (did not mention headache). The patient did not go to doctor as she thought she was already suffering from Flu and she decided to just wait. The patient stated that, she never had the Flu and was sure that, as the sun came up her symptoms were dead and just dry aggravating cough remained (gotten worse). The patient stated that, on Sunday she was getting better but 2 weeks 1 day after vaccination, she felt like all the symptoms were starting over again. The patient stated that, she was pretty good in health. The patient stated that, she was staying hydrated but still she was exhausted.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Rash erythematous
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of local swelling in a 50-year-old female patient who received FLUARIX QUADRIVALENT (batch number NR952, expiry date 25th June 2016). On 12th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 12th October 2015, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was not recovered/not resolved. It was unknown if the reporter considered the local swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 12th October 2015, in the evening, the patient began experiencing tiny bumps across both shoulders and on back. The bumps were described as being a bit red and not itching.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chronic obstructive pulmonary disease, Increased bronchial secretion, Nasopharyngitis, Productive cough, Respiratory rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of increased bronchial secretion in a male patient who received ANORO ELLIPTA inhalation powder for chronic obstructive pulmonary disease. Co-suspect products included FLUARIX. Concurrent medical conditions included lung cancer. Concomitant products included FLOVENT, LIPITOR, metoprolol, MVI, oxygen and PLAVIX. On 1st August 2015, the patient started ANORO ELLIPTA (inhaled) 1 puff(s) once daily. In September 2015, the patient received FLUARIX (injection). In September 2015, an unknown time after receiving ANORO ELLIPTA and FLUARIX, the patient experienced increased bronchial secretion, sinus disorder, tachypnea and cold. On an unknown date, the patient experienced productive cough. ANORO ELLIPTA was continued with no change. FLUARIX was continued with no change. On an unknown date, the outcome of the increased bronchial secretion, sinus disorder, tachypnea, cold and productive cough were not recovered/not resolved. The reporter considered the increased bronchial secretion to be related to ANORO ELLIPTA and FLUARIX. The reporter considered the sinus disorder, tachypnea and cold to be possibly related to ANORO ELLIPTA and FLUARIX. It was unknown if the reporter considered the productive cough to be related to ANORO ELLIPTA and FLUARIX. Additional information: This case was received via call center representative on 12 October 2015. Caller reported that he was switched from SPIRIVA to ANORO around the first of August. Around or about the first of September he began to notice increase mucous in his lungs, panting in his breathing, cold and sinus problems. He noted he had also gotten a flu shot by unknown manufacturer at a pharmacy around that first of September also. He made a phone call and spoke to his Internist's nurse who prescribed an antibiotic but after taking that there was no improvement. He then called back and asked for a steroid and after taking that also still no improvement. He will be traveling back to his hometown this Friday and was encouraged to see his physician. He noted the flu shot was the senior dose, but didn't know any other details of the vaccine. He also stated that he does use oxygen when he walks on his treadmill. He stated the mucous makes it feel as if his lungs are full and it rattles when he coughs but he can't cough it out. No further information was reported.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Sinus disorder, Tachypnoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of increased bronchial secretion in a male patient who received ANORO ELLIPTA inhalation powder for chronic obstructive pulmonary disease. Co-suspect products included FLUARIX. Concurrent medical conditions included lung cancer. Concomitant products included FLOVENT, LIPITOR, metoprolol, MVI, oxygen and PLAVIX. On 1st August 2015, the patient started ANORO ELLIPTA (inhaled) 1 puff(s) once daily. In September 2015, the patient received FLUARIX (injection). In September 2015, an unknown time after receiving ANORO ELLIPTA and FLUARIX, the patient experienced increased bronchial secretion, sinus disorder, tachypnea and cold. On an unknown date, the patient experienced productive cough. ANORO ELLIPTA was continued with no change. FLUARIX was continued with no change. On an unknown date, the outcome of the increased bronchial secretion, sinus disorder, tachypnea, cold and productive cough were not recovered/not resolved. The reporter considered the increased bronchial secretion to be related to ANORO ELLIPTA and FLUARIX. The reporter considered the sinus disorder, tachypnea and cold to be possibly related to ANORO ELLIPTA and FLUARIX. It was unknown if the reporter considered the productive cough to be related to ANORO ELLIPTA and FLUARIX. Additional information: This case was received via call center representative on 12 October 2015. Caller reported that he was switched from SPIRIVA to ANORO around the first of August. Around or about the first of September he began to notice increase mucous in his lungs, panting in his breathing, cold and sinus problems. He noted he had also gotten a flu shot by unknown manufacturer at a pharmacy around that first of September also. He made a phone call and spoke to his Internist's nurse who prescribed an antibiotic but after taking that there was no improvement. He then called back and asked for a steroid and after taking that also still no improvement. He will be traveling back to his hometown this Friday and was encouraged to see his physician. He noted the flu shot was the senior dose, but didn't know any other details of the vaccine. He also stated that he does use oxygen when he walks on his treadmill. He stated the mucous makes it feel as if his lungs are full and it rattles when he coughs but he can't cough it out. No further information was reported.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Fall, Head injury, Muscle spasms, Syncope
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of syncope in a 56-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4LX29, expiry date 30th June 2016). Concomitant products included PAXIL and Low Dose Aspirin. On 8th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 9th October 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced syncope, fall and bruise of head. On an unknown date, the patient experienced leg cramps. On an unknown date, the outcome of the syncope and leg cramps were recovered/resolved and the outcome of the fall and bruise of head were recovering/resolving. The reporter considered the syncope, fall and bruise of head to be possibly related to FLUARIX QUADRIVALENT. The reporter considered the leg cramps to be unrelated to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a nurse who herself was the patient. On 8th October 2015, at 16:30, the patient received a dose of FLUARIX QUADRIVALENT. On 9th October 2015, at around 4am (approximately 12 hours after vaccination), the patient woke up with leg cramps. She began walking around and experienced syncope. Due to syncope, the patient experienced a fall and hit her head, which resulted in head contusion. The patient went to emergency room, no overnight hospitalization was required.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 32-year-old female patient who received FLUARIX QUADRIVALENT. On 19th September 2014, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 19th September 2014, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. The patient was treated with Anti-Inflammatory. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was not reported previously to anyone. This case was reported by the patient herself. The healthcare professional reported that, last year after she received a dose of FLUARIX QUADRIVALENT she started experiencing pain from the same evening. For 6 months she experienced a deep soreness and pain in the deltoid where the vaccine was given. When her arm was lifted up she would feel the pain and when her arm was put behind her back she would experience pain radiating through her arm to her shoulder blade. She did not seek medical attention for this, but she was treated with over the counter anti-inflammatory medications. The patient would like to be followed up with through mail regarding this. She may have additional information to add (lot number and expiration date).
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in a 60-year-old male patent who received FLUARIX QUADRIVALENT (batch number 4M4FS, expiry date 28th June 2016). On 6th October 2015, the patient received FLUARIX QUADRIVALENT. On 6th October 2015, 12 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced general body pain and chills. On an unknown date, the outcome of the general body pain and chills were recovered/resolved. It was unknown if the reporter if the reporter considered the general body pain an chills to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: The patient experienced body aches and chills. At the time of reporting, the patient was asymptomatic. The reporter did not ask for patient's initials.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in a female patient who received FLULAVAL QUADRIVALENT (batch number 93T79, expiry date June 2016). On 9th October 2015, the patent received FLULAVAL QUADRIVALENT .5 ml. On 9th October 2015, 10 hrs after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site redness and injection site warmth. On an unknown date, the outcome of the injections site redness and injection site warmth were not recovered/not resolved. The reporter considered the injection site redness and injection site warmth to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient experienced red and warm area around the injection site, which was 2 inches in diameter. The healthcare professional did not have date of birth of the patient.
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Hyperhidrosis
Clinical narrative: This case was reported from a pharmacist via call center representative and described the occurrence of feels awful in a female patient who received FLULAVAL QUADRIVALENT (batch number 93T79, expiry date June 2016). Concurrent medical conditions included rheumatoid arthritis. In 2015, the patient received FLULAVAL QUADRIVALENT .5 ml. On an unknown date, 10 hrs after receiving FLULAVAL QUADRIVALENT, the patient experienced feels awful and excess sweating. On an unknown date, the outcome of the feels awful was not recovered/not resolved and the outcome of the excess sweating was unknown. The reporter considered the feels awful and excess sweating to be possibly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The healthcare professional reported that one of her patients was administered FLULAVAL QIV. The healthcare professional stated that the patient was feeling yucky and sweating profusely. The healthcare professional did not have date of birth of the patient.
Sex: U
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site reaction in unspecified number of patients who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patients experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. The reporter considered the injection site reaction to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details provided were as follows: This case was reported by a hospital pharmacist via GlaxoSmithKline employee (sales rep). The reporter stated that approximately 10 patients experienced various injection site reactions after receiving FLULAVAL QUADRIVALENT. The pharmacist reported that several patients needed to be treated at the emergency room. The pharmacist did not report any quality issue, just basically was saying that he had seen more reactions this year. The pharmacist told the field rep that he had contacted the FDA Med Watch system to file this adverse event as well.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Pt. developed cellulitis in right arm after receiving the flu vaccine and PNEUMOVAX.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pt. complains of pain in arm still after 2 weeks. Hurts doing normal day to day activity, ex. putting seat belt on. Stiffness gets progressively worse as day goes on. Going to MD 10/21/15.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient received FLUZONE high dose vaccine in error. He is of inappropriate age for the vaccine. No adverse events reported by the patient as a result of this incorrect vaccination.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient states allegedly arm/muscle still sore from vaccination.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea, nausea, vomiting. Symptoms getting better now.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Injected limb mobility decreased, Injection site pain, Nausea, Pyrexia
Clinical narrative: Arm hurt all night in the arm where he got the PREVNAR. Could barely move arm. Felt like he was dying today at 4pm. Felt very nauseous and has fever per wife (101 degrees).
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Large hives on most of body but not face. Started about 4 hours after vaccine. Increased over next several days.
Sex: U
Vaccine: FLU4
Symptoms: Chest discomfort, Eye swelling, Headache, Lip swelling, Pharyngeal oedema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of throat swelling in a patient who received FLUARIX QUADRIVALENT (batch number 9JX2N, expiry date unknown). In 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, 5 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced throat swelling, eye swelling, lip swelling, chest tightness and headache. On an unknown date, the outcome of the throat swelling, eye swelling, lip swelling, chest tightness and headache were unknown. It was unknown if the reporter considered the throat swelling, eye swelling, lip swelling, chest tightness and headache to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: The patient experienced eye or throat or lip swelling, chest tightness and headache. The healthcare professional wanted to know if prior, similar reports have been reported for the reported lot number.
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a female patient who received Influenza vaccine. Previously administered products included nebulizer Concurrent medical conditions included chronic obstructive pulmonary disease and chronic bronchitis. In 2012, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to influenza vaccine. Additional details were received as follows: The reporter herself was the patient. In 2012, the patient had a flu vaccine and another flu vaccine over 65 years of age. The reporter stated that, she experienced a violent reaction to the flu vaccine received in 2012 (had almost all of the side effects listed on the form). After 2012, the patient did not receive the stronger vaccine. The physician's office and the county health department were unable to find out what ingredient caused the patient those adverse events. So, they could determine potential problems in future vaccines.
Sex: U
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of sickness in a patient who received FLULAVAL QUADRIVALENT. On 2nd October 2015, the patient received FLULAVAL QUADRIVALENT. On 5th October 2015, 3 days after receiving FLULAVAL QUADRIVALENT, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This is one of the 7 cases reported by the same reporter. The reporter indicated that FLULAVAL vaccines were administered to a group of individuals at a company or clinic. The sales rep stated that the reporter said six other individuals called out sick (possibly October 5th) after receiving the Flu vaccine but details were unknown and it was not known if related.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HPV4, RV1, HPV4
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a 2-month-old male patient. The patient's medical history included premature birth. No information about the patient's drug reactions or allergies was provided. On 12-OCT-2015, the patient was receiving routine vaccinations and inadvertently received either a GARDASIL intramuscularly (dose, lot #, expiration date were not reported) or GARDASIL 9 intramuscularly (dose, lot#, expiration date were not reported). The reporter could not confirm which vaccine was administered to the patient. Concomitant therapies included ROTATEQ, HIB and DTAP. On an unknown date, approximately in October 2015, the patient became very cranky and lethargic at times. He was seen in the physician's office but no treatment was advised or given for the events. The outcome of the events was reported as not recovered. The relatedness between th events and GARDASIL 9 or GARDASIL was not reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HPV4, RV1, HPV4
Symptoms: Drug administered to patient of inappropriate age, Irritability, Lethargy
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a 2-month-old male patient. The patient's medical history included premature birth. No information about the patient's drug reactions or allergies was provided. On 12-OCT-2015, the patient was receiving routine vaccinations and inadvertently received either a GARDASIL intramuscularly (dose, lot #, expiration date were not reported) or GARDASIL 9 intramuscularly (dose, lot#, expiration date were not reported). The reporter could not confirm which vaccine was administered to the patient. Concomitant therapies included ROTATEQ, HIB and DTAP. On an unknown date, approximately in October 2015, the patient became very cranky and lethargic at times. He was seen in the physician's office but no treatment was advised or given for the events. The outcome of the events was reported as not recovered. The relatedness between th events and GARDASIL 9 or GARDASIL was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Hair less in frontal midline. 4 x 1 cm area. No other changes. Symptom started 3 day after getting Tdap, HPV and MCV. Alopecia and Areata.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pruritus, Injection site swelling
Clinical narrative: Arm at injection site swelled and became red and itchy. Patient saw doctor and he determined it was an allergic reaction to vaccine. 5 days in durations.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patients were vaccinated with unspecified doses of improperly stored VARIVAX (Merck) (lot # L017144 with expiration date 13-MAY-2017, L006386 with expiration date 25-FEB-2017, K021934 with expiration date 10-NOV-2016 and lot# reported as L025205 with expiration date 07-JUL-2017; dose, dose number and route were not reported). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. Informaiton about patients' concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with multiple doses of M-M-R II (dose, route not reported, lot # L009213 with expiration date 17-MAR-2017) that had been stored improperly. Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot# K013868, 27-MAY-2016; lot# K010221, expiration date 12-MAY-2016; dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Fatigue, Headache, Malaise, Oral mucosal eruption, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse (patient's mother) reporting on a 18 year old male patient. The patient did not have any pertinent medical history, drug reactions or allergies. On 29-SEP-2015, the patient was vaccinated with VARIVAX (Merck) (1.0 ml, lot # and expiration date were not reported), subcutaneously, for a school requirements. The patient did not have any concomitant medications. On 04-OCT-2015, the patient developed a headache, a high fever, fatigue and was "so sick". The patient took TYLENOL and ibuprofen as a treatment, however TYLENOL "did not help". The patient woke up on 06-OCT-2015 and was covered with a rash everywhere, it was on his skin, his mouth, his throat and even his eyes and was itchy. The patient sought medical attention, was seen by an unspecified physician and was diagnosed with chickenpox. The patient was taking BENADRYL for the itching. The reporter thought it was an overdose since the correct dose of VARIVAX (Merck) was 0.5 ml. The outcome of the events was reported as not recovered. The relatedness between the events and VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Rash pruritic, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a registered nurse (patient's mother) reporting on a 18 year old male patient. The patient did not have any pertinent medical history, drug reactions or allergies. On 29-SEP-2015, the patient was vaccinated with VARIVAX (Merck) (1.0 ml, lot # and expiration date were not reported), subcutaneously, for a school requirements. The patient did not have any concomitant medications. On 04-OCT-2015, the patient developed a headache, a high fever, fatigue and was "so sick". The patient took TYLENOL and ibuprofen as a treatment, however TYLENOL "did not help". The patient woke up on 06-OCT-2015 and was covered with a rash everywhere, it was on his skin, his mouth, his throat and even his eyes and was itchy. The patient sought medical attention, was seen by an unspecified physician and was diagnosed with chickenpox. The patient was taking BENADRYL for the itching. The reporter thought it was an overdose since the correct dose of VARIVAX (Merck) was 0.5 ml. The outcome of the events was reported as not recovered. The relatedness between the events and VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 59 year old male patient with none pertinent medical history and none drug reactions/allergies. On 13-OCT-2015 the patient was vaccinated with ZOSTAVAX (lot # L024997, expiration date: 06-OCT-2016, route and dose were unknown). On the same day, the patient experienced warmth and minor swelling at the injection site. The next day on 14-OCT-2015, the patient experienced a low-grade fever and body aches. The patient called the pharmacy for medical attention. No treatment was given for the events and no lab diagnostics studies were performed. The patient's low-grade fever resolved on 14-OCT-2015 however, the patient continued to experience the other symptoms. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medial assistant and refers to two patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant therapies were not reported. The reporter stated that a shipment of ZOSTAVAX (lot # reported as L028281, expiration date: 28-OCT-2016) was shipped out on 12-OCT-2015 in a shipper that was only rated to maintain the correct shipping temperatures for 2 days. However, the shipment did not arrive at the physician's office until 15-OCT-2015. It was unspecified what temperatures the ZOSTAVAX could had been exposed to during that third day in transit. As soon as the ZOSTAVAX  shipment was received in the physician's office on 15-OCT-2015, this ZOSTAVAX (doses unspecified; subcutaneous) was administered to each of 2 patients. No known adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a 62 year old female patient, who was also a pharmacist and reported on herself. The patient had no pertinent medical history and no drug reactions or allergies. Concomitant therapies included metoprolol and SYNTHROID. On an unknown date in November 2014, the patient was vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were not reported). On an unknown date in 2015 (reported as either January or February), the patient began to experience a tingling sensation on her left side, near her waist. On an unknown date in 2015, either in February or March (reported as a month later), she began to experience tingling in her left eye every once in a while. The patient sought medical attention by calling the physician. There was no treatment given for the adverse events. No laboratory tests were performed. The outcome of tingling sensation and pinching in the eye was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were unknown. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored VARIVAX (Merck) lot # L019125; expiry date-27-MAY-2017. No adverse effects were reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patients were vaccinated with unspecified doses of improperly stored PROQUAD (Merck) (lot # L027634 with expiration date 21-JAN-2017; dose, dose number and route were not reported). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. On unknown dates since 03-APR-2015, the patients were vaccinated with doses of ZOSTAVAX (lot # K016320 with expiration date: 24-DEC-2015 or lot # K016318 with expiration date: 24-DEC-2015), which were exposed to temperatures outside of the recommended range. The reporter was not aware of any adverse effects. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a 1  year old male patient. The patient's pertinent medical history and concurrent conditions were not reported. Concomitant medications were not reported. On 08-OCT-2015, the patient who was less than 2  years of age was vaccinated with PNEUMOVAX23 (lot #L003227; expiry date 13-OCT-2015), 0.5 ml, intramuscular in the left thigh instead of PREVNAR13. No adverse effects reported. The healthcare worker stated that it was staff error only. Product quality complaint was not filed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 25-SEP-2015 the patient was vaccinated with improperly stored ZOSTAVAX (0.65 ml, once, lot #: L021609, expiry date: 10-SEP-2016, subcutaneous) in the left arm. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with unspecified number of improperly stored VAQTA, (dose and route not provided) (lot number#L002717, expiration date: 02-JUN-2017, lot number #K002831, expiration date: 15-JAN-2016, lot number #K024697, expiration date: 28-APR-2017, or lot number #L004745, expired date 28-APR-2017). No adverse reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, frequency, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (doses, frequencies and route were not reported, lot# K009758 with expiration date: 09-JUL-2016; lot#K006139 with expiration date: 29-APR-2016, lot # L020000 with expiration date: 02-JUN-2017; lot# L007227 with expiration date: 03-MAR-2017, lot # L015047 with expiration date: 29-APR-2017). It was unknown which lots # of (Oka/Merck) VARIVAX were administered. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (doses, frequencies and route were not reported, lot # L016283 with expiration date: 07-AUG-2016; lot#K010630 with expiration date: 30-OCT-2015). IT was unknown which lots # of ZOSTAVAX were administered. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot# J014152, expiration date 07-NOV-2015, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant (healthcare professional) regarding unknown number of patients. Age and gender of the patients were not provided. No medical history and concurrent conditions were reported. On an unknown date the patients was vaccinated with incorrectly stored (incorrectly stored product) PNEUMOVAX23. Concomitant medication were not reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint was reported. This is one of the report from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unknown number of patients (age and gender not provided). No medical history and concurrent conditions were reported. On an unknown date the patients was vaccinated with incorrectly stored (incorrectly stored product) M-M-R II. Concomitant medication were not reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Bipolar disorder, Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: This spontaneous report as received from a patient's father regarding his two daughters of unknown age. This case report refers to the oldest daughter. The patient's pertinent medical history and concurrent conditions were unspecified. On an unknown date (reported as 5 to 6 years ago) the patient was vaccinated with two out of the three GARDASIL. When it was discovered that she had missed the third dose, more than a year after her last dose, the physician's office vaccinated her with all three doses of GARDASIL. No concomitant medications were reported. The father stated that the patient experienced soreness at the injection site each time she was vaccinated. On an unknown date the patient was diagnosed with bipolar disorder. No product quality complaint (PQC) was involved. The outcome of the events is unknown. The causality assessment for the events soreness at the injection site and bipolar disorder was not provided. This is one of the two reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Injection site pain
Clinical narrative: This spontaneous report was received from the patients father regarding his two daughters of unknown age. This case report refers to the youngest daughter. The patient's pertinent medical history and concurrent conditions were unspecified. On an unknown date the patient was vaccinated with two out of the three GARDASIL. No concomitant medications were reported. It was discovered that she had missed the third dose. The patient experienced soreness at the injection site each time she was vaccinated. No product quality complaint (PQC) was involved. The outcome of the events is unknown. The causality assessment for the events soreness at the injection site was not provided. This is one of the two reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients concurrent conditions and medical history was provided. On an unknown date, the patients received doses of improperly stored VAQTA (lot # reported as 1018499, expiration date 25-FEB-2017) (dose and route were not reported). Concomitant medications were not reported. No adverse events were reported. Lot number 1018499 is an invalid lot number for VAQTA. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative concerning an unspecified adult female patients greater than 26 years old (specific ages were not provided). Patient's concurrent conditions and medical history were not provided. On an unknown date, the patients who are greater than 26 years of age were vaccinated with GARDASIL 9 (dose, route, frequency, Lot No. and expiration date not provided). There was no concomitant medication described. No adverse symptoms were reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site reaction - redness slight swelling left lower delt to elbow. Patient states it is a radiating burn feeling. More when he lies down on it. Symptoms began evening of Oct 7 2015 and still occurring 2 days later.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Warm to touch. Redness. Pain. Swelling. 5 in diameter.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Rash pruritic, Skin warm, Swelling
Clinical narrative: 4 days after vaccination - developed large area of itchy and painful rash, red swollen, hot. Approx 4 inch long 3 inch wide used BENADRYL 25 mg PO q4-6 hours and cortisone cream. Seen by PMD 10/5/15 for recheck.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling abnormal, Skin warm, Swelling
Clinical narrative: After having the pneumonia shot at 9 AM, and later fasting for blood work, and late breakfast, I began to feel bad, took a TYLENOL and went to bed. I woke about 4 PM and discovered the elbow, very red, and feverish. I called my doctor who recommended a trip to the ER where I was prescribed medication to control adverse condition. The medicine was Hydroxyzine HCL 25 mg. The swelling, redness, and fever continued to move on past the elbow to the wrist area. It took a week for the swelling to subside. I also used ice packs and TYLENOL in addition to the ATARAX. This was my second pneumonia shot.
Age: 0.78
Sex: F
Vaccine: IPV
Symptoms: Erythema, Induration, Skin discolouration, Skin exfoliation, Swelling
Clinical narrative: Large area of induration and redness with subsequent sloughing of skin, discoloration, swelling.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy, redness, swelling, hard lump at injection site.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Skin reaction
Clinical narrative: Localized skin reaction.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: A day or 2 after injection, site was red, swollen, hot. Sore to touch, not sore with movement. Had headache. Took no OTC meds, went away w/o treatment.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Very swollen and reddened area from area of vaccination. I advised to seek medical treatment-was given SOLU-MEDROL- IV, BENADRYL IV and PEPCID IV.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration
Clinical narrative: Induration 4.5 cm x 4 cm. Erythema 6 cm x 9 cm.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Pt experienced extreme pain at injection site, developed body aches and fever, swelling and hot to touch area at injection site. Pt went to ER and diagnosed w/cellulitis. Was told to follow up with primary MD.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Pt experienced extreme pain at injection site, developed body aches and fever, swelling and hot to touch area at injection site. Pt went to ER and diagnosed w/cellulitis. Was told to follow up with primary MD.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient seen on 10/12/15 for painful rash on chest and back for about 1 week. Diagnosed with shingles and prescribed Acyclovir 800 mg. One 4x day for 10 days and Ibuprofen 800 mg.
Age: 62.0
Sex: F
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Hypersensitivity, Pain in extremity
Clinical narrative: Client's husband telephoned approximately three hours after travel vaccine administration to report his wife telephoned him c/o severe (L) arm pain ("like it's being pulled off") and possibly swelling of the mouth and tongue. Advised to call for immediate transport to nearest E.R. ER report documentation: Chief complaint allergic reaction; pain reaction after shot admin. Admin. Morphine sulfate x2. D/C to home. Addendum: Husband reports (R) arm pain in wife on 10-19-15.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Incorrect route of drug administration, Injection site swelling, Pyrexia
Clinical narrative: 1 cc of ROTARIX/diluent given IM to left thigh.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood pressure decreased, Dizziness
Clinical narrative: This spontaneous report was received from a physician refers to a 11 year old female patient. The patient's pertinent medical history, drug allergies or reactions and concomitant medications were reported as none. On 23-MAR-2015, the patient was vaccinated with GARDASIL (lot # not reported) dose 1. On 13-OCT-2015, the patient was vaccinated with GARDASIL (lot # K072764, expiry date 02-MAR-2017) dose 2. On 23-MAR-2015, after 5 mins the patient experienced dizziness, a drop in blood pressure, feeling that she was going to pass out and weakness. Physician reported that symptoms resolved after approximately 30 minutes. On 13-OCT-2015, within 5 minutes, the patient experienced dizziness, feeling that she was going to pass out, weakness and her blood pressure dropped to 89/56. The Physician stated that the only treatment he provided for the patient was that he had the patient to lie down. Lab diagnostics performed was reported as none. Physician reported that the patient was recovering, but not yet fully recovered after 30 minutes. Physician reported that the adverse experience was "worse after the second administration, than with the first administration". Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site urticaria
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 15-OCT-2015, the patient was vaccinated with ZOSTAVAX intradermally (lot# reported as L024998, expiration date 06-OCT-2016, dose, anatomical location were not reported). On 15-OCT-2015, the patient experienced a "wheal-like bubble" at the injection site after intradermal instead of subcutaneous route of administration. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.