chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown dates the patients were vaccinated with an improperly stored dose of ROTATEQ (Lot number L048854, expiry date 31-AUG-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken and the outcome of the events was unknown. There was no product quality complaint reported. This case is linked to case number 1609USA014777 and 1609USA013289 via same reporter link. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Product use issue, Therapeutic response unexpected
Clinical narrative: This spontaneous report as received from a 60 year old female patient regarding herself. There were no concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 15-SEP-2016 the patient was vaccinated with ZOSTAVAX (dosing details, lot# and expiry were not reported) subcutaneously (developed herpes about 6 years ago and had break outs on her upper lip, maybe 5 times a year). Her sister as a physician suggested her to try ZOSTAVAX, because she knew of someone{unspecified} who was a teenager with HSV3 who had the smallpox vaccine and it cured herpes. The patient stated "My large sore on my lip disappeared in 2 days (approximately 17-SEP-2016) from the day I received the ZOSTAVAX". The patient did not seek any medical attention. There were no product quality complaints (PQC) involved. 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 medical assistant regarding unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown day in 2016, the patients were vaccinated with an improperly stored dose of ZOSTAVAX (lot # L044528, expiry date 02-SEP-2017) dosage regimen and route unknown. Concomitant medications were not reported. No adverse events were reported. The vaccine was subjected to temperature excursion of 45.9 degrees Fahrenheit for 4.5 hours on 11-JUL-2016. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not filed. This report is one of several reports 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 refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (lot # M004330, 26-JAN-2018), (lot # M009767, 23-FEB-2018). No symptoms were reported. There was no previous temperature excursion. It was administered. Temperature 5.5F for 15 minutes, 11.3F for 45mins, 5.1F for 15mins, 9.3F for 30mins, 5.1F for 15mins, 8.6 F for 15mins. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Muscle pain-on arm where vaccine was given.
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt's arm got significantly red and swollen (from injection site to below elbow)-painful to touch and very swollen. Right arm.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Neck pain, Pruritus, Rash generalised
Clinical narrative: Rash on body, itching, swollen neck, burning pain in neck. As of 9/19/16 on prednisone and hydroxyzine still. Only symptoms is itching feeling and burning neck pain.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Diarrhoea, Dysphonia, Headache, Muscular weakness
Clinical narrative: Started with hoarseness, then coughing with mucus, tightness of chest, headache, muscle weakness, vomiting and diarrhea. Time went on for hours. Had to go to Emergency Room and then admitted to hospital.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Productive cough, Vomiting
Clinical narrative: Started with hoarseness, then coughing with mucus, tightness of chest, headache, muscle weakness, vomiting and diarrhea. Time went on for hours. Had to go to Emergency Room and then admitted to hospital.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Diarrhoea, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Started with hoarseness, then coughing with mucus, tightness of chest, headache, muscle weakness, vomiting and diarrhea. Time went on for hours. Had to go to Emergency Room and then admitted to hospital.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting projectile
Clinical narrative: Started with hoarseness, then coughing with mucus, tightness of chest, headache, muscle weakness, vomiting and diarrhea. Time went on for hours. Had to go to Emergency Room and then admitted to hospital.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Redness at injection site - arm, itchy - from shoulder to elbow.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Arthralgia, Asthenia, Burning sensation, CSF protein increased
Clinical narrative: 8/26 RT shoulder pain at site, went back to pharmacy. 9/12 Orthopedic appt (R) shoulder pain and bil hand numb/tingle, swollen 3 fingers ea hand, cannot make a fist. Prescribed MEDROL DOSEPAK and high dose NEURONTIN. 9/16 Doctor appt whole body pain, feels on fire, muscle tightness/hand swelling, arthralgia, joint swelling, pain Kw/standing possible rxn to NEURONTIN, stop meds, use BENADRYL prn. Doctor appt 9/20 excessive sweat, muscle pain, weak all over, all 4 extremities, diaphoresis, fatigue, trouble swallowing, temperature intolerant, arthralgia, gait problem, myalgia, weakness, numbness, sensory deficit bilateral lower extremities, abnormal muscle tone all 4 extremities unable to walk. Direct admit to hospital. 9/21 Admission hospital GBS following vaccination. 9/22 Lumbar puncture, CSF protein elevated. Neurology Dr confirmed diagnosis.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Dysstasia, Fatigue, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: 8/26 RT shoulder pain at site, went back to pharmacy. 9/12 Orthopedic appt (R) shoulder pain and bil hand numb/tingle, swollen 3 fingers ea hand, cannot make a fist. Prescribed MEDROL DOSEPAK and high dose NEURONTIN. 9/16 Doctor appt whole body pain, feels on fire, muscle tightness/hand swelling, arthralgia, joint swelling, pain Kw/standing possible rxn to NEURONTIN, stop meds, use BENADRYL prn. Doctor appt 9/20 excessive sweat, muscle pain, weak all over, all 4 extremities, diaphoresis, fatigue, trouble swallowing, temperature intolerant, arthralgia, gait problem, myalgia, weakness, numbness, sensory deficit bilateral lower extremities, abnormal muscle tone all 4 extremities unable to walk. Direct admit to hospital. 9/21 Admission hospital GBS following vaccination. 9/22 Lumbar puncture, CSF protein elevated. Neurology Dr confirmed diagnosis.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Hypoaesthesia, Hypotonia, Injection site pain, Joint swelling
Clinical narrative: 8/26 RT shoulder pain at site, went back to pharmacy. 9/12 Orthopedic appt (R) shoulder pain and bil hand numb/tingle, swollen 3 fingers ea hand, cannot make a fist. Prescribed MEDROL DOSEPAK and high dose NEURONTIN. 9/16 Doctor appt whole body pain, feels on fire, muscle tightness/hand swelling, arthralgia, joint swelling, pain Kw/standing possible rxn to NEURONTIN, stop meds, use BENADRYL prn. Doctor appt 9/20 excessive sweat, muscle pain, weak all over, all 4 extremities, diaphoresis, fatigue, trouble swallowing, temperature intolerant, arthralgia, gait problem, myalgia, weakness, numbness, sensory deficit bilateral lower extremities, abnormal muscle tone all 4 extremities unable to walk. Direct admit to hospital. 9/21 Admission hospital GBS following vaccination. 9/22 Lumbar puncture, CSF protein elevated. Neurology Dr confirmed diagnosis.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Mobility decreased, Muscle tightness, Muscular weakness, Myalgia
Clinical narrative: 8/26 RT shoulder pain at site, went back to pharmacy. 9/12 Orthopedic appt (R) shoulder pain and bil hand numb/tingle, swollen 3 fingers ea hand, cannot make a fist. Prescribed MEDROL DOSEPAK and high dose NEURONTIN. 9/16 Doctor appt whole body pain, feels on fire, muscle tightness/hand swelling, arthralgia, joint swelling, pain Kw/standing possible rxn to NEURONTIN, stop meds, use BENADRYL prn. Doctor appt 9/20 excessive sweat, muscle pain, weak all over, all 4 extremities, diaphoresis, fatigue, trouble swallowing, temperature intolerant, arthralgia, gait problem, myalgia, weakness, numbness, sensory deficit bilateral lower extremities, abnormal muscle tone all 4 extremities unable to walk. Direct admit to hospital. 9/21 Admission hospital GBS following vaccination. 9/22 Lumbar puncture, CSF protein elevated. Neurology Dr confirmed diagnosis.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Paraesthesia, Peripheral swelling, Sensory loss, Temperature intolerance
Clinical narrative: 8/26 RT shoulder pain at site, went back to pharmacy. 9/12 Orthopedic appt (R) shoulder pain and bil hand numb/tingle, swollen 3 fingers ea hand, cannot make a fist. Prescribed MEDROL DOSEPAK and high dose NEURONTIN. 9/16 Doctor appt whole body pain, feels on fire, muscle tightness/hand swelling, arthralgia, joint swelling, pain Kw/standing possible rxn to NEURONTIN, stop meds, use BENADRYL prn. Doctor appt 9/20 excessive sweat, muscle pain, weak all over, all 4 extremities, diaphoresis, fatigue, trouble swallowing, temperature intolerant, arthralgia, gait problem, myalgia, weakness, numbness, sensory deficit bilateral lower extremities, abnormal muscle tone all 4 extremities unable to walk. Direct admit to hospital. 9/21 Admission hospital GBS following vaccination. 9/22 Lumbar puncture, CSF protein elevated. Neurology Dr confirmed diagnosis.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash macular
Clinical narrative: Patient developed large rash an arm not at site of injection but the entire area below. Rash was elevated and blotchy out patient reported not itchy. Patient was going to take BENADRYL.
Age: 38.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Hyperhidrosis, Night sweats, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported for himself. This 38-year-old male patient received PREVNAR 13 (lot L04915, expiry date Jul2016, NDC number 0005-1971-01) at 0.5 ml single, intramuscular,in left deltoid, on 20Mar2015 at 3:20 PM, for immunization. The reporter specified that this vaccine was recommended by an oncologist at and was administered at the Pharmacy per protocol by pharmacist. Relevant medical history included Hodgkin lymphoma from Jan2008 to Sep2008 (cured). Illness at time of vaccination, adverse event following prior vaccination (unspecified) and concomitant medications were reported as none.   On 21Mar2015, the patient experienced drenching night sweats, fever, and chills. The pharmacist mentioned that for two nights he had been experiencing drenching night sweats. He did not have any other symptoms. Especially on third night after the vaccination night sweats got worse; he had a little bit of fever and chills, but the night sweat was getting worse. The pharmacist purchased the vaccine at the pharmacy. The events did not require an emergency room or physician visit or specific tests and/or treatment. The event night sweats had not been yet resolved and the outcome of the events fever and chills was unknown. The pharmacist considered there was a reasonable possibility that the events were related to the suspect vaccine.  Follow-up (15May2015): Follow-up attempts completed. No further information expected.  Follow-up (26Sep2016): New information from the same contactable pharmacist includes: updated patient age, medical history, suspect vaccine details, events onset date and details.; Sender's Comments: Linked Report(s) : 2015104669  Legacy paper report number
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable medical assistant on behalf of a doctor via a Company representative and from the contactable physician. This medical assistant reported similar events for 3 patients. This is the third of 3 reports. A 20-year-old female patient of an unspecified ethnicity received TRUMENBA; (lot M74081, expiry date 30Jun2017) on 15Jul2016 at 0.5 ml single intramuscular in the deltoid for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2016 the patient experienced pain at injection site that traveled down the arm, fibroid type of swelling and limitation of arm movement. Therapeutic measures were taken as a result of the events, the patient was given antibiotics prophylactically (it was unknown if she was still taking them). The events did not require hospitalization. The patient recovered from the reported events on an unspecified date in 2016. The reporting physician considered the suspect vaccine has a causal effect to the adverse events. Follow up (26Sep2016): New information from a contactable physician includes: patient age, suspect vaccine details, reporter causality assessment. Follow-up attempts completed. No further information expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2016376082 same reporter, same drug, same events, different patient;US-PFIZER INC-2016376280 same reporter, same drug, same events, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Cough
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported for two patients. This is one of the two reports. A patient of unspecified age and gender received a single dose of  PREVNAR 13 , on an unspecified date for immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced cough on an unspecified date with outcome of unknown.  Follow-up attempts completed. No further information expected.
Age: 13.0
Sex: U
Vaccine: MENB
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative who reported the same events for 3 different patients. This is the 1st of 3 reports. A 13-year-old patient of an unspecified ethnicity and gender received TRUMENBA on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced chills, fever, headache, malaise, all on an unspecified date with unknown outcome. Sender's Comments: Linked Report(s): US-PFIZER INC-2016450423 Same reporter/drug/events, different patient; US-PFIZER INC-2016449750 Same reporter/drug/events, different patient; US-PFIZER INC-2016449750 Same reporter/drug/events, different patient.
Age: 13.0
Sex: U
Vaccine: MENB
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative who reported the same events for 3 different patients. This is the 2nd of 3 reports. A 13-year-old patient of an unspecified ethnicity and gender received TRUMENBA on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced chills, fever, headache, malaise, all on an unspecified date with unknown outcome. Sender's Comments: Linked Report(s): US-PFIZER INC-2016450423 Same reporter/drug/events, different patient; US-PFIZER INC-2016449736 Same reporter/drug/events, different patient.
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Death, Lethargy, Loss of consciousness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Other-HCP. A currently 19-year-old female patient of an unspecified ethnicity received the 1st dose of TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient passed out, experienced fever, lethargy, weakness. The events outcome was unknown. The patient was not deceased. The reporter was willing to be contacted again on the reported adverse events. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 81.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 81-year-old female patient received PREVNAR 13, intramuscular in right arm on 09Sep2016 at 10:30 at 0.5 ml single to avoid pneumonia and influenza vaccine (FLU) in left arm on 09Sep2016 as immunization. Medical history included cataract surgery in both eyes in 2010, high cholesterol from 2004 and ongoing, irritable bowel from 2004 and ongoing, Barrett's esophagus from 2004 and ongoing, hiatal hernia from 2004 and ongoing, diverticulosis from 2004 and ongoing, gastritis erosive from 2004 and ongoing, gastrooesophageal reflux disease (GERD) from 2004 and ongoing, ongoing osteoporosis start two years before the report and allergy to sulfa from 2004 and ongoing. In 2004, patient received two high blood pressure medications (unspecified) and she had bad reactions. Patient received influenza vaccine, one injection every year since 2004 as immunization. Concomitant medication included calcium carbonate, CALTRATE started ages before the report and ongoing at 1 DF 2x/day oral as supplementation therapy, omeprazole capsule since at least 2009 and ongoing for Irritable bowel at 20 mg daily oral, PRESERVISION Capsule soft from 2010 and ongoing for eyes at 1 DF 2x/day oral, vitamin B capsules started ages before the report and ongoing as supplementation therapy at 50 mg 1x/day oral, biotin capsules started ages before the report and ongoing as Supplementation therapy at 1000 ug daily oral, LIPITOR tablet started around 2004 and ongoing for High cholesterol at 10 mg every evening oral, and CENTRUM SILVER tablet ongoing as Supplementation therapy at 1 DF 1x/day oral. On 24Sep2016 (in the afternoon) the patient experienced an itchy rash on the right arm that was two inches in length. On 26Sep2016 at 13:00 the rash worsened and grew to 4 inches in length. The outcome of the event was not recovered.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received on 22Sep2016 a single dose of PREVNAR 13, (lot number N16560, expiration date Sep2017, NDC number 00005197102) for immunization. Concomitant medications and medical history were not reported. On 22Sep2016, the patient had huge bruise  (around the size of the egg) in that area (thinking there was internal bleeding in the area) that was recovering and swollen up, that was recovered with lasting effects (Sep2016). Additionally it was reported that the patient experienced in Sep2016 pain in the area where the patient received the injection, still ongoing. The patient did not have a prescribing healthcare professional for the product. The pharmacist explained that no prescription is needed to receive pneumococcal 13-val conj vac (dipht crm197 protein) at the patient's age. The pharmacy gave the product without a prescription.
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. An adolescent female patient received TRUMENBA for immunization, via an unspecified route at single dose on unknown date. The patient had received also other unknown vaccinations. Medical history and concomitant medications were not reported. On unknown date in 2016 the patient experienced faint with outcome of recovered on unknown date in 2016.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site erythema, Injection site reaction, Myosclerosis
Clinical narrative: Initial unsolicited report received from a consumer on 19-SEP-2016. This case involves 84-year-old female patient who was vaccinated with a dose of FLUZONE HD (manufacturer, expiry date, batch number, route of administration were not reported) in left arm on an unspecified date (in 2016). The patient's illness at time of vaccination was reported as was not reported and the pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as Allergies: no medication allergies. The patient previously vaccinated with several flu vaccines. Concomitant medications were not reported. On an unspecified date in 2016, in the afternoon, 3 weeks following vaccination, patient had experienced severe dizziness, and then developed red area on arm around injection site, and muscle at injection site became "hard like a rock". It was also reported that, last year in 2015, on an unspecified date following the vaccination with FLUZONE HD (Lot number: unknown), patient had only redness at injection site. The patient's laboratory data and corrective treatment was not reported. The events outcome was reported as unknown. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Body temperature increased, Chills, Fatigue, Tremor
Clinical narrative: Initial unsolicited report received from a consumer on 21 September 2016. This case involves 70 years old female patient, who was vaccinated with a dose of FLUZONE QIV (batch number, expiration date, dose, dose series were not reported) via intramuscular route, in left deltoid on 20 September 2016. The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as none. The patient did not receive any other vaccinations within 4 weeks of vaccinations was not reported. On 20 September 2016 at 6 pm, same day after following the vaccination, patient had developed symptoms of chills, trembling, temperature of 102 degree Fahrenheit, and felt tired. Other lab data was reported as none. Corrective treatment were not reported. Patient recovered from all events on an unknown date. List of documents held by sender: none.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 20-AUG-2016, the patient was vaccinated with improperly stored VARIVAX lot # L049534, expiry date 08-DEC-2017, 0.5 ml. Vaccine was exposed to a maximum of 9F and a minimum of 6.8F for a cumulative time frame out of recommended storage range for 23 hours. Data logger in use yes. On 20-AUG-2016, the patient was vaccinated with M-M-R II, rHA, (lot # L030162, expiry date 11-AUG-2017), intramuscularly instead of subcutaneously, 0.5 ml. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. This is one of several reported received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Antinuclear antibody negative, Arthralgia, C-reactive protein increased, Hypergammaglobulinaemia benign monoclonal, Laboratory test abnormal
Clinical narrative: This spontaneous report was received from a physician regarding a 67 year male patient. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date in May 2016, the patient was vaccinated with ZOSTAVAX (dosing details, lot#, expiry date and route of administration not known). Concomitant therapies included CRESTOR. On an unknown date in 2016 reported as "2.5 weeks"  after receiving ZOSTAVAX, the patient developed "joint pains in the upper torso which has spread distally". On an unknown date in July 2016, the patient was seen by an unspecified rheumatologist due to the "joint pains" and had multiple unspecified laboratory studies performed which showed "Antinuclear Antibodies (ANA) was negative, Rheumatoid Factor(RF) was negative and negative antibodies". Also in July 2016, the patient was seen by an unspecified hematologist due to the "joint pains" and had an unspecified "workup" performed which showed "mono gammopathy of unknown significance". The patient was seen by his unspecified primary care provider as well due to the "joint pains" (on unspecified date, approximated to 2016). The patient was given with "multiple rounds" of unspecified steroids PLAQUENIL as treatment for the adverse reactions reported above (on unspecified date). On an unspecified date in 2016, the patient has "an increase in c-reactive protein" after receiving ZOSTAVAX. The outcome of the events were reported as not recovered/not resolved. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rheumatoid factor negative
Clinical narrative: This spontaneous report was received from a physician regarding a 67 year male patient. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date in May 2016, the patient was vaccinated with ZOSTAVAX (dosing details, lot#, expiry date and route of administration not known). Concomitant therapies included CRESTOR. On an unknown date in 2016 reported as "2.5 weeks"  after receiving ZOSTAVAX, the patient developed "joint pains in the upper torso which has spread distally". On an unknown date in July 2016, the patient was seen by an unspecified rheumatologist due to the "joint pains" and had multiple unspecified laboratory studies performed which showed "Antinuclear Antibodies (ANA) was negative, Rheumatoid Factor(RF) was negative and negative antibodies". Also in July 2016, the patient was seen by an unspecified hematologist due to the "joint pains" and had an unspecified "workup" performed which showed "mono gammopathy of unknown significance". The patient was seen by his unspecified primary care provider as well due to the "joint pains" (on unspecified date, approximated to 2016). The patient was given with "multiple rounds" of unspecified steroids PLAQUENIL as treatment for the adverse reactions reported above (on unspecified date). On an unspecified date in 2016, the patient has "an increase in c-reactive protein" after receiving ZOSTAVAX. The outcome of the events were reported as not recovered/not resolved. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The office manager reported that the patients received unspecified oral doses of ROTATEQ (lot # M004885 with expiration date: 23-OCT-2017 and lot# M019691 with expiration date: 02-NOV-2017) that were improperly stored (freezer: temperature of 31F for 5 hours; refrigerator: temperature of 54F for 7 hours; there was a data logger in combination with manual monitoring system). Vaccinations occurred between 15-SEP-2016 and 16-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Musculoskeletal stiffness, Rash
Clinical narrative: PATIENT GOT PNEUMOVAX ON LEFT ARM AND FLUARIX QUADRIVALENT ON RIGHT ARM. SHE CALLED THE PHARMACY TO REPORT THAT SHE BELIEVES THAT SHE DEVELOPED A RASH ON HER ARMS AND STIFFNESS IN HER WHOLE BODY. SHE SAID THAT SHE WILL BE TAKING BENADRYL FOR THE RASHES AND WILL WAIT TO SEE HOW TEH COURSE GOES. SHE WAS ADVISED TO SEEK MEDICAL ATTENTION IMMEDIATELY TO FOLLOW UP WITH HER STIFFNESS. PATIENT STATED THAT SHE WILL BE WAITING 24 HOURS BEFORE SEEN A DOCTOR.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site rash, Pain in extremity, Pyrexia
Clinical narrative: Fever, small bump in arm where immunization was given, arm red and sore.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Approximately 12 hours after receiving the shot, I started itching on my torso area, behind knees, in armpits and groin area. Had hundreds of hives/rash over a 7 day period. Went to the clinic the next morning, told them what was going on, they said I probably did something else that caused it. I had done nothing differently. They told me to take BENADRYL. This was the front desk staff, not a doctor, they said to take the BENADRYL. I bought a bottle of generic BENADRYL, and followed the directions, taking 2 every 6 hours (or whatever it was). I usually fall asleep when I take that stuff, I was at work and was fine, never got sleepy. I had hives for a week, they finally went away the next Monday, 10/7/2013.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Localized area of annular, raised erythema measuring 50 X 70 mm surrounding injection site. The area was pruritic. Patient treated with Cetirizine 10 mg initially, then 10 mg qhs for 72 hours.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 26-SEP-2016, unspecified patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ lot # M004883 (expiry date: 02-OCT-2017), lot# M019691 (expiry date: 02-NOV-2017) and lot # M025568 (expiry date: 07-NOV-2017). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were not provided. On 12-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M029599, expiry date: 10-DEC-2017). A data logger was involved. Healthcare worker reported that the vaccine underwent temperature excursion at 19.5F for 23 hours. They stated that the vaccine was previously exposed at 8.5F for 4 hours and 15 minutes. No adverse effect was reported. This is one of the four reports received 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 an office manager referring to a patient of unknown age and gender. Information about medical history and concurrent condition was unspecified. On an unknown date the patient was vaccinated with an improperly stored dose of M-M-R II (lot number, expiration date and dose were unknown, subcutaneous). The vaccine was exposed to unsupported temperature excursion. No adverse effects were reported. No PQC was involved. This is one of two reports 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 medical assistant and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot#, expiration date, dose and route of administration were not reported). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The office manager reported that the patients received unspecified doses of M-M-R II (lot# M004305 with expiration date: 25-JAN-2018, lot# L039613 with expiration date: 08-OCT-2017 and lot# M015930 with expiration date: 29-MAR-2018) that were improperly stored (freezer: temperature of 31F for 5 hours; refrigerator: temperature of 54F for 7 hours; there was a data logger in combination with manual monitoring system). Route of administration was not reported. Vaccinations occurred between 15-SEP-2016 and 16-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 29-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as M006733 with expiration date 09-FEB-2018). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The office manager reported that the patients received unspecified doses of RECOMBIVAX HB (lot # reported as L042470 with expiration date: 15-SEP-2017, lot# L048236 with expiration date: 13-MAR-2018 and lot# reported as M027339 with expiration date: 31-MAY-2018) that were improperly stored (freezer: temperature of 31F for 5 hours; refrigerator: temperature of 54F for 7 hours; there was a data logger in combination with manual monitoring system). Route of administration was not reported. Vaccinations occurred between 15-SEP-2016 and 16-SEP-2016. No adverse effects were reported. 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: This spontaneous report was received from a nurse refers to a multiple unspecified patients of unknown age, The medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored ROTATEQ (lot # was not provided). No adverse effect was reported. Temperature 48.79 Fahrenheit, time frame was 13 hours for 30 minutes. Previous temperature excursion was 46.5 Fahrenheit for 10 hours 48 minutes. There was no data logger. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a multiple unspecified patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored GARDASIL 9 (lot # was not provided). No adverse effect was reported. Temperature 48.79 Fahrenheit, time frame was 13 hours for 30 minutes. Previous temperature excursion was 46.5 Fahrenheit for 10 hours 48 minutes. There was no data logger. This is one of the several reports received 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 healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of MMR II (lot# M002419, expiry date: 12-JAN-2018) (lot# L032182, expiry date: 25-AUG-2017) (dose and route not reported). No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports 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 healthcare worker refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were not provided. On 26-SEP-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M012992, expiry date: 14-MAR-2018). A data logger was involved. Healthcare worker reported that the vaccine underwent temperature excursion at 19.5F for 23 hours. They stated that the vaccine was previously exposed at 8.5F for 4 hours and 15 minutes. No adverse effect was reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot#, expiration date, dose and route of administration were not reported). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route were unknown, lot # M009766 with expiration date 23-FEB-2018). The vaccines were exposed to temperature excursion of -10.4 degree centigrade for 50 minutes on one occasion and -10.4 degree centigrade for 19 minutes on another occasion. No previous temperature excursion was reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: DTAP, HEPA, OPV
Symptoms: Adverse reaction
Clinical narrative: This case was reported by other health professional via call center representative and described the occurrence of adverse reaction in a patient who received DTPa (DTaP) vaccine. Co-suspect products included Hepatitis A vaccine and Polio (oral or inactivated unknown) (Polio vaccine). On an unknown date, the patient received DTaP vaccine, Hepatitis A vaccine and Polio vaccine, On an unknown date, an unknown time after receiving DTaP vaccine, Hepatitis A vaccine and Polio 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 DTaP vaccine, Hepatitis A vaccine and Polio vaccine. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by a medical assistant. The age at vaccination was reported. The patient experienced unknown reaction after receiving Dtap, polio, and hepatitis A vaccine in 2009. All vaccines were from unknown manufacturer. No patient information or vaccine information was available.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# L048848, expiry date: 09-AUG-2018) (dose and route not reported). No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a other health professional via sales rep an described the occurrence of swelling arm in a patient who received MENVEO (batch number M15098, expiry date unknown). On 30th September 2016, the patient received MENVEO. On 20th September 2016, less than a day after receiving MENVEO, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to MENVEO. Additional details were provided as follows: The patient received vaccine on an unknown arm.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# L036301, expiry date: 20-DEC-2017) (dose and route not reported). No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Lymph gland infection
Clinical narrative: Lymph gland infection.
Age: 0.08
Sex: M
Vaccine: 6VAX-F, RVX, UNK
Symptoms: Abnormal behaviour, Decreased eye contact, Pyrexia, Staring
Clinical narrative: Staring into space started within 30 minutes. Fever lasted 3 days and controlled by Tylenol. Infant was not himself, did not smile or make eye contact for a few days.
Age: 0.33
Sex: M
Vaccine: 6VAX-F, RVX, UNK
Symptoms: Abnormal behaviour, Pyrexia
Clinical narrative: Fever of 102- 103 for about 3 days afterwards.  Infant did not smile for a few days.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Bacterial infection, Peripheral swelling
Clinical narrative: Arm became very swollen, went to doctor, and it was determined to be a bacterial infection. Prescribed cephalexin for the infection.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT STATED THAT SITE BRUISED THAT EVENING, THEN TURNED INTO RED RAISED AREA, WARM AND HARD TO TOUCH.
Age: 91.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site mass, Pain of skin, Peripheral swelling, Pruritus
Clinical narrative: Swelling and tenderness of arm, has lump at injection site, that has lasted more than a week. Itchiness experienced occasionally.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling, Weight bearing difficulty
Clinical narrative: Received influenza vaccine yesterday to (L) thigh IM. Today presents with swelling warm, mild erythema to (L) knee. Pain with weight bearing.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Chest discomfort, Pain in extremity
Clinical narrative: Left arm pain, left upper back pain, chest tightness.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were not provided. On 27-SEP-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M024702, expiry date: 18-MAY-2018). A data logger was involved. Healthcare worker reported that the vaccine underwent temperature excursion at 19.5F for 23 hours. They stated that the vaccine was previously exposed at 8.5F for 4 hours and 15 minutes. No adverse effect was reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Arthritis, Injected limb mobility decreased, Injection site mass, Injection site rash, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself and from a contactable nurse on behalf of a physician. A 79-year-old male patient received PREVNAR 13, (lot L99261, expiry date Feb2017) at 0.5 ml single, intramuscular in left arm on 17Dec2015 for immunization. Medical history included arthritis in hands, fibromyalgia, blood pressure abnormal, heart surgery, shocks going in him (his body) like electric fire, triple bypass surgery. Ongoing concomitant medications included oral atorvastatin tablet, since 2012, at 7 PM, 80 mg, 1x/day, as he had triple bypass surgery, oral Lisinopril tablet, since 2012 for 7 years, at 7 PM, 10 mg, 1x/day, for blood pressure, oral warfarin tablet, since 2013, 7.5 mg, 3 times a week and 7 mg, 4 times a week, as blood thinner and oral gabapentin capsule since 2016, 300 mg, 3x/day, for shock. On 17Dec2015, the patient experienced rash, swelling, lump at the site of shot and rash on it, his arm hurt for days and days and about 5 to 6 inches from the joint it swelled up. Since then his arm continually hurt, sometime he could hardly move it. No treatment was taken for the events. Due to the events, that the patient had reported to the nurse on 11May2016, he was visited by a physician but he was not hospitalized. He underwent X-ray on an unspecified date which showed arthritis in his arm. The outcome of the events was not recovered. Follow up (18Jul2016): New information reported from a contactable nurse on behalf of a physician includes: suspect product details (lot number, expiry date, route and time of administration), details on patient's visit and no hospitalization, medical confirmation of case. Follow-up (23Sep2016 and 23Sep2016): New information obtained from a contactable consumer includes: date of administration for PREVNAR 13 updated, start date for concomitant drugs updated, onset and outcome of the events, no treatment.