chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Eye swelling, Herpes zoster, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: Case number PHEH2013US026669, is an initial spontaneous report received from the consumer and Vaccine Adverse Event Reporting System (VAERS id: 512267) on 31 Dec 2013 and a follow-up received from Quality Assurance department (QA, reference number: 273104) on 07 Feb 2014. This report refers to a 54-year-old female patient. Her medical history included possible myasthenia gravis and concomitant medications included ibuprofen, vitamin D, aspirin and cetirizine. Her vaccination history included double vision within in two weeks of influenza (unknown manufacturer, batch number: not reported) in Oct 2012 (see case number: PHHY2013US154759). It was reported that she did not have any symptoms of illness prior to the flu shot. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: 1309701, Expiry date: 31 May 2014) intramuscularly in the left arm on 04 Nov 2013. On 05 Nov 2013, less than twelve hours after vaccination, she experienced shingles on her nose and her left eye. She visited the emergency room. The physician prescribed acyclovir tablets and prednisolone acetate ophthalmic suspension. She also felt terrible eye pain, eye swelling, and extreme redness, shingles rash. The event outcome was condition improving as of 31 Dec 2013. The reporter considered the event as serious and causality was not reported. No additional information was available. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1309701) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 273104) on 07 Feb 2014: Updated batch review report.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Case number PHEH2013US026669, is an initial spontaneous report received from the consumer and Vaccine Adverse Event Reporting System (VAERS id: 512267) on 31 Dec 2013 and a follow-up received from Quality Assurance department (QA, reference number: 273104) on 07 Feb 2014. This report refers to a 54-year-old female patient. Her medical history included possible myasthenia gravis and concomitant medications included ibuprofen, vitamin D, aspirin and cetirizine. Her vaccination history included double vision within in two weeks of influenza (unknown manufacturer, batch number: not reported) in Oct 2012 (see case number: PHHY2013US154759). It was reported that she did not have any symptoms of illness prior to the flu shot. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: 1309701, Expiry date: 31 May 2014) intramuscularly in the left arm on 04 Nov 2013. On 05 Nov 2013, less than twelve hours after vaccination, she experienced shingles on her nose and her left eye. She visited the emergency room. The physician prescribed acyclovir tablets and prednisolone acetate ophthalmic suspension. She also felt terrible eye pain, eye swelling, and extreme redness, shingles rash. The event outcome was condition improving as of 31 Dec 2013. The reporter considered the event as serious and causality was not reported. No additional information was available. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1309701) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 273104) on 07 Feb 2014: Updated batch review report.
Age: 56.0
Sex: M
Vaccine: FLUC3, TDAP, FLUC3, TDAP
Symptoms: Chills, Influenza like illness, Nausea, Pyrexia, Vomiting
Clinical narrative: Case number is an initial spontaneous report received from a pharmacist on 27 Jan 2014. This report refers to a 56-year-old male patient. His concomitant medications and medical history were not reported. It was reported that he did not experience any adverse event, following the receipt of any prior immunization. On 05 Jan 2014, at approximately 13.00-14.00 pm, he was vaccinated with FLUCELVAX (batch number: 010031A) along with a 0.5 ml dose of BOOSTRIX (other manufacturer, batch number: 3T549). On the same date, at approximately 19.00-20.00 p.m. nearly six hours after the vaccinations, he experienced flu like symptom, nausea, vomiting, fever and chills. The pharmacist reported that the events were disabling. He further reported that, that the events were probably related to vaccination with BOOSTRIX and did not specifically mention FLUCELVAX as a possible cause for the symptoms. At the time of reporting, the events were unresolved.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Erythema, Feeling hot, Gait disturbance, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Initial case received from a consumer, who is also the patient, on 29 January 2014. A 71-year-old male patient, with a history of high blood pressure, well controlled, and shingles in 2002, received a dose of FLUZONE (lot number UH908AA) and a dose of ZOSTAVAX (Merck, lot not reported) on 01 October 2013. The patient reported he had received "many" prior doses of influenza vaccine. Approximately 48 hours post-vaccination, on 03 October 2013, he began experiencing numbness in his right foot. He was seen by his physician, who prescribed gabapentin. The pain and numbness later progressed to the right foot. He was again seen by his physician, who ordered "40 blood tests and two MRI's (magnetic resonance imaging)". Symptoms did not improve, and he was subsequently seen by another physician who performed an EMG and diagnosed him with neuropathy. The patient reported having "five infusions in December, some sort of blood serums with four to six hours infusions". He reported constant numbness with pain in the feet, "feet and legs from knee down have gone numb, stabbing pain like nails. No two days are the same". He stated that he "feels some days like the bones in his feet are broken, some days feels like the bottom of his foot is 4 inches thick". He stated that the experience had 'reduced him to a semi-cripple" and he now walks with a cane. Additional information and has been requested. Additional documents held by sender: None.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Walking aid user
Clinical narrative: Initial case received from a consumer, who is also the patient, on 29 January 2014. A 71-year-old male patient, with a history of high blood pressure, well controlled, and shingles in 2002, received a dose of FLUZONE (lot number UH908AA) and a dose of ZOSTAVAX (Merck, lot not reported) on 01 October 2013. The patient reported he had received "many" prior doses of influenza vaccine. Approximately 48 hours post-vaccination, on 03 October 2013, he began experiencing numbness in his right foot. He was seen by his physician, who prescribed gabapentin. The pain and numbness later progressed to the right foot. He was again seen by his physician, who ordered "40 blood tests and two MRI's (magnetic resonance imaging)". Symptoms did not improve, and he was subsequently seen by another physician who performed an EMG and diagnosed him with neuropathy. The patient reported having "five infusions in December, some sort of blood serums with four to six hours infusions". He reported constant numbness with pain in the feet, "feet and legs from knee down have gone numb, stabbing pain like nails. No two days are the same". He stated that he "feels some days like the bones in his feet are broken, some days feels like the bottom of his foot is 4 inches thick". He stated that the experience had 'reduced him to a semi-cripple" and he now walks with a cane. Additional information and has been requested. Additional documents held by sender: None.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Blood test, Electromyogram, Hypoaesthesia, Infusion, Neuropathy peripheral
Clinical narrative: Initial case received from a consumer, who is also the patient, on 29 January 2014. A 71-year-old male patient, with a history of high blood pressure, well controlled, and shingles in 2002, received a dose of FLUZONE (lot number UH908AA) and a dose of ZOSTAVAX (Merck, lot not reported) on 01 October 2013. The patient reported he had received "many" prior doses of influenza vaccine. Approximately 48 hours post-vaccination, on 03 October 2013, he began experiencing numbness in his right foot. He was seen by his physician, who prescribed gabapentin. The pain and numbness later progressed to the right foot. He was again seen by his physician, who ordered "40 blood tests and two MRI's (magnetic resonance imaging)". Symptoms did not improve, and he was subsequently seen by another physician who performed an EMG and diagnosed him with neuropathy. The patient reported having "five infusions in December, some sort of blood serums with four to six hours infusions". He reported constant numbness with pain in the feet, "feet and legs from knee down have gone numb, stabbing pain like nails. No two days are the same". He stated that he "feels some days like the bones in his feet are broken, some days feels like the bottom of his foot is 4 inches thick". He stated that the experience had 'reduced him to a semi-cripple" and he now walks with a cane. Additional information and has been requested. Additional documents held by sender: None.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Walking aid user
Clinical narrative: Initial case received from a consumer, who is also the patient, on 29 January 2014. A 71-year-old male patient, with a history of high blood pressure, well controlled, and shingles in 2002, received a dose of FLUZONE (lot number UH908AA) and a dose of ZOSTAVAX (Merck, lot not reported) on 01 October 2013. The patient reported he had received "many" prior doses of influenza vaccine. Approximately 48 hours post-vaccination, on 03 October 2013, he began experiencing numbness in his right foot. He was seen by his physician, who prescribed gabapentin. The pain and numbness later progressed to the right foot. He was again seen by his physician, who ordered "40 blood tests and two MRI's (magnetic resonance imaging)". Symptoms did not improve, and he was subsequently seen by another physician who performed an EMG and diagnosed him with neuropathy. The patient reported having "five infusions in December, some sort of blood serums with four to six hours infusions". He reported constant numbness with pain in the feet, "feet and legs from knee down have gone numb, stabbing pain like nails. No two days are the same". He stated that he "feels some days like the bones in his feet are broken, some days feels like the bottom of his foot is 4 inches thick". He stated that the experience had 'reduced him to a semi-cripple" and he now walks with a cane. Additional information and has been requested. Additional documents held by sender: None.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Erythema, Hypoaesthesia, Immediate post-injection reaction, Paraesthesia, Skin warm
Clinical narrative: Initial case received from a consumer, who is also the patient, on 29 January 2014. A 71-year-old male patient, with a history of high blood pressure, well controlled, and shingles in 2002, received a dose of FLUZONE (lot number UH908AA) and a dose of ZOSTAVAX (Merck, lot not reported) on 01 October 2013. The patient reported he had received "many" prior doses of influenza vaccine. Approximately 48 hours post-vaccination, on 03 October 2013, he began experiencing numbness in his right foot. He was seen by his physician, who prescribed gabapentin. The pain and numbness later progressed to the right foot. He was again seen by his physician, who ordered "40 blood tests and two MRI's (magnetic resonance imaging)". Symptoms did not improve, and he was subsequently seen by another physician who performed an EMG and diagnosed him with neuropathy. The patient reported having "five infusions in December, some sort of blood serums with four to six hours infusions". He reported constant numbness with pain in the feet, "feet and legs from knee down have gone numb, stabbing pain like nails. No two days are the same". He stated that he "feels some days like the bones in his feet are broken, some days feels like the bottom of his foot is 4 inches thick". He stated that the experience had 'reduced him to a semi-cripple" and he now walks with a cane. Additional information and has been requested. Additional documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PT HAD A SWOLLEN ARM FROM THE TOP OF HIS RIGHT SHOULDER DOWN TO ABOUT AN INCH ABOVE HIS ELBOW. IT WAS WRAPPED AROUND THE OUTER ASPECT OF HIS ARM. HERE WAS REDNESS AND SWELLING, ITCHING AND BURNING.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 72 year old male consumer referring on himself. With no pertinent medical history or drug reactions/allergies. Approximately in January-2008, reported as six years ago, the patient was vaccinated 1 time with ZOSTAVAX to prevent shingles (dose, route, lot and expiration date were not reported). Concomitant therapies included gabapentin (manufacturer unknown) also reported as gabapentin. In June 2013, the patient stated that he had the shingles, after getting ZOSTAVAX. The patient sought for medical attention and was treated with a prescription medication. No lab diagnostics were performed. The outcome for shingles was unknown at the time of the report. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist. On an unknown date PNEUMOVAX 23 (lot #, expiration date and dose unspecified) was stored in freezer, -2F for 36 hours. Pharmacist stated doses currently refrigerated and no doses were administered that were improperly stored yet pharmacist stated PNEUMOVAX 23 doses were mistakenly put in the freezer because unspecified staff thought the doses were ZOSTAVAX. Pharmacist stated PNEUMOVAX 23 cartons resemble ZOSTAVAX cartons. AE filed for potential doses that could be administered due to packaging. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 11 year old male patient. On 14-MAY-2013 the patient was vaccinated intramuscularly with first 0.5 ml dose of GARDASIL (injection site and lot# not provided). On 15-JUL-2013 and 16-SEP-2013, the patient was vaccinated with second and third dose of GARDASIL respectively (injection site and lot# not provided). Third dose given early and no adverse effects were reported. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Pregnancy test urine positive, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a 28 year old pregnant female refers to herself. The patient had drug reactions/allergies with penicillin. The patient had no known pertinent medical history. On 17-JAN-2014, the patient was vaccinated with the second dose of MMR II (lot # H015833, expiry date 24-AUG-2014) injection for immigration purposes (dose, strength and route not reported). The patient was vaccinated with her first dose of MMR II (lot#, expiry date, dose, strength and route not reported) in her childhood. No concomitant medication was reported. The patient became pregnant with Last Menstrual Period (LMP) of 24-DEC-2013 (subtract 6 weeks of pregnancy from 04-FEB-2014) and Estimated date of delivery (EDD) of 30-SEP-2014. The patient reported that she had now discovered that she was currently 6 weeks pregnant as of today, 04-FEB-2014 which she confirmed that a positive urine pregnancy test. The patient also stated that 2 weeks after vaccination (on 31-JAN-2014) she developed a red rash that was not itchy on her abdomen. The patient didn't seek medical attention at this time. The patient was treated with EXODERM topical cream. The rash still remained at this time. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site extravasation
Clinical narrative: This spontaneous report as received from a Registered Product (R.Ph.) via a company representative, refers to an unknown number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On unknown dates, the patients were vaccinated with ZOSTAVAX, subcutaneously (dose and lot numbers not provided). No co-suspect or concomitant therapies were reported. The pharmacist reported that, on unkonwn dates, when he pulled the needle out of the patients' skin, some liquid leaked onto the patients' skin. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blepharospasm, Cold sweat, Crying, Dizziness, Dyspnoea
Clinical narrative: This spontaneous report as received through email from a physician via company representative refers to a 14 year old female patient. The patient's concurrent condition included depression. The patient historical drug included unspecified Attention deficit disorder treatment. The patient was not pregnant. On 04-FEB-2014, the patient was vaccinated with GARDASIL (Lot number unspecified) dose 1, intramuscular injection in the office. Other suspect therapies included AFLURIA (dose unspecified) intramuscular injection administered on 04-FEB-2014 at the same time with GARDASIL. Concomitant therapies included PROZAC and ADDERALL Tablets. On 04-FEB-2014, following the administration the patient became dizzy, clammy and experienced fluttering eyelids. Additional symptoms included intermittent crying, tears and quivering. She was kept at rest in the office and was able to sit up after about a half hour had passed. However the patient continued to experience some dizziness and was short of breath. Labs diagnostics unspecified. The patient sought medical attention and was treated by other physician. There was no significant disability or incapacity to the patient. No hospitalization needed for the events. The events were not life threatening. No product quality complaint involved. No additional information was available. The outcome of events was unknown. The reporters causality assessment for the events with the therapy of GARDASIL and AFLURIA was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Lacrimation increased, Tremor
Clinical narrative: This spontaneous report as received through email from a physician via company representative refers to a 14 year old female patient. The patient's concurrent condition included depression. The patient historical drug included unspecified Attention deficit disorder treatment. The patient was not pregnant. On 04-FEB-2014, the patient was vaccinated with GARDASIL (Lot number unspecified) dose 1, intramuscular injection in the office. Other suspect therapies included AFLURIA (dose unspecified) intramuscular injection administered on 04-FEB-2014 at the same time with GARDASIL. Concomitant therapies included PROZAC and ADDERALL Tablets. On 04-FEB-2014, following the administration the patient became dizzy, clammy and experienced fluttering eyelids. Additional symptoms included intermittent crying, tears and quivering. She was kept at rest in the office and was able to sit up after about a half hour had passed. However the patient continued to experience some dizziness and was short of breath. Labs diagnostics unspecified. The patient sought medical attention and was treated by other physician. There was no significant disability or incapacity to the patient. No hospitalization needed for the events. The events were not life threatening. No product quality complaint involved. No additional information was available. The outcome of events was unknown. The reporters causality assessment for the events with the therapy of GARDASIL and AFLURIA was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, expiry date, dose and route unknown). The patient developed shingles at an unspecified time after receiving ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 63 year old male patient. On 29-JAN-2014, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). Concomitant therapies included LIPITOR, ZOLOFT, aspirin and oxycodone. On 03-FEB-2014, 6 days after onset of therapy, the patient experienced shingles. The patient sought medical attention and visited the office. No treatment was given for the event. The outcome of shingles was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via field employee, concerns to a male patient of unknown age. Approximately on 21-JAN-2014, reported as about two weeks ago, patient was vaccinated with ZOSTAVAX. (Dose, lot number and strength not provided). Co-suspect or concomitant therapies were not reported. On 04-JAN-2014, the patient called the physician office reporting that he had an active case of shingles that started on an unspecified date in 2014. The patient has not been seen by the physician yet and no treatment was provided. At the time of the report, the patient was not recovered from shingles. The causality between ZOSTAVAX and the event was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Polycystic ovaries
Clinical narrative: This spnotaneous report as received from a physicia via company representative refers to a female patient of unkonwn age. On 30-MAR-2009 the patient was vaccinated with first dose of GARDASIL with lot # 0843X and unknown expiry date, (dose units and route was unspecified). On 08-JUL-2009, patient was administered with second dose of GARDASIL wiht lot # 0100Y and unknown expiry date. On 04-AUG-2010, third dose of GARDASIL with lot # 1099Y and unknown expiry date was administered. On an unknown date recently the patient was diagnosed with polycystic ovarian syndrome after she received the three doses of GARDASIL. The outcome of polycystic ovarian syndrome was unknown. No further information was provided. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous pregnancy report was received from a physician refers to a 36 year old female patient. On an unknown date, the patient who was currently pregnant and was at 30 weeks gestation was vaccinated with GARDASIL dose 1. Concomitant therapies included SINGULAIR, vitamins (unspecified) and iron (unspecified). The patient LMP was calculated as on 20-NOV-2013. The date of conception was 04-DEC-2013. It was reported that the dose of GARDASIL was administered by mistake by the nurse who had planned to administer DTAP, but accidentally administered GARDASIL. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to two patients of unknown age. On 28-JAN-2014 those two patients were vaccinated with a dose of PNEUMOVAX23 (lot # J006921, expiration date 09-AUG-2014, dose not reported, intramuscularly). On an unkonwn date in 2014 after vaccination, both patients developed cellulitis at the site of PNEUMOVAX23 injection. The patients sought medical attention via going to see a physician. The present status of both patients was unspecified. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: First dose of MENACTRA administered. Subsequent urine pregnancy test was positive (same day).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Furuncle, Injection site rash, Injection site reaction
Clinical narrative: Boil and rash at injection site.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Electromyogram normal, Hypoaesthesia, Nuclear magnetic resonance imaging normal, Pain, Paraesthesia
Clinical narrative: 9 days after receiving the tetanus vaccine, I woke with severe pain, intermittent numbness and tingling (L) arm shoulder to fingertips. Now less pain, but still present.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture, Blood test, CSF test, Electroencephalogram, Hypotonic-hyporesponsive episode
Clinical narrative: Hypotonic-hyporesponsive episode >10 min on 2/3/14 requiring ER evaluation and hospitalization.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Nuclear magnetic resonance imaging brain, Polymerase chain reaction, Urine analysis, Viral test positive
Clinical narrative: Hypotonic-hyporesponsive episode >10 min on 2/3/14 requiring ER evaluation and hospitalization.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from a Medical Assistant (also reported healthcare worker) refers to a 49 year old female patient with allergic to AFRIN, lidocaine, lisinopril, hydralazine, type 1 diabetic and hypothyroidism. The patient's medical history included Temporo Mandibular Joint (TMJ). On 20-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date, dose not reported, subcutaneously). On 23-JAN-2014 the patient called the physician, stated that at the site of the injection her arm had swelled and the swelling was "from her elbow to under her arm pit", she also stated that it was painful and there was redness. Patient had been applying warm compresses to injection site and taking MOTRIN and the swelling was starting to go down. Patient was seen in the physician's office on 24-JAN-2014. It was documented by the physician that the inner posterior brachium had redness and swelling. The patient's arm was still stiff. Patient was prescribed ADVIL and TYLENOL to alleviate discomfort and to ice injection site for 30 minutes a day as well as range to motion for the stiffness in her arm for an unspecified amount of time. No lab work completed. The outcome of the event was reported as recovering. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a Medical Assistant (also reported healthcare worker) refers to a 49 year old female patient with allergic to AFRIN, lidocaine, lisinopril, hydralazine, type 1 diabetic and hypothyroidism. The patient's medical history included Temporo Mandibular Joint (TMJ). On 20-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date, dose not reported, subcutaneously). On 23-JAN-2014 the patient called the physician, stated that at the site of the injection her arm had swelled and the swelling was "from her elbow to under her arm pit", she also stated that it was painful and there was redness. Patient had been applying warm compresses to injection site and taking MOTRIN and the swelling was starting to go down. Patient was seen in the physician's office on 24-JAN-2014. It was documented by the physician that the inner posterior brachium had redness and swelling. The patient's arm was still stiff. Patient was prescribed ADVIL and TYLENOL to alleviate discomfort and to ice injection site for 30 minutes a day as well as range to motion for the stiffness in her arm for an unspecified amount of time. No lab work completed. The outcome of the event was reported as recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 15 year old female patient who on 20-NOV-2012, was vaccinated with the first dose of GARDASIL and on 05-FEB-2014, was vaccinated with the second dose of GARDASIL (doses, routes and lot numbers not reported). No adverse experience has been observed. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No pertinent medical history and no drug reactions or allergies. On 04-FEB-2014 the patient was vaccinated with ZOSTAVAX lot # J010447, 0.65 ml, subcutaneous. No concomitant medication. The pharmacist reported that the patient developed an injection site reaction. The patient described it to the pharmacist over the phone as, redness and swelling (not raised) about the size "of a half dollar" with pain. The patient described it as a "rash" but gave no details as to whether any lesions were present. No treatment was given. The outcome of the events was reported as not recovered/not resolved. The causal relationship was not provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Local reaction
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 21 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 03-FEB-2014 the "healthy" patient was vaccinated with second dose of VARIVAX (Merck) lot # J008229, Expiration Date 12-JUL-2015, 0.5 ml once, subcutaneously "in forearm". There was no concomitant medication. On 03-FEB-2014, the patient experienced local reaction. Nurse stated VARIVAX (Merck) dose showed "a little bubbling" and did not feel the dose was intradermal. Nurse stated for treatment that patient received ice and the arm was elevated. Nurse stated she watched patient for half hour at which time the injection site looked red from the ice so nurse stated "I put hydrocortisone on it and sent her home with ice." Nurse stated patient later was advised to use BENADRYL and ibuprofen for any discomfort. The outcome of the event was unknown.
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Pruritus, Somnolence
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 21 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 03-FEB-2014 the "healthy" patient was vaccinated with second dose of VARIVAX (Merck) lot # J008229, Expiration Date 12-JUL-2015, 0.5 ml once, subcutaneously "in forearm". There was no concomitant medication. On 03-FEB-2014, the patient experienced local reaction. Nurse stated VARIVAX (Merck) dose showed "a little bubbling" and did not feel the dose was intradermal. Nurse stated for treatment that patient received ice and the arm was elevated. Nurse stated she watched patient for half hour at which time the injection site looked red from the ice so nurse stated "I put hydrocortisone on it and sent her home with ice." Nurse stated patient later was advised to use BENADRYL and ibuprofen for any discomfort. The outcome of the event was unknown.
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Tenderness, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 21 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 03-FEB-2014 the "healthy" patient was vaccinated with second dose of VARIVAX (Merck) lot # J008229, Expiration Date 12-JUL-2015, 0.5 ml once, subcutaneously "in forearm". There was no concomitant medication. On 03-FEB-2014, the patient experienced local reaction. Nurse stated VARIVAX (Merck) dose showed "a little bubbling" and did not feel the dose was intradermal. Nurse stated for treatment that patient received ice and the arm was elevated. Nurse stated she watched patient for half hour at which time the injection site looked red from the ice so nurse stated "I put hydrocortisone on it and sent her home with ice." Nurse stated patient later was advised to use BENADRYL and ibuprofen for any discomfort. The outcome of the event was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On 06-FEB-2014, the patient was vaccinated with expired M-M-R II, Lot # 0287AG (Expiry: 01-FEB-2014) subcutaneous dose. No known adverse effects were reported. No further information provided. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Crying
Clinical narrative: This spontaneous report as received from a patient's mother refers to her 14 month old female daughter. On 09-DEC-2005, the patient was vaccinated with an unknown dose of M-M-R II, unknown route, lot number, expiration date and dose. On 09-DEC-2005, after received M-M-R II, the patient cried all night on the first night and she was not herself the whole week. She did not remember any more details of the adverse experience of her first daughter which occurred after receipt of M-M-R II on 09-DEC-2005. She did not have the physician's name who was attending her daughter at that time, but she stated that there was a new doctor who had her daughter's medical records now. She stated that when this adverse effect occurred, she did not report it at the time. She did not know if the previous physician reported it, either. The outcome of cried all night and she was not herself the whole week was reported as recovered/resolved in December 2005. This case is linked to case 1402CAN003590 via same reporter link. Additional information has been requested.
Sex: M
Vaccine: FLUC3
Symptoms: Cerebrovascular accident
Clinical narrative: Case number PHEH2014US002137 is a combined initial and spontaneous report received from a consumer on 27 Jan 2014. This report refers to a male patient of unknown age. His medical history included a heart attack and had a heart condition. His concomitant medication was not reported. He was vaccinated with FLUCELVAX (batch number: 010021A, expiry date: Jun 2014) on 30 Dec 2013. On the same day shortly after vaccination, he experienced a stroke. Patient's wife reported that he was doing good and feeling ok (complete recovery) on an unspecified date. The seriousness and causality of the event were not reported.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza virus test positive, Pyrexia, Rhinorrhoea
Clinical narrative: This initial case was received from a consumer, who is also the patient's parent, on 29 January 2014. Of note, the reporter also experienced an adverse event following vaccination with FLUZONE (difficulty breathing, cough, throat swelling, chills, eyes swollen); the reporter (parent) events are captured in case 2014SA010247. A five-year-old female patient, with no reported concomitant medications or relevant medical history, received a first intramuscular injection of FLUZONE (lot number UH922AB) on 20 January 2014. Five days post-vaccination, on 25 January 2014, she began experiencing cough, runny nose, and fever. On 29 January 2014 she was seen by her physician, and rapid flu test was positive per the reporter. Outcome was not reported. Additional documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Oedema mouth, Urticaria
Clinical narrative: Case number PHEH2014US002600 is an initial spontaneous report from the nurse received on 04 Feb 2014. This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: 1310301) intramuscularly on 28 Jan 2014. On the same date, 15 minutes after vaccination she experienced severe swelling and hives in and around mouth. It was reported that patient did not experience anaphylaxis and was not hospitalized. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: When pt returned to office 1/29 localized swelling and redness at site. PA prescribed antibiotic 11:00 1/29 pt returned to clinic 1/31 at 1:30 pm swelling was spreading down arm we recommended she go to ER.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Electrocardiogram normal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 29 January 2014. A male subject (date of birth not reported), with no medical history, experienced a slightly elevated troponin lab result, considered mild in severity, 15 days after he received an injection of ACAM2000, lot number, route, site and side not reported) on 14 January 2014 and concomitantly, an injection of TYPHOID (manufacturer, lot number, route and site not reported) and ANTHRAX, other manufacturer, (lot number, route, site and side not reported) on 14 January 2014. On 29 January 2014, 15 days post vaccination the Troponin I result was reported as slightly elevated, 0.12 ng/mL. On 29  January 2014, electrocardiogram (ECG) was reported as normal. According to the reporter, if the ERT report says otherwise or more information becomes available, a follow-up report will be submitted. The subject did not require any medical treatment. The patient's outcome was reported as still present, not recovered. According to the investigator, the event of elevated troponin was considered other important medical event and possibly related to the trial product. Documents held by sender: None.
Age: 0.47
Sex: M
Vaccine: PNC13, RV5
Symptoms: Crying, Irritability
Clinical narrative: Crying and irritability x 2 wks post vaccine.
Age: 27.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: Severe abdominal pain after 3rd capsule.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dysphonia, Headache, Local swelling, Mobility decreased, Pain
Clinical narrative: First arm so sore, swollen, difficult to lift or touch. Next morning, ache all over, headache that would not go away, hoarseness, fever of 100.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: First arm so sore, swollen, difficult to lift or touch. Next morning, ache all over, headache that would not go away, hoarseness, fever of 100.
Age: 0.81
Sex: F
Vaccine: HIBV
Symptoms: Injection site mass, Rash
Clinical narrative: Mother of Patient states 9mo female received hib vaccine at 9AM on 2/7/14 . Mother noticed patient had a rash on her scalp, back and sides of her body around 8:00 PM 2/7/14. Mother states  vaccine was given left thigh and that injection site had no rash or redness just a slightly raised lump. Mother states patient was acting normal with no trouble breathing.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cognitive disorder, Dizziness, Dysgeusia, Electrocardiogram, Laboratory test
Clinical narrative: Dizziness, cognition changes that evening. Next AM presented with hives, swelling of face, itchy skin, racing heart, metallic taste. Took Benadryl total of 3 doses. Was seen at MD office 5 days later and then took Benadryl every 6 hours x 48 hours.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Palpitations, Pruritus, Swelling face, Urticaria
Clinical narrative: Dizziness, cognition changes that evening. Next AM presented with hives, swelling of face, itchy skin, racing heart, metallic taste. Took Benadryl total of 3 doses. Was seen at MD office 5 days later and then took Benadryl every 6 hours x 48 hours.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Localised oedema, Skin warm
Clinical narrative: 4 INCH SWELLING TO LEFT ARM. RED AND WARM. INSTRUCTED PARENT TO APPLY COOL COMPRESSES TO ARM.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Developed redness pain swelling at injection site and down arm.  Fever to 102.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 4" diameter red circle, warm to touch at injection site.
Age: 1.03
Sex: M
Vaccine: MMR, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling developed, increasing until seen in clinic 02/10/2014.
Age: 36.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Chest discomfort, Electrocardiogram normal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 27 January 2014. A 36 year old female subject, developed mild chest pressure, considered mild in severity, 9 days after she received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on 08 January 2014 and concomitantly, an injection of ANTHRAX, other manufacturer, (lot number, route, site and side not reported on 08 January 2014). On 17 January 2014, 9 days post vaccination, the subject experienced intermittent episodes times three of chest pressure lasting seconds, since vaccination. On 23 January 2014 the Troponin I result was reported as normal, less than (<) 0.10 ng/mL. On 23 January 2014, electrocardiogram (ECG) was reported as normal. The patient had an abnormal ECG on an unspecified date in 2008. The subject was referred for care. The subject did not seek medical attention and did not require any further evaluation. The patient was well and asymptomatic at the second visit. The chest pressure was considered resolved on 20 January 2014. The patient's outcome was reported as recovered, referred for care. According to reporter, no further information was expected to follow. According to the investigator, the event of chest pressure was considered other important medical events and possibly related to the trial product. Documents held by sender: None.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Anxiety, Bacterial test, Bilevel positive airway pressure, Breath sounds abnormal, Bronchiectasis
Clinical narrative: 12/25/13 - ED, c/o SOB, leukocytosis, bilat. shoulder pain at vaccine sites. WBC = 23.1. Placed on BiPAP. 12/29/13 bronchiectasis, pulm HTN, increased O2 needs. Decreased exp wheeze 12/31/13, increased anxiety, decreased breath sd, 12/31 - culture enterococcus sputum, Coag neg Staph, yeast/transferred to another hospital 1/2/14. Pneumothorax 1/31/14 - intubated due to respiratory failure ICU.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Endotracheal intubation, Fungal test, Intensive care, Leukocytosis
Clinical narrative: 12/25/13 - ED, c/o SOB, leukocytosis, bilat. shoulder pain at vaccine sites. WBC = 23.1. Placed on BiPAP. 12/29/13 bronchiectasis, pulm HTN, increased O2 needs. Decreased exp wheeze 12/31/13, increased anxiety, decreased breath sd, 12/31 - culture enterococcus sputum, Coag neg Staph, yeast/transferred to another hospital 1/2/14. Pneumothorax 1/31/14 - intubated due to respiratory failure ICU.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pneumothorax, Pulmonary hypertension, Respiratory failure, Staphylococcus test, Vaccination site pain
Clinical narrative: 12/25/13 - ED, c/o SOB, leukocytosis, bilat. shoulder pain at vaccine sites. WBC = 23.1. Placed on BiPAP. 12/29/13 bronchiectasis, pulm HTN, increased O2 needs. Decreased exp wheeze 12/31/13, increased anxiety, decreased breath sd, 12/31 - culture enterococcus sputum, Coag neg Staph, yeast/transferred to another hospital 1/2/14. Pneumothorax 1/31/14 - intubated due to respiratory failure ICU.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Wheezing, White blood cell count increased
Clinical narrative: 12/25/13 - ED, c/o SOB, leukocytosis, bilat. shoulder pain at vaccine sites. WBC = 23.1. Placed on BiPAP. 12/29/13 bronchiectasis, pulm HTN, increased O2 needs. Decreased exp wheeze 12/31/13, increased anxiety, decreased breath sd, 12/31 - culture enterococcus sputum, Coag neg Staph, yeast/transferred to another hospital 1/2/14. Pneumothorax 1/31/14 - intubated due to respiratory failure ICU.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Burning sensation, Chills, Confusional state, Depression
Clinical narrative: Pain in all joints, aches in arm muscle and legs, headache, neck pain, chills, depression, tingling and burning in arms and legs, confusion.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Myalgia, Neck pain, Paraesthesia
Clinical narrative: Pain in all joints, aches in arm muscle and legs, headache, neck pain, chills, depression, tingling and burning in arms and legs, confusion.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Immediate swelling/tenderness at inj. site no pruritus, erythema, SOB or other concerns noted.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Swollen tongue
Clinical narrative: Itching. Rash on feet, legs, arms. Swollen tongue approx 1 week later. Went to dermo and got cream. OK - now.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Joint stiffness, Pain, Vaccination site swelling
Clinical narrative: 2-3 hours after vaccination, patient developed red, swollen arm from vaccination site to elbow. By next morning swelling had extended to fingers. C/O joint stiffness and pain. By 1/29/14 swelling reducing, joint stiffness improved. ROM back to baseline took BENADRYL 25 mg PO Rx TID PRN.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, FLU3, HEPA, HPV4, MNQ
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: (L) upper arm, red, itchy, edematous. Dx ICD - 682.9 cellulitis and abscess. Rx KEFLEX 500mg bid x 10 days.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dyspnoea, Eye pruritus, Eyelid oedema, Rash
Clinical narrative: Puffy itchy eyes within 30 minutes, breathing difficulty, chest rash. Patient went to ER was given IV BENADRYL. Prescribed Prednisone and BENADRYL.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Pain in extremity
Clinical narrative: Patient complained of arm pain after flu shot was given. She said pain went away after a few day the returned and worsened to the point that she could not lift her arm and requires help with dressing. She has visited MD 2 times.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red circle rash around injection site.
Age: 39.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Lip swelling, Pruritus, Rash, Swollen tongue
Clinical narrative: Noticed rash on arms while changing clothes the evening of 20May and progressively increased/spread to torso. Associated sx include pruritus but no wheezing, swelling of lips/tongue. Seen by PCM 3 days later with no change in sx. However, 2 days later had swelling of lips so went to ER and tx with antihistamine and steroid via IV.
Age: 0.86
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased
Clinical narrative: Child developed 104 temp shortly after receiving vaccines.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Swelling, Urticaria, Wound secretion
Clinical narrative: Pt. developed hives, urticaria, swollen buttocks, and mood behavioral changes after vaccine was administered (weeping wound).
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.