chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 59 year old male patient with no pertinent medical history and no drug reactions/allergies. It was reported that, on 19-SEP-2012, the patient might had vaccinated with a dose of PNEUMOVAX 23, intravenously during hospitalization (patient was in hospital due to an unspecified reason). Lot number and expiry date was reported as 0217AE and 22-AUG-2013 respectively. No concomitant medications were reported. Subsequently on an unknown date in September 2012, the patient experienced a slight rise in temperature. Hospitalization was not prolonged. On an unknown date in September 2012, the event slight rise in temperature was resolved. The relatedness for slight rise in temperature was unknown for PNEUMOVAX 23. The patient sought unspecified medical attention. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 years and a half old female patient with none medical history or drug reactions/allergies. The patient was vaccinated with the first 0.5ml dose of VARIVAX (Merck) subcutaneously (lot# was unknown) on 17-APR-2003. There were no concomitant medications. The patient had developed a case of shingles on an unspecified date after receiving the first dose vaccine. Medical assistant noted that the first dose of VARIVAX (Merck) was given by an unspecified healthcare provider at an unspecified pediatric office location. The patient contacted physician for medical attention. No treatment was given for the adverse events. The outcome of shingles was reported as recovered/resolved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a unknown number of patient. The nurse practitioner reported that an unknown number of doses of PNEUMOVAX 23 that were improperly stored -5 degrees centigrade for 1 to 2 months, may have been administered. No concomitant medications were reported. No adverse effect was reported. It was unknown if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Crying, Screaming
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of kids. On an unknown date patients were vaccinated with a doses of MMR II (doses, route and lot numbers were not reported). It was reported that the kids have screamed and cried after receiving MMR II (onset date and outcome were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot# unspecified) intramuscularly on 12-OCT-2012 and 0.65 ml ZOSTAVAX (lot# unspecified) subcutaneously at the same time on the same day. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. The patient was in pharmacy when this happened. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a registered nurse refers to a child patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of MMR II (dose, route and Lot # not reported). On an unknown date, reported also as "now", the patient experienced rash on legs. The outcome of rash on legs was not reported. This is one form several reports from the same source. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous, Urticaria, Vaccination failure
Clinical narrative: This spontaneous report as received from a 64 years old female consumer refers to herself, who was with arthritis and high cholesterol. The patient had drug allergies to sulfa and DAYPRO. In approximately 2009, "about 3 years ago" the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) under the skin in the arm. "Last week", on 11-OCT-2012, the patient broke out in red welts on her forehead above right eye. So the patient sought for medical attention by going to the public health dept on 12-OCT-2012. The nurse practitioner diagnosed her with shingles and prescribed VALTREX. It was also reported that the patient underwent cholesterol screening "2-3 weeks ago", in approximately September 2012. The patient was already feeling better at the time of reporting. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Irritability, Swelling
Clinical narrative: This spontaneous report was received from a physician's purchasing agent via a company representative concerning two patients of unknown age and gender (query pending). On an unknown date, patients were vaccinated with single dose of 0.5 milliliter PNEUMOVAX 23, intramuscularly. No concomitant medications were reported. On an unknown date, immediately after the vaccination in the office, both the patients experienced redness, puffiness and became irritable. The physician questioned regarding the lot and requested for lot check. The physician wanted a replacement of that lot. The outcome of redness, puffiness and became irritable was unknown. The relatedness for redness, puffiness and became irritable was unknown for PNEUMOVAX 23. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with ZOSTAVAX on 17-SEP-2012. On 19-SEP-2012, the patient developed "a rash scattered on the upper torso." At the time of the report, the patient had not recovered. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from an office administrative staff member refers to a 44 years old female patient with no medical history and no known drug reactions/allergies. The patient was vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX 23 on 08-OCT-2012. Lot # H0123972 (in validation), exp. date 09-MAR-2014. No other co-suspects were reported. Concomitant medications included hydrocodone, metformin, lisinopril, ARMOUR THYROID TABLETS, methotrexate and cyclosporine. On 08-OCT-2012, the patient's arm became very hard around the injection site, as well as very warm, and hot to the touch after receiving PNEUMOVAX 23. The patient was also unable to lift her arm above her head. The patient sought medical attention. No laboratory tests were performed. Treatment included KEFLEX. At the time of reporting the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: Information was received via telephone call from a nurse practitioner regarding a female patient, allergic to aspirin, who in 1993, was vaccinated with 3 doses of RECOMBIVAX from another provider and did not seroconvert. The patient sought medical attention in the form of an office visit for school-required physical. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Chills, Night sweats, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patients of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. The patients was vaccinated intramuscularly with PNEUMOVAX 23 on 16-OCT-2012. Lot # (670187/0895AA). No other co-suspects were reported. No concomitant medications were reported. Later the same day (16-OCT-2012) the patient reported to the nurse alternating chills and night sweats with fever. The nurse did not have any specific information for the patient. No treatment information was reported. The outcome of alternating chills, night sweats and fever was unknown. The relatedness for alternating chills, night sweats and fever was unknown for PNEUMOVAX 23. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This spontaneous report as received from a registered nurse refers to 3 patients of unknown age and gender. The patients' medical history and drug reactions/allergies were not reported. The 3 patients were vaccinated intramuscularly with PNEUMOVAX 23 on 16-OCT-2012. Lot # (670187/0895AA). No other co-suspects were reported. No concomitant medications were reported. Later the same day (16-OCT-2012) the three patients reported the nurse a sore arm with swelling and warmth at the injection site. The nurse did not have any specific information for the patients. No treatment information was reported. The outcome of sore arm, warmth at the injection site and swelling at the injection site was unknown. The relatedness for sore arm, warmth at the injection site and swelling at the injection site was unknown for PNEUMOVAX 23. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: This spontaneous report was received from a 67-year-old female patient regarding herself. Current conditions included allergy to codeine. The patient was vaccinated with ZOSTAVAX (lot # not reported) dosing details not reported for prophylaxis (reported as shingles vaccine) subcutaneously on 06-SEP-2012. Other suspect therapies included PNEUMOVAX 23 (lot # not reported) on 28-AUG-2012. Patient stated on 06-SEP-2012 she had redness and irritation at the injection site, no other side effects was noted. Patient questioned the efficacy of PNEUMOVAX 23 and ZOSTAVAX after 8 days. No treatment was given for the events. The patient did not recover from the events at the time of this report. Medical attention was not sought for the events. No further AE information provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a company representative refers to a female acquaintance of hers who had posted a status on a social network. The patient was vaccinated with a second 0.5 ml dos eof (Merck) VARIVAX (Lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The company representative reported that on 15-OCT-2012, the patient posted that she might have shingles and just got two vaccinations for chickenpox. The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles was unknown for (Merck) VARIVAX. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 years old male patient. The patient was vaccinated with lot # (669748/0760AA) ZOSTAVAX (SQ left arm) on 18-NOV-2011. On 19-NOV-2011 the patient developed a rash at the injection site, abdomen, and thigh. The pharmacist stated the rash looked a lot like hives. The patient visited office with physician and the pharmacy for medical attention and treated with prednisone. The rash resolved initially but recurred on the abdomen and thigh if the prednisone was discontinued. The patient was taking prednisone 1mg every other day to control the rash. The patient was not recovered from the events. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 65 years old male patient. On 02-AUG-2012, the patient was vaccinated subcutaneously in his left with 0.65 ml of expired ZOSTAVAX (lot # 669263/1361Z, expiry 15-JAN-2012). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient between 50 and 60 years old. The patient's medical history and drug reactions/allergies were not reported. The patient was vaccinated subcutaneously with ZOSTAVAX on 15-OCT-2012. The dose and lot number were not reported. No other co-suspects were reported. No concomitant medications were reported. While on ZOSTAVAX the patient developed a small rash on 17-OCT-2012. No treatment was given for the adverse experience. No laboratory tests were performed. At the time of reporting, the patient's outcome was unknown. Relatedness was not provided. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age with a history of kidney transplant. On an unknown date the patient was administered with the vaccine with the lot # 0590F, exp 10-MAY-2008, but could not confirm if the vaccine was ZOSTAVAX or (Merck) VARIVAX. (Merck) VARIVAX was the intended dose for this patient but patient might have received wrong vaccine, ZOSTAVAX instead. The patient was on several immunosuppressant medications at the time of vaccination. No adverse effects reported. Lot number 653964/0590F, expired date 10-MAY-2008 is valid for (Merck) VARIVAX. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Chills, Computerised tomogram head abnormal, Dizziness, Dyskinesia, Epistaxis
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 15 years old female patient. The patient was vaccinated with 0.5 ml GARDASIL (lot # 672233/1561AA; expiry date 26-AUG-2014), intramuscularly on 02-OCT-2012. No other co-suspects were reported. Concomitant medications included: MENACTRA, which was administered at the same visit. The patient fainted after receiving GARDASIL. She slumped to the floor after receiving the vaccine, but was awake and talking within seconds. The patient was treated with ice, water and feet were elevated. The patient had recovered. The relatedness for the event was not reported for GARDSIL. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Face injury, Facial bones fracture, Headache, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 15 years old female patient. The patient was vaccinated with 0.5 ml GARDASIL (lot # 672233/1561AA; expiry date 26-AUG-2014), intramuscularly on 02-OCT-2012. No other co-suspects were reported. Concomitant medications included: MENACTRA, which was administered at the same visit. The patient fainted after receiving GARDASIL. She slumped to the floor after receiving the vaccine, but was awake and talking within seconds. The patient was treated with ice, water and feet were elevated. The patient had recovered. The relatedness for the event was not reported for GARDSIL. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Mouth haemorrhage, Nasal discomfort, Nasal inflammation, Rhinalgia, Toothache
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 15 years old female patient. The patient was vaccinated with 0.5 ml GARDASIL (lot # 672233/1561AA; expiry date 26-AUG-2014), intramuscularly on 02-OCT-2012. No other co-suspects were reported. Concomitant medications included: MENACTRA, which was administered at the same visit. The patient fainted after receiving GARDASIL. She slumped to the floor after receiving the vaccine, but was awake and talking within seconds. The patient was treated with ice, water and feet were elevated. The patient had recovered. The relatedness for the event was not reported for GARDSIL. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: X-ray abnormal
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 15 years old female patient. The patient was vaccinated with 0.5 ml GARDASIL (lot # 672233/1561AA; expiry date 26-AUG-2014), intramuscularly on 02-OCT-2012. No other co-suspects were reported. Concomitant medications included: MENACTRA, which was administered at the same visit. The patient fainted after receiving GARDASIL. She slumped to the floor after receiving the vaccine, but was awake and talking within seconds. The patient was treated with ice, water and feet were elevated. The patient had recovered. The relatedness for the event was not reported for GARDSIL. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 15 years old female patient. The patient was vaccinated with 0.5 ml GARDASIL (lot # 672233/1561AA; expiry date 26-AUG-2014), intramuscularly on 02-OCT-2012. No other co-suspects were reported. Concomitant medications included: MENACTRA, which was administered at the same visit. The patient fainted after receiving GARDASIL. She slumped to the floor after receiving the vaccine, but was awake and talking within seconds. The patient was treated with ice, water and feet were elevated. The patient had recovered. The relatedness for the event was not reported for GARDSIL. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Intense pain in left arm in area where inoculation occurred; pain chronic; range of motion limited; disturbed sleep due to pain; muscle weakness. Ibuprofen caused stomach upset.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal discomfort, Injected limb mobility decreased, Injection site pain, Muscular weakness, Sleep disorder
Clinical narrative: Intense pain in left arm in area where inoculation occurred; pain chronic; range of motion limited; disturbed sleep due to pain; muscle weakness. Ibuprofen caused stomach upset.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Fatigue, Pallor, Palpitations
Clinical narrative: Approximately 10 minutes after receiving the vaccination, patient experienced intense palpitations and dizziness. This progressed into pallor physical weakness and fatigue within 10 minutes and lasting approximately four hours. No treatment was delivered as patient lived alone and fell asleep upon entering home.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: Swelling, pain and reddening of vaccine site. Fever of 100.5 F. chills, muscle aches, exhaustion, sleeping, headache, then sweats. As of 10/22/2012 at 10:12 PM on this report, pain, swelling and redness are still there, fever is down, chills and sweats are gone, some muscle aches remain.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia, Somnolence
Clinical narrative: Swelling, pain and reddening of vaccine site. Fever of 100.5 F. chills, muscle aches, exhaustion, sleeping, headache, then sweats. As of 10/22/2012 at 10:12 PM on this report, pain, swelling and redness are still there, fever is down, chills and sweats are gone, some muscle aches remain.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Influenza like illness, Injection site erythema, Night sweats
Clinical narrative: Aches, weakness, chills, fever, night sweats.  These flu like symptoms were episodic with worse on 19 and 20 October.  Large red area in vicinity of shot...3 inch radius that persisted 10 days.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Aches, weakness, chills, fever, night sweats.  These flu like symptoms were episodic with worse on 19 and 20 October.  Large red area in vicinity of shot...3 inch radius that persisted 10 days.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Haemorrhage in pregnancy, Maternal exposure during pregnancy, Oligohydramnios, Premature delivery, Premature separation of placenta
Clinical narrative: Pt. was not aware that she was pregnant at the time. She had 1st and 2nd trimester bleeding with oligohydramios and abruption with delivery at 28 weeks gestation.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound scan
Clinical narrative: Pt. was not aware that she was pregnant at the time. She had 1st and 2nd trimester bleeding with oligohydramios and abruption with delivery at 28 weeks gestation.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Discomfort, Erythema, Feeling abnormal, Immunology test, Laboratory test normal
Clinical narrative: Slight discomfort, "weird" on Thurs. Was on leave and going to B&B, felt sick on Fri - nausea, LH, malaise, pain/erythema/warmth RUE. Returned home early from vacation on Sat, went to military health same day and was given Septra DS 1 tab po daily (not bid) and has been taking since then. Still not feeling well.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Malaise, Nausea, Pain in extremity, Skin warm, Ultrasound scan normal
Clinical narrative: Slight discomfort, "weird" on Thurs. Was on leave and going to B&B, felt sick on Fri - nausea, LH, malaise, pain/erythema/warmth RUE. Returned home early from vacation on Sat, went to military health same day and was given Septra DS 1 tab po daily (not bid) and has been taking since then. Still not feeling well.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: White blood cell count normal
Clinical narrative: Slight discomfort, "weird" on Thurs. Was on leave and going to B&B, felt sick on Fri - nausea, LH, malaise, pain/erythema/warmth RUE. Returned home early from vacation on Sat, went to military health same day and was given Septra DS 1 tab po daily (not bid) and has been taking since then. Still not feeling well.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Brain natriuretic peptide increased, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Cough, Dyspnoea
Clinical narrative: Approx 1 wk after getting Flu and Pneumococcal vaccines at PCP began having wheezing, increased SOB, increased amount of coughing especially lying down at night, throat felt sore and on fire.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oropharyngeal pain, Pneumonia, Throat irritation, Wheezing
Clinical narrative: Approx 1 wk after getting Flu and Pneumococcal vaccines at PCP began having wheezing, increased SOB, increased amount of coughing especially lying down at night, throat felt sore and on fire.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction: red, raised circle about 4 to 5 inches in diameter around injection.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Influenza, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills, low grade fever, nausea, muscle ache, flu symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The injection site became red, warm, and swollen (similar to the size of a spider bite).  Patient went to the Emergency room under the advice of the home nurse.  The emergency room doctor gave her an antibiotic to prevent an infection.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Pruritus, Rash generalised
Clinical narrative: Severe itching where it caused inflamed skins from the constant itching. Rash bumps throughout body.
Age: 66.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site movement impairment in a 66-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included FLUARIX; GlaxoSmithKline; unknown; right deltoid given on 5 October 2012. Concurrent medications included Iron Tablets, SYNTHROID, Aspirin, Digoxin, TOPROL XL, CYMBALTA, PROTONIX, ANTARA, Metformin, Hydrochlorothiazide, PROAIR HFA, COZAAR, ZETIA and Nitroglycerin. On 5 October 2012 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown route, left deltoid). In October 2012, less than one week after vaccination with BOOSTRIX, the subject experienced injection site movement impairment, arm pain after injection, shoulder pain in injection arm and decreased ability to perform daily activities. The subject's appointment was at 13:30 on 05 October 2012 and between 13:30 and 17:19 she was administered the vaccine. According to the healthcare professional, it had been more than 10 years since the subject had received the vaccine so it was suggested that she get vaccine at the office visit. The healthcare professional stated that the subject was "not able to move her left arm" and was "having pain down her left arm to the elbow and back into the shoulder blade area". The healthcare professional explained that "we can't say for sure the causality is the BOOSTRIX", but the subject was referred to a neurologist to evaluate further. According to the healthcare professional, the subject seems to think the events are definitely related to the BOOSTRIX. The subject had gotten flu vaccines previously so the FLUARIX was not considered suspect according to the healthcare professional. The subject had thought about going to the emergency room due to the events, but did not go. The subject reported the events another physician who advised her to take TYLENOL because at that point she was just having pain to the injection site. The healthcare professional considered the events were disabling. She explained that the subject was not able to use/move her left arm and was having difficulty getting dressed. At the time of reporting the events were unresolved.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: Muscle aches, weakness, headache, stiff neck.
Age: 45.0
Sex: F
Vaccine: ANTH, FLUN3, HEP, TYP
Symptoms: Arthralgia, Headache, Injection site swelling, Pain in extremity
Clinical narrative: PT states she received anthrax vaccine on 18OCT12 and almost immediately began to experience headaches, joint pain and swelling at the injection site (L shoulder) PT states this was her third anthrax in the series.  Previously with some local reaction with tenderness, erythema, nodule, but it resolved rapidly.  Denies fever/chills.  Does have radiating pain from site to shoulder and down arm.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 11 October 2012. A 55-year-old female patient had received a dose one intramuscular injection in the left deltoid of ADACEL, lot number not reported, and a dose eight intramuscular injection in the right deltoid of Influenza Vaccine, manufacturer and lot number not reported, on 04 October 2012. Twelve hours later on 05 October 2012, the patient had hives with intense itching on lower back and left arm. There were three inches of hives over the injection site. By the next day, it was up to the shoulders and both arms then spread to the hips, thighs, face, feet and palms of hands. The patient saw an allergist and was treated with BENADRYL and a prednisone schedule. The patient was on BACTRIM for a sinus infection, had no known med allergies and seasonal allergies. The patient's outcome was recovered. Documents held by sender: None.
Sex: U
Vaccine: TTOX
Symptoms: VIIth nerve paralysis
Clinical narrative: Initial case received from a consumer on 11 October 2012. An unidentified patient, sex, age not provided, received a tetanus vaccine, manufacturer unknown, on an unspecified date. The patient experienced Bells Palsy after the vaccination on an unspecified date. Patient medical history, relevant history, relevant lab tests and concomitant medications were not reported. The reporter declined to provide patient details or contact information or reporter contact information. This case is invalid due to patient information details and reporter contact information was not reported. No further details available at the time of this report. Patient outcome is unknown. Documents held by sender: None.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site reaction, Muscular weakness, Myalgia, Pain
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 12 October 2012. The reporter reported another adverse event which was captured in case number 2012-09535. A 77-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE on 06 July 2012 (lot number not reported). On 07 July 2012, the patient began having severe muscular pain at the left deltoid, can't lift her arm, had weakness in her hand when holding things and certain movements caused severe pain. The patient was seen by a physician and an orthopedic physician and was scheduled for an MRI. Treatment included a cortisone shot which did not help the symptoms at all. An x-ray was negative. The patient had no illness at the time of vaccination and no known drug allergies (NKDA). The patient's outcome was not recovered. Documents held by sender: None.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 12 October 2012. The reporter reported another adverse event which was captured in case number 2012-09535. A 77-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE on 06 July 2012 (lot number not reported). On 07 July 2012, the patient began having severe muscular pain at the left deltoid, can't lift her arm, had weakness in her hand when holding things and certain movements caused severe pain. The patient was seen by a physician and an orthopedic physician and was scheduled for an MRI. Treatment included a cortisone shot which did not help the symptoms at all. An x-ray was negative. The patient had no illness at the time of vaccination and no known drug allergies (NKDA). The patient's outcome was not recovered. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: RAB
Symptoms: Hemiparesis, Hyperaesthesia, Neuralgia, Paraesthesia, Pruritus
Clinical narrative: Initial report was received from a consumer on 08 October 2012, who is also the patient. A 52-year-old female patient received an intramuscular injection in the deltoid of IMOVAX Rabies, lot number unknown, on 10 September 2012. The patient also received post exposure prophylaxis with a Rabies Vaccine and Human Rabies Immune Globulin (manufacturers and lot numbers unknown; routes, sites of administration, and dates given not reported). On 13 September 2012, the patient experienced nerve pain, tingling, weakness, and pressure down the right side. The patient went to the emergency department three times. The physician diagnosed the patient with "vaccine serum sickness" and told her it would resolve in a month. She later developed the same symptoms down her left side with constant pressure in her skin, which was puffy, sensitive, and developed welts if she scratched it. Patient was taking over-the-counter antihistamines and ibuprofen per physician. Patient claimed the symptoms were getting worse. The patient's outcome was not recovered. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: RAB
Symptoms: Sensation of pressure, Serum sickness, Skin swelling, Urticaria
Clinical narrative: Initial report was received from a consumer on 08 October 2012, who is also the patient. A 52-year-old female patient received an intramuscular injection in the deltoid of IMOVAX Rabies, lot number unknown, on 10 September 2012. The patient also received post exposure prophylaxis with a Rabies Vaccine and Human Rabies Immune Globulin (manufacturers and lot numbers unknown; routes, sites of administration, and dates given not reported). On 13 September 2012, the patient experienced nerve pain, tingling, weakness, and pressure down the right side. The patient went to the emergency department three times. The physician diagnosed the patient with "vaccine serum sickness" and told her it would resolve in a month. She later developed the same symptoms down her left side with constant pressure in her skin, which was puffy, sensitive, and developed welts if she scratched it. Patient was taking over-the-counter antihistamines and ibuprofen per physician. Patient claimed the symptoms were getting worse. The patient's outcome was not recovered. Documents held by sender: None.
Sex: U
Vaccine: SMALL
Symptoms: Cow pox
Clinical narrative: This initial spontaneous case was received from a nurse via another manufacturer under reference number 1-5584828450. A patient of unknown age and gender with no reported medical history experienced cow pox after receiving an unspecified smallpox vaccine (manufacturer unknown; lot number not reported) at an unspecified time in the past. No further information was available at the time of the report. The outcome of the patient was not reported. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Aphasia, Eye swelling, Immediate post-injection reaction, Mobility decreased
Clinical narrative: Initial case received from a consumer on 11 October 2012. A female patient, age not reported, with no known allergies, received a dose of FLUZONE with Lot # UH722AA (to be confirmed), expiry 30 June 2013, site and route of administration not reported on an unspecified date. Concomitant medications and lab results were not reported. The patient experienced an "anaphylactic reaction" right after vaccination. The patient developed swollen eyes, was unable to talk or unable to move her arm. The patient was treated with 25 mg of BENADRYL, reported as BENEDRYL, and was transported to the hospital. The reporter declined to provider further information for the patient, but reported that this was the first flu vaccination the patient had received. No further details were available at the time of this report. The patient outcome was not reported. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Malaise, Rash generalised
Clinical narrative: Initial case received from a health care professional on 11 October 2012. The female patient, age 42, with no pre-existing allergies or medical conditions had received a dose of FLUZONE vaccine intramuscularly on 08 October 2012 (lot number UH717AC, expiry 30 June 2013) into the left deltoid. Concomitant medications were not reported. It was reported that the patient received yearly flu vaccinations in the past. The patient developed hives and generalized body rash with redness, swelling and itching at the injection site and generalized malaise at an unspecified time. The patient was self treated with BENADRYL 50 mg every 6 hours, duration not specified. The patient was administered an unspecified steroid shot by their physician on an unreported date. No further information was available at the time of report. The symptoms were reported as beginning to resolve on 09 October 2012. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Initial case received from a health care professional on 11 October 2012. The female patient, age 42, with no pre-existing allergies or medical conditions had received a dose of FLUZONE vaccine intramuscularly on 08 October 2012 (lot number UH717AC, expiry 30 June 2013) into the left deltoid. Concomitant medications were not reported. It was reported that the patient received yearly flu vaccinations in the past. The patient developed hives and generalized body rash with redness, swelling and itching at the injection site and generalized malaise at an unspecified time. The patient was self treated with BENADRYL 50 mg every 6 hours, duration not specified. The patient was administered an unspecified steroid shot by their physician on an unreported date. No further information was available at the time of report. The symptoms were reported as beginning to resolve on 09 October 2012. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Bruxism, Chills, Decreased appetite, Heart rate increased
Clinical narrative: Vomiting, chills, increased heart rate, fever, muscle pain, anxiety, loss of sleep, loss of appetite, teeth/jaw clenching.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Myalgia, Pyrexia, Trismus, Vomiting
Clinical narrative: Vomiting, chills, increased heart rate, fever, muscle pain, anxiety, loss of sleep, loss of appetite, teeth/jaw clenching.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: I received a pneumonia vaccine in the left arm and lost the use of the arm. It has been extremely painful and I could not use it for a week. Had a fever of 101.1 on Tuesday.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain, Musculoskeletal pain
Clinical narrative: Mild pain in shoulder where shot was administered beginning 10/18/12, followed by the appearance 10/22/12 of bruises at the shot site and 2 additional locations a few inches below the shot site. Each bruise has underlying mild pain.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash above wrist. 10/21 red spots with white dots in center on palm of hand.
Age: 29.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Employee received Flu vaccine a developed cellulitis extending from injection point and spreading up and around left upper arm.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Neutrophil count increased, Pruritus generalised, Streptococcus test negative, Urine analysis normal, Urticaria
Clinical narrative: Hives, itching all over body. Have not resolved with treatment of Benadryl and prednisone, and famotadine.
Age: 61.0
Sex: F
Vaccine: FLU3, TTOX
Symptoms: Cough, Dysphonia, Erythema, Immediate post-injection reaction, Injection site pain
Clinical narrative: Stinging and pain when administered. Within a couple of hours following receipt of the shot arm became red, swollen, hot, and itchy.  Woke up the following morning with hoarseness and coughing.  Arm very red, swollen, hot, and itchy. Took Benadryl, which helped relieve some of the intense itching.  All adverse events listed persisted for approximately 52 hours with the swelling beginning to go down after this and itching lessened.  After 5 days all adverse effects disappeared.
Age: 61.0
Sex: F
Vaccine: FLU3, TTOX
Symptoms: Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Stinging and pain when administered. Within a couple of hours following receipt of the shot arm became red, swollen, hot, and itchy.  Woke up the following morning with hoarseness and coughing.  Arm very red, swollen, hot, and itchy. Took Benadryl, which helped relieve some of the intense itching.  All adverse events listed persisted for approximately 52 hours with the swelling beginning to go down after this and itching lessened.  After 5 days all adverse effects disappeared.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: So far regular symptoms- arm is sore.  Concern is that first needle inserted, I thought I was finished.  Then he said that one was empty.  Then gave another shot.  Concerned why one was empty?  Why it wasnt logged, was it used before.  Very concerned.
Age: 0.7
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Body temperature increased, Rash generalised
Clinical narrative: 102 temp, rash all over body 1-2 days later.  Lasted 2 weeks, seen in ER for evaluation.  P.O. meds given, d/c to home, no admission.  Hx of eczema.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Lymphadenopathy
Clinical narrative: Pain and redness at the site, swollen enlarged lymph note in Axilla.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Rash generalised
Clinical narrative: Rash all over body. On head, elbows and hands raised rash and blisters. Taking Benadryl every four hours and hydrocortisone cream.
Age: 46.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Decreased appetite, Dizziness, Erythema, Fatigue, Nodule
Clinical narrative: Swollen and red left arm, knot in arm (golf-ball sized), dizziness, fatigue, no appetite.
Age: 46.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Swollen and red left arm, knot in arm (golf-ball sized), dizziness, fatigue, no appetite.
Age: 1.19
Sex: M
Vaccine: DTAPHEPBIP, FLU3
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Within minutes after influenza and Pediarix vaccines in his thighs, he developed erythematous patches/mild hives on bilateral thighs.  No systemic symptoms.  He was given one dose of Benadryl and rash improved within 10 minutes.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Chest pain, Dizziness, Dyspnoea, Erythema, Injection site pain
Clinical narrative: Began with soreness at injection site then moved to total arm then left shoulder left back and left chest, developed difficulty breathing, difficulty to take a deep breath continues, dizziness and now a large red splotch on lower right arm and lower left arm.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Rash macular
Clinical narrative: Began with soreness at injection site then moved to total arm then left shoulder left back and left chest, developed difficulty breathing, difficulty to take a deep breath continues, dizziness and now a large red splotch on lower right arm and lower left arm.
Age: 70.0
Sex: M
Vaccine: HEPAB, TYP, YF
Symptoms: Blood creatinine increased, Pyrexia, Pyuria, Renal failure acute, Tubulointerstitial nephritis
Clinical narrative: It is suspected that the Client had an adverse reaction to his yellow fever vaccination, with onset of symptoms beginning 8 days after vaccination. Client seen several times, and then seen at ER on 9-20-12. He has been seen by Nephrologist on 9-26-12 and 10- 16-12, and has another follow-up appointment scheduled in 6 weeks. Client reported to have had a mild version of a viscerotropic reaction to the vaccination. Noted that client had an acute kidney injury, and is now clinically improving. Symptoms included fevers up to 104, sterile pyuria, elevated WBC's (up to 18,000) and elevated creatinine (peaking at 3.17). Interstitial nephritis suspected. Client followed by Nephrologist. Client is improving clinically, and will continue to be followed with blood chemistries and follow-up at Nephrologist's office in 6 weeks.
Age: 70.0
Sex: M
Vaccine: HEPAB, TYP, YF
Symptoms: White blood cell count increased, Yellow fever vaccine-associated viscerotropic disease
Clinical narrative: It is suspected that the Client had an adverse reaction to his yellow fever vaccination, with onset of symptoms beginning 8 days after vaccination. Client seen several times, and then seen at ER on 9-20-12. He has been seen by Nephrologist on 9-26-12 and 10- 16-12, and has another follow-up appointment scheduled in 6 weeks. Client reported to have had a mild version of a viscerotropic reaction to the vaccination. Noted that client had an acute kidney injury, and is now clinically improving. Symptoms included fevers up to 104, sterile pyuria, elevated WBC's (up to 18,000) and elevated creatinine (peaking at 3.17). Interstitial nephritis suspected. Client followed by Nephrologist. Client is improving clinically, and will continue to be followed with blood chemistries and follow-up at Nephrologist's office in 6 weeks.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Injection site swelling, Tenderness
Clinical narrative: Immediate swelling beneath ejection site in a 2 inch diameter. Slight redness, tender to touch.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Activities of daily living impaired, Dizziness, Gait disturbance, Posture abnormal, Vision blurred
Clinical narrative: Student reported to school office complaining of blurry vision, dizziness, and his head appeared to be weaving. Parent called to pick student up and he walked down the hall with the parent bumping into her as they walked. He was unable to locate the door handle as he tried to open the car door.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Disorientation, Vision blurred
Clinical narrative: Student reported to school office complaining of blurry vision, dizziness, and his head appeared to be weaving. Parent called to pick student up and he walked down the hall with the parent bumping into her as they walked. He was unable to locate the door handle as he tried to open the car door.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Balance disorder, Blood potassium decreased, Blood pressure increased, Burning sensation
Clinical narrative: 10/7/2009- paresthesias feet- last several days then resolved. 10/23/09-paresthesias L foot then bilateral feet, spread to hands, then face. Difficulty lifting left foot. 10/27/2009-  severe Shortness of breath, dyspnea, palpitations, severely elevated blood pressure and heart rate. Then progression of severe lower extremity weakness, upper extremity weakness,  motor/ neurological motor processing difficulty, orthostatic hypotension and labile blood pressures, hyperventilation, anxiety, fatigue, severe burning sensations in spine and extremities, temperature sensitivity, Raynauds, insomnia, myalgias, slow speech, hypokalemia, abnormal balance/gait. severe sensitivity to sound, cholecystitis. Treatment- hospitalization, blood pressure meds, physical therapy, massage therapy.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Cholecystitis, Dyspnoea, Fatigue, Gait disturbance, Heart rate increased
Clinical narrative: 10/7/2009- paresthesias feet- last several days then resolved. 10/23/09-paresthesias L foot then bilateral feet, spread to hands, then face. Difficulty lifting left foot. 10/27/2009-  severe Shortness of breath, dyspnea, palpitations, severely elevated blood pressure and heart rate. Then progression of severe lower extremity weakness, upper extremity weakness,  motor/ neurological motor processing difficulty, orthostatic hypotension and labile blood pressures, hyperventilation, anxiety, fatigue, severe burning sensations in spine and extremities, temperature sensitivity, Raynauds, insomnia, myalgias, slow speech, hypokalemia, abnormal balance/gait. severe sensitivity to sound, cholecystitis. Treatment- hospitalization, blood pressure meds, physical therapy, massage therapy.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperacusis, Hyperventilation, Hypokalaemia, Insomnia, Labile blood pressure
Clinical narrative: 10/7/2009- paresthesias feet- last several days then resolved. 10/23/09-paresthesias L foot then bilateral feet, spread to hands, then face. Difficulty lifting left foot. 10/27/2009-  severe Shortness of breath, dyspnea, palpitations, severely elevated blood pressure and heart rate. Then progression of severe lower extremity weakness, upper extremity weakness,  motor/ neurological motor processing difficulty, orthostatic hypotension and labile blood pressures, hyperventilation, anxiety, fatigue, severe burning sensations in spine and extremities, temperature sensitivity, Raynauds, insomnia, myalgias, slow speech, hypokalemia, abnormal balance/gait. severe sensitivity to sound, cholecystitis. Treatment- hospitalization, blood pressure meds, physical therapy, massage therapy.