chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Unevaluable event
Clinical narrative: On 09/05/2013 patient called our Employee Health office and notified us of a potential adverse vaccine reaction. She previously received a Tdap injection on 07/31/2013 during her pre-employment health screening. Referred her to Work Comp MD for evaluation.
Age: 46.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Electromyogram, Hypoaesthesia, Injection site pain, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: On 09/05/2013 patient called our Employee Health office and notified us of a potential adverse vaccine reaction. She previously received a Tdap injection on 07/31/2013 during her pre-employment health screening. Referred her to Work Comp MD for evaluation.
Age: 46.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Nerve conduction studies, Pain in extremity, Radiculitis brachial
Clinical narrative: On 09/05/2013 patient called our Employee Health office and notified us of a potential adverse vaccine reaction. She previously received a Tdap injection on 07/31/2013 during her pre-employment health screening. Referred her to Work Comp MD for evaluation.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Fever next day, muscle aches, local erythema, warmth, induration extending 10 cm from injection site.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Nausea, Secretion discharge, Vision blurred
Clinical narrative: Incredibly excessive mucous discharge with nausea and vomiting, lasting until next morning. Chills, fatigue and blurry vision, improved but not gone 24 hours later.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Incredibly excessive mucous discharge with nausea and vomiting, lasting until next morning. Chills, fatigue and blurry vision, improved but not gone 24 hours later.
Age: 42.0
Sex: F
Vaccine: DTAP, HEP, MMR
Symptoms: Electromyogram abnormal, Neuropathy peripheral
Clinical narrative: Pt has had onset of peripheral neuropathy 7 months after initial vaccine with Hepatitis B, MMR and Tdap.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Hypoaesthesia, Rash, Swelling
Clinical narrative: Rash, swollen, bruised. Numbness. Pharmacist took picture.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Somnolence
Clinical narrative: Extreme fatigue - slept from 11 hours Tuesday night and slept another 10 hours Wednesday night.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash macular
Clinical narrative: Red flat non-itchy macules across anterior chest extending to umbilicus which persisted for 2 days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Intense itching on neck arms and torso, 24 hours later around 5:00 PM, I started itching again but with hives. I called my doctor and she prescribed Betamethasone DP 0.05% she also recommended to take Benadryl at night, and Claritin during the day.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Soreness in arm, 101.3 temperature, joint/muscle pain. High temperature through 4:25 pm 9/19/19.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Alopecia, Condition aggravated, Madarosis
Clinical narrative: Loss of scalp hair and eyebrows. To this day I am losing hair all over my body and extremely minor hair has returned to my head.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pain, Rash erythematous, Urticaria
Clinical narrative: Large raised red rash/ welt approximately 3 inches in diameter, pt states hot and painful. MD told patient that it was questionable whether the rash was a severe injection site reaction or if it was something else like cellulitis. Patients was give a prescription for an antibiotic.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Gait disturbance, Pallor, Visual impairment
Clinical narrative: Patient was administered vaccines at 4:20 PM, and while waiting to schedule his next appointment, he felt dizzy, saw spots and stumbled backwards. His face was pale, although he denied any chest pain, shortness or breath or difficulty breathing. He was immediately brought into the exam room and placed in a chair. I examined him, and he had a normal physical exam. His vitals were taken and initially revealed a BP of 86/51 and subsequently came up to 98/55 with a HR of 65. His pulse ox was 98% on RA throughout. He had some water and was able to describe the entire incident. He was alert and oriented, and reported after sitting for 10 minutes that he felt much better. His color came back, and he felt well subsequently. Mom reported after the incident that this has happened before, and he had to sit down for 20-30 minutes after another vaccine in the past. No other issues.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from another health professional refers to a patient, who was over 60 years of age. On 27-AUG-2013 the patient was vaccinated with VARIVAX (Merck), 0.5 ml, instead of intended ZOSTAVAX. Route of administration of VARIVAX (Merck) was not provided. Lot number J00609, expiry date 21-MAY-2015. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Pallor
Clinical narrative: 5 in x 5 in area of erythema (blanchable) and warmth around injection site (right ant. thigh).
Sex: M
Vaccine: FLU3
Symptoms: Amnesia
Clinical narrative: This case was reported by a physician and described the occurrence of transient amnesia in a male subject aged between 70 and 79 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included forgetfulness. The subject did not have a history of amnesia. The subject had received previous flu shots with no adverse events to previous flu shots. The reporter did not know what flu vaccines the subject received previously. On 6 September 2013 the subject received a dose of FLULAVAL (1 injection, unknown route, left arm). On 6 September 2013, less than one day after vaccination with FLULAVAL, the subject experienced transient amnesia and possible transient ischemic attack. Per the physician, the subject "was fine after the vaccination and left office." Per the physician, the subject reported "transient amnesia that lasted 8 to 12 hours" and the subject reported that he "can't remember what happened in the 8 to 12 hour timeframe of amnesia." At the time of reporting, the subject was "aware." The physician "was unsure if this was due to FLULAVAL, as it may also be 'possible TIA (possible transient ischemic attack).'" This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were resolved.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Throat tightness, Urticaria
Clinical narrative: Sent to the ER due to hives, some throat and chest tightness. Given epinephrine, steroids and antihistamines. Was seen in the ER x2 and had a doctors visit in follow up.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Diarrhoea, Hyperhidrosis
Clinical narrative: Patient came over to pharmacy next day and said 3 hrs after FLUVIRIN vaccine given, she experienced sweating, diarrhea, pain in her chest area. She doesn't know if reaction is from vaccine or heartburn. She has not taken her heartburn med since June. She said her symptoms have improved. Followed up with patient 9/19/12 patient had no more symptoms.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Bone disorder, Diarrhoea, Hypokinesia, Pain
Clinical narrative: About 3 hours after the shot, the patient began to ache severely. She stated that her bone felt "locked" and that she could not move for 12 hours. She then hurt all over for another 12 hours, but was able to move. Then she developed extremely severe diarrhea for another day.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Dark red "hot" rash extending to elbow and up into neck region on left arm. Distinct border (problem both shots given in left deltoid per patient). Can't tell which vaccine caused problem.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Developed 13cm x 13cm erythematous, warm to touch area below injection site that she noticed this morning. Arm tender to touch. No fever or chills. Stopped by office at 1 pm to have staff check it. Cold compress, BENADRYL, and TYLENOL. Patient advised to monitor for increase pain, swelling, or redness.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Blood sodium decreased, Chills, Tremor
Clinical narrative: Had vaccination at 2 pm 9/16/2013. Did well throughout the day. Began to shiver/shake at 1030 PM. No altered mental status. No seizure. Shaking subsided 2 hours/0030 on 9/17/13.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blister
Clinical narrative: Noticed 1x4mm blister about 3cm towards (L) side of injection site when GARDASIL was given.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Cyanosis, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Red/purple swelling in right arm around and down from injection site. MD prescribed antibiotics to treat.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever and pain on site for 4 days.
Age: 51.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Rash
Clinical narrative: Started with quarter sized rash (Monday 9/16), when presented to pharmacy on Wed. 9-18, rash at injection site red, swollen, painful and about 8 in x 5 in wide. Referred her to MD.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased, Hyperhidrosis
Clinical narrative: Pt was given a ZOSTAVAX vaccination. 5-10 mins after pt felt dizzy and was sweating heavily. Blood pressure was taken and was read as 66/44 - pulse 45. Epipen 0.3mg was given IM. Paramedic was called in and pt was taken to the hospital.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Local swelling, Pain in extremity, Pruritus
Clinical narrative: Sore, swollen, red, itchy arm. From wrist to shoulder. MD suspects allergic Rxn, but gave Augmentin in case cellulitis was cause of swelling.
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: This spontaneous report as received from a patient's daughter, reporting on her mother of unknown age, who on an unknown date was vaccinated with a dose of PNEUMOVAX23, 2.5 ml instead 0.5 ml. Also the patient experienced injection site pain as well (date not provided). At the time of report the outcome patient and relatedness between injection site pain and PNEUMOVAX23 were not reported. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Urticaria
Clinical narrative: Hives (L) arm within 12 hours. Tx with BENADRYL, ice, CORTAID cream.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Electrocardiogram, Injection site reaction, Local reaction, Loss of consciousness
Clinical narrative: Patient received vaccination and had local reaction at site of injection. Patient complained of lightheadedness and passed out. Called 911 and she was sent to ER for observation.
Age: 71.0
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Musculoskeletal stiffness, Pyrexia, Tremor
Clinical narrative: (1 AM) About 36 hrs after vacine pt reports shaking/tremors w/ slight fever (100 degrees). Shaking was "intense" w/ muscle stiffness. About 1 hr later shaking stopped but fever of 102.9 degrees - was able to go back to sleep but awoke tired and weak w/ temp 100.2 degrees. Temp was back to normal by 9 AM.
Age: 79.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chest discomfort, Dizziness, Nausea, Pyrexia
Clinical narrative: Patient developed fever over 100 degrees, nausea, chest pressure and dizziness. He went to his doctor and he told him to tell the pharmacy.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Rash, Skin warm, Tenderness
Clinical narrative: Patient presented with large bruise rash, and redness with warm tender arm. Called patient MD and patient follow up with MD.
Age: 42.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 42 year old male patient. The patient's relevant medical history and past drug history are unknown. On an unknown date in August 2013, 1 month and 2 days ago the patient was vaccinated with a dose 1 of GARDASIL (lot#, expiry not reported) one injection once for an unknown indication. On 14-SEP-2013, this pharmacist reported that a 42 year old male would receive his second dose of GARDASIL. It was unknown if there was any laboratory data. As of 14-SEP-2013, the patient was planning on getting the second GARDASIL today and the outcome of a 42 year old patient getting the GARDASIL was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Malaise, Mobility decreased, Pallor
Clinical narrative: Pt said she got the vaccine in the afternoon and went to dinner later - after only 1 bite of food, she was pale, weak, couldn't move herself - had to be help carried out to the car, felt sick. She was better the next morning. She's ok now.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Rash generalised, Rash vesicular, Scab, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a licensed practical nurse via a company representative concerning a 4 year old female patient. On 29-AUG-2013, the patient was vaccinated with a dose (dose 1) of PROQUAD (lot number and expiry date were reported as J007859 and 28-DEC-2014 respectively, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in 2013, the patient was diagnosed with chickenpox after receiving PROQUAD (Merck). About 13 days after administration of PROQUAD (Merck), the mother of the patient brought the patient into the office of an unspecified physician. At the time of the visit, the mother of the patient stated that, about 2 weeks prior, spots that resembled bug bites began to appear on the skin of the patient. At the time of the visit, the patient had a varicella-like rash on her legs, her arms, her abdomen, the trunk of her body, the nape of her neck, and her face. At the time of the visit, some of these blisters had already crusted over and other new ones were still cropping up. It was unspecified if any treatment was provided or if any lab tests were performed. It was reported that this was the second dose of varicella vaccine component of the patient 9dose 1 of PROQUAD). She was previously vaccinated with a dose of VARIVAX (Merck) at the 12-15 month recommended range. The outcome of chickenpox was unknown. The relatedness for chickenpox was unknown for PROQUAD (Merck). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: 24 hrs after ZOSTAVAX administration a rash appeared locally on upper arm at administration site. As of 9/15/13 rash better.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Retching, Vomiting
Clinical narrative: Severe vomiting, dry heaving, chills, sweating significant improvement by morning on 9/13.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus
Clinical narrative: 1 hour following injection at 4:15pm patient experienced itching and shortness of breath at 5:15pm. Patient then went to ER.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 22-AUG-2013 the patient was vaccinated with ZOSTAVAX (route and dose unknown) lot # 672608/1715AA  dose 1. No other suspect therapy or concomitant medication was reported. On 22-AUG-2013, the patient was administered an expired dose of ZOSTAVAX that may have also been stored improperly. No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. On 07-SEP-2013 the patient was vaccinated with ZOSTAVAX lot # J003723, subcutaneous. On 07-SEP-2013 the patient stated that the injection site was getting warm and she was feeling discomfort in the local area. The patient went back to the pharmacy on 08-SEP-2013 and was still experiencing the warmth and redness was about 1.5 inches around the injection site. No rash present. The outcome and relatedness were not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old patient. No information regarding the patient's medical history was provided. On 11-SEP-2013 the patient was vaccinated with VARIVAX (Merck) 1350 U, 0.5 ml subcutaneously, with valid lot # 1409AA. The vaccine had been expired on 03-SEP-2013 (reported as 06-SEP-2013 as well). No concomitant medication was reported. No adverse events were reported. No outcome was reported. This case was linked to case # 1309USA008745 (same reporter). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown age patient (gender unknown). Pertinent medical history, drug reactions or allergies were not reported. On 10-SEP-2013, the patient was vaccinated with ZOSTAVAX (concentration, dose and indication were not reported) lot # H011331, expiration date 08-SEP-2013. Concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old patient. No information regarding the patient's medical history was provided. On 11-SEP-2013 the patient was vaccinated with VARIVAX (Merck) 1350 U, 0.5 ml subcutaneously, with valid lot # 1409AA. The vaccine had been expired on 03-SEP-2013 (reported as 06-SEP-2013 as well). No concomitant medication was reported. No adverse events were reported. No outcome was reported. The case was linked to case # 1309USA005691 (same reporter). Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Paraesthesia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 64 year old female patient with penicillin allergy. The patient had a reported history of rash after taking penicillin in the past. The patient's medical history included right kidney damage. On 11-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J003359, expiry: 21-JUN-2014) subcutaneously in the left upper arm. On 11-SEP-2013 in the evening, the patient experienced tingling down her left arm to the fingers. The patient also developed a "50 cent sized" area of redness, swelling, soreness, and warmth at the injection site. On 13-SEP-2013, the patient reported an increase in the tingling sensation. Patient sought medical attention-called the pharmacist. No treatment was given. No laboratory tests were performed. Today, 16-SEP-2013, the patient reported the affected area was still sore but the tingling had improved. The outcome of the events were reported as recovering. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown ages. On an unknown date, the "unknown number of patients" may have received VARIVAX (Merck) (dose, duration, indication and lot number were not provided). No concomitant medications were reported. The reporter stated that the "unknown number of patients" may have received VARIVAX (Merck) that had multiple excursions possibly due to defrost cycles. No adverse effects reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 18 year old male patient. On an unknown date, when the patient was one week of birth, approximately in 1995, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (manufacturer unknown) (Lot #, dose and route not reported) for prevention of hepatitis b. The second through fourth doses of RECOMIBVAX were administered at 6 weeks of age on an unspecified date, the third dose was administered at 9 months of age on an unspecified date and the fourth dose was administered at 5 years of age on an unspecified date. No adverse effect reported. No adverse effect reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Arthralgia, Influenza like illness, Myalgia
Clinical narrative: Onset <12 hrs generalized myalgias, arthralgias, upset stomach ("flu-like symptoms"). No history of similar reaction to prior usual doses.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt was given injection on 09/13/13 - developed redness swelling Rt deltoid on 9/14/13. In the shape of a "Z" about 4 cm long. Treated with LEVAQUIN 500 mg dly x 7 days.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site warmth, Nausea, Pyrexia
Clinical narrative: Pt was given injection on 09/13/13 - developed redness swelling Rt deltoid on 9/14/13. In the shape of a "Z" about 4 cm long. Treated with LEVAQUIN 500 mg dly x 7 days.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abscess, Cellulitis, Culture wound, Injection site mass
Clinical narrative: 7/9/13 Healthy 6 month baby receives vaccinations 9/20/13 Mother calls health center stating a lump noted on baby's leg 1 week after vaccinations. No infection, not warm to touch, not bothering baby. 8/25/13 To urgent care for lump (R) thigh. DX cellulitis and abscess unspecified. Treatment: Keflex.
Age: 0.7
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 month old female patient. On 16-SEP-2013, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB, 5 mcg, lot # 668060/1519Z, expiration date 29-MAR-2013 (route was not provided). On 16-SEP-2013, a dose of RECOMBIVAX HB with expiration date of 29-MAR-2013 was administered. No adverse effect was reported. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
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 an expired dose of ZOSTAVAX 19500 PFU (dose, lot number and route were not reported) (expiration date: January 2013). Concomitant medications were not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients in her facility received doses of GARDASIL (strength, dose, route and lot number were not provided). that may have been exposed to 9C for approximately 8 days. Concomitant medications were not provided. At the time of the report medical assistant did not have access to the vaccination records, or the lot numbers of the doses that were administered. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 61 year old female patient. On 12-SEP-2013, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (Lot # H022280, expiration date 16-JUL-2014), intramuscularly. The pharmacist reported that on 12-SEP-2013, the patient noticed that the injection site was red, swollen, painful to touch and a slight fever had developed. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. At the time of the report, the patient was recovering. This is one of several reports received from the same source. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 48 year old female patient. On 12-SEP-2013, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (Lot # H022280, expiration date 16-JUL-2014), intramuscularly. The pharmacist reported that on 12-SEP-2013, the patient noticed that the injection site was red, swollen, painful to touch and a slight fever had developed. The patient did not receive treatment for the adverse events. There were no lab diagnostics or studies performed. At the time of the report, the patient was recovering. This is one of several reports received from the same source. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 34 year old patient. On 12-SEP-2013, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (Lot # H022280, expiration date 16-JUL-2014), intramuscularly. The pharmacist reported that on 12-SEP-2013, the patient noticed that the injection site was red, swollen, painful to touch and a slight fever ha developed. The patient did not receive treatment for the adverse events. There were no lab diagnostics or studies performed. At the time of the report, the patient was recovering. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a 65 year old female registered nurse with hypertension and no drug reaction/allergies, reporting on behalf of herself. On 11-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose route and lot number not provided) in the left arm. There was no concomitant medication. On 11-SEP-2013 the patient experienced soreness, a big red mark and swollen at the administration site. No treatment was given for the adverse events. No lab diagnostic tests were performed. The outcome of the events was reported as recovering. The casual relationship was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unspecified date in 2007 the patient received the first dose of GARDASIL (Lot #, dose and route not reported). On an unspecified date in 2013, the patient received a second dose of GARDASIL (Lot #, dose and route not reported) and two months later received the third dose of GARDASIL (Lot #, dose and route not reported). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cell marker increased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical history and drug reaction include latex allergy. On 21-FEB-2013 the patient was vaccinated with GARDASIL dose 1. On 22-APR-2013 the patient was vaccinated with GARDASIL dose 2. On 26-AUG-2013 the patient was vaccinated with GARDASIL dose 3. Dose description, concentration and route of administration were not reported. Concomitant medications were not reported. A blood test was performed on an unknown date and the results came back with cancer antigens increased. The outcome of blood cancer antigens increased was reported as not recovered. The relatedness between GARDASIL and cancer antigens increased was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age concerning herself. On 28-MAY-2010 the patient was vaccinated with GARDASIL (route and lot # not provided) dose 1. The patient reported that she received only one dose in the series of GARDASIL, which was other than indicated. No adverse effects were reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Nerve conduction studies
Clinical narrative: Initial report was retrieved from the scientific literature on 12 September 2013. This case is linked to case numbers 2012-10777, 2013-09582, 2013-09583, 2013-09584, 2013-09585 and 2013-09603. A 50-year-old female patient had received an injection of FLUZONE Intradermal (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced chronic inflammatory demyelinating polyneuropathy. The patient had a history of diabetes mellitus and hypertension, but no recent history of respiratory or gastrointestinal infections. Outcome was not reported. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Initial report was retrieved from the scientific literature on 12 September 2013. This case is linked to case numbers 2012-10777, 2013-09582, 2013-09583, 2013-09584, 2013-09585 and 2013-09603. A 50-year-old female patient had received an injection of FLUZONE Intradermal (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced chronic inflammatory demyelinating polyneuropathy. The patient had a history of diabetes mellitus and hypertension, but no recent history of respiratory or gastrointestinal infections. Outcome was not reported. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 19-Feb-2013. The patient experienced EXPIRED FLUMIST ADMINISTERED which started on 19-Feb-2013. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The reporter gave an expired dose of FLUMIST to a patient. The report was considered to be non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 19-Feb-2013. The patient experienced EXPIRED FLUMIST ADMINISTERED which started on 19-Feb-2013. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The reporter gave an expired dose of FLUMIST to a patient. The report was considered to be non-serious.
Age: 0.26
Sex: M
Vaccine: RV5, RV5
Symptoms: Irritability, Vomiting
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 3 month old male patient. Patient had no pertinent medical history or drug reactions/allergies. On 25-JUL-2013 the patient was vaccinated with ROTATEQ lot # H013164, expiry date 01-MAR-2014, dose 1. Dosing information and route of administration were not provided. Concomitantly the patient received TRI-VI-SOL multivitamins. On approximately 01-AUG-2013 the patient experienced vomiting. The patient vomited after every feeding and in between every feeding for the next 2 weeks. The patient's famiy did not bring the patient to the office or consult with the nurse practitioner during this time. The nruse practitioner stated that this was the only vaccine the patient had ever received, as the parents refused to give any other vaccines. Nurse practitioner also stated that the patient received ROTATEQ because other unvaccinated siblings developed rotavirus in the past and were hospitalized as a result. The patient had been free of vomiting since approximately 15-AUG-2013 (reported as the last 19 days, reported on 03-SEP-2013). No treatment was given for the event. No lab diagnostics studies were performed and no intervention was done. Causality assessment was not provided. Additional information has been requested.
Age: 0.26
Sex: M
Vaccine: RV5, RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 3 month old male patient. Patient had no pertinent medical history or drug reactions/allergies. On 25-JUL-2013 the patient was vaccinated with ROTATEQ lot # H013164, expiry date 01-MAR-2014, dose 1. Dosing information and route of administration were not provided. Concomitantly the patient received TRI-VI-SOL multivitamins. On approximately 01-AUG-2013 the patient experienced vomiting. The patient vomited after every feeding and in between every feeding for the next 2 weeks. The patient's famiy did not bring the patient to the office or consult with the nurse practitioner during this time. The nruse practitioner stated that this was the only vaccine the patient had ever received, as the parents refused to give any other vaccines. Nurse practitioner also stated that the patient received ROTATEQ because other unvaccinated siblings developed rotavirus in the past and were hospitalized as a result. The patient had been free of vomiting since approximately 15-AUG-2013 (reported as the last 19 days, reported on 03-SEP-2013). No treatment was given for the event. No lab diagnostics studies were performed and no intervention was done. Causality assessment was not provided. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Cough, Dyspnoea, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Client received flu shot around 3 pm. Client called pharmacy around 6-6:30 pm complaining of chest tightness due to coughing and fever. Client was instructed to take BENADRYL and TYLENOL and to seek medical attention if symptoms worsened to any degree. After follow-up / client's symptoms had resolved completely by the following morning.
Age: 28.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pulmonary congestion, Pyrexia, Tremor
Clinical narrative: Client received flu shot around 3 pm. Client called pharmacy around 6-6:30 pm complaining of chest tightness due to coughing and fever. Client was instructed to take BENADRYL and TYLENOL and to seek medical attention if symptoms worsened to any degree. After follow-up / client's symptoms had resolved completely by the following morning.
Age: 28.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Chest discomfort, Cough, Pyrexia
Clinical narrative: Client received flu shot around 3 pm. Client called pharmacy around 6-6:30 pm complaining of chest tightness due to coughing and fever. Client was instructed to take BENADRYL and TYLENOL and to seek medical attention if symptoms worsened to any degree. After follow-up / client's symptoms had resolved completely by the following morning.
Age: 46.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Unevaluable event
Clinical narrative: Deep aching from shoulder down to hand in left arm. Stiffness in elbow and shoulder. Some numbness in 4th and 5th digits. Still awaiting further testing approval.
Age: 46.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Electromyogram, Hypoaesthesia, Injection site pain, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Deep aching from shoulder down to hand in left arm. Stiffness in elbow and shoulder. Some numbness in 4th and 5th digits. Still awaiting further testing approval.
Age: 46.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Nerve conduction studies, Pain in extremity, Radiculitis brachial
Clinical narrative: Deep aching from shoulder down to hand in left arm. Stiffness in elbow and shoulder. Some numbness in 4th and 5th digits. Still awaiting further testing approval.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: Bruise that about 1 1/2 inch in diameter at the site of flu shot injection.  Round in shape, black and blue in color, at time of report (9/17/2013) according to pt the bruise was fading and wasn't as dark as before. No other symptoms reported. Contacted pt today (9/19/13) and pt reported the bruise is still fading and no other symptoms.
Age: 43.0
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Injection site erythema, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever 102 F developed 24 hours later lasted 1-2 days - also nasal congestion and sore throat (URI vs. vaccine adverse event), also erythema at site of injection appeared at 48 hours later - still evident after 5 days but fading.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Injection site erythema, Injection site swelling
Clinical narrative: Vaccine given on 9/12/13 at approx 3pm. Redness and swelling of (Lt) deltoid where admin the next day. (+) joint pain ever since with increasing intensity - worse today.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Erythema, Headache, Local swelling, Malaise
Clinical narrative: Site of shots, arm swelled, formed a huge knot and large area of arm turned red. Spiked a fever for 3 days of over 102 degrees. Severe headache for 3 days. Severe muscle aches in entire body. Swelling under arm - like mumps. (-) diarrhea. But missed work on Friday and was so sick on Sat, Sun. and still having ill effects on Monday.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Myalgia, Nodule, Pyrexia
Clinical narrative: Site of shots, arm swelled, formed a huge knot and large area of arm turned red. Spiked a fever for 3 days of over 102 degrees. Severe headache for 3 days. Severe muscle aches in entire body. Swelling under arm - like mumps. (-) diarrhea. But missed work on Friday and was so sick on Sat, Sun. and still having ill effects on Monday.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Syncope
Clinical narrative: Initial report was retrieved from a scientific literature on 12 September 2013. This case is linked to case numbers 2012-10777, 2013-09581, 2013-09583, 2013-09584, 2013-09585 and 2013-09603. A pregnant female patient (age range of 25-35 years) had received an injection of FLUZONE Intradermal (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced syncope. Outcome was not reported. Documents held by sender: None.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Crying, Injection site erythema, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Mother reported today at visit that about 3 hours after receiving DTap at the 2 month visit, patient became very fussy and cried inconsolably for approximately 12 hours. He also had fever, and his right thigh was red and swollen. She administered TYLENOL, and the symptoms gradually subsided.
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Exposure during pregnancy
Clinical narrative: Initial report was retrieved from a scientific literature on 12 September 2013. This case is linked to case numbers 2012-10777, 2013-09581, 2013-09582, 2013-09584, 2013-09585 and 2013-09603. A pregnant female patient (age range of 25-35 years) had received an injection of FLUZONE Intradermal (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced seizures. Outcome was not reported. Documents held by sender: None.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Drug administered to patient of inappropriate age
Clinical narrative: Initial report was retrieved from the scientific literature on 12 September 2013. This case also involved misuse (drug administered to patient of inappropriate age). This case is linked to case numbers 2012-10777, 2013-09581, 2013-09582, 2013-09583, 2013-09584 and 2013-09603. A 67-year-old male patient had received an injection of FLUZONE Intradermal (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced anaphylaxis. Outcome was reported as recovered. Documents held by sender: None.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Urticaria
Clinical narrative: Initial case received from a healthcare professional (pharmacist) on 14 September 2013. A 68 year old female patient was administered FLUZONE HD vaccine, batch U4713 intramuscularly on 10 September 2013. The site of vaccination and dosage were not reported. On 10 September 2013, the same day, the patient experienced hives over her entire body and a fever. The temperature and duration was not reported. The patient saw her own healthcare professional on an unspecified date and was treated with doxycycline, dose and route not reported. The patient medical history was reported as an unspecified allergy to latex. Concomitant medications and other medical history were unknown by the reporter. Laboratory tests were not reported. The patient outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Rash generalised, Rash pruritic, Respiration abnormal
Clinical narrative: Initial report was received on 17 September 2013 from a health care professional, who is also the patient. A female patient (date of birth not reported) with a history of allergy to doxycycline had received on 13 September 2013 an intramuscular left deltoid injection of FLUZONE, lot number UH900AC and four hours after vaccination developed a generalized pruritic rash. The patient stated "at 5 am" she developed upper lip swelling. The patient self-medicated with two doses of BENADRYL and four to five hours later she "only had mild upper lip swelling and her breathing was much better". The patient self-medicated with ALLEGRA and symptoms resolved. The patient did not seek physician evaluation. The patient is considering consulting an allergist. Outcome was recovered. Documents held by sender: none.
Age: 1.57
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 213 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 16 September 2013. These 213 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. A case of pertussis disease in a four year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received four doses of PENTACEL; dose one lot number C3287AA received on 04 June 2009, dose two lot number C3299AA received on 14 August 2009, dose three lot number C3471AA received on 09 November 2009 and dose four lot number not reported on 29 October 2010 (routes and sites of administration for all doses not reported). The subject developed cold-like symptoms on 14 August 2013, approximately 33 months after the last dose. On 21 August 2013, the subject developed a cough and paroxysmal cough with whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 04 September 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 04 September 2013 for five days. The subject was not hospitalized. At the time of final contact on 06 September 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.57
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 213 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 16 September 2013. These 213 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. A case of pertussis disease in a four year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received four doses of PENTACEL; dose one lot number C3287AA received on 04 June 2009, dose two lot number C3299AA received on 14 August 2009, dose three lot number C3471AA received on 09 November 2009 and dose four lot number not reported on 29 October 2010 (routes and sites of administration for all doses not reported). The subject developed cold-like symptoms on 14 August 2013, approximately 33 months after the last dose. On 21 August 2013, the subject developed a cough and paroxysmal cough with whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 04 September 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 04 September 2013 for five days. The subject was not hospitalized. At the time of final contact on 06 September 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Electrocardiogram T wave inversion, Electrocardiogram abnormal, Troponin I normal
Clinical narrative: This study case was received from the investigator in a trial on 11 September 2013. A 21-year-old male subject with no reported past medical history had received on 26 August 2013 the following vaccines: ACAM2000 (lot number, route, site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported) and nine days later was found to have on 04 September 2013 possible myopericarditis. The subject presented with one hour of chest pain on 04 September 2013. On 06 September 2013, the subject had an abnormal ECG which revealed inverted T-waves and a normal Troponin I. No further information was available at the time of the report. The subject's outcome was not recovered. According to the investigator, the event of possible myopericarditis was considered mild in severity, an other important event and possibly related to vaccination. Documents held by sender: medical record.