chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Inflammation, Injected limb mobility decreased, Injection site pain, Local swelling
Clinical narrative: Swelling, inflammation, pain, unable to lift arm - pain at injection site and under armpit toward back.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Pyrexia
Clinical narrative: Cough, shortness of breath, chest tightness, subjective fever, significant h/o coronary disease. Sent to Emergency Department for care.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient returned to office this morning with 10 x 11 in rash on LD. Rash is warm to touch, firm and itches. Advised per Dr. to take BENADRYL and prednisolone as directed and return to clinic if worsening.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Sl. swelling several hrs. after injection. Redness and warmth and itch the next AM.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Headache, Migraine, Nausea
Clinical narrative: Received Tdap vaccine on 9-27-13. Awakened AM at 9-30-13 complaining of migraine, nausea, and "possibly a fever". Mom does not have thermometer to check actual temperature. Headache went away around 5 PM but continued to have upset stomach until 10/1/13 evening. Mother did not contact Doctor's office. States gave her something for headache.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Redness, swelling, knot at site and warm to touch. Patient said has headache and sweating. 1 week after injection. Applied CORTIZONE to site and warm compress.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Redness, swelling, knot at site and warm to touch. Patient said has headache and sweating. 1 week after injection. Applied CORTIZONE to site and warm compress.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Give intradermal vaccine influenza vaccine to 66 yr old licensed for 18-64 yrs.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Erythema, Immediate post-injection reaction, Induration, Skin warm
Clinical narrative: Swelling, erythemia, warmth, induration starting right after injection 5"x7"cm. Temperature 48 hours after injection. Benadryl 50 mg PO QGH PRN; R 20 min, QID
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling, erythemia, warmth, induration starting right after injection 5"x7"cm. Temperature 48 hours after injection. Benadryl 50 mg PO QGH PRN; R 20 min, QID
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Rash generalised, Rash papular
Clinical narrative: Patient states about 3 hours after receiving vaccine she had red, raised, burning, stinging red bumps all over her body that looked similar to chicken pox. Dr. at ER gave her hydroxyzine to help treat symptoms.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Pt. received only the diluent on 9/16/13 of Menveo not the powdered Serotype, revaccinated 10/2/13.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt developed red swelling about palm-sized on left arm (adm. site) x1 day post injection. 11 days later pt said it turned black and blue, pain upon touching. Pt will see PCP in 6 days to elevate.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: PNEUMOVAX and FLUZONE administered on 9-30-13. Patient went to M.D. on 10-2 and was diagnosed with cellulitis and was prescribed cephalexin.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Patient reported of fever early morning of 10/2. Started running fever of 102 degrees F. After notifying MD, they were instructed to stay hydrated and to take TYLENOL to reduce fever. In the afternoon, patient noticed red swollen spot on right arm 5 inches by 7 inches.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Swollen, red thigh, rash.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Haemorrhage, Immediate post-injection reaction, Injection site bruising, Injection site swelling
Clinical narrative: Patient starting bleeding immediately following injection and immediately started bruising/swelling at injection site. She then states she was dizzy.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site swelling
Clinical narrative: Upon administration of IM FLUVIRIN to the left deltoid, swelling hard bump formed immediately after administration.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: 24 after vaccine local swelling, redness, and tenderness. Symptoms began 2 hr after having IM injection.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: Tenderness, redness past 3-4 day normal reaction. (1 week).
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Dizziness, Headache, Nausea
Clinical narrative: 1 hour after vaccine patient was sent to ER due to headache, weakness, dizziness, nausea. She may have had tongue swelling. Her temperature was 101. She received TYLENOL in the ER.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: 2 cm in length area of erythema around vaccine site with mild induration.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Musculoskeletal pain, Neck pain
Clinical narrative: Patient described pain in lower neck and between shoulder blades. Did not feel sick, no fever just didn't feel great.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Local swelling
Clinical narrative: Patient came into pharmacy 9/23 - left arm red and swollen told her to go to clinic - the could not see her had to go to primary - they gave her a shot and oral antibiotic and said it was a "bad infection" - cellulitis.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Rcd vaccine 9/27/13 A.M. 0 Fri and Sat. 9/28/13 - didn't see any unusual symptoms. Sun 9/29 - reddish patch size of deck of cards. Mon - 9/30 hot, red, slight swelling. Tx - KEFLEX 500mg once Q6 hrs.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Moments after receiving flu vaccine, patient passed out for a few seconds. I applied a cool, damp cloth to the patients neck and gave him water as he woke up.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Headache, Nausea, Neck pain
Clinical narrative: Felt pain from shot travel from arm to neck; severe pain in spine (mostly neck area) and painful headache (above the eyebrows) within a few hours of shot. Within 3 hours from shot, felt very nauseous. Injection site checked by NP - okay. Four hours from shot feeling very, very cold - shivering. After 6 hours from shot headache better and nauseous feeling gone, but pain in spine (from neck to lower back) remained for 2 days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Spinal pain
Clinical narrative: Felt pain from shot travel from arm to neck; severe pain in spine (mostly neck area) and painful headache (above the eyebrows) within a few hours of shot. Within 3 hours from shot, felt very nauseous. Injection site checked by NP - okay. Four hours from shot feeling very, very cold - shivering. After 6 hours from shot headache better and nauseous feeling gone, but pain in spine (from neck to lower back) remained for 2 days.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersomnia, Local swelling, Pain in extremity, Skin warm
Clinical narrative: The night after she got the vaccines, she felt her arm was warm and she had pain. She took TYLENOL (325mg) that night. She slept for most of 2 days. Came in to the store. Her arm is very red and warm in 2 places Near both injection sites). Is swollen near the pneumonia site. Still has pain.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient threw up a few hours after vaccine was administered.
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Erythema, Feeling hot, Pain in extremity, Pyrexia
Clinical narrative: Arm felt hot, red, fever, non prod cough 12 hours after injection. Arm very painful for at least 48 hours. Slept most of day the day after injection.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Headache, Palpitations
Clinical narrative: Flu vaccine administered on 9-27. After shot she felt palpitations, weak, headache, dizziness, upset stomach. Each day the symptoms are getting worse.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Injection arm, swollen, red, painful shoulder to elbow. Nausea/vomiting, diarrhea.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Injection arm, swollen, red, painful shoulder to elbow. Nausea/vomiting, diarrhea.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Swelling, Tenderness
Clinical narrative: Red rash from armpit to wrist, swelling, extreme tenderness.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Swollen, red and warm arm.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient came in 9-30-13 and showed me her upper left arm which had a bruise about 6-8 inches long and 2-3 inches wide going down, starting a few inches from her shoulder. She said it started around 9-20-13. She had no pain, itching, or any noticeable swelling.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Myalgia
Clinical narrative: Approximately 3 hours after receiving the vaccine pt started having muscle pain, fatigue, and diarrhea which lasted approximately 48 hours. Pt reported feeling fine before the vaccine was administered.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Myalgia, Vomiting
Clinical narrative: Approximately 3 hours after receiving vaccine pt started having muscle aches, fatigue, diarrhea, and vomiting which lasted approximately 48 hours. Pt reported no illness prior to vaccine administration.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Burning sensation, Chest pain, Contusion, Pain
Clinical narrative: Pt called 10/2/2013 stating he received a flu vaccine and had mild soreness the day of vaccine. The next day he said he experienced burning, bruising, chest pain, back pain, etc. He reported that he did not seek medical attention. He states 12 days later that symptoms are improving.
Sex: U
Vaccine: HPVX, MNQ
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Pt received HPV and MCv4 on L arm, hep A R arm. On 9/24/13 developed swelling, redness and tenderness on L arm. Seen on 9/26/13 - Rocephin IM given for possible cellulitis. Rocephin given again 9/27/13. Phone call 9/30/13 swelling resolved. No redness or tenderness. Returned to school.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure normal, Chest discomfort, Dizziness, Dry mouth
Clinical narrative: After vaccine pt. stated she felt light headed and had a dry mouth. She said she was having some tightness in her chest. We called her Dr. and they instructed her to go to ER. Pt went home and ate and laid down.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Pain
Clinical narrative: Felt dizzy, nauseous, achy.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMR, VARCEL
Symptoms: Cough, Croup infectious, Stridor
Clinical narrative: Developed cough on 9/20/13 after receiving FLUMIST on 9/17/13. Dx with croup at clinic on 9/22/13. Seen in office 9/23/13 with persistent croup and stridor. Given prednisolone x3 days.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough
Clinical narrative: Mom reported that child received FLUMIST in school on 9/30/2013 given by health dept. 10/1/13 he awoke with croupy cough.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Stridor
Clinical narrative: FLUMIST administered 9/25/13 when seen for mild URI sxs. Onset barky cough 9/27/13AM stridor with cough. Given prednisolone x3 days. OV again 9/30/13 for persistent cough. Albuterol inhaler prescribed.
Sex: F
Vaccine: HEP, TDAP
Symptoms: Axillary pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of axillary arm pain in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included hepatitis B vaccine recombinant; GlaxoSmithKline; unknown; unknown given on 2 October 2012. Concurrent medications included TUBERSOL. On 2 October 2012 at 08:30 the subject received unspecified dose of BOOSTRIX (.5 cc, unknown, left arm). On 4 October 2012, 2 days after vaccination with BOOSTRIX, the subject experienced axillary arm pain. The subject is a staff member who was vaccinated on 02 October 2012 and complained of pain in her left axilla area that has moved around to the front. It started two days after the vaccination and has become worse each day especially at night time. The reporting healthcare professional did not think it was related to the vaccination. The reporter was unsure if the subject received a hepatitis B vaccine on the same day, if she was given the hepatitis B vaccine it was a GSK vaccine. At the time of reporting the axilla arm pain was worse. The healthcare professional considered the event was unrelated to vaccination with BOOSTRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pain
Clinical narrative: This spontaneous report as received from pharmacist refers to a female patient of unknown age with an unspecified pre-existing medical condition. Within the last week, in approximately September 2013, the patient was vaccinated with ZOSTAVAX, (dose, route and lot number were not reported). Concomitant medications were not reported. The pharmacist reported that the patient developed pain and inflammation from a pre-existing medical condition (name of pre-existing medical condition was unspecified) a few days after a vaccination with ZOSTAVAX, in September 2013. The outcome of pain and inflammation was unknown. The relationship between ZOSTAVAX and the events was not reported. Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 55 year old male patient with high cholesterol. On 22-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route: Not provided). Concomitant therapies included pravastatin sodium and carisoprodol. The pharmacist reported that a patient developed shingles following vaccination with ZOSTAVAX (onset date: not provided). The pharmcist reported that the patient had a current case of shingles (start date of the current case of shingles was unspecified) and had at least one other prior case of shingles (date unspecified) since vaccination with ZOSTAVAX. The pharmacist was unsure if the patient had a history of shingles prior to vaccination with ZOSTAVAX. The patient was treated with valacyclovir hydrochloride. Patient's outcome was reported as not recovered. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Myalgia, Neuralgia
Clinical narrative: This spontaneous report as received from a consumer on behalf of her sister, a 61 year old female patient. The patient had shingles twice before receiving ZOSTAVAX however the cases of shingles had resolved before receiving the ZOSTAVAX. Patient had no drug reactions/allergies. On 19-SEP-2013 the patient was vaccinated with ZOSTAVAX in the left upper arm, lot #, dose, route, frequency and indication unspecified. On 24-SEP-2013, the patient experienced nerve and muscular pain. She self-diagnosed that she had Shingles again however no rash has developed. No treatment had been given for the events, and no lab diagnostics studies performed. The patient did not seek medical attention. The outcome of the events was reported as not recovered/not resolved. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a Physician Assistant refers to a 75 year old female patient. The patient's current condition included peripheral arterial disease and hypertension. The patient had drug reaction/allergy to Statin (unspecified) and Armour Thyroi, and the reaction was myalgia. On 23-NOV-2102 the patient was vaccinated with a dose of ZOSTAVAX, (lot # unspecified) 0.65, subcutaneously. Concomitant medication included blood pressure medications. Approximately on 14-SEP-2013, the patient developed shingles  specifically, rash that followed dermatome. Patient sought medical attention with the Physician Assistant and was prescribed Acyclovir and Prednisone as treatment. The event was reported as recovering/resolving with treatment. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age with not pertinent medical history, allergies or drug reactions. On September 2013, the patient was vaccinated with PNEUMOVAX23 (lot # J007059; expiration date, 31-JUL-2013) 0.5 ml, intramuscular, applied in her left deltoid. There were not concomitant medications by the time of the report. On September 2013, the patient experienced a fever with redness and swelling at the administration site within 24 to 72 hours of administration. Treatment recommended over the phone was ice and TYLENOL. Diagnostic studies were not performed. The outcome of the events was reported as recovered. The relatedness between the events and PNEUMOVAX23 was not reported. A lot check was requested by medical assistant. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 years old male patient, who on 16-SEP-2013 was vaccinated with PROQUAD (lot number were not reported) 0.5 ml subcutaneous for vaccination (outside of prescribing information). Concomitant medications were not reported. No adverse effects reported. Patient did not seek medical attention. Nurse noted that patient was new to the country of the report. This case is linked to case 1310USA001432 via same reporter link. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 65 year old male patient with no drug reactions or allergies. Current condition of the patient included hypertension. On 22-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J004269 and 12-JUL-2014 respectively), subcutaneously in the right upper arm. Concomitant therapies included hydrochlorothiazide, LISINOPRIL, amlodipine, MOBIC, simvastatin (manufacturer unknown) and potassium supplement (unspecified). Approximately on an unknown date in September 2013, the patient developed a red rash at the injection site. The area of the rash was about the size of a quarter. There was no pain or itching. The patient sought medical attention (came into pharmacy). No treatment was provided and no lab tests were performed. The patient was not recovered from the red rash at the injection site at the time of report. The relatedness for red rash at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 years old patient (gender unknown), who on 16-SEP-2013 was vaccinated with PROQUAD (lot number were not reported) 0.5 ml, subcutaneous (outside of prescribing information). Concomitant medications were not reported. No adverse effects reported. Nurse noted that patient was new to the country of the report. This case is linked to case 1309USA008084 via same reporter link. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No symptoms were reported. Follow-up received from the registered nurse. Lot # of RECOMBIVAX HB were reported as: lot # 1741AA, expiration date 27-JUN-2014 and lot # H017304, expiration date 11-JUN-2015. The RECOMBIVAX HB was administered to a 2 month old patient, gender unspecified. Dates of vaccination were unknown. This is one of the several reports from the same source. Additional information has been requested.
Age: 0.02
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No symptoms were reported. Follow-up received. Lot# of RECOMBIVAX HB were reported as : lot# 1741AA, expiration date 27-JUN-2014 and lot# H107304, expiration date 11-JUN-2015. RECOMBIVAX HB was administered to a 2 month old patient, gender unspecified. This is one of the several reports from the same source. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a 62 year old male patient with no pertinent medical history. Current conditions of the patient included GARAMYCIN allergy and unspecified allergic reaction. On 15-SEP-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J001698 and 08-MAY-2014 (also reported as 01-JAN-2014) respectively), subcutaneously. There were no concomitant medications. Approximately on an unknown date in September 2013, the patient developed a welt, currently 2 inch x 1 inch at the injection site and has had the welt for approximately one week. It was also reported that the welt had become larger over that time-frame but the patient had no complaints of pain or itching. The patient sought medical attention (at pharmacy). No treatment was given. No lab tests were performed. The patient was not recovered from the event at the time of report. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Patient developed severe urticarial reaction after vaccine admnistration.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Lung disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient with lung infection and diltiazem (manufacturer unknown) allergy (MARRS #). The patient's medical history included Chronic Obstructive Pulmonary Disease (COPD). On 11-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J002242, 21-MAY-2014) 0.65 ml, subcutaneous. Concomitant therapies included Levothyroxine sodium (manufacturer unknown), Levofloxacin, DEXILANT, Atenolol, Digoxin and SPIRIVA. Pharmacist stated that on 12-SEP-2013 patient visited physician for a "lung issue". Physician prescribed patient to receive Prednisone (manufacturer unknown0 for lung issue. Pharmacist stated patient had a history of COPD and had received a MEDROL dose pack for an unspecified lung infection the month prior to ZOSTAVAX administration, in approximately August 2013. Pharmacist stated "seems patient had been battling a lung infection for a few months". The outcome of lung issue was not reported. The relationship between ZOSTAVAX and the lung issue was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Injection site nodule, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nodule injection site in a 62-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included influenza vaccine; manufacturer unspecified; unknown; left arm given on 9 October 2012. On 9 October 2012 the subject received a dose of BOOSTRIX (unknown route, right arm). In October 2012, less than one week after vaccination with BOOSTRIX, the subject experienced nodule injection site and injection site pruritus. At the time of reporting, the events were unresolved. "The arm where BOOSTRIX was given developed a knot which had not gone away and it is now itching."
Sex: F
Vaccine: TDAP
Symptoms: Tinnitus
Clinical narrative: This case was reported by a pharmacist (subject) and described the occurrence of tinnitus in an adult female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). In 2012 the subject received a dose of BOOSTRIX (unknown details). In 2012, within months of vaccination with BOOSTRIX, the subject experienced tinnitus. The subject stated that she received BOOSTRIX "a few months ago" and has been experiencing "ringing in the ears/tinnitus". She described it as "not going away, there all the time and feels like bees buzzing in her head." The pharmacist attributes the adverse event to a BOOSTRIX vaccination [possibly related to BOOSTRIX vaccination]. At the time of reporting the event was unresolved.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site reaction, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 5 November 2012 the subject received 1st dose of BOOSTRIX (.5 ml, unknown, left arm). On 5 November 2012, within hours of vaccination with BOOSTRIX, the subject experienced injection site pain and welt injection site. The subject received BOOSTRIX on 05 November 2012. The subject was seen at the office on 07 November complaining of welt at the injection site and tender/pain at the injection site. The subject was instructed to apply cold compresses and over the counter NSAIDS. At the time of the report no additional information was available. At the time of reporting the outcome of the injection site pain and welt injection site was unspecified.
Sex: U
Vaccine: TDAP
Symptoms: Injection site joint effusion
Clinical narrative: This case was reported by a physician and described the occurrence of injection site joint effusion in an adult subject of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown details). At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site joint effusion. The physician stated that the joint effusion was "near" the injection site. The physician also documented that the subject did not experienced fever. The lot number was reported as AC528103AA; however, based on lot number characterization, this lot number is incorrect and the correct lot number will be verified. At the time of reporting the outcome of the event was unspecified. This physician reported three cases of adverse events with BOOSTRIX. See cases A1010985A and A1010984A for details on the other cases. Follow up received from Vaccine Safety on 8 March 2013. The lot number reported as AC528103AA from the reporter; however, based on a safety lot number review, the lot number was updated to AC52B103AA.
Sex: U
Vaccine: MMR, TDAP
Symptoms: Injection site joint effusion
Clinical narrative: This case was reported by a physician and described the occurrence of injection site joint effusion in an adult subject of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline), MMR vaccine (non-gsk). On an unspecified date the subject received a dose of BOOSTRIX (unknown route, unknown arm), unspecified dose of MMR vaccine (Non-GSK) (unknown route, unknown arm). The physician reported that both vaccinations were in the same arm. At an unspecified time after vaccination with BOOSTRIX and MMR vaccine (Non-GSK), the subject experienced injection site joint effusion. The physician described "shoulder effusion at injection site but no hematoma." The physician described this event as "severe". The lot number was reported as AC528103AA; however, based on lot number characterization, this lot number is incorrect and the correct lot number will be verified. At the time of reporting the outcome of the event was unspecified. This physician reported three cases of adverse events with BOOSTRIX. See cases A1010984AA and A1010986A for details on the other cases. Follow up received from Vaccine Safety on 8 March 2013. The lot number reported was AC528103AA from the reporter; however, based on the safety lot number review, the lot number was updated to AC52B103AA.
Sex: U
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician and described the occurrence of injection site pain in an adult subject of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown details). Forty-eight hours after vaccination with BOOSTRIX, the subject experienced injection site pain. At the time of reporting the event was resolved. The physician stated that the injection site pain "spontaneously resolved 24 hours later (72 hours after injection)." The lot number was reported as AC528103AA; however, based on lot number characterization, this lot number is incorrect and the correct lot number will be verified. This physician reported three cases of adverse events with BOOSTRIX. See cases A1010985A and A1010986A for details on the other cases. Follow up received from Vaccine Safety on 8 March 2013. The lot number reported was AC528103AA from the reporter; however, based on a safety lot number review, the lot number was updated to AC52B103AA.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site itching over arm in a 74-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other healthcare professional has not verified this report. On the morning of 4 February 2013 the subject received a dose of BOOSTRIX (.5 ml, unknown route, right arm). On the morning of 4 February 2013, within hours of vaccination with BOOSTRIX, the subject experienced injection site itching over arm. The subject described "itchiness on top of right arm (vaccinated arm)." At the time of reporting, no treatment had been rendered. At the time of reporting the outcome of the event was unspecified.
Age: 33.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Rash generalised, Rash papular, Rash pruritic
Clinical narrative: This case was reported by a healthcare professional (certified medical assistant) via a sales representative and described the occurrence of diffuse rash in a 33-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), FLUARIX. On 28 January 2013 at 12:00 the subject received a dose of BOOSTRIX (.5 ml, unknown route, unknown deltoid). On 28 January 2013 the subject received a dose of FLUARIX (unknown route, unknown deltoid). On 28 January 2013, 4 hours after vaccination with BOOSTRIX and FLUARIX, the subject experienced diffuse rash, itching, and raised rash. The subject described the diffuse rash as "raised" and experienced itching on "his trunk, back and both arms." The subject was treated with BENADRYL 50mg. On 30 January 2013, 2 days after vaccination with BOOSTRIX and FLUARIX, the subject reported to the physician's office that he experienced injection site pain; however, it was unclear as to which injection site or both. The subject also reported to the physician's office that the rash had "disappeared, but comes back at night. The BENADRYL helps the rash." The subject was advised to stay on BENADRYL and contact the physician if the rash "persists to come back." At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX and FLUARIX.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist and described the occurrence of raised bump at injections site in a 30-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 17 January 2013 at 9:00 the subject received 1st dose of BOOSTRIX (unknown route, right arm). On 17 January 2013, "within" 2 hours after vaccination with BOOSTRIX, the subject experienced raised bump at injection site and hotness at injections site. The subject "noticed a raised bump on her arm. The bump was giving off some heat/fever like sensation (hotness at injections)." At the time of reporting the events were unresolved. The pharmacist considered the events were possibly related to vaccination with BOOSTRIX. Case correction on 8 February 2013. The lot number from the reporter was incorrectly reported as AC52B099AA. Upon lot number review, this lot number has been corrected as AC52B099AA.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer (subject's wife) and described the occurrence of sore arm (injection site) in a 35-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. In 2012, "6 months ago", the subject received a dose of BOOSTRIX (unknown details, unknown arm). In 2012, less than one week after vaccination with BOOSTRIX, the subject experienced sore arm (injection site). In 2012, the event was resolved. The reporter stated that the subject "had a sore arm for a week and a half after receiving the BOOSTRIX vaccine." The consumer reported two cases with events after vaccination with BOOSTRIX. See case A1005931A for details on the other case.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site soreness-muscle in a 65-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included seasonal influenza vaccine (non-gsk); Novartis; unknown; unknown given on 6 December 2012. On 7 December 2012 at 11:20 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left arm). On 7 December 2012, less than one day after vaccination with BOOSTRIX, the subject experienced injection site soreness-muscle described as "sore muscle and tender muscle and surrounding area". On 8 December 2012, 1 day after vaccination with BOOSTRIX, the subject experienced shoulder pain in injection arm. "By the weekend, she experienced "pain left shoulder" also described as "left shoulder joint pain." At the time of reporting the events of shoulder pain in injection arm and injection site soreness-muscle were worse. The pharmacist stated that there was an "increase in the pain left shoulder and the site is getting progressive worse" but also reported that the "tenderness has subsided." The sore muscle was reported as unresolved. No further information was provided at the time of reporting. The pharmacist considered the events were possibly related to vaccination with BOOSTRIX.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered, Incorrect route of drug administration, Injection site erythema, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of injections site redness in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to Phenergan. Concurrent vaccination included BOOSTRIX; GlaxoSmithKline; intramuscular; right deltoid given on 29 November 2012. Concurrent medications included Birth control. On 29 November 2012 at 17:30 the subject received a dose of BOOSTRIX (.1 ml, intradermal, right forearm) and experienced inappropriate route of vaccination, wrong vaccine administered. The reporter stated that "she had the BOOSTRIX and Tuberculin test sitting beside each other. She picked up the BOOSTRIX and withdrew 0.1 mls which was administered intradermally in the right forearm." On 29 November 2012, within minutes of vaccination with intradermally administered BOOSTRIX, the subject experienced injections site redness. The reporter stated that the subject "started rubbing her forearm and the area turned red." On 29 November 2012, the subject received a dose of BOOSTRIX (0.5ml, intramuscularly, right deltoid) and experienced overdose. The subject received more BOOSTRIX antigen than indicated on the same date. The nurse practitioner provided subject with the BOOSTRIX intramuscularly when she realized what she had done. At the time of reporting the event was resolved. The reporter stated that "after 5 hours, there was no problem with her right forearm where the BOOSTRIX was accidentally administered intradermally."
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pain, Ultrasound antenatal screen normal
Clinical narrative: This prospective pregnancy case was reported by a consumer and described the occurrence of sore arm (injection site) in a 31-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. The subject's medical history included no previous pregnancies. The subject was not using contraception. The conception was normal. There was no maternal medical history that may have an impact on the outcome of this pregnancy. On 10 December 2012 the subject received a dose of BOOSTRIX (unknown details, right arm) and experienced vaccine exposure during the third trimester of pregnancy. The gestational age at the time of vaccination was calculated to be approximately 29 weeks. Date of last menstrual period was reported as May 2012 with an estimated delivery date reported as 24 February 2013. Relevant test results included an ultrasound at 18 weeks gestation. There was no evidence of a defect from prenatal testing. At the time of the report, the pregnancy was ongoing. On 11 December 2012, 1 day after vaccination with BOOSTRIX, the subject experienced sore arm (injection site). The reporter considered the event to be related to vaccination with BOOSTRIX. The reporter also stated that the event was not the result of transmission of an infectious agent via a medicinal product. Relevant test results included an ultrasound examination at 18 weeks gestation. At the time of reporting the event was unresolved. The consumer reported two cases with events after vaccination with BOOSTRIX. See case A1005930A for details on the other case. 06 May 2013 - No further information provided; patient lost to follow-up.
Age: 70.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of musculoskeletal pain in a 70-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), seasonal influenza vaccine (non-gsk). On 29 October 2012 at 09:00 the subject received booster dose of BOOSTRIX (.5 ml, unknown, right deltoid) and seasonal influenza vaccine (Non-GSK) (unknown). On 1 November 2012, 3 days after vaccination with BOOSTRIX and seasonal influenza vaccine (Non-GSK), the subject experienced musculoskeletal pain. The subject experienced musculoskeletal pain around her rib and pain when turning her neck which radiates to her back and chest. The healthcare professional did not know if the influenza vaccination that the subject received was also a co-suspect vaccine. At the time of reporting the event was unresolved.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test positive, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of whooping cough in a 27-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included eczema. There were no concurrent medications. On 5 May 2012 the subject received unspecified dose of BOOSTRIX (unknown, right arm). On 23 July 2012, 79 days after vaccination with BOOSTRIX, the subject experienced whooping cough and vaccination failure. This case was assessed as medically serious by GSK. The subject stated that she began to experience symptoms on 23 July 2012 and that whooping cough was confirmed by nasal swab on 06 August 2012. She stated that her healthcare provider prescribed her antibiotics. At the time of reporting the whooping cough was unresolved. Follow-up information as received on 05 November 2012 via physician who reported "the patient has not received any vaccination in our office. She either received the vaccine in the hospital or from another physician. Please contact the patient." No other information was provided.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: 4mm blister at injection site. Received vaccination on Thurs. 9/26 and noticed blister on Sunday 9/29. Use antibiotic ointment on Monday 9/30. No pain with blister.
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of fever in a male subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown route, unknown arm). At an unspecified time after vaccination with BOOSTRIX, the subject experienced fever and injection site warmth. The subject's wife described to the pharmacist "a 4 inch band around his arm that was warm to touch." The pharmacist stated that the vaccination was administered at a different location from her pharmacy. Relevant test results included body temperature of 101 degrees Fahrenheit. At the time of reporting the outcome of the events was unspecified. The pharmacist reported another adverse event with BOOSTRIX for the subject's wife. The subject's wife had contacted the pharmacist. See case A0997904A for details.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Fatigue, Hypersensitivity, Pain, Pain in extremity
Clinical narrative: This was reported by a pharmacist and described the occurrence of low grade fever in a 30-year-old male subject who was vaccinated with BOOSTRIX. On 1 May 2013 at 19:30 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, left arm). Lot number was reported as "739Y2". On 2 May 2013, less than on one day after vaccination with BOOSTRIX, the subject experienced low grade fever, tiredness, sore left arm, upper body pains and back pain. The pharmacist reported that a subject vaccinated on 01 May 2013 at 19:30 and called on 02 May 2013 at 14:30 to report the adverse events. No other details were available at the time of the report. At the time of reporting the outcome of the low grade fever, tiredness, sore left arm, upper body pains and back pain were unspecified. The pharmacist considered the events were probably related to vaccination with BOOSTRIX. Follow-up information was received on 03 June 2013 via healthcare professional who reported the subject had an allergic reaction or severe side effect on 02 May 2013 after receiving IM vaccination of BOOSTRIX. The events resolved on 04 May 2013. The reporting healthcare professional attributed the events to "just had a baby. Probably lack of sleep and tiredness post-partum delivery". No laboratory tests were performed. The reporting healthcare professional considered the events probably related to vaccination with BOOSTRIX, but did not consider them to be serious.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: This was reported by a pharmacist and described the occurrence of low grade fever in a 30-year-old male subject who was vaccinated with BOOSTRIX. On 1 May 2013 at 19:30 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, left arm). Lot number was reported as "739Y2". On 2 May 2013, less than on one day after vaccination with BOOSTRIX, the subject experienced low grade fever, tiredness, sore left arm, upper body pains and back pain. The pharmacist reported that a subject vaccinated on 01 May 2013 at 19:30 and called on 02 May 2013 at 14:30 to report the adverse events. No other details were available at the time of the report. At the time of reporting the outcome of the low grade fever, tiredness, sore left arm, upper body pains and back pain were unspecified. The pharmacist considered the events were probably related to vaccination with BOOSTRIX. Follow-up information was received on 03 June 2013 via healthcare professional who reported the subject had an allergic reaction or severe side effect on 02 May 2013 after receiving IM vaccination of BOOSTRIX. The events resolved on 04 May 2013. The reporting healthcare professional attributed the events to "just had a baby. Probably lack of sleep and tiredness post-partum delivery". No laboratory tests were performed. The reporting healthcare professional considered the events probably related to vaccination with BOOSTRIX, but did not consider them to be serious.
Age: 50.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer and described the occurrence of sore arm (injection site) in a 50-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included seasonal influenza vaccine (non-gsk); Novartis; unknown, right arm given on 3 October 2012. Concurrent medications included Spironolactone, Citalopram, Bupropion and Multi Vitamin. On 3 October 2012 the subject received a dose of BOOSTRIX (unknown route, left arm). On 4 October 2012, less than one day after vaccination with BOOSTRIX, the subject experienced sore arm (injection site), erythema of arm at injection site and arm swelling (injection site). On 8 October 2012, the subject experienced "spreading of redness on arm hot to touch" (injection site hot to touch). The subject reported that the injection site soreness of arm was resolved on 7 October 2012. At the time of reporting the subject stated that the injection site swelling and injection site redness of the arm had improved. At the time of reporting the "spreading of redness on arm hot to touch" (injection site hot to touch) was worse.