chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash generalised
Clinical narrative: About 5 to 10 minutes after receiving vaccine, patient broke out in a rash. The rash spread throughout the body including face, chest, upper back, wrists, and left leg. Patient was monitored closely for the next 15 minutes at which point some of the rash diminished. Patient was given BENADRYL at 1945.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Bone pain, Chest pain, Headache, Pain
Clinical narrative: 5 hrs after vaccination, legs started to ache. Took Ibuprofen "All my bones ached esp hips and thighs". "Shooting pain in head". Extremely sensitive to touch. "It hurts to touch my hair". No fever. No redness, or swelling or discomfort at site of injection. No cough, sore throat or rash. R chest pains for 3 days. Missed work, saw Dr. Recovered on 4th day.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Tenderness
Clinical narrative: 5 hrs after vaccination, legs started to ache. Took Ibuprofen "All my bones ached esp hips and thighs". "Shooting pain in head". Extremely sensitive to touch. "It hurts to touch my hair". No fever. No redness, or swelling or discomfort at site of injection. No cough, sore throat or rash. R chest pains for 3 days. Missed work, saw Dr. Recovered on 4th day.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Back pain, Mobility decreased, Pain
Clinical narrative: Tdap. Thursday 3 wks ago 6/27. Sore Evening Ibuprofen taken. Hard to raise arm up and lower back down hurts. Area itself feels weak, going on since Ibuprofen seems to help then wears off. Has not applied ice, Can bring arm over head but hurts. Called NP instructed to tell client continue with Ibuprofen apply ice if no improvement. Seek medical attention.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Patient received HPV #2 at 10:05. One to two minutes after it was given, she felt dizzy, and had headache. She was placed on Trendelenburg position and slowly recovered. BP-HR was check every 5 minutes and were normal; she went home after 20 minutes and was well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Dyspnoea, Injection site rash, Rash generalised, Urticaria, Wheezing
Clinical narrative: On 7/15 Received KINRIX in L arm - On 7/16 on awakening at 7 AM mom noted raised rash at site of injection and also chest/arms/legs/back/buttocks. Seen in office at 9:30 AM - Dx urticaria/ no S/S SOB/no wheezing.
Age: 58.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Arthralgia, Discomfort, Insomnia, Myalgia, Restlessness
Clinical narrative: C/o myalgias x 6 wks post injection. Was uncomfortable, hard to be still or sleep. TYLENOL/MOTRIN no effect. Discussed at 6/19/13 visit. Joints burning sensation entire body.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Pt received MMR vaccine on 6/20/13. On 7/16, pt. came to office with (L) jaw gland lymph node swelling, tender, mild fever (per parent), and overlying erythema. Pt. able to talk, open mouth. Pt. given PRELONE 15/5 - 5 mL BID x 5d. Told to use ice, MOTRIN, eat soft foods PRN.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pain in extremity, Swelling
Clinical narrative: Inflammation, erythremia, pain to inferior portion of RT arm. PICC line scars swelled up. This reaction occurred at a different area than where injection was placed.
Age: 18.0
Sex: F
Vaccine: TTOX
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: Pt received tetanus vaccine instead of PPD when receiving TB skin test. Tetanus was given intradermally. Redness and swelling developed at the site no other complication.
Age: 20.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Patient threw up last pill. No other symptoms.
Age: 20.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Vomiting
Clinical narrative: Patient threw up last pill. No other symptoms.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Swelling, Tenderness
Clinical narrative: Patient had increased left arm pain and tenderness with swelling.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Decreased appetite, Dyspnoea, Erythema, Immediate post-injection reaction
Clinical narrative: Immediately following injection a large red swollen hot mass formed followed by a bruise.  The next morning she woke up with a fever up to 103.2 and breathing difficulty.  She did not want to speak says she has mouth sores. Very lethargic.  Does not wish to eat or drink now for 2 days. Phone Dr. office and told to observe and that it is common with a live virus.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Mass, Pyrexia, Skin warm, Stomatitis
Clinical narrative: Immediately following injection a large red swollen hot mass formed followed by a bruise.  The next morning she woke up with a fever up to 103.2 and breathing difficulty.  She did not want to speak says she has mouth sores. Very lethargic.  Does not wish to eat or drink now for 2 days. Phone Dr. office and told to observe and that it is common with a live virus.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Swelling
Clinical narrative: Immediately following injection a large red swollen hot mass formed followed by a bruise.  The next morning she woke up with a fever up to 103.2 and breathing difficulty.  She did not want to speak says she has mouth sores. Very lethargic.  Does not wish to eat or drink now for 2 days. Phone Dr. office and told to observe and that it is common with a live virus.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Patient arrived to clinic at 2:30pm very upset registered for the vaccines. When I called her back to get vaccinated she said she was going to be sick. Father talked to her. Administered shots. She said she was going to faint and vomit. She did lay down. After 10 min felt better sat up for 5-10 min then left. Starting "feeling better".
Age: 37.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: On evening of 11/17/2012 noticed increasing itching and a red area of approx 60mm.  Took Benadryl po at that time.  Itching and redness lasted until approximatly 11/21/2012.  Did not see a physician.
Age: 31.0
Sex: F
Vaccine: HPV2
Symptoms: Discomfort, Oedema, Systemic lupus erythematosus
Clinical narrative: Patient was in vaccine trial (VT) and received 3 doses of HAVRIX; last dose was received 3/29/05. Was closed out of VT 11/12/09 and continued in Crossover Study (from 4/13/10) and Follow-up Study (from 8/1/11). In Crossover Study, patient received 3 doses of CERVARIX (see below) and was closed out 9/28/12. At Follow-up Study visit on 7/12/13, patient reported that symptoms (discomfort, edema) began in June 2013. Was tested at doctor visit on 6/6/13, and dx was systemic lupus erythematosus. Pt received rx and reported she feels fine; condition currently is asymptomatic.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Heart rate increased, Malaise
Clinical narrative: Approx. 3 hrs after vaccine, client c/o dizziness, increased heart rate, and just not feeling well.
Age: 65.0
Sex: F
Vaccine: MMR, TD
Symptoms: Abdominal discomfort, Asthenia, Erythema, Headache, Mobility decreased
Clinical narrative: Swelling and redness of arm.  Pain, limited mobility, weakness, headache, upset stomach, vertigo.
Age: 65.0
Sex: F
Vaccine: MMR, TD
Symptoms: Oedema peripheral, Pain, Vertigo
Clinical narrative: Swelling and redness of arm.  Pain, limited mobility, weakness, headache, upset stomach, vertigo.
Age: 53.0
Sex: F
Vaccine: TYP
Symptoms: Arthralgia, Bursitis, Diarrhoea, Nausea
Clinical narrative: Nausea, diarrhea, bursitis in right knee increasing in pain after each administration of the vaccine. Ice, Aleve, rest.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Headache, nausea, diarrhea, body aches, joint pain.
Age: 12.0
Sex: F
Vaccine: HPV2
Symptoms: Arthralgia, Dizziness, Injection site pain, Insomnia, Mobility decreased
Clinical narrative: Burning at site location. Dizziness, almost fainting. During the night, had trouble sleeping and arm throbbed. The following morning - 07/17/2013 - woke up and arm was in immense pain. Had trouble moving it. Nausea and light headedness. Tingling in fingers.  Upper arm was in pain as was the shoulder joint. Almost fainted. Took daughter back to doctor. Temp and blood pressure was normal. When doctor lifted arm up to side - caused light headedness and dizziness. Took 600 mg ibuprofen, iced shoulder and told to keep hydrated.
Age: 12.0
Sex: F
Vaccine: HPV2
Symptoms: Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Burning at site location. Dizziness, almost fainting. During the night, had trouble sleeping and arm throbbed. The following morning - 07/17/2013 - woke up and arm was in immense pain. Had trouble moving it. Nausea and light headedness. Tingling in fingers.  Upper arm was in pain as was the shoulder joint. Almost fainted. Took daughter back to doctor. Temp and blood pressure was normal. When doctor lifted arm up to side - caused light headedness and dizziness. Took 600 mg ibuprofen, iced shoulder and told to keep hydrated.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed itchy welts on back and buttocks.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Dysphonia, Lip swelling, Neck pain, Skin discolouration, Streptococcus test negative
Clinical narrative: St, throat fullness, voice change, neck pain, color change of face, mild upper lip swelling.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Throat tightness
Clinical narrative: St, throat fullness, voice change, neck pain, color change of face, mild upper lip swelling.
Age: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Blood culture negative, CSF culture negative, Chest X-ray normal, Computerised tomogram head normal, Culture urine negative
Clinical narrative: Complex febrile seizure - fever 103.9 degrees on morning after received DTaP, had multiple prolonged generalized tonic-clonic seizures over 1-2 hrs. EMS to hospital, PICU admit. CT head (-) CSF cx (-).
Age: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Febrile convulsion, Grand mal convulsion, Intensive care, Pyrexia
Clinical narrative: Complex febrile seizure - fever 103.9 degrees on morning after received DTaP, had multiple prolonged generalized tonic-clonic seizures over 1-2 hrs. EMS to hospital, PICU admit. CT head (-) CSF cx (-).
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Back pain, Electromyogram, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Symptoms started with a severe back ache. Admitted to the hospital on 12/12/11 and experienced progressive weakness. Remained hospitalized 11 days.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Back pain, Electromyogram, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Symptoms started with a severe back ache. Admitted to the hospital on 12/12/11 and experienced progressive weakness. Remained hospitalized 11 days.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Symptoms started with a severe back ache. Admitted to the hospital on 12/12/11 and experienced progressive weakness. Remained hospitalized 11 days.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Vaccination site red and sore evening of administration.  Next day pain and redness increased with swelling. Pt. was febrile. MD visit on 7/12/13, prescribed Keflex 500 mg TID for 7 days.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, hot to the touch.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Anaphylactic reaction, Discomfort, Rash
Clinical narrative: Anaphylactic like reaction after DPT leading to 2 urgent care visits and I continue to have disfiguring uncomfortable rash sequelae on hands and face.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Injection site cellulitis, Injection site discolouration, Injection site erythema
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner, refers to herself: a 59 year old female patient. Patient had no pertinent medical history or drug reactions/allergies. On 25-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number not provided) in the left arm for prophylaxis which was recommended by physician. After receiving ZOSTAVAX (exact date in 2013 not provided) the patient experienced a "local reaction" and cellulitis at the injection site that got progressively worse. The nurse stated the injection site reaction progressed to a 3 inch welt that was hard underneath, red and warm to the touch. The nurse stated she felt feverish, had achy joints and 'just felt crappy overall'. ZOSTAVAX was administered to the back of the left arm by an unspecified health department worker. The nurse stated the ZOSTAVAX was pre-drawn into a plastic syringe that may have been left out for more than 30 minutes. ON 03-JUL-2013 the nurse stated she felt much better, however there was still a 1.5 inch area at the injection site that was red and discolored. The nurse also stated that 10 unspecified "co-workers" had the exact same reaction after receiving the pre-drawn syringes of ZOSTAVAX on 25-JUN-2013 (see case 1307USA009035). Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site urticaria, Injection site warmth, Local reaction, Pyrexia
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner, refers to herself: a 59 year old female patient. Patient had no pertinent medical history or drug reactions/allergies. On 25-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number not provided) in the left arm for prophylaxis which was recommended by physician. After receiving ZOSTAVAX (exact date in 2013 not provided) the patient experienced a "local reaction" and cellulitis at the injection site that got progressively worse. The nurse stated the injection site reaction progressed to a 3 inch welt that was hard underneath, red and warm to the touch. The nurse stated she felt feverish, had achy joints and 'just felt crappy overall'. ZOSTAVAX was administered to the back of the left arm by an unspecified health department worker. The nurse stated the ZOSTAVAX was pre-drawn into a plastic syringe that may have been left out for more than 30 minutes. ON 03-JUL-2013 the nurse stated she felt much better, however there was still a 1.5 inch area at the injection site that was red and discolored. The nurse also stated that 10 unspecified "co-workers" had the exact same reaction after receiving the pre-drawn syringes of ZOSTAVAX on 25-JUN-2013 (see case 1307USA009035). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Nausea, Pallor
Clinical narrative: Pt was given vaccines and approximately 5 minutes later he began feeling nauseous, and turned pale in color. Cold water and a cold towel was given, and Dr came in to check on pt. Pt. drank 2 glasses of water in 20 mins. Complexion returned and left w/ father.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Case number PHEH2013US014802 is an initial spontaneous report received from a medical assistant on 10 Jul 2013: This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12002) intramuscularly on 10 Jul 2013. He also received Tdap (other manufacturer, batch number: not reported) on the same time as MENVEO. It was reported that approximately 10 minutes after receiving the vaccine, he passed out. The reporter stated that the patient was seen by a physician and was evaluated. He stayed in the office another 5 minutes and went home with his mother. The reporter stated that the patient had no injury. The outcome of the event was unknown. No further information was provided.
Age: 45.0
Sex: F
Vaccine: RAB, UNK
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Case number PHEH2013US014736 is an initial spontaneous report from the health care professional (patient who is a veterinarian) received on 10 Jul 2013. This report refers to a 45-year-old female patient. She was vaccinated with the booster dose of RABAVERT (batch number: not reported) intramuscularly in the arm on unknown date. It was reported that "vaccine booster doses were administered in each arm" (no information regarding the other booster doses). On 06 Jul 2013 (approximately 8 weeks after vaccination), she had numbness and tingling in the right foot. On 08 Jul 2013, the symptoms continued all day long and during night, symptoms migrated to the right thigh. On 10 Jul 2013, she noticed tingling in the right arm. It was reported that she had perfect strength and had no weakness or lack of coordination. The patient called the neurosurgeon about the symptoms and the physician stated that she might had symptoms of Guillain Barre and told her to observe the symptoms for the next 48 hours and if it continued or worsen, she was requested to consult the physician. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 24.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Cerebral haemorrhage, Concussion, Convulsion, Ear haemorrhage, Fall
Clinical narrative: This case was reported by a healthcare professional (office manager and nurse) and described the occurrence of convulsion in a 24-year-old male subject who was vaccinated with HAVRIX adult (GlaxoSmithKline). Concurrent medical conditions included sulfa allergy. Concurrent vaccination included Tdap; GlaxoSmithKline; unknown; right deltoid given on 15 June 2013. On 15 June 2013 at 10:30 the subject received 1st dose of HAVRIX adult (intramuscular, left deltoid). On 15 June 2013, 10 minutes after vaccination with HAVRIX adult, the subject experienced convulsion, bleeding from inside ear, fall, hit head, concussion, and brain hemorrhage. The nurse reported that the subject "was rubbing his left arm and started to fall forward and then fell backwards and hit his head on the floor." Per the nurse, the subject then "experienced convulsions" and "blood came out of his ear." The subject was "hospitalized for 2 days, and 1 day was spent in the Intensive Care Unit." The subject was diagnosed with a severe concussion and minor brain bleed per the nurse. The nurse suspected HAVRIX "because of the issues they have been encountering within the past month after administering HAVRIX" (see case A1032762A). The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was treated with BENADRYL. At the time of reporting the events were improved. The office manager reported another case with HAVRIX. See case A1033622A for details on the other case.
Age: 24.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Head injury, Intensive care
Clinical narrative: This case was reported by a healthcare professional (office manager and nurse) and described the occurrence of convulsion in a 24-year-old male subject who was vaccinated with HAVRIX adult (GlaxoSmithKline). Concurrent medical conditions included sulfa allergy. Concurrent vaccination included Tdap; GlaxoSmithKline; unknown; right deltoid given on 15 June 2013. On 15 June 2013 at 10:30 the subject received 1st dose of HAVRIX adult (intramuscular, left deltoid). On 15 June 2013, 10 minutes after vaccination with HAVRIX adult, the subject experienced convulsion, bleeding from inside ear, fall, hit head, concussion, and brain hemorrhage. The nurse reported that the subject "was rubbing his left arm and started to fall forward and then fell backwards and hit his head on the floor." Per the nurse, the subject then "experienced convulsions" and "blood came out of his ear." The subject was "hospitalized for 2 days, and 1 day was spent in the Intensive Care Unit." The subject was diagnosed with a severe concussion and minor brain bleed per the nurse. The nurse suspected HAVRIX "because of the issues they have been encountering within the past month after administering HAVRIX" (see case A1032762A). The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was treated with BENADRYL. At the time of reporting the events were improved. The office manager reported another case with HAVRIX. See case A1033622A for details on the other case.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old male patient with diabetes, heart condition (unspecified) and hypertension and no known drug reaction/allergies. On 24-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J000493, subcutaneous, in the left arm, for prevention shingles. Concomitant therapies included nitroglycerin, metformin, glipizide, PROTONIX, enalapril maleate (manufacturer unspecified), VITAMIN D2, CRESTOR, FLOMAX and NORVASC. On 25-JUN-2013, the patient had a black and blue and red area at the injection site, which was also burning and itching. The patient called the pharmacist on 25-JUN-2013 reporting the adverse reaction but was not seen by the pharmacist until 27-JUN-2013. No lab diagnostic tests were performed. On 27-JUN-2013, the pharmacist recommended the patient put ice on the site but provided no further treatment recommendations. The outcome of the events was reported as not recovered. The causal 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 was received from a registered nurse via a company representative concerning 2 patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route unspecified) and waited less than 12 weeks between second and third dose. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. No demographic information was provided. VAQTA (lot number not provided) was improperly stored. The improper storage started on 29-DEC-2012. The improperly stored VAQTA may have been administered to an unspecified number of patients on unspecified dates. No adverse event reported. This is one of several reports received from the same source (other case IDs 1306USA008658, 1307USA008944, 1307USA008945, 1307USA008946, 1307USA008947 and 1307USA008948). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. No demographic information was provided. LIQUID PEDVAXHIB (lot number not provided) was improperly stored. The improper storage started on 29-DEC-2012. The improperly stored LIQUID PEDVAXHIB may have been administered to an unspecified number of patient on unspecified dates. No adverse event reported. This is one of several reports received from the same source (other case IDs 1306USA008658, 1307USA008944, 1307USA008945, 1307USA008946, 1307USA008947 and 1307USA008949). Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site discolouration, Vaccination site discomfort, Vaccination site reaction, Vaccination site swelling
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 62 year old male patient (weight reported as 200). On 30-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported) for the prevention of shingles. Concomitant medications were not reported. On 30-JUN-2013 or 01-JUL-2013 the patient experienced stress in vaccination area, if patient touched it, it was very "milt" and swelling. If the patient looked at it, it looked a little bit of discoloration. The outcome of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 30-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # 0168AE, expiry date: 06-MAR-2013). Dose strength and route were not provided. No concomitant medications were reported. The nurse stated that the dose of ZOSTAVAX was expired. No adverse effects were reported. No further information was available. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Local swelling, Pain in extremity, Tenderness
Clinical narrative: Increased pain in right arm with swelling and tenderness.
Age: 18.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a healthcare student regarding an 18 year old patient (gender unknown). On 15-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001697, 08-MAY-2014) 0.65 ml, subcutaneously instead of a dose of VARVIAX (Merck). The patient had not reported or demonstrated any adverse effects. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Hives about 1 hr after vaccine administered. BENADRYL = treatment.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Influenza, Muscle spasms, Nasal discharge discolouration
Clinical narrative: This solicited report was received and was assigned manufacturer report number 13P-163-1063644-00 for HUMIRA. This was originally reported by a consumer and refers to a 61 year old male patient with hypertension. On 28-JAN-2013 the patient started using HUMIRA (injection, 40 mg) for ankylosing spondylitis. The patient's last HUMIRA injection was on 25-FEB-2013 and he was instructed to skip the 11-MAR-2013 injection due to shingles vaccine administration in the last week of February 2013. In the last week of February 2013 the patient was vaccinated with ZOSTAVAX (manufacturer unknown; reported as "shingles vaccine") and on an unknown date the PNEUMOVAX23 (manufacturer unknown; reported as "pneumonia vaccine"). Concomitant therapies included lisinopril (manufacturer unknown) for "blood pressure", VIAGRA for erectile dysfunction, oxycodone (manufacturer unknown)(30 mg every 4 hours as needed) for pain and PREVACID for acid reflux. On 11-MAR-2013 the patient experienced flu, fever and chills. The patient was advised to contact their physician. The patient will be discontinuing HUMIRA. On 12-MAR-2013 the patient experienced leg cramps, yellow nasal drainage, loss of appetite and body aches. The events were ongoing. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This solicited report was received and was assigned manufacturer report number 13P-163-1063644-00 for HUMIRA. This was originally reported by a consumer and refers to a 61 year old male patient with hypertension. On 28-JAN-2013 the patient started using HUMIRA (injection, 40 mg) for ankylosing spondylitis. The patient's last HUMIRA injection was on 25-FEB-2013 and he was instructed to skip the 11-MAR-2013 injection due to shingles vaccine administration in the last week of February 2013. In the last week of February 2013 the patient was vaccinated with ZOSTAVAX (manufacturer unknown; reported as "shingles vaccine") and on an unknown date the PNEUMOVAX23 (manufacturer unknown; reported as "pneumonia vaccine"). Concomitant therapies included lisinopril (manufacturer unknown) for "blood pressure", VIAGRA for erectile dysfunction, oxycodone (manufacturer unknown)(30 mg every 4 hours as needed) for pain and PREVACID for acid reflux. On 11-MAR-2013 the patient experienced flu, fever and chills. The patient was advised to contact their physician. The patient will be discontinuing HUMIRA. On 12-MAR-2013 the patient experienced leg cramps, yellow nasal drainage, loss of appetite and body aches. The events were ongoing. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fat tissue increased, Myalgia
Clinical narrative: This spontaneous report was received from an 88 year old female patient regarding herself. Current conditions of the patient included thyroid cancer and seasonal allergies. On 11-APR-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant medication included an unspecified antibiotic. Since 11-APR-2012 (also reported as since 01-JAN-2013), the patient developed extra fat around her hips and pain in her joints and muscles since she received ZOSTAVAX. The patient also stated that she preferred to use prescription products rather than over the counter products because over the counter products were hard on her organs. The patient sought an unspecified medical attention. She was treated with antibiotics (unspecified), ALEVE (dosage unspecified). No lab tests were performed. The patient was not recovered from the events at the time of report. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an unspecified number of patients of unknown age and gender. It was reported that on an unknown date, an unspecified number of patients may have vaccinated with a dose of RECOMBIVAX HB (lot number, expiry date, dose and route unspecified) which was exposed to 10 degrees Fahrenheit (F) for 8 hours, which was an excursion that was unsupported by in-house stability data. No concomitant medications were reported. No adverse symptoms were reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck), a pregnancy registry product, concerning a 21 year old female patient with no drug reactions/allergies who on 30-NOV-2011 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck). The patient stated that she was 18 weeks pregnant on 31-DEC-2011. The last menstruation period was approximately 17-AUG-2011, the estimated delivery date would be 23-MAY-2012. The patient was not scheduled to return to the health office and would probably not have further contact with the reporter. Lab: titer after vaccination was positive. It was unknown whether any additional tests were performed.  The patient sought unspecified medical attention. At the time of the report the patients status was unknown.  ***Follow up information has been received concerning the patient who on 30-NOV-2011 was received the first dose of 0.5 ml VARVIAX (Merck) (lot # 670802/0815AA, expired date: 02-JUN-2013) for negative varicella titer. Additional information is not expected. No further information is available.
Age: 27.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dizziness, Dyspnoea, Headache, Palpitations, Rash
Clinical narrative: Patient reports rash/hives left arm and left posterior thigh within hours of receiving vaccine. Also reports intermittent dizziness moderate to severe headache, blurry vision, shortness of breath, palpitations.
Age: 27.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Urticaria, Vision blurred
Clinical narrative: Patient reports rash/hives left arm and left posterior thigh within hours of receiving vaccine. Also reports intermittent dizziness moderate to severe headache, blurry vision, shortness of breath, palpitations.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Hypoaesthesia, Injection site reaction, Rash macular
Clinical narrative: Employee states that after receiving her Zoster on Thursday morning, that afternoon her arm became hot, red with big red splotches at the injection site. States on Sat. and Sun. she experienced numbness. States called her Dr. on Sat. and reported it and was given inst. for comfort measures and reporting.
Age: 35.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Burning sensation, Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Itching, redness, burning, pain and swelling, low grade fever.
Age: 35.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Swelling
Clinical narrative: Itching, redness, burning, pain and swelling, low grade fever.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 25-JUN-2013, the patient was vaccinated with GARDASIL (lot number and expiry date not provided) (route not provided) dose 2. The medical assistant reported that the first dose of GARDASIL was administered on 28-APR-2008 and the second dose on 25-JUN-2013. No adverse effect reported. The outcome of first dose of GARDASIL was administered on 28-APR-2008 and the second dose on 25-JUN-2013 and no adverse effect is unknown. The reporter considered first dose of GARDASIL was administered on 28-APR-2008 and the second dose on 25-JUN-2013 and no adverse effect to be not related to GARDASIL. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a registered nurse via company representative referring to a female patient of unknown age who on 08-MAY-2013, was vaccinated with second dose of PNEUMOVAX 23 (lot # H017759, expiration date 04-JUL-2014). On 22-MAY-2013, the patient developed pneumonia. The outcome of pneumonia was unknown. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus
Clinical narrative: This spontaneous report as received from an approximately 71 year old male patient regarding on himself. The patient concurrent condition included high blood pressure. No drug reaction/allergies were reported. In 2012 the patient was vaccinated with a dose of ZOSTAVAX (dose not reported) for shingles prevention. In approximately March 2013 (reported as "4 months ago exact date unspecified) the patient experienced itching and burning sensation all over his body after receiving ZOSTAVAX. The patient went to physician's office. The patient was treated with Cetaphil (dosage unspecified). No lab diagnostic studies were performed. At the time of the report the patient had not recovered from itching and burning sensation all over his body. All attempts of his dermatologist to alleviate the itching and burning had been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age On 03-JUL-2012 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). The patient received second dose of GARDASIL on 28-MAY-2013 (dose, route and lot # not reported). Patient was in the office on 05-JUL-2013, and physician did not specify if patient will receive the third dose on 05-JUL-2013. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age without any pertinent medical history or drug reactions/allergies. On 13-JUN-2013 the patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot #J00043, expired date: 10-APR-2014). There was no concomitant therapy. It was reported that the patient experienced developed redness, soreness and bruising around injection site on an unspecified date. The patient treated with BENADRYL. There was no diagnostics studies performed. The outcome of all the events was reported as recovering/resolving. The patient sought medical attention by coming to pharmacy. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age without any pertinent medical history or drug reactions/allergies. On 13-JUN-2013 the patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot #J00043, expired date: 10-APR-2014). There was no concomitant therapy. It was reported that the patient experienced developed redness, soreness and bruising around injection site on an unspecified date. The patient treated with BENADRYL. There was no diagnostics studies performed. The outcome of all the events was reported as recovering/resolving. The patient sought medical attention by coming to pharmacy. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a 19 year old female patient with no pertinent medical history reported. On an unknown date the patient was vaccinated with VAQTA (lot number and expiration date not reported) (dose and route not specified). The reporter stated that the patient received a pediatric dose of VAQTA. No adverse reaction reported. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from 2 healthcare workers refers to numerous unspecified patients. No demographic information was provided. RECOMBIVAX HB (lot number not provided) was exposed to 29-35 degrees Fahrenheit multiple times over a period of 3 months. The improper storage started on 29-DEC-2012. The improperly stored RECOMBIVAX HB was administered to numerous unspecified patients on unspecified dates. Reportedly RECOMBIVAX HB was "not supported by in-house stability data". No adverse event reported. This is one of several reports received from the same source (other case IDs 1306USA008658, 1307USA008944, 1307USA008945, 1307USA008947, 1307USA008948 and 1307USA008949). Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. No demographic information was provided. COMVAX (lot number not provided) was improperly stored. The improper storage started on 29-DEC-2012. The improperly stored COMVAX may have been administered to an unspecified number of patients on unspecified dates. No adverse event reported. This is one of several reports from the same source (other case IDs 1306USA008658, 1307USA0089544, 1307USA008945, 1307USA008946, 1307USA008948 and 1307USA008949). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from 2 healthcare workers refers to numerous unspecified patients. No demographic information was provided. PNEUMOVAX23 (lot number not provided) was exposed to 29-35 degrees Fahrenheit multiple times over a period of 3 months. The improper storage started on 29-DEC-2012. The improperly stored PNEUMOVAX23 was administered to numerous unspecified patients on unspecified dates. Reportedly PNEUMOVAX23 was "not supported by in-house stability data". No adverse event reported. This is one of several reports received from the same source (other case IDs 1306USA008658, 1307USA008944, 1307USA008946, 1307SUA008947, 1307USA008948 and 1307USA008949). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Needle issue, No adverse event
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 a dose of ZOSTAVAX (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. It was reported that the patient was administered ZOSTAVAX with a one inch needle. No adverse symptoms reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a health care professional refers to a 49 year old female patient. On 02-NOV-2011, the patient was vaccinated with a first dose of ZOSTAVAX (lot # 671611/1161AA, expiration date 18-OCT-2012) intramuscularly instead of subcutaneously. Additional information has been requested.
Age: 1.95
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 a 23 months old patient of unknown gender. Healthcare worker stated that on 20-MAY-2013, VARIVAX (Merck) (lot number, dose and route were not reported) that was stored improperly, was administered to the patient. Concomitant medications were not reported. Healthcare worker stated that VARIVAX (Merck) was storage with multiple temperature excursions up to 13F since February 2013 (vaccines were received in November 2012) exceeding one week (168 hours), then progressively up to 22F for an estimated 96 hours through June 2013. The healthcare worker did not believe overall temperature was maintained at 5F. No adverse effects reported. This case is linked to cases MARRS # 1307USA002434, 1307USA002437. 1307USA001233, 1307USA002436 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Medical assistant refers to a patient of unknown age and gender. On 09-JUL-2013 the patient was vaccinated with VARIVAX (INJ) (0.5 ml) (lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. The medical assistant reported that the patient received a dose of VARIVAX (Merck) instead of ZOSTAVAX. No adverse effect reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Medical assistant refers to a patient of unknown age and gender. On 09-JUL-2013 the patient was vaccinated with VARIVAX (Merck) (0.5 ml)(lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. The medical assistant reported that the patient received a dose of VARIVAX (Merck) instead of ZOSTAVAX. No adverse effect reported. This is one of two reports from the same source. 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 licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, "several years ago", the patient was vaccinated with the first dose of GARDASIL (Lot #, route and indication not provided); and was in the office on 09-JUL-2013, to receive the second dose of GARDASIL (Lot#, route and indication not provided). No concomitant medication reported. No adverse symptoms were reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 15 year old male patient. The patient had no pertinent medical history and no known drug allergies. On 17-AUG-2004 and 17-FEB-2009, the patient was vaccinated with unspecified VARIVAX (Merck). No lot# was provided. There was no concomitant medication. On 05-JUL-2013, the patient experienced a mild case of chicken pox, without a fever and without a cough. It was also reported that the patient's "mom had shingles" on an unspecified date before the patient developed chicken pox. Patient was treated with acyclovir. The outcome of a mild case of chicken pox, without a fever and without a cough was reported as recovering/resolving. The patient went to physician's office to seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On unspecified dates the patients were vaccinated with GARDASIL (lot number not provided) injections. The patient who had reported having completed her GARDASIL series went for a routine PAP smear and the results showed a high-risk positive PAP which was but 'non HPV 16 and 18'. The outcome of adverse event was unknown. The patient spoke with physician's office for seeking medical attention. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient, who on 10-JUL-2013 was vaccinated with an expired 0.65 ml dose of ZOSTAVAX Lot # 0750AA, expiry date 18-AUG-2012. There was no concomitant medication reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from other (purchaser) refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The reported mentioned that a nurse stated that the patient could have received expired PNEUMOVAX23. No adverse effects reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a 5 years old patient of unknown gender. Healthcare worker stated that on 02-MAY-2013, VARIVAX (Merck) (lot number, dose and route were not reported), that was stored improperly, was administered to the patient. Concomitant medications were not reported. Healthcare worker stated that VARIVAX (Merck) was storage with multiple temperature excursions up to 13F since February 2013 (vaccines were received in November 2012) exceeding one week (168 hours), then progressively up to 22F for an estimated 96 hours through June 2013. The healthcare worker did not believe overall temperature was maintained at 5F. No adverse effects reported. This case is linked to cases MARRS# 1307USA002435, 1307USA002437, 1307USA001233, 1307USA002436 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender with no pertinent medical history reported. On 03-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # 0467AE, expiration date 04-APR-2013), (0.65ml, subcutaneous). No other suspect therapies or concomitant medications were reported. The registered nurse stated that the patient was administered a ZOSTAVAX that had expired. No adverse effect reported. Additional information has been requested.