chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 51 year old female patient with no drug reactions and allergies. On 26-APR-2013 the patient was vaccinated with PNEUMOVAX23 (lot number, route and dose were not reported). Concomitant medication included OTC for pain relief/unspecified and antibiotics unspecified. The nurse at physician office stated patient presented with "joint pain, body aches all over, fever, soreness, and swelling with rash at the injection site" with an onset on 27-APR-2013. Lab diagnostics studies performed on 27-APR-2013 included full blood cells count (white blood cells count was 12.5), (white blood cells count was 5.5 on 12-APR-2013). It was also reported that patient did not seek medical attention. The outcome of events is unknown. 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 physician refers to a patient of unknown age and gender. On 01-MAR-2013 the patient was vaccinated with VAQTA (lot # 0273AE and expiration date 06-DEC-2014) (dose, therapy route and anatomical location unspecified). The physician reported that VAQTA was exposed to multiple low temperature excursions. Excursion time at -1:18:50 hours. The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site reaction, Oropharyngeal pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with edema/swelling and no drug reactions or allergies. on 07-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number # J000446, expiry date was 11-APR-2014 and dose was not reported), subcutaneous in the right arm. Concomitant therapies included gabapentin, prednisone, furosemide, and simvastatin. On 10-APR-2013, the patient felt tired, and had chills and a high fever and also had a "dime injection site reaction". On 13-APR-2013, the patient woke up with "post nasal drip and a sore throat with headache". Approximately on an unknown date in May 2013 (reported as currently) the patient has a raspy throat. Diagnostic test was unknown. The patient sought no medical attention and no treatment was provided. Raspy throat was not recovered/not resolved. The outcome of felt tired, had chills and a high fever, had a "dime injection site reaction" and "post nasal drip and a sore throat with headache" was reported as recovering/resolving. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Throat irritation, Upper-airway cough syndrome
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with edema/swelling and no drug reactions or allergies. on 07-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number # J000446, expiry date was 11-APR-2014 and dose was not reported), subcutaneous in the right arm. Concomitant therapies included gabapentin, prednisone, furosemide, and simvastatin. On 10-APR-2013, the patient felt tired, and had chills and a high fever and also had a "dime injection site reaction". On 13-APR-2013, the patient woke up with "post nasal drip and a sore throat with headache". Approximately on an unknown date in May 2013 (reported as currently) the patient has a raspy throat. Diagnostic test was unknown. The patient sought no medical attention and no treatment was provided. Raspy throat was not recovered/not resolved. The outcome of felt tired, had chills and a high fever, had a "dime injection site reaction" and "post nasal drip and a sore throat with headache" was reported as recovering/resolving. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from Registered Nurse via field representative refers to a 6 year old male patient. On an unknown date the patient was vaccinated with the second dose of VARIVAX (Merck) (route of administration and dosage unknown) (lot number and expiration date not provided). After unspecified amount of time from the second dose of VARIVAX (Merck) the patient experienced varicella breakthrough. The outcome of varicella breakthrough was reported as not recovered. The patient sought medical attention via office visit. The relatedness between headache and of VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 15.0
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 15 year old male patient. On an unknown date the patient was vaccinated with PROQUAD (dose and lot # were unknown) subcutaneously. No adverse effect reported. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: HEP, TDAP, YF
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: 5/7/13 Administered Yellow Fever, Tdap, Hep B, PPD. YF administered at 0830 remaining shots 30 min later. Pt experienced whole body itching and hives approx. 8 hours later. Went to urgent care facility and got meds.
Age: 1.91
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pyrexia
Clinical narrative: Mother called 4-12-13 and said running fever of 104. Advised not typical reaction. Child needs to see MD.
Age: 1.11
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: Patient taken to ER d/t seizure activity possibly from vaccines given the day before.
Age: 30.0
Sex: M
Vaccine: HEPAB, MMR, TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Client states on Thursday (4/11) he begin to have fever, headache and body aches.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Approximately 61 hours after administration, client presented to clinic with non-irritating, non-itchy rash over bilateral arms and trunk. Injection site demonstrates erythema and swelling of 35mm. Denies fever, trouble breathing. Education provided.
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. On 06-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # 6169AE, exp date 06-MAR-2013),  0.65 ml, subcutaneous (anatomical location unspecified). The Registered Nurse reported that patient received an expired dose of ZOSTAVAX. No adverse effects reported. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 1.51
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever 104. Febrile seizure.
Sex: M
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report as received from a consumer refers to her son, a male patient of unknown age. On 19-MAR-2013 the patient was vaccinated with a first dose of GARDASIL (route and lot number were not reported). No other concomitant medications were reported. The reporter stated the patient did not have any warts on his hand before getting the vaccine, and about 3-4 weeks ago, in approximately on 02-APR-2013 the patient developed one wart on his hand. The patient had been to see a dermatologist. The outcome of wart on his hand was reported as not recovered. The relationship between GARDASIL and the wart on his hand was unknown. Additional information is not expected.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying
Clinical narrative: High pitch cry.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal pain
Clinical narrative: Myalgia; joint pain shoulder pain, hip pain; pain, warmth, redness at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Myalgia; joint pain shoulder pain, hip pain; pain, warmth, redness at injection site.
Age: 17.0
Sex: F
Vaccine: HEP, HPV4, IPV, MMRV, TD
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: MMRV given to 17 year old.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Injection site oedema, Pyrexia
Clinical narrative: Severe fatigue, one episode of dizziness, edema of the right deltoid and fever.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Redness, raised, tender, itchy, red ring around area - advised to apply ice for discomfort.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Erythema, Induration, Nodule, Pain, Pruritus
Clinical narrative: CHILD COMPLAINED OF PAIN. MUSCLE AREA WAS RED WITH GOLF BALL SIZED KNOT, WARM AND HARD TO THE TOUCH. REDNESS HAS SPREAD FROM SHOULDER TO ELBOW AND VERY WARM. COMPLAINS OF "ITCHY".
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: CHILD COMPLAINED OF PAIN. MUSCLE AREA WAS RED WITH GOLF BALL SIZED KNOT, WARM AND HARD TO THE TOUCH. REDNESS HAS SPREAD FROM SHOULDER TO ELBOW AND VERY WARM. COMPLAINS OF "ITCHY".
Age: 1.56
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Swelling size of golf ball to right arm/deltoid with redness/warmth around it.  Had slight fever of 99.1 last night. To go to physician today, putting ice on it.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Lip swelling, Rash, Urticaria
Clinical narrative: Patient reports breaking out in hives a few hours after receiving the Engerix-B vaccine.  Additionally, she reported that her lips began to swell.  She self-treated with OTC diphenhydramine which alleviate oral symptoms.  But with persisting rash and hives, she presented to the ED and was subsequently treated with oral corticosteroids and antihistamines.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red, swollen and itchy.
Age: 17.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Dizziness, Nausea, Vomiting
Clinical narrative: Within an hour extreme dizziness, followed by diarrhea. Within a few hours was feeling queasy. Ate lunch. Nauseous by 1:30 PM. Vomiting by 6 PM.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: PAIN IN ARM LAST NIGHT NUMBNESS AND TINGLING IN LEFT HAND.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Body temperature increased, Muscle tightness, Respiratory arrest, Skin warm, Staring
Clinical narrative: My son became unresponsive and his facial expressions became blank. It was like he was not present. I believe he suffered a seizure. At 8:26 PM, it occurred again while I was administering children's Tylenol. He became normally warm with a temperature of 100.3. He suddenly became unresponsive, his jaw tightened, and he stopped breathing.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Unresponsive to stimuli
Clinical narrative: My son became unresponsive and his facial expressions became blank. It was like he was not present. I believe he suffered a seizure. At 8:26 PM, it occurred again while I was administering children's Tylenol. He became normally warm with a temperature of 100.3. He suddenly became unresponsive, his jaw tightened, and he stopped breathing.
Age: 1.12
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blister, Pyrexia, Rash, Skin exfoliation
Clinical narrative: Rash, fever, blisters, peeling skin.
Age: 19.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Dizziness, Miosis, Nausea, Paraesthesia, Visual impairment
Clinical narrative: Felt light headed, nausea, hands and fingers tingling, vision- not able to focus, pupils pin-point. Lasted about 10 minutes. Symptoms started to subside after water.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Pruritus
Clinical narrative: Crops of vesicles; pruritic and with a burning sensation on face and right forearm and hand; injxn site was left deltoid.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Crops of vesicles; pruritic and with a burning sensation on face and right forearm and hand; injxn site was left deltoid.
Age: 77.0
Sex: F
Vaccine: DTAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Skin rash and urticaria pruritus. Diphenhydramine 25 mg PRN.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Warm, raised, red 4 cm x 2 cm area above site where Zostavax was given on right arm. No other symptoms reported.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Stated experiencing pain to injection site.  Observed area to be warm to touch, mildly red with tenderness noted.  Area firm to touch approx 1 inch all around injection site.
Age: 19.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Raised red hardened bump over injection site. Hot to touch. Very itchy. Fifty cent peice size. 5mm on wheal.
Age: 19.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site pustule, Injection site swelling, Mycobacterium tuberculosis complex test
Clinical narrative: Raised red hardened bump over injection site. Hot to touch. Very itchy. Fifty cent peice size. 5mm on wheal.
Age: 4.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Blister, Erythema, Local swelling
Clinical narrative: Very large area of redness/swelling (measuring approx 10 cm x 8 cm).  Small blister just above site of redness.
Age: 0.93
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Developed shingles 1 mo. after receiving varicella vaccine.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash pruritic, Scab
Clinical narrative: Patient contacted call center on 11/27 and stated, I had a vaccine at the clinic on 11/7/12 and I have broken out in with a rash in the last two days. Not sure if it is chicken pox or hives? The rash is itchy and red with some scabs where I scratched them. The rash is NOT draining, swollen or painful. I have NOT used anything OTC on them. Had f/u appt with PCP, prescribed calamine lotion plus BENADRYL topical and PO PRN. Diphenhydramine 25 mg PRN.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Hyperhidrosis, Induration, Influenza like illness, Neck pain
Clinical narrative: Flu like symptoms, hot to touch, large induration, body aches, pain in neck radiating down arm, chills, sweats.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Skin warm
Clinical narrative: Flu like symptoms, hot to touch, large induration, body aches, pain in neck radiating down arm, chills, sweats.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old female patient with no pertinent medical history and no drug reactions or allergies. On 03-MAY-2013, the patient was vaccinated with a single dose of ZOSTAVAX (Lot # J000432, expiration date 10-APR-2014) SQ. Concomitant therapies included iron (unspecified). The nurse reported that on 04-MAY-2013, the patient developed lesions on the right side of her forehead and scalp. The patient was evaluated in the office on 06-MAY-2013 and was diagnosed with shingles. The patient was prescribed VALTREX 500 mg three times per day for 3 weeks. There were no Lab diagnosis or studies performed. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Contusion, Menorrhagia, Platelet count decreased
Clinical narrative: Patient had first GARDASIL 8-15-11. Began having bruising around Jan 2012. Had second GARDASIL 7-26-12. On 9-25-12 admitted to hosp for excessive menstrual bleeding and platelet count of 2,000.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 03-MAY-2013 the patient was given an expired dose of MMR II (lot number 0515AA; expired date 08-APR-2013) (dose, route, frequency, indication and injection site were not reported). No adverse effect reported. The outcome was unknown. The action taken and causality were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site urticaria, Urticaria, Vomiting
Clinical narrative: Child received PROQUAD at 11:06am - vomited right after shot was given. He was well and acting fine after vomiting. Around 11:50am he developed about 8 hives on and around shot site (left arm). 10 min later mom called back because hives moved to his face. No distress, breathing fine. Can eat and drink swallowing fine. Told mom to give BENADRYL 1 tsp per 22 lb. Any distress needs to go to ER.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Vaccination complication
Clinical narrative: Right deltoid with 3 in by 2.5 in area of erythema, edema and warmth to the touch, pin point area. Treatment is to apply cool compresses TID for 5 days and iboprofen.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Skin warm, Swelling
Clinical narrative: Patient developed rash 4-6 inches in diameter on arm at site of injection. Swelling below site of injection (gravitational) hot to touch. Called M.D. on phone. Patient saw MD 1 week after injection.
Age: 0.25
Sex: M
Vaccine: PNC13, RV5
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Developed rotavirus 2 days after receiving immunization. Vomiting, diarrhea - diagnosed in ER.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Rash pruritic
Clinical narrative: Client received IZs at 5 pm began developing itchy spots on face in the morning. Approximately 8-10 spots were clearly visible around her eyes.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: Mild discomfort and swelling in the (L) deltoid area where vaccine administered. Raised pink lesions in area as well. Treated with prednisone and CLARITIN.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC, VARCEL, HIBV, MMR, MMRV, PNC13, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a Nurse practitioner regarding a 12 month old female patient with no pertinent medical history or drug reactions or allergies. On 29-MAR-2013 the patient was vaccinated with (merck) VARIVAX (lot number and expiration date not reported) (dose and route not reported). Other suspect therapies included (merck) PROQUAD (lot number and expiration date not reported) (dose and route not reported). Concomitant therapies included PREVENAR and ACTHIB. The Nurse reported that the patient came in for her 12 month checkup and was accidentally administered with (merck) VARIVAX and (merck) PROQUAD. The intended vaccination was MMR and (merck) VARIVAX. The patient did not have a reaction. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC, VARCEL, HIBV, MMR, MMRV, PNC13, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Nurse practitioner regarding a 12 month old female patient with no pertinent medical history or drug reactions or allergies. On 29-MAR-2013 the patient was vaccinated with (merck) VARIVAX (lot number and expiration date not reported) (dose and route not reported). Other suspect therapies included (merck) PROQUAD (lot number and expiration date not reported) (dose and route not reported). Concomitant therapies included PREVENAR and ACTHIB. The Nurse reported that the patient came in for her 12 month checkup and was accidentally administered with (merck) VARIVAX and (merck) PROQUAD. The intended vaccination was MMR and (merck) VARIVAX. The patient did not have a reaction. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Disorientation, Lethargy
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old male patient with drug allergy - AUGMENTIN - hives. The patient's medical history included obesity. On 18-APR-2013 the patient was vaccinated with GARDASIL (lot # H021608, exp. 13-AUG-2015; left deltoid intramuscularly) in the left arm. On 25-APR-2013 the patient experienced rhinitis, viral symptoms, body aches, headache and lethargy, one week after patient received GARDASIL. Patient was prescribed an "Z-PACK" and told not to use the "Z-PACK" until instructed and the doctor elected to watch patient, for one week. Patient's mother called doctor back on 02-MAY-2013, when patient developed mental confusion and "was not making sense talking". Patient was taken to Hospital Emergency Room, on 02-MAY-2013. CT scan performed in emergency "showed nothing" and patient was sent home. Patient was advised in Emergency room to start "Z-PACK" for sinus infection. The doctor referred patient to another doctor, neurologist who admitted patient to another Hospital, on 03-MAY-2013. Lumbar puncture showed two WBC'S (white blood cells). CT scan and possibly an EEG were done, results not specified by doctor. Culture on spinal fluid is pending. Patient was sent home, on 04-MAY-2013. Headache had persisted through 06-MAY-2013. Patient had vomited on two occasions, since patient was discharged from the hospital. Patient has used "a couple of MOTRIN" for headache, which "doesn't really help". The doctor reported "patient does not seem to be confused, but is sleepier more than usual, probably due to headaches." Patient was scheduled to follow-up with doctor on an unspecified date. Both physicians may be contacted. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: CSF culture, CSF white blood cell count negative, Computerised tomogram normal, Confusional state, Headache
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old male patient with drug allergy - AUGMENTIN - hives. The patient's medical history included obesity. On 18-APR-2013 the patient was vaccinated with GARDASIL (lot # H021608, exp. 13-AUG-2015; left deltoid intramuscularly) in the left arm. On 25-APR-2013 the patient experienced rhinitis, viral symptoms, body aches, headache and lethargy, one week after patient received GARDASIL. Patient was prescribed an "Z-PACK" and told not to use the "Z-PACK" until instructed and the doctor elected to watch patient, for one week. Patient's mother called doctor back on 02-MAY-2013, when patient developed mental confusion and "was not making sense talking". Patient was taken to Hospital Emergency Room, on 02-MAY-2013. CT scan performed in emergency "showed nothing" and patient was sent home. Patient was advised in Emergency room to start "Z-PACK" for sinus infection. The doctor referred patient to another doctor, neurologist who admitted patient to another Hospital, on 03-MAY-2013. Lumbar puncture showed two WBC'S (white blood cells). CT scan and possibly an EEG were done, results not specified by doctor. Culture on spinal fluid is pending. Patient was sent home, on 04-MAY-2013. Headache had persisted through 06-MAY-2013. Patient had vomited on two occasions, since patient was discharged from the hospital. Patient has used "a couple of MOTRIN" for headache, which "doesn't really help". The doctor reported "patient does not seem to be confused, but is sleepier more than usual, probably due to headaches." Patient was scheduled to follow-up with doctor on an unspecified date. Both physicians may be contacted. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Lethargy, Pain, Rhinitis, Sinusitis, Somnolence
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old male patient with drug allergy - AUGMENTIN - hives. The patient's medical history included obesity. On 18-APR-2013 the patient was vaccinated with GARDASIL (lot # H021608, exp. 13-AUG-2015; left deltoid intramuscularly) in the left arm. On 25-APR-2013 the patient experienced rhinitis, viral symptoms, body aches, headache and lethargy, one week after patient received GARDASIL. Patient was prescribed an "Z-PACK" and told not to use the "Z-PACK" until instructed and the doctor elected to watch patient, for one week. Patient's mother called doctor back on 02-MAY-2013, when patient developed mental confusion and "was not making sense talking". Patient was taken to Hospital Emergency Room, on 02-MAY-2013. CT scan performed in emergency "showed nothing" and patient was sent home. Patient was advised in Emergency room to start "Z-PACK" for sinus infection. The doctor referred patient to another doctor, neurologist who admitted patient to another Hospital, on 03-MAY-2013. Lumbar puncture showed two WBC'S (white blood cells). CT scan and possibly an EEG were done, results not specified by doctor. Culture on spinal fluid is pending. Patient was sent home, on 04-MAY-2013. Headache had persisted through 06-MAY-2013. Patient had vomited on two occasions, since patient was discharged from the hospital. Patient has used "a couple of MOTRIN" for headache, which "doesn't really help". The doctor reported "patient does not seem to be confused, but is sleepier more than usual, probably due to headaches." Patient was scheduled to follow-up with doctor on an unspecified date. Both physicians may be contacted. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Viral infection, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old male patient with drug allergy - AUGMENTIN - hives. The patient's medical history included obesity. On 18-APR-2013 the patient was vaccinated with GARDASIL (lot # H021608, exp. 13-AUG-2015; left deltoid intramuscularly) in the left arm. On 25-APR-2013 the patient experienced rhinitis, viral symptoms, body aches, headache and lethargy, one week after patient received GARDASIL. Patient was prescribed an "Z-PACK" and told not to use the "Z-PACK" until instructed and the doctor elected to watch patient, for one week. Patient's mother called doctor back on 02-MAY-2013, when patient developed mental confusion and "was not making sense talking". Patient was taken to Hospital Emergency Room, on 02-MAY-2013. CT scan performed in emergency "showed nothing" and patient was sent home. Patient was advised in Emergency room to start "Z-PACK" for sinus infection. The doctor referred patient to another doctor, neurologist who admitted patient to another Hospital, on 03-MAY-2013. Lumbar puncture showed two WBC'S (white blood cells). CT scan and possibly an EEG were done, results not specified by doctor. Culture on spinal fluid is pending. Patient was sent home, on 04-MAY-2013. Headache had persisted through 06-MAY-2013. Patient had vomited on two occasions, since patient was discharged from the hospital. Patient has used "a couple of MOTRIN" for headache, which "doesn't really help". The doctor reported "patient does not seem to be confused, but is sleepier more than usual, probably due to headaches." Patient was scheduled to follow-up with doctor on an unspecified date. Both physicians may be contacted. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RVX, UNK, DTAPHEPBIP, HIBV, RVX
Symptoms: Convulsion
Clinical narrative: Seizure lasting 15 minutes requiring treatment with Ativan and subsequent respiratory supression resulting in intubation.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RVX, UNK, DTAPHEPBIP, HIBV, RVX
Symptoms: Convulsion, Electroencephalogram, Endotracheal intubation, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Seizure lasting 15 minutes requiring treatment with Ativan and subsequent respiratory supression resulting in intubation.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RVX, UNK, DTAPHEPBIP, HIBV, RVX
Symptoms: Respiratory disorder
Clinical narrative: Seizure lasting 15 minutes requiring treatment with Ativan and subsequent respiratory supression resulting in intubation.
Sex: U
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Influenza
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient under 1 years old with protein allergy. On an unknown date the patient was vaccinated with ROTATEQ (lot# unspecified), oral. On an unknown date the patient developed diarrhea one week later. The diarrhea was on going and seemed to improve (date unspecified) until the patient developed the flu at which point the diarrhea once again began to get worse. The patient was hospitalized for dehydration associated with the persistent diarrhea. The date the patient was hospitalized in unspecified. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left leg swelling thigh to knee, with warm to touch, slightly red. Tx -> TYLENOL OTC and BENADRYL. Return 1 wk if not improve.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a patient of unknown age. On an unknown date, the patient vaccinated with a single dose of PNEUMOVAX23, intramuscularly or Subcutaneously (start date, strength not provided). While at medical forum nurse practitioner stated their practice had a patient with pain and swelling at injection site after receiving PNEUMOVAX23. The outcome of the events were unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Blood glucose increased, Exposure during pregnancy, Glucose tolerance test normal, No adverse event
Clinical narrative: Information has been received from a Registered Nurse for a GARDASIL (lot # was unknown), a pregnancy registry product, concerning a 20 years old female patient. The patient's history of previous pregnancies and live births was unknown. The patient was vaccinated intramuscularly with first dose of GARDASIL (lot # was unknown), on 27-Apr-2012, was subsequently determined to have pregnancy (LMP was on 09-APR-2012 and an EDD was on 14-JAN-2013). Nurse Practitioner reports that "a first trimester dating ultrasound performed on 4-Jun-2012 determined fetal age to be 8 weeks and 0 days". Concomitant medications included: ibuprofen, which nurse reported the patient took 2-3 times and stopped as soon as she realized she was pregnant. Initial exposure to GARDASIL was at 2 week(s). The patient was exposed to GARDASIL during trimester 1 and 2. No treatment information was reported. The patient sought medical attention in an unspecified way. No adverse event was reported. Follow-up information was received from the licensed practical nurse. On 25-MAY-2012, pregnancy test was positive. On 17-AUG-2012 fetal survey showed 18 5/7 weeks. On 17-AUG-2012, maternal serum alpha-fetoprotein (MSAFP) was unlimited (at 18 2/7 weeks of pregnancy). On 25-OCT-2012, glucose test was elevated (at 27 1/7 weeks of pregnancy). On 25-OCT-2012, GTT (glucose tolerance test) was normal and on 18-DEC-2012 Group B streptococcus (B-strep) was negative (at 36 1/7 weeks). At 39 3/7 weeks of LMP, on 10-JAN-2013, the patient delivered a male infant via vaginal delivery. The outcome of vaccine exposure during pregnancy was reported as recovered/resolved and the pregnancy outcome was live birth on 10-JAN-2013. The infant was born normal with no congential anomalies. APGAR scores were 8 in 1 minute and 9 in 5 minutes. The birth weight was 8.75 pounds and length was 141 centimeters. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive, Streptococcus test negative, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a Registered Nurse for a GARDASIL (lot # was unknown), a pregnancy registry product, concerning a 20 years old female patient. The patient's history of previous pregnancies and live births was unknown. The patient was vaccinated intramuscularly with first dose of GARDASIL (lot # was unknown), on 27-Apr-2012, was subsequently determined to have pregnancy (LMP was on 09-APR-2012 and an EDD was on 14-JAN-2013). Nurse Practitioner reports that "a first trimester dating ultrasound performed on 4-Jun-2012 determined fetal age to be 8 weeks and 0 days". Concomitant medications included: ibuprofen, which nurse reported the patient took 2-3 times and stopped as soon as she realized she was pregnant. Initial exposure to GARDASIL was at 2 week(s). The patient was exposed to GARDASIL during trimester 1 and 2. No treatment information was reported. The patient sought medical attention in an unspecified way. No adverse event was reported. Follow-up information was received from the licensed practical nurse. On 25-MAY-2012, pregnancy test was positive. On 17-AUG-2012 fetal survey showed 18 5/7 weeks. On 17-AUG-2012, maternal serum alpha-fetoprotein (MSAFP) was unlimited (at 18 2/7 weeks of pregnancy). On 25-OCT-2012, glucose test was elevated (at 27 1/7 weeks of pregnancy). On 25-OCT-2012, GTT (glucose tolerance test) was normal and on 18-DEC-2012 Group B streptococcus (B-strep) was negative (at 36 1/7 weeks). At 39 3/7 weeks of LMP, on 10-JAN-2013, the patient delivered a male infant via vaginal delivery. The outcome of vaccine exposure during pregnancy was reported as recovered/resolved and the pregnancy outcome was live birth on 10-JAN-2013. The infant was born normal with no congential anomalies. APGAR scores were 8 in 1 minute and 9 in 5 minutes. The birth weight was 8.75 pounds and length was 141 centimeters. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 07-FEB-2012, the patient was vaccinated with the first dose of GARDASIL (lot # not reported) (intramuscular, strength and total daily dose not reported). On 03-APR-2012, the patient was vaccinated with the second dose (lot # not reported) (intramuscular, strength and total daily dose not reported). On 07-MAY-2013, the patient was in the office to receive a third dos eof GARDASIL (lot # not reported) (intramuscular, strength and total daily dose not reported). No adverse effect was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Ear pain, Heart rate increased, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient with stroke. On 03-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot# J000446; expiry date: 11-APR-2014), 0.65 ml, subcutaneous in the arm for prevention of shingles. Her relevant concomitant medications and relevant past drug history were unknown. Immediately after getting ZOSTAVAX on 03-MAY-2013, she experienced shooting pain all the way to the spine from her arm. Later that same day, she began experiencing swelling in her arm where she received the injection, upset stomach, increased heart rate, dizziness, right ear pain, and mild fever. Her temperature was around 100 degrees. As of 04-MAY-2013, it was unknown if she would received ZOSTAVAX again and the events continued. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Spinal pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient with stroke. On 03-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot# J000446; expiry date: 11-APR-2014), 0.65 ml, subcutaneous in the arm for prevention of shingles. Her relevant concomitant medications and relevant past drug history were unknown. Immediately after getting ZOSTAVAX on 03-MAY-2013, she experienced shooting pain all the way to the spine from her arm. Later that same day, she began experiencing swelling in her arm where she received the injection, upset stomach, increased heart rate, dizziness, right ear pain, and mild fever. Her temperature was around 100 degrees. As of 04-MAY-2013, it was unknown if she would received ZOSTAVAX again and the events continued. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Dyspnoea, Lymphadenopathy, Paraesthesia
Clinical narrative: Initial report received from a consumer on 25 January 2012. A 35-year-old female patient, had received first intramuscular dose of IMOVAX rabies (batch number: not reported) in deltoid and 5 intramuscular shots of RIG (manufacturer: unknown and batch number: not reported) in right and left gluteal region, on 05 January 2013. The patient reported that she had some kind of infection and was undergoing 10 day antibiotic treatment for the same. She also had swollen lymph glands. On 06 January 2013, the patient experienced tingling going down both the legs. The patient also reported increase in lymph node swelling on an unspecified date and one night the patient woke up with shortness of breath which lasted for a minute. Laboratory data were not reported. Corrective treatment received by the patient was not reported. The event increase in lymph node swelling went away on an unspecified date, shortness of breath lasted for 1 minute and the outcome for the event tingling going down both the legs was unknown. Documents held by sender: None.
Sex: M
Vaccine: RAB
Symptoms: Adverse event
Clinical narrative: Initial report received from a consumer on 15 June 2012. A female patient, whose age, medical history and concomitant medication were not reported, received a dose of Rabies vaccine on an unspecified date (Lot number, route and site of administration were not reported). It was reported that the patient was effected by the rabies vaccine. As of 15 June 2012 the outcome was not reported. Documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Local erythema around sites of injection pt scratching.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site erythema, Local reaction, Pyrexia
Clinical narrative: Fever, reddish at site. Local Reaction.
Sex: F
Vaccine: RAB
Symptoms: Incorrect route of drug administration, Injected limb mobility decreased, Injection site discolouration
Clinical narrative: Initial report received from a healthcare professional on 24 August 2012. A female patient (age not provided), whose medical history and concomitant medications were unknown, received third dose of IMOVAX rabies vaccine (lot number: unknown, route of vaccination was not reported) in the arm on an unknown date. The patient had received Immunoglobulin and third dose of rabies vaccine in last 4 weeks of the IMOVAX rabies. It was reported that dose 3 was not given in the arm muscle but given in the skin or the lower part of the muscle as the shirt sleeve was too tight. On an unknown date, the patient experienced slight pinkness at the injection site in the upper arm. Corrective medications and laboratory investigations were not reported. Outcome of the event was unknown at the time of this report. List of documents held by sender: none.
Age: 46.0
Sex: M
Vaccine: RAB, TTOX
Symptoms: Blood test, Decreased appetite, Lymphocyte count increased, Malaise, Night sweats
Clinical narrative: Initial information received from a consumer on 21 September 2012. A 46-year-old male patient received IMOVAX Rabies (batch number: not reported) intramuscularly in the left arm on 05 September 2012. On 12 September 2012, the patient received next dose of IMOVAX rabies intramuscularly in the left arm (batch number: not reported). He had also received RABAVERT (other manufacturer vaccine, intramuscular in the left arm, batch number: not reported), Tetanus (other MFR, intramuscular in the right arm, Batch number: not reported), RIG (other MFR, intramuscular in the gluteus and arm, batch number not reported) on 29 August 2012. On 01 September 2012, the patient received second dose of RABAVERT intramuscularly in the right arm. Medical history included hypertension. Ongoing illness at the time of vaccination included bat bite on left side of the collarbone. Concomitant medications not reported. On 16 September 2012, after completion of post exposure series the patient had fever 99-101, decreased appetite, night sweats and general malaise. On an unspecified date WBC and lymphocytes were elevated and blood work was done. Treatment medications were not reported. At the time of this report, the events were continued. Documents held by sender: none.
Age: 46.0
Sex: M
Vaccine: RAB, TTOX
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Initial information received from a consumer on 21 September 2012. A 46-year-old male patient received IMOVAX Rabies (batch number: not reported) intramuscularly in the left arm on 05 September 2012. On 12 September 2012, the patient received next dose of IMOVAX rabies intramuscularly in the left arm (batch number: not reported). He had also received RABAVERT (other manufacturer vaccine, intramuscular in the left arm, batch number: not reported), Tetanus (other MFR, intramuscular in the right arm, Batch number: not reported), RIG (other MFR, intramuscular in the gluteus and arm, batch number not reported) on 29 August 2012. On 01 September 2012, the patient received second dose of RABAVERT intramuscularly in the right arm. Medical history included hypertension. Ongoing illness at the time of vaccination included bat bite on left side of the collarbone. Concomitant medications not reported. On 16 September 2012, after completion of post exposure series the patient had fever 99-101, decreased appetite, night sweats and general malaise. On an unspecified date WBC and lymphocytes were elevated and blood work was done. Treatment medications were not reported. At the time of this report, the events were continued. Documents held by sender: none.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Summary narrative including initial information received from a healthcare professional (nurse) on 10 May 2012 and follow-up information received on 14 September 2012. A 24-year-old female patient had received 3 dose of IMOVAX Rabies vaccine (batch number: G10761) first dose on 18 April 2012 intramuscularly in the right arm, second dose on 25 April 2012 intramuscularly in the left arm and third dose intramuscularly in the right arm on an unspecified date. Concomitant medications were none. On 05 May 2012, the patient developed dizziness, headache and nausea. The lab investigations were none and treatment medications were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Antibody test abnormal
Clinical narrative: This case is linked to case number: 2013-02221 (same reporter, same product and same adverse event). Initial report received from a healthcare professional on 04 February 2013. A 55-year-old female patient, had received third dose of IMOVAX (batch number: D0792-1, route and site of administration were not reported) on 01 June 2010. The patient had received 2 pre-exposure doses of IMOVAX previously. The patient had received dose 1 with lot number D0792-1 on 04 May 2010, expiry date 09/04/2011 and dose 2 with number D0792-1 on 11 May 2010, expiry date 09/04/2011. The patient's concomitant medications were not reported. On an unspecified date of June 2012, the titer value was below acceptable level. The patient's outcome was not reported. List of documents held by sender: none.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Headache, Lymphadenopathy
Clinical narrative: Initial report received from a Healthcare professional on 19 June 2011. A 32-year-old female patient, with no concurrent conditions nor any known allergy, received a second dose of pre-exposure series of Intramuscular IMOVAX rabies vaccine (Batch lot number: G1377-1) on left deltoid on 15 June 2012. The patient had received first dose (dose: 0) of Intramuscular IMOVAX Rabies vaccine in Right Deltoid (Batch lot number: G1377-1) on 12 June 2012. On 15 June 2012, the date of vaccination, the patient had swelling of lymph node under left arm of size of a baseball, had light headed feeling and HA. The lymph node had swelled up to size of baseball. The patient took BENADRYL as corrective treatment and the swelling had gone down. The length of needle was 1 inch. Outcome of Light Headed feeling was not reported. As of 19 June 2012, the patient had not recovered. Follow-up information received on 3 August 2012: The first dose of IMOVAX rabies (Lot number G1377-1) was received in the Left deltoid area intramuscularly on 8 June 2012 and not on 12 June 2012. The date of birth of the patient was updated as 12 June 1988. The second dose of IMOVAX rabies (Lot number G1377-1) was received in the Left deltoid area intramuscularly on 15 June 2012. On an unspecified date, the patient had recovered from the events. List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Eczema, Swollen tongue
Clinical narrative: Case number PHEH2013US010210 is an initial spontaneous report received from a physician on 02 May 2013. This report refers to a 19-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with second dose of pre-exposure series of RABAVERT (batch number: 500011A) intramuscularly on 25 Apr 2013. On the same date, she developed eczema on her right elbow. The next morning she had swelling of tongue. It was reported that the third dose was due on May 2013 and was not administered at the time of call. The outcome of the events was not reported.
Age: 48.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 12 June 2012. A male patient, whose medical history was unknown and concomitant medications were not reported, received post exposure series 1st dose of Rabies vaccine (batch number, manufacturer, route and site of administration not reported) on 09 June 2012. The patient had received either pre or post exposure rabies vaccine (the patient was not sure about the type of vaccine) series in the past on unspecified dates. On 10 June 2012, the patient developed fever and muscle ache. Lab details and corrective medications was not reported. The events of fever and muscle aches continue till date (12 June 2012). List of documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: Gait disturbance
Clinical narrative: Initial information received from another manufacturer (service request number 1-5744669503) on 19 November 2012. The information was originally provided to the other manufacturer by a non-healthcare professional. A female patient of unspecified demographics, whose concurrent conditions and concomitant medications were not reported, had exposed to rabid animal and received Rabies vaccine (Manufacturer, lot number, route, dose and anatomical site of vaccination were not reported) on unspecified date in 1945 or 1946. The patient was barely able to walk after vaccination. The patient had not recovered. Corrective treatment and laboratory tests were not reported. List of documents held by the reported. None.