chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea, Syncope
Clinical narrative: Light headed, aurora sensation, nausea immediately.  Then syncope & seizure less than 1 min. Fell from chair when he went unconscious hitting head on floor as per nurse.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 08-AUG-2013 the patient was vaccinated with an expired dose of GARDASIL lot # 1511Z exp. date 26-APR-2013. Route was unspecified. No adverse effect reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Ophthalmological examination
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old male patient with none pertinent medical history and none drug reactions/allergies. In 2008 the patient was vaccinated with ZOSTAVAX (dose, strength, route and site of administration not reported). Concomitant therapies included aspirin (reported as baby aspirin) and unspecified prostate medications. On an unspecified date in June 2013 the patient developed a zoster rash on his face and eyelid. There were unspecified ophthalmology examination performed. The events were treated with VALTREX. The outcome of "zoster rash" on his face and eyelid was reported as recovering/resolving. The relatedness between ZOSTAVAX and "zoster rash" on his face and eyelid was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning a male patient of unknown age. On unknown dates, the patient was vaccinated with the first and second doses of GARDASIL (lot number, expiry date, dose and route unspecified) after he had turned 26 years of age. A third dose of GARDASIL was not administered to the patient. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as receiving from a 76 year old female consumer with high blood pressure and pulmonary hypertension refers to herself. The patient did not have drug reactions/allergies. In August 2010 the patient was vaccinated with ZOSTAVAX (1 time vaccine, lot number not provided) subcutaneously. Concomitant therapies included TRACLEER for pulmonary hypertension. In December 2012 the patient got shingles after she had received the ZOSTAVAX vaccine. She also stated that she got the shingles, without them appearing openly on her. She said they were located in her right rib cage under her breast going onto her back side. She also stated in July 2013 she had had itching on her left leg in the front side that went from her knee up to her groin. LYRICA was given for adverse events. No lab diagnostics studies were performed. The patient had sought medical attention. The outcome of adverse events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abnormal sensation in eye, Fatigue
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of GARDASIL. On 05-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (dose and strength were not provided) intramuscular injection in arm for prevent HPV. During the night, but after midnight on Tuesday 06-AUG-2013 she felt suddenly fatigued and had a feeling of her "eye balls shaking." The patient called the office. The outcome of event was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patient. On an unknown date the patient may have been vaccinated with improperly stored VARIVAX (Merck) (dose, route and indication not reported). The healthcare worker reported that an improperly stored VARIVAX (Merck) that was exposed to 4.2C for 192 hours may have been administered. Due to the healthcare worker being unsure if the VARIVAX (Merck) had been administered, patient and physician details were not available. The healthcare worker did not have the lot# or expiration date available at the time of the call. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes, Simplex virus test positive
Clinical narrative: This spontaneous report as received from a female consumer on an unknown age. In May 2012 the patient was vaccinated with ZOSTAVAX, injection (dose, route, lot number and exp date not reported). On an unknown date also reported as recently the patient had been tested positive for genital herpes. The outcome of event was unknown. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On 23-JUL-2013 the patient was vaccinated with one dose of ZOSTAVAX (lot # J000434, expiration date 10-APR-2015) 0.65ml, subcutaneous. The patient was allergy to cephalosporin. There was no concomitant medication and no medical history. On an unknown date in July 2013 (a couple days after vaccination) the patient developed a rash and "what looks like shingles". The patient saw physician on 27-JUL-2013, and was prescribed unspecified antiviral medication. The reporter did not know whether the patient was diagnosed with shingles or if the rash is still present. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Itchy, red welt, hot and hardened area on right thigh.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Itchy, red welt, hot and hardened area on right thigh.
Age: 4.0
Sex: M
Vaccine: FLUX, IPV, MMR
Symptoms: Skin lesion
Clinical narrative: Over 50 lesions.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site swelling, Rash, Rash erythematous
Clinical narrative: Pt developed red rash on face (both cheeks) and legs. Injection area swelled to size of "goose egg" with rash surrounding. MD administered KENALOG injection and diphenhydramine.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Malaise, Nausea, Pyrexia
Clinical narrative: Pt developed red rash on face (both cheeks) and legs. Injection area swelled to size of "goose egg" with rash surrounding. MD administered KENALOG injection and diphenhydramine.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Pt developed red rash on face (both cheeks) and legs. Injection area swelled to size of "goose egg" with rash surrounding. MD administered KENALOG injection and diphenhydramine.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: Bad muscle cramp in L leg (calf area) and L tricep. Vaccine given on 7/31/13. Symptoms started 8/6/13. Also started volleyball camp on 8/5/12. Pt to call back in 72 hrs.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Erythema, Pruritus
Clinical narrative: After 6 days developed severe itch on left leg and left arm. After 7 days developed red pimples on left leg and left arm. Used cortisone to relief itch.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Client received Td vaccination 8/1/13. The next day she noted a red, round welt at the inj. site. The area cont to worsen and Sat 8/3 noted area larger and welted area now 3 1/2" diameter by Sun the swollen and reddened area covered a 3 1/2" wide are and encompassed most of the upper arm. C/O purple discoloration and itching. She wore sleeve over to protect area while outside and applied ice. TC to H/D 8/5 AM. Swelling started to lessen, still discolored and no longer itching. Is now improving but not yet fully recovered.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Client received Td vaccination 8/1/13. The next day she noted a red, round welt at the inj. site. The area cont to worsen and Sat 8/3 noted area larger and welted area now 3 1/2" diameter by Sun the swollen and reddened area covered a 3 1/2" wide are and encompassed most of the upper arm. C/O purple discoloration and itching. She wore sleeve over to protect area while outside and applied ice. TC to H/D 8/5 AM. Swelling started to lessen, still discolored and no longer itching. Is now improving but not yet fully recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed lesions that were diagnosed as shingles on 7/8/13.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Receiveda tetanus shot on 8/08/13. The next day it was very swollen, a lot of pain. I went to ER on 8/10/13. The injection spot was very swollen and red. Today it has doubled in size.
Age: 35.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Chills, Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: Vaccination given on 8/2/13; on 8/4/13 site of injection became very red and sore. 8/7, patient went to ER and was treated for allergic reaction and given antibiotic. Pt was having chills and fever so went back to ER the following day and was diagnosed with cellulitis. She was hospitalized for 3 days and treated with antibiotics. Patient was released on oral antibiotics and is doing well.
Age: 35.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Pyrexia
Clinical narrative: Vaccination given on 8/2/13; on 8/4/13 site of injection became very red and sore. 8/7, patient went to ER and was treated for allergic reaction and given antibiotic. Pt was having chills and fever so went back to ER the following day and was diagnosed with cellulitis. She was hospitalized for 3 days and treated with antibiotics. Patient was released on oral antibiotics and is doing well.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Agitation, Anxiety, Back pain, Disturbance in attention, Fatigue
Clinical narrative: Aggravation next day, anxiety, night sweats a couple days later, fatigue, tired, hard time concentrating, and less than a week later extreme lower back pain that continues especially walking or stand for short periods of time. She has never had nights sweats or pain in the back or anxiety like this till the shot.  She is a swimmer on the swim team at school, honor roll student and know she can't hardly make it through the mall with out back pain.  Our orthopedic is ordering a MRI next week and blood work.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Night sweats
Clinical narrative: Aggravation next day, anxiety, night sweats a couple days later, fatigue, tired, hard time concentrating, and less than a week later extreme lower back pain that continues especially walking or stand for short periods of time. She has never had nights sweats or pain in the back or anxiety like this till the shot.  She is a swimmer on the swim team at school, honor roll student and know she can't hardly make it through the mall with out back pain.  Our orthopedic is ordering a MRI next week and blood work.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal behaviour, Arthralgia, Back pain, Night sweats
Clinical narrative: Aggravation next day, anxiety, night sweats a couple days later, fatigue, tired, hard time concentrating, and less than a week later extreme lower back pain that continues especially walking or stand for short periods of time. She has never had nights sweats or pain in the back or anxiety like this till the shot.  She is a swimmer on the swim team at school, honor roll student and know she can't hardly make it through the mall with out back pain.  Our orthopedic is ordering a MRI next week and blood work.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Drug ineffective, Injection site pain
Clinical narrative: Pt developed left upper arm/shoulder pain and slight weakness that has lasted for 3 weeks, unresponsive to OTC meds.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Pt presented with a large amount of redness and swelling around the smallpox site.  The inflammation and redness covered most of the deltoid with a few spots on the inside of the arm.  Patient had no other issues at that time.  Pt was instructed to keep the site covered with a different bandage and monitor the site for increased size or any changes in medical condition.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection swelled and became red.  It was warm to the touch and burned but didn't hurt.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site rash
Clinical narrative: Rash like at site of injection. Dr thought it was cellulitis and gave rx for antibiotics.
Age: 24.0
Sex: M
Vaccine: SMALL, YF
Symptoms: Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Patient states woke up with hives of all different sizes on body. Mostly on elbows, knees, arms, wrists.  Hives were itchy and in clusters.  They went away as the day went on.  Past two mornings I've woken up with swollen hands & fingers. Also hives not as bad as Sundays first breakout. Swollen hands also go away a few hours after I'm awake.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Mental status changes
Clinical narrative: Altered mental status.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Dysarthria, Full blood count normal, Gait disturbance
Clinical narrative: Altered mental status.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Metabolic function test normal, Neurological examination normal, Toxicologic test normal, Vertigo
Clinical narrative: Altered mental status.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Electrocardiogram, Immediate post-injection reaction, Loss of consciousness, Pallor, Respiratory arrest
Clinical narrative: Immediately after administration of vaccines, patient lost consciousness, became pale, and stopped breathing for approximately 45 seconds.  He regained consciousness and full mental capacity within minutes of recovery.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: Very hot and hard spot on the back of her arm that is two inches long, starting at the point of injection, and one inch wide.
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Feeling cold, Hyperaesthesia, Influenza like illness, Injection site reaction
Clinical narrative: Flu-like weakness, pins and needles, tingling feelings, difficulty staying warm, sensitivity to touch (like when you're sick and just sitting on a hard chair is painful). Symptoms subsided somewhat, and then after each shot (cause it takes 3 for Gardasil) was administered they would come back. 1 year after having the last shot I found I no longer had symptoms. Pain and weakness/tingling/pins and needles especially at the injection site, not necessarily when the rest of the body had the same symptoms. I also found that these vaccinations became progressively more painful - the first one hurt more than vaccines or shots usually do, the second one was worse and the third was like "holy fucking shit, are you injecting me with acid?" - I have a high pain tolerance too so I'm not just bitching.
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Paraesthesia
Clinical narrative: Flu-like weakness, pins and needles, tingling feelings, difficulty staying warm, sensitivity to touch (like when you're sick and just sitting on a hard chair is painful). Symptoms subsided somewhat, and then after each shot (cause it takes 3 for Gardasil) was administered they would come back. 1 year after having the last shot I found I no longer had symptoms. Pain and weakness/tingling/pins and needles especially at the injection site, not necessarily when the rest of the body had the same symptoms. I also found that these vaccinations became progressively more painful - the first one hurt more than vaccines or shots usually do, the second one was worse and the third was like "holy fucking shit, are you injecting me with acid?" - I have a high pain tolerance too so I'm not just bitching.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal dreams, Cold sweat, Disorientation, Feeling cold, Immediate post-injection reaction
Clinical narrative: Upon administration of Gardasil #3 vaccine to sitting pt, pt immediately passed out, just before I could pull the needle out of her arm. I caught the pt as she was collapsing (pulled the needle out of her arm), and she started snoring (I couldn't see her face so at first I was concerned she was having a mild seizure). She was out cold for approximately 15 seconds. When she woke up she did not remember where she was at first, I laid her down, and she reported having a very strange dream. She was pale and clammy. I had her lay down for the remainder of the visit and took her vitals twice - once immediately after laying down and once before leaving the office. I gave her a glass of water and a snack. Pt reported feeling better by the end of the visit.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Pallor, Snoring, Syncope
Clinical narrative: Upon administration of Gardasil #3 vaccine to sitting pt, pt immediately passed out, just before I could pull the needle out of her arm. I caught the pt as she was collapsing (pulled the needle out of her arm), and she started snoring (I couldn't see her face so at first I was concerned she was having a mild seizure). She was out cold for approximately 15 seconds. When she woke up she did not remember where she was at first, I laid her down, and she reported having a very strange dream. She was pale and clammy. I had her lay down for the remainder of the visit and took her vitals twice - once immediately after laying down and once before leaving the office. I gave her a glass of water and a snack. Pt reported feeling better by the end of the visit.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Area of erythema measuring 6 cm x 8 cm at injection site.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Angioedema, Blood test, Chest pain, Chronic spontaneous urticaria, Full blood count
Clinical narrative: This spontaneous report as received from a healthcare student, refers to a 20 year old female patient, with none pertinent medical history or drug reaction allergies. It was reported that when the patient had 13 years old (approximately in 2006), she received the first dose of GARDASIL (Lot # not reported) (dose and route not reported) and received the second dose when she had 14 years old (approximately in 2007). Concomitant therapies included doxepin hydrochloride, ZYRTEC and BENADRYL. The reporter stated the patient developed what was described as chronic idiopathic urticarial sometime after the second dose of GARDASIL (unspecified time frame or date for the development of the chronic idiopathic urticarial). The student reported that the patient had been having intermittent urticarial and angioedema since April 2013. The patient was admitted to the hospital on 07-AUG-2013 with symptoms of chest pain, swelling of the lips and itching. The patient received treatment for the adverse events including SOLU-MEDROL injection, famotidine oral and BENADRYL oral. While hospitalized, the patient was tested for unspecified blood tests including a complete blood count (CBC) and basic metabolic panel (BMP) (results not reported). At the time of the report, the patient's outcome was recovering. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Metabolic function test, Pruritus
Clinical narrative: This spontaneous report as received from a healthcare student, refers to a 20 year old female patient, with none pertinent medical history or drug reaction allergies. It was reported that when the patient had 13 years old (approximately in 2006), she received the first dose of GARDASIL (Lot # not reported) (dose and route not reported) and received the second dose when she had 14 years old (approximately in 2007). Concomitant therapies included doxepin hydrochloride, ZYRTEC and BENADRYL. The reporter stated the patient developed what was described as chronic idiopathic urticarial sometime after the second dose of GARDASIL (unspecified time frame or date for the development of the chronic idiopathic urticarial). The student reported that the patient had been having intermittent urticarial and angioedema since April 2013. The patient was admitted to the hospital on 07-AUG-2013 with symptoms of chest pain, swelling of the lips and itching. The patient received treatment for the adverse events including SOLU-MEDROL injection, famotidine oral and BENADRYL oral. While hospitalized, the patient was tested for unspecified blood tests including a complete blood count (CBC) and basic metabolic panel (BMP) (results not reported). At the time of the report, the patient's outcome was recovering. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a multiple unspecified patient's of unknown age and gender, who on unspecified dates were vaccinated with a dose of VARIVAX (Merck) (dose, indication, route, site of administration and lot # were reported), that might have been subjected to significant light exposure. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Erythemais skin approximately 9 cm diameter to left buttock x2 days after KINRIX vaccine at this exam. No itching, systemic pruritus, raised borders or scaled skin appearance. Mtr noticed erythema x2 days after immunization.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pruritus
Clinical narrative: 90 minutes afer injection of MENACTRA and GARDASIL, patient was itching intensely, itching subsided after 4-5 hrs.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Nodule, Skin warm
Clinical narrative: Big knot that was red, hard and warm to the touch that started 24 hours after the vaccine. He went to ER and was treated with cephalexin and hydroxyzine. The redness and warmth are gone. The knot is still there (8/12/13).
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Headache, Insomnia, Nausea, Pain in extremity
Clinical narrative: 8/12/13 sore arm, couldn't sleep, HA, vomiting. 8/13/13 vomiting, nausea, HA, unsteady feet.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: 8/12/13 sore arm, couldn't sleep, HA, vomiting. 8/13/13 vomiting, nausea, HA, unsteady feet.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nausea, Syncope
Clinical narrative: Fainted on way home after receiving vaccines. Was out for first a few seconds only. Then was nauseous, no vomiting. Was hungry shortly there after and did fine without other symptoms after that. No treatment.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Child received DTAP 4 IM, right thigh. 48 hours later thigh was red, slightly swollen and c/o mild pain.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Anxiety, Asthenia, Hyperhidrosis, Injection site haemorrhage, Malaise
Clinical narrative: 10 am (8/13/13) SQ Varicella given left deltoid. Slight bleeding at site. 10:03 am pt states not feeling well, weak, thirsty, asking for water. Sweating at face, upper exts, apprehensive. BP 6/0. 10:04 Epinephrin 0.3 mg rt outer thigh given. 10:04 BP 94/48. 10:05 pulse stronger BP 104/50. 10:10 HR 63 BP 105/51. in 15 BP 104/60 stood up, states feeling well. 11 am left to go home.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Pulse pressure decreased, Thirst
Clinical narrative: 10 am (8/13/13) SQ Varicella given left deltoid. Slight bleeding at site. 10:03 am pt states not feeling well, weak, thirsty, asking for water. Sweating at face, upper exts, apprehensive. BP 6/0. 10:04 Epinephrin 0.3 mg rt outer thigh given. 10:04 BP 94/48. 10:05 pulse stronger BP 104/50. 10:10 HR 63 BP 105/51. in 15 BP 104/60 stood up, states feeling well. 11 am left to go home.
Sex: U
Vaccine: HEP, VARCEL
Symptoms: Rash erythematous, Rash macular, Urticaria
Clinical narrative: Described as red blotchy rash which occurred 1-2 days after vaccine (mother stated it looked like hives over abdomen and lower extremities) No other symptoms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles, diagnosed 8/8/13 and is being treated with a 7 day course of antiviral.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Rash, Rash pruritic
Clinical narrative: Rash on trunk, arms, legs, developed 3 days ago. Spots are very itchy. Started out like bug bites, some are developing blisters. Treated with HC cream.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a multiple unspecified patient's of unknown age and gender, who on unspecified dates were vaccinated with a dose of PROQUAD (Merck) (dose, indication, route, site of administration and lot # were not reported), that might have been subjected to significant light exposure. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a multiple unspecified patients of unknown age and gender, who on an unspecified dates were vaccinated with doses of RECOMBIVAX HB (dose, indication, route, site of administration and lot # were not reported) that might have been subjected to significant light exposure. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a multiple unspecified patients of unknown age and gender, who on an unknown dates were vaccinated with a dose of GARDASIL (dose, indication, route, site of administration, and lot # were not reported), that might have been subjected to significant light exposure. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a multiple unspecified dates were vaccinated with M-M-R II (dose, indication, route, site of administration and lot # were not reported) that might have been subjected to significant light exposure. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old male patient. On an unspecified date in August 2012 (a year ago), the patient was vaccinated with his first dose of GARDASIL (dose, route and lot # not reported). The patient was then administered the second dose of GARDASIL in June 2013 on an unspecified day. The third dose of GARDASIL was administered on 07-aug-2013. Nurse stated that the second and third doses of GARDASIL were only separated by two months. No adverse effects reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug reactions/allergies. On 06-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J002241, exp. 21-MAY-2014), 0.65 ml, subcutaneous. This pharmacist noted that the patient experienced an injection site reaction after ZOSTAVAX administration. This patient called this pharmacist today to report that in the morning, on 08-AUG-2013, she noted her unspecified injection site had some redness, swelling and tenderness to touch. No treatment was given. No lab diagnostics studies were performed. The outcome of injection site tenderness to touch, injection site swelling and injection site some redness was reported as recovering. Additional information has been requested.
Age: 1.66
Sex: F
Vaccine: VARCEL
Symptoms: Folliculitis, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 20 month old female patient with no medical history and no drug allergies. On 14-JUN-2013 the patient was vaccinated with a dose of VARIVAX dose, route and lot # not reported. Concomitant therapies included albuterol. The patient developed a red, itchy rash after receiving VARIVAAX. The rash started on 17-JUL-2013 (approximately two days before the date of report) and started on the back of the right shoulder and spread to right scapula. The reporter mentioned there were no clear vesicles and the rash looked like folliculitis. No lab diagnostics studies were performed. The patient was treated with unspecified steroid cream. The patient sought medical attention by office visit. The outcome of adverse event was reported as not recovered/not resolved. The relatedness between adverse event and VARIVAX was not reported. 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 Registered Nurse refers to a multiple unspecified patients of unknown age and gender, who on unspecified dates were vaccinated with a doses of PEDVAXHIB (dose, indication, route, site of administration and lot # were not reported) that might have been subjected to significant light exposure. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an approximately 27 year old female patient with no drug reactions or allergies. On 30-JUL-2012 (also reported as 30-JUL-2013), the patient was vaccinated with the first dose of 0.5 milliliter (ml) of VARIVAX (Merck) (lot number reported as 0418AE, expiry date unspecified), subcutaneously. On 31-AUG-2012, the patient was vaccinated with the second dose of 0.5 ml of VARIVAX (Merck (lot number reported as H01174, expiry date unspecified), subcutaneously. No concomitant therapy was reported. Post-vaccination titers were performed twice, once on an unspecified date in July 2012 and again on an unspecified date in January 2013. The results for the titers were negative for anti-varicella antibody. The patient sought medical attention (went to physician office). No treatment was provided. The patient was not recovered from the event. The relatedness for the event was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Antibody test abnormal, Product quality issue
Clinical narrative: Case number PHEH2013US016745 is an initial spontaneous report received from a nurse on 06 Aug 2013. This is also a quality complaint report (reference number: 238867). This report refers to a 24-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with RABAVERT (batch number: 473011C) at a dose of one ml, intramuscularly, with first dose on 07 Sep 2011 (day 0) at right deltoid, second dose on 14 Sep 2011 (day 7) at left deltoid and third dose on 05 Oct 2011 (day 28) at left deltoid. On 15 May 2013, he had equivocal rabies titer, which was an insufficient result. He required a booster dose of rabies. Reporter assessed the case as serious (significant). No other information was provided.
Age: 0.02
Sex: U
Vaccine: HPV4
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 8 week old patient of unknown gender. On 05-AUG-2013 the patient was inadvertently vaccinated with one dose of GARDASIL (lot number was not reported) 0.5 ml, intramuscular. Concomitant medication were not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practitioner nurse refers to a patient of unknown age and gender. The nurse reported that on 23-DEC-2011 the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date not reported). On 25-JUL-2013 the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number and expiration date not reported). No adverse event was reported. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 79 year old female patient (reporter's wife). The patient's medical history included trabeculectomia. It was reported that on an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reported). Additionally it was reported that on an unknown date the patient experienced the rash (unspecified). The outcome of rash (unspecified) was not reported. The relatedness between the rash and the vaccination with ZOSTAVAX was not reported. This case is linked with MARRS #1307USA009864 (Same Patient Link)
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 77 years old male patient, who was also a physician. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # not reported) for prevention of shingles. At an unspecified time, after he had received ZOSTAVAX, the patient developed shingles. The outcome of adverse event was unknown. The relatedness between ZOSTAVAX and adverse event was unknown. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Excoriation, Fall, Head injury, Loss of consciousness, Pallor
Clinical narrative: I responded to a call from help in the lobby. Patient had apparently received vaccination a few minutes prior. He reportedly had told his mother he needed to sit down but before he could he passed out and reportedly fell to the floor in the lobby, striking the top of hit head on a nearby wheelchair. Upon my arrival at the scene, patient was responsive to voice, spontaneously opened his eyes and did not complain of any injury. He denied pain in his head. He was able to answer questions and respond to commands. On exam he was pale. He had a superficial abrasion to his left knee and no visible or palpable wound to his head where he indicated he hit the chair. Nursing had also responded and he was treated with sugar (safety sucker) and ice packs to his head and neck. His color improved. I reassured his mother this a know side effect to vaccines in adolescents and he should recover without difficulty. I left him in the care of nursing, who observed him until he was recovered.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Wound
Clinical narrative: I responded to a call from help in the lobby. Patient had apparently received vaccination a few minutes prior. He reportedly had told his mother he needed to sit down but before he could he passed out and reportedly fell to the floor in the lobby, striking the top of hit head on a nearby wheelchair. Upon my arrival at the scene, patient was responsive to voice, spontaneously opened his eyes and did not complain of any injury. He denied pain in his head. He was able to answer questions and respond to commands. On exam he was pale. He had a superficial abrasion to his left knee and no visible or palpable wound to his head where he indicated he hit the chair. Nursing had also responded and he was treated with sugar (safety sucker) and ice packs to his head and neck. His color improved. I reassured his mother this a know side effect to vaccines in adolescents and he should recover without difficulty. I left him in the care of nursing, who observed him until he was recovered.
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea
Clinical narrative: This spontaneous report was received from a consumer concerning her daughter of unknown age. On an unknown date in March 2013 the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On an unknown date in June 2013, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Since an unknown date, the patient experienced severe menstrual cramps. The patient did not seek any medical attention. The outcome of severe menstrual cramps was reported as not resolved as the patient was experiencing severe menstrual cramps at the time of report. The relatedness for severe menstrual cramps was unknown for GARDASIL. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Shot administered on 8/8/13 (Thursday). Fine initially. She had dizziness/lightheadedness and just didn't feel right for 2-3hrs the day of shot. Redness around area of shot started that nite. Friday she was more red, sore and hard around site. Sat- I told her to take BENADRYL. Monday I called it was gone away, but still a little sore.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: C-reactive protein, Migraine, Nuclear magnetic resonance imaging brain, Red blood cell sedimentation rate
Clinical narrative: This spontaneous report was received from a 73 year old female patient with asthma, many allergies (unspecified), and allergies to beta blockers and iodine. The patient's medical history included cancer (not further specified) and shingles twice before receiving ZOSTAVAX. On 16-MAR-2013, the patient was vaccinated with ZOSTAVAX one dose via "injection". Concomitant therapies included DEPAKOTE, ZOMIG, and several unspecified medications. On 18-MAR-2013, the patient developed severe migraine headaches after receiving ZOSTAVAX. Treatment included acupuncture therapy and physical therapy. An MRI of the brain and blood tests described as ESR/CRP (erythrocyte sedimentation rate/C-reactive protein) were performed (results not provided). She went to a neurologist. The migraine headaches have not recovered. The patient also reported that DEPAKOTE and ZOMIG (unspecified manufacturer) did not work (dates not provided). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: C-reactive protein, Computerised tomogram, Computerised tomogram thorax, Migraine, Nuclear magnetic resonance imaging brain
Clinical narrative: This spontaneous report was received from a 73 year old female patient with asthma, many allergies (unspecified), and allergies to beta blockers and iodine. The patient's medical history included cancer (not further specified) and shingles twice before receiving ZOSTAVAX. On 16-MAR-2013, the patient was vaccinated with ZOSTAVAX one dose via "injection". Concomitant therapies included DEPAKOTE, ZOMIG, and several unspecified medications. On 18-MAR-2013, the patient developed severe migraine headaches after receiving ZOSTAVAX. Treatment included acupuncture therapy and physical therapy. An MRI of the brain and blood tests described as ESR/CRP (erythrocyte sedimentation rate/C-reactive protein) were performed (results not provided). She went to a neurologist. The migraine headaches have not recovered. The patient also reported that DEPAKOTE and ZOMIG (unspecified manufacturer) did not work (dates not provided). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Red blood cell sedimentation rate
Clinical narrative: This spontaneous report was received from a 73 year old female patient with asthma, many allergies (unspecified), and allergies to beta blockers and iodine. The patient's medical history included cancer (not further specified) and shingles twice before receiving ZOSTAVAX. On 16-MAR-2013, the patient was vaccinated with ZOSTAVAX one dose via "injection". Concomitant therapies included DEPAKOTE, ZOMIG, and several unspecified medications. On 18-MAR-2013, the patient developed severe migraine headaches after receiving ZOSTAVAX. Treatment included acupuncture therapy and physical therapy. An MRI of the brain and blood tests described as ESR/CRP (erythrocyte sedimentation rate/C-reactive protein) were performed (results not provided). She went to a neurologist. The migraine headaches have not recovered. The patient also reported that DEPAKOTE and ZOMIG (unspecified manufacturer) did not work (dates not provided). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Aphonia, Blood test normal, C-reactive protein normal, Computerised tomogram thorax normal, Lung infection
Clinical narrative: This spontaneous report was received from a 73 year old female patient with asthma, many allergies (unspecified), and allergies to beta blockers and iodine. The patient's medical history included cancer (not further specified) and shingles twice before receiving ZOSTAVAX. On 16-MAR-2013, the patient was vaccinated with ZOSTAVAX one dose via "injection". Concomitant therapies included DEPAKOTE, ZOMIG, and several unspecified medications. On 18-MAR-2013, the patient developed severe migraine headaches after receiving ZOSTAVAX. Treatment included acupuncture therapy and physical therapy. An MRI of the brain and blood tests described as ESR/CRP (erythrocyte sedimentation rate/C-reactive protein) were performed (results not provided). She went to a neurologist. The migraine headaches have not recovered. The patient also reported that DEPAKOTE and ZOMIG (unspecified manufacturer) did not work (dates not provided). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Migraine, Nuclear magnetic resonance imaging brain normal, Red blood cell sedimentation rate normal, Viral infection
Clinical narrative: This spontaneous report was received from a 73 year old female patient with asthma, many allergies (unspecified), and allergies to beta blockers and iodine. The patient's medical history included cancer (not further specified) and shingles twice before receiving ZOSTAVAX. On 16-MAR-2013, the patient was vaccinated with ZOSTAVAX one dose via "injection". Concomitant therapies included DEPAKOTE, ZOMIG, and several unspecified medications. On 18-MAR-2013, the patient developed severe migraine headaches after receiving ZOSTAVAX. Treatment included acupuncture therapy and physical therapy. An MRI of the brain and blood tests described as ESR/CRP (erythrocyte sedimentation rate/C-reactive protein) were performed (results not provided). She went to a neurologist. The migraine headaches have not recovered. The patient also reported that DEPAKOTE and ZOMIG (unspecified manufacturer) did not work (dates not provided). Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a registered pharmacist, concerning a 57 year old male patient with phenothiazine allergy and penicillin allergy. The patient had no pertinent medical history. On 05-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported), subcutaneously for shingles prevention. In AUG-2013, after receiving ZOSTAVAX, the patient experienced a lump the size of an egg at the site of injection on an unspecified day. It was also stated that there was no rash and the injection site was a little red. However, there was no pain associated with the redness. The patient sought medical attention by calling the pharmacist. No treatment was given for the events. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age with allergy to pork who on an unknown date, was vaccinated with a dose of ZOSTAVAX. It was reported that on an unknown date, the patient had an anaphylactic reaction to ZOSTAVAX. At the time of the report, the patient's outcome was unknown. The relatedness for anaphylactic reaction and ZOSTAVAX was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown dates the patient was administered GARDASIL (dose, route and lot number were not provided), at 0, 2 and 4 months on unspecified dates, in regard to the full series of GARDASIL. Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster
Clinical narrative: This spontaneous report as received from a medical assistant, via company representative, refers to a 7 year old male patient. On an unknown date the patient received a dose of VARIVAX (Merck) (dose, route and lot number were not provided). Concomitant medications were not reported. It was believed that the patient had received the recommended 2 doses of VARIVAX (Merck) (dates, dose, route and lot number unspecified). Medical assistant stated that in the fall of 2012 (in September 2012) the patient developed shingles after having VARIVAX (Merck). the patient developed blisters on the upper and lower body, on both sides of the body. The blisters were diagnosed as shingles specifically and not Varicella. Patient was recovered of shingles on an unknown date. The relationship between VARIVAX (Merck) and shingles was not reported. Patient sought unspecified medical attention. It was reported that the patient was possibly treated with acyclovir (unspecified). Additional information has been requested.