chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Feeling jittery, Induration, Local swelling
Clinical narrative: Swollen (L) arm, jittery, dizzy started about hour and a half after shot. Client received shingles vaccine on her left arm. Developed large reddened induration 3 x 3 (24 hours after vaccination). Client advised to call her MD/PCP.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a nurse practitioner for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female patient. On 30-JUN-2014, the patient was vaccinated with the first dose of GARDASIL (route and lot # not reported). The nurse reported that 15 minutes after vaccination, the patient's pregnancy test came back and it was positive. The nurse stated that the patient only missed one period, therefore it was not believed to be far along. The LMP and EDD were not known. The pregnancy outcome was pending. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at site of injection.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient blacked out twice.
Age: 1.05
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Celluliits at injection site.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as recovered from a healthcare worker (also reported as Certified Medical Assistant (CMA)) refers to unspecified patients (less than 5) of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On an unknown date, the unspecified patients were vaccinated with improperly stored PNEUMOVAX 23 (lot#, dose, route and frequency were unknown). The reporter was at the early stage of identifying how many patients were involved, so she was unable to provide further details at this time. No adverse symptoms reported. The outcome of the events was unknown. 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 healthcare worker (also reported as Certified Medical Assistant (CMA)) refers to unspecified patients (less than 5) of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On an unknown date, the unspecified patients were vaccinated with improperly stored GARDASIL (lot#, dose, route and frequency were unknown). The reporter was at the early stage of identifying how many patients were involved, so she was unable to provide further details at this time. No adverse symptoms reported. The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.14
Sex: M
Vaccine: DTP, OPV, UNK
Symptoms: Abnormal behaviour, Cognitive disorder, Nervous system disorder, Reaction to preservatives
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological deficit in a male subject aged between 10 and 19 years old who was vaccinated with DTP ((A or W not known), manufacturer unspecified), Oral polio vaccine and unspecified vaccine. A physician or other health care professional has not verified this report. The following information was received via legal complaint, which alleged that on or about 15 July 1994, approximately at 6 months of age, the subject received unspecified dose of DTP (A or W not known) (unknown lot number), unspecified dose of Oral polio vaccine (oral, unknown lot number), unspecified dose of Vaccine unspecified (unknown lot number) in a foreign country. On 19 October 1994, the subject was adopted. As a minor, the subject developed normally; he sat up, walked, and babbled at the appropriate ages. He interacted with his parents like a normal infant. The subject's behavior eventually changed dramatically prior to his twentieth birthday, several years after vaccination. He suffered from unspecified neurological deficiencies, cognitive deficiencies and permanent disability. It was believed the subject was exposed to mercury through the mercury-based preservative, Thimerosal, and/or other toxic additives which had been added to several of the vaccine injections that the subject received in July of 1994. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Hypersensitivity, Hypoaesthesia oral, Lethargy, Oropharyngeal pain
Clinical narrative: Patient was administered vaccine and shortly after developed an allergic reaction to it. Patient had denied any allergies or contraindications to the vaccine prior to it being administered. Patient had to be given BENADRYL and medically transported for follow-up, but had no serious consequences. Dizziness, skin rash, rash, urticaria pruritus and sore throat, numbness of tongue, lethargy. Diphenhydramine 25 mg once.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient was administered vaccine and shortly after developed an allergic reaction to it. Patient had denied any allergies or contraindications to the vaccine prior to it being administered. Patient had to be given BENADRYL and medically transported for follow-up, but had no serious consequences. Dizziness, skin rash, rash, urticaria pruritus and sore throat, numbness of tongue, lethargy. Diphenhydramine 25 mg once.
Age: 1.06
Sex: F
Vaccine: HEPA, HIBV, PPV, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Nurse administered Tdap (although previously documented historical ADR to tetanus). Shortly after patient was seen by physician and reported numbness/tingling in mouth and chest pain. Diphenhydramine 25 mg once, prednisone 20 mg every day, ranitidine 150 mg BID.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site rash, Livedo reticularis, Rash
Clinical narrative: Less than 1 hour after administration, pt returned with mottling rash on legs, chest and arms. After eating, rash faded without treatment. Advised to monitor at home. No recurrence.
Age: 17.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Stomach cramps, threw up.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. No relevant history of the patient was reported. On 27-JUN-2014 the patient was vaccinated with PNEUMOVAX 23, subcutaneous (strength, dose, lot number and expiration dates were not reported) instead of a purified protein derivative (PPD). No concomitant medications were reported. On 27-JUN-2014, shortly after PNEUMOVAX 23 the patient developed a red induration on the vaccinated arm and the arm was swollen to the elbow. It was unspecified if the patient had sought any medical attention. There was no intervention done to prevent the seriousness criteria. There was not product quality complaint (PQC) involved. The outcome of patient developed a red induration on the vaccinated arm and the arm was swollen to the elbow was reported as not recovered. The causality of the event patient developed a red induration on the vaccinated arm and the arm was swollen to the elbow was unknown. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site plaque, Injection site reaction, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Macular papular rash on torso, face and extremities that evolved to plaques and patches, erythematous but not pruritic. No other symptoms. Mostly residual rash after prednisolone.
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Skin plaque
Clinical narrative: Macular papular rash on torso, face and extremities that evolved to plaques and patches, erythematous but not pruritic. No other symptoms. Mostly residual rash after prednisolone.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a nurse regarding a patient of unknown age and gender. On 01-JUL-2014, the patient received expired M-M-R II (lot # H012572, expiration date 29-JUN-2014, route was not provided). The nurse reported that M-M-R II had no prior temperature excursions. No adverse symptoms reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Left arm - pain unbearable at time of injections. 2 months later, still experiencing pain and unable to move arm.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Joint swelling, Local swelling, Pain, Pyrexia
Clinical narrative: Patient called back to clinic the next day to report that he had a fever in the morning but had resolved by afternoon, headache, pain all over and his legs were swollen especially knees and feet. The patient declined an appointment with his provider or going to the local ER.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 29-OCT-2013 the patient was vaccinated with GARDASIL 120 Y (dose number, dose, route of administration unknown). Pertinent medical history and concomitant medications were unknown. The reporter stated that on an unknown date the patient would like to receive the subsequent doses in the series now. No adverse symptoms were reported. The outcome of the event was unknown. No further information provided. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid, visible red puncture site with spreading area sl redness extending inferior to injection site. Redness is blotchy/lacy and blanching. 10cm x 11cm. Area is indurated and warm. Slightly swollen.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Pallor, Rash macular
Clinical narrative: Left deltoid, visible red puncture site with spreading area sl redness extending inferior to injection site. Redness is blotchy/lacy and blanching. 10cm x 11cm. Area is indurated and warm. Slightly swollen.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Abdominal pain, Enema administration, Laboratory test, Rectal haemorrhage, Stool analysis
Clinical narrative: Received 2nd dose of ROTATEQ on 6/17/14. Had severe belly pain and blood per rectum on 6/27/14. Had X-Ray and ultrasound one hospital showed possible intussusception. Sent to another hospital had rectal procedure to resolve successfully. F/U here in clinic 7/1/14 - all back to normal.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal, Urinary system X-ray
Clinical narrative: Received 2nd dose of ROTATEQ on 6/17/14. Had severe belly pain and blood per rectum on 6/27/14. Had X-Ray and ultrasound one hospital showed possible intussusception. Sent to another hospital had rectal procedure to resolve successfully. F/U here in clinic 7/1/14 - all back to normal.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse who reported that at her office three different unspecified patients lapsed one year between doses of GARDASIL (dose #, route, site of application and lot #s not reported). No adverse effects were noted. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This spontaneous report as received from a physician refers to a 73 year old female patient with coronary disease, gastroesophageal reflux disease, depression, arthritis and hyperlipidemia. The patient's medical history included coronary bypass surgery, compression fracture in her back, shingles, and no drug reactions/allergies. On 12-JUN-2014 the patient was vaccinated with ZOSTAVAX. Dose, route, lot number and expiration date were not reported. Concomitant therapies included ZYRTEC, aspirin, ZOCOR, CELEXA, ibuprofen, omeprazole (manufacturer unknown), alprazolam, acetaminophen/hydrocodone, NORFLEX and vitamin D. The physician reported that the patient developed shingles in April 2014 (wild-type shingles). She had recovered from the shingles sometime in June 2014. She then received ZOSTAVAX from an unspecified pharmacy. At the time of this report on 24-JUN-2014 she came to the physician's office with a vesicular lesion on her left cheek. It was not painful. Physician said it looked similar to a fever blister (approximately in June 2014). The outcome of vesicular lesion on her left cheek/looks similar to a fever blister was reported as not recovered. Treatment was given for adverse event, acyclovir. No lab studies were performed. Patient sought medical attention, office visit. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states that on 12/23, he received a tetanus shot to his right upper arm. Says that that evening, he noticed that the area was starting to get red and swell, which has been getting worse since then. Denies feeling feverish. Advised of clinic recommendation and to apply ice to arm. Says that pain increases to an 8 when he grazes it; asks what can be taken for that? States he has no liver involvement to take ibuprofen.
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 an unknown number of patients. Approximately in JUNE-2014 (reported as between 15-JUN-2014 and 25-JUN-2014) the patients were inadvertently administered with VARIVAX (Lot # expiry date not reported) dose not reported, that had been improperly stored. No adverse effects reported. No product quality complaint reported. The outcome of the event is unknown. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor, Urticaria
Clinical narrative: 8:40 am Tdap IM administered to (L) deltoid per MD. Pt observed x 15 minutes with no reaction reported. Pt discharged without incident. 9:20 am pt called to report hives, rash extreme urticaria, and shakiness.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Convulsion, Dyskinesia, Middle insomnia
Clinical narrative: She started waking up at night jerk movements a week after vaccine. Then on August 29th 2013 she had her first seizure.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Abnormal behaviour, Daydreaming, Disorientation, Lethargy, Vomiting
Clinical narrative: Vomiting, acting lethargic and strange, "like she was awake but dreaming and not aware of her surroundings" per mother. Vomiting continued until approximately 03:00 AM on 07/02/2014.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient had nausea, diarrhea and vomited three times.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse drug reaction, Feeling hot, Swelling
Clinical narrative: Localized adverse reaction to drug-- swelling, warmth. Required MD visit in office 2 days post injection.
Age: 13.0
Sex: F
Vaccine: HPV2
Symptoms: Chills, Headache, Hypotension, Pruritus generalised, Pyrexia
Clinical narrative: Developed chills, bad headache, fever 102, generalized itching, hypotensive.
Age: 18.0
Sex: F
Vaccine: ADEN_4_7, FLU3, MNQ, TDAP
Symptoms: Pruritus, Rash, Throat irritation
Clinical narrative: c/o itching, rash to arms with sensation of throat itching.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Fall, Head injury, Lip injury, Mydriasis, Seizure like phenomena
Clinical narrative: Student was sitting on bench in hall of clinic and fell forward off bench onto floor hitting Left forehead and top lip of mouth on the floor.  Observed student having seizure activity with bilateral pupils dilated with fixed gaze down and to the right for approximately 30-60 seconds.  Student vital signs at 09:55 AM were BP 111/64, Pulse 57, Temp 98.5 orally with PERL with Right eye sluggish response to light and dilated 3mm.  At 10:15 AM BP 105/63 Pulse 66 Temp 98.8 orally with both eyes PEARL and pupil dilated at 2mm.  At 10:30 AM BP 100/62 Pulse 63 Temp 99.5 orally Respirations 16.  Student stated he felt much better, had normal pallor and was released to complete our new student Intake Processes.  Of Note: student had also had blood drawn approximately 20 minutes prior to receiving immunizations in which student had started to pass out, but was given juice to drink and allowed to lie on exam table for about 5-10 minutes at which time the student stated he felt much better and had normal pallor.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Staring
Clinical narrative: Student was sitting on bench in hall of clinic and fell forward off bench onto floor hitting Left forehead and top lip of mouth on the floor.  Observed student having seizure activity with bilateral pupils dilated with fixed gaze down and to the right for approximately 30-60 seconds.  Student vital signs at 09:55 AM were BP 111/64, Pulse 57, Temp 98.5 orally with PERL with Right eye sluggish response to light and dilated 3mm.  At 10:15 AM BP 105/63 Pulse 66 Temp 98.8 orally with both eyes PEARL and pupil dilated at 2mm.  At 10:30 AM BP 100/62 Pulse 63 Temp 99.5 orally Respirations 16.  Student stated he felt much better, had normal pallor and was released to complete our new student Intake Processes.  Of Note: student had also had blood drawn approximately 20 minutes prior to receiving immunizations in which student had started to pass out, but was given juice to drink and allowed to lie on exam table for about 5-10 minutes at which time the student stated he felt much better and had normal pallor.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site reaction, Injection site swelling
Clinical narrative: Mother states child developed a hard red swollen knot at DtaP site which was red and warm to touch. The red swollen area covered the deltoid area and approx. 2 inches below. Did not notice area until Sunday night. Child also states he did not notice any thing until Sunday night.  On Monday evening the area began to clear at the center where the shot was given.  Mother states as the red area began to clear, a red raised hive like rash developed around the skin that was clearing.  Child c/o intense itching. Has scratched some areas of skin and has broken the skin in several places.  Mother called MD and he sent child here today 7/2/14.  Child has a red band of raised rash starting just behind and under the deltoid area which circles around the arm to the front. At about the 7 o'clock area the rash widens and then becomes slightly smaller.  Rash stops just to the inside of the arm.  Does not go all the way around.  Widest part, rash is about 8cm wide. Smallest part of the band is about 3-4cm wide. Mother states she has put some anti itch cream on the area. Advised mother to contact MD for further recommendations.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site warmth, Pruritus, Rash erythematous, Skin injury, Urticaria
Clinical narrative: Mother states child developed a hard red swollen knot at DtaP site which was red and warm to touch. The red swollen area covered the deltoid area and approx. 2 inches below. Did not notice area until Sunday night. Child also states he did not notice any thing until Sunday night.  On Monday evening the area began to clear at the center where the shot was given.  Mother states as the red area began to clear, a red raised hive like rash developed around the skin that was clearing.  Child c/o intense itching. Has scratched some areas of skin and has broken the skin in several places.  Mother called MD and he sent child here today 7/2/14.  Child has a red band of raised rash starting just behind and under the deltoid area which circles around the arm to the front. At about the 7 o'clock area the rash widens and then becomes slightly smaller.  Rash stops just to the inside of the arm.  Does not go all the way around.  Widest part, rash is about 8cm wide. Smallest part of the band is about 3-4cm wide. Mother states she has put some anti itch cream on the area. Advised mother to contact MD for further recommendations.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event is being reported at this time. However, Zostavax was administered instead of Varivax.
Age: 33.0
Sex: F
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Anxiety, Fall, Nervousness, Pallor
Clinical narrative: Client very nervous with International Travel Vaccinations; received 4 immunizations and was about to receive one more, when she slumped over in the chair.  The nurse held her up in the chair around the waist and called out for help.  An administrative employee came quickly and assisted the nurse to lowering the client to the floor. She began to respond as she was gently laid on the floor.  She was pale and anxious and described the incident as "like a dream".  A covered ice pack was placed on her forehead and she took a couple sips of water. She refused a Capri Sun drink ("I don't drink sugary things"), but had a cup of pure apple juice a bit later. Refused the 5th shot at that time.
Age: 60.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Herpes zoster
Clinical narrative: SHingles rash in the L mid thoracic dermatome.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Itchy papular red rash on face under chin anterior neck and upper chest extending into ears; persists yet a week later despite MEDROL dose pack and Tamarac.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cough, Erythema, Induration, Local swelling, Nodule
Clinical narrative: Within 5 min of receiving DTaP vaccine child developed hard, hot red lump on arm with red welts were vaccine had dropped out onto skin. Child complained of itching and pain. The following day knot had progressed to large, reddish purple, hot lump approximately 3 inches in diameter. Within 4 days of administration, redness eps had faded to dull purple and heat had subsided. Child developed runny nose and deep coughing by day 4 after immunization.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pain, Pruritus, Rhinorrhoea, Skin warm, Urticaria
Clinical narrative: Within 5 min of receiving DTaP vaccine child developed hard, hot red lump on arm with red welts were vaccine had dropped out onto skin. Child complained of itching and pain. The following day knot had progressed to large, reddish purple, hot lump approximately 3 inches in diameter. Within 4 days of administration, redness eps had faded to dull purple and heat had subsided. Child developed runny nose and deep coughing by day 4 after immunization.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Vaccination complication
Clinical narrative: Pt had rxn where she had trouble breathing. Was in hospital x 3 days. Provider thinks it was due to vaccine.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Mobility decreased
Clinical narrative: Localized swelling and slight blush, decreased movement.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site discolouration, Local swelling, Pain in extremity
Clinical narrative: Pt reports swelling and soreness of arm. Pt states injection site was blue and turned yellow 3 days later.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Pain in (R) arm. Swelling at site. No fever, no redness.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Hypoaesthesia oral, Hypogeusia, Paraesthesia oral, Speech disorder
Clinical narrative: Speech impaired, trouble focusing, tongue swollen, tingle in tongue, and numbness in tongue, yellow film on tongue in the morning. Blurred eyes, trouble tasting food, and intermittent unsteadiness.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Swollen tongue, Tongue coated, Vision blurred
Clinical narrative: Speech impaired, trouble focusing, tongue swollen, tingle in tongue, and numbness in tongue, yellow film on tongue in the morning. Blurred eyes, trouble tasting food, and intermittent unsteadiness.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on legs and abdomen. BENADRYL given. Rash gone within 45 minutes.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a 68 year old female register nurse reporting on herself with hypertension, cardiomegaly, sulfa allergy and other unspecified allergy. On 10-JUN-2014, the patient was vaccinated with ZOSTAVAX in the left arm (dose, strength, lot number and expiration date were not reported). Secondary therapies were not reported. Concomitant therapies included unspecified angiotensin-converting-enzyme (ACE) inhibitor and "a lot of blood meds". Nurse reported that she began to experience and adverse effect "almost immediately" after receiving ZOSTAVAX. She did not know whether these effects began to developed in the same day the dose was administered, but on 11-JUN-2014 (also reported as following day) the patient noticed that injection site was red, tender and swollen. Patient also stated that she began to experience fever of 101 or 102 and headache, for which she took TYLENOL. She reported that over the next "few days" (in June 2014), the injection site became hard. She did not experience a rash. On 18-JUN-2014 (reported as "on day 8"), the patient noticed when she was putting deodorant that her lymph nodes in her armpit were swollen and tender. On 24-JUL-2014 (reported also as currently) the injection site was "a little bump" but her headaches and fevers had persisted. Patient had not notified her healthcare provider nor sought medical attention. Outcome for injection site red, tender and swollen, injection site hard, lymph nodes swollen and tender and injection site was a "little bump" was reported as recovering. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous report as received from a 68 year old female register nurse reporting on herself with hypertension, cardiomegaly, sulfa allergy and other unspecified allergy. On 10-JUN-2014, the patient was vaccinated with ZOSTAVAX in the left arm (dose, strength, lot number and expiration date were not reported). Secondary therapies were not reported. Concomitant therapies included unspecified angiotensin-converting-enzyme (ACE) inhibitor and "a lot of blood meds". Nurse reported that she began to experience and adverse effect "almost immediately" after receiving ZOSTAVAX. She did not know whether these effects began to developed in the same day the dose was administered, but on 11-JUN-2014 (also reported as following day) the patient noticed that injection site was red, tender and swollen. Patient also stated that she began to experience fever of 101 or 102 and headache, for which she took TYLENOL. She reported that over the next "few days" (in June 2014), the injection site became hard. She did not experience a rash. On 18-JUN-2014 (reported as "on day 8"), the patient noticed when she was putting deodorant that her lymph nodes in her armpit were swollen and tender. On 24-JUL-2014 (reported also as currently) the injection site was "a little bump" but her headaches and fevers had persisted. Patient had not notified her healthcare provider nor sought medical attention. Outcome for injection site red, tender and swollen, injection site hard, lymph nodes swollen and tender and injection site was a "little bump" was reported as recovering. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to his 68 year old female wife with subclinical hypothyroidism and without any pertinent drug reactions or allergies. On 15-APR-2014, the patient was vaccinated with ZOSTAVAX (dose, strength, frequency, lot number and expiration date were not reported). Secondary therapies were not reported. Concomitant therapies included simvastatin (manufacturer unknown) and SYNTHROID. On 22-JUN-2014, patient developed a rash on her back. It was toward her left side and had possible crossed over to her right side. It was at the T3 or T4 level on her back close to the spine. The rash seem like tiny vesicles that were red, raise and itchy. There was no pain. No treatment was given for the adverse event. No labs diagnostics studies were performed. At the time of the report, the outcome of vesicular rash was reported as not recovered. It was reported that the patient sought medical attention by sending an email to her primary care physician. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and unknown age. On 20-JUN-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 10 vials of 1, lot # H012972, expiration date 09-MAR-2014, 0.5 ml, intramuscular injection (indication not reported). No adverse effects were reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: This spontaneous report as received from a pharmacist via a field employee refers to a 67 year old male patient. On 14-MAR-2014 the patient was vaccinated with ZOSTAVAX (lot# unknown, strength, dosage, route and indication unknown). On unspecified date, in 2014, the patient developed sores in his mouth that "looked like thrush" after receiving ZOSTAVAX. The patient was treated with VALTREX and the sores resolved within a few days. The causality between the event and ZOSTAVAX was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Skin lesion, Tattoo
Clinical narrative: PATIENT REPORTED TO CLINIC 30 MAY 2014 C/O MULTIPLE LESIONS TO SMALLPOX SITE TO RT DELTOID AREA AFTER RECEIVING TATTOO TO AREA ON 23MAY2014 AGAINST MEDICAL ADVICE. PATIENT SEEN BY PROVIDER AND TREATED WITH BENDARYL AND IBUPROFEN. INSTRUCTED ON HOW TO TAKE CARE OF LESIONS AND TO F/U EVERY 2 DAYS.
Age: 1.93
Sex: M
Vaccine: MMR
Symptoms: Cough, Ear pain, Mumps, Salivary gland enlargement, Sneezing
Clinical narrative: Patient woke up with mumps of which was between 16 to 18 days incubation period after the shot was administered, right saliva gland swollen with ear hurting.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Body temperature increased, Ear swelling, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: About 24hr after receiving DTP (a) #4 site of vaccine (R) upper deltoid) red; swollen, tender, temp. 102 degrees, then swelling, started to spread to lower arms decreased (R) side of face, esp. lips and ears.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Lip swelling, Local swelling, Swelling face
Clinical narrative: About 24hr after receiving DTP (a) #4 site of vaccine (R) upper deltoid) red; swollen, tender, temp. 102 degrees, then swelling, started to spread to lower arms decreased (R) side of face, esp. lips and ears.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness, swelling, hard lump, warmth where vaccination was given.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Larger than expected red raised area at site of immunization. Four days post injection warm to touch, not resolving. Pt referred to NP at primary care for evaluation.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. The healthcare worker reported that, on unknown date, ROTATEQ (dose, frequency, route, lot number and exp. date were not reported) that underwent a temperature excursion hs been administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Arthralgia, skin rash, nausea, vomiting and chills; Injection site reaction (warm, red, tender).
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: Arthralgia, skin rash, nausea, vomiting and chills; Injection site reaction (warm, red, tender).
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 3 year old male patient with no pertinent medical history and drug reactions/allergies. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot #, expiration date, dose and route were unknown). No concomitant therapies were reported. The patient was diagnosed with chicken pox, after receiving (Oka/Merck) VARIVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. The patient had no pertinent medical history. The patient had drug reactions/allergies to statins, iodine, penicillin, CECLOR, KEFLEX, erythromycin, tetracycline and azithromycin. On 16-JUN-2014 the patient was vaccinated with ZOSTAVAX (19400 PFU, batch #/lot # K000726, expiration date 09-JAN-2015 (dose, frequency and route unknown). Concomitant therapies included COREG, NEXIUM, SYNTHROID, REQUIP, ZETIA, WELCHOL and CELEBREX. On 17-JUN-2014, the patient developed redness at the injection site after receiving ZOSTAVAX. This report was the second of two adverse events reported by the pharmacist. The pharmacist requested a lot check for the ZOSTAVAX that both of the patients received in both reports since they both had injection site adverse events. Lot check was requested. There was no treatment given for the event. There were not laboratories studies performed. The patient sought medical attention via contacted pharmacist. The outcome of redness at the injection site was reported as recovered/resolved on an unspecified date in June 2014. Lot check has been initiated. This is one of several reports received from the same reporter. 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 nurse refers to a patient of unknown age and gender. No information regarding to medical history/concurrent conditions and concomitant medications. On 06-JUN-2014, patient was inadvertently administered with a dose of liquid PEDVAXHIB (dose, dose number, route and lot # not reported) that had been improperly stored. No adverse effects reports. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Secondary transmission, Varicella
Clinical narrative: This spontaneous report was received from a pharmacist technician via company representative, refers to an about 70 year old female patient. Medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX vial, 1 host, strength, route, dosage and lot number were not reported. Concomitant therapy was not reported. The reporter informed that other pharmacist has a patient who received ZOSTAVAX while she held her infant grandchild and the infant developed chicken pox the company representative said that the contact between patient and the infant may have occurred the same day as the ZOSTAVAX vaccination. The patient sought medical attention by a pharmacy visit. The outcome of the event was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Local reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 65 year old female patient. Concomitant medication and pertinent medical history were not provided. On approximately 18-JUN-2014 (about one week ago) the patient was vaccinated with ZOSTAVAX (19400 unit 1 standard package vial of 1, lot #, dose, route and frequency were not provided). On an unspecified date of June 2014 patient developed localized reaction at injection site, further described as round lump which was red and warm. Patient didn't seek for medical attention. Patient was directed by unspecified person to take BENADRYL for the adverse events. Events remained on going and the patient was not recovered. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 year old female patient. Patient's medical history was unknown. On an unknown date, the patient started GARDASIL, one injection for unknown indication. On 30-JUN-2014, the patient was vaccinated with the second GARDASIL injection, lot # J012212; expiration date: 18-FEB-2016, (dose, frequency and route were unknown) which had a cold temperature excursion. The patient did not have any problems after receiving the injection. At the time of the report was unknown if the patient continued to get GARDASIL injections. Additional information has been requested.
Age: 0.27
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 3 months old patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with liquid PEDVAXHIB (lot #: J016185, expiry date: 02-OCT-2015, dose and route of administration were not reported) that was exposed to temperatures out of range (multiple excursion over a 24 hour period totaling 5 hours below 36F, including three cycles below 28F, have occurred on unspecified date, reported as prior to the morning 23-JUN-2014) that were not supported by Merck's stability data. No adverse effects have been reported. This is one of several linked reports received from the same reporter.  Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 60 year-old patient presents for right deltoid and biceps pain, redness, itching and swelling which began several hours after receiving PNEUMOVAX in his right arm. He simultaneously received influenza vaccination in the left deltoid but did not experience any type of reaction.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Redness and swelling right after injection (Hib) administered on RV IM at 8:50 am 6/19/2014. Ice pack applied on affected area per RN instruction. Patient was observed in office 30 min after swelling noted. Patient in no acute distress. Pt discharged. Site was warm to touch.
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 male patient of unknown age. On 20-JUN-2013 the patient was vaccinated with his first dose of GARDASIL (strength, route, indication, lot number and expiration date not reported). On 12-JUN-2014 the patient was vaccinated with his second dose of GARDASIL (strength, route, indication, lot number and expiration date not reported). No adverse effect reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Rash
Clinical narrative: Pt states that he gets a rash when he gets a temperature. Pt states that the rash usually gets really hot, then the temperature leaves my body and the rash goes away. Usually resolves in 3 days or so.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) and a nurse refers to a 4 year old patient (gender unknown). On 28-MA-2014, the patient was vaccinated with VARIVAX  lot # J001177, expiration date: 31-JAN-2015, which was improperly exposed to 10F for 3 days, exposed to 16F for 120 hours and to 59.6F for 360 hours, subcutaneously. No known adverse effects. This is one of the several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: This spontaneous report was received from a pharmacist referring to 66 year old male patient. The patients medical history included bypass surgery performed in 2010. Patient had a history of developing cold sores. On 24-OCT-2007 the patient was vaccinated with ZOSTAVAX vial (lot # 1080U, expiry date 12-JAN-2009) 0.65ml, subcutaneous. Concomitant therapies included LYRICA, TRIBENZOR, LOVAZA and meloxicam. After receiving ZOSTAVAX, the patient did not developed cold sores for almost 7 years. On an unknown date in 2014 the pharmacist reports thta hte cold sores are starting to develop in the patient again. No lab diagnostic test performed. The patietn received treatment with acyclovir for cold sores (treatment received also reported as "no"). The patient did not sought medical attention. No intervention required to present the seriousness criteria. There was no signifcant disability, no hospitalization, and the event was not life-threatening. The outcome of cold sores was unknown. The causality of the event was unspecified. No PQC reported. No further information was provided. Addiitional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Oral herpes, Vascular graft
Clinical narrative: This spontaneous report was received from a pharmacist referring to 66 year old male patient. The patients medical history included bypass surgery performed in 2010. Patient had a history of developing cold sores. On 24-OCT-2007 the patient was vaccinated with ZOSTAVAX vial (lot # 1080U, expiry date 12-JAN-2009) 0.65ml, subcutaneous. Concomitant therapies included LYRICA, TRIBENZOR, LOVAZA and meloxicam. After receiving ZOSTAVAX, the patient did not developed cold sores for almost 7 years. On an unknown date in 2014 the pharmacist reports thta hte cold sores are starting to develop in the patient again. No lab diagnostic test performed. The patietn received treatment with acyclovir for cold sores (treatment received also reported as "no"). The patient did not sought medical attention. No intervention required to present the seriousness criteria. There was no signifcant disability, no hospitalization, and the event was not life-threatening. The outcome of cold sores was unknown. The causality of the event was unspecified. No PQC reported. No further information was provided. Addiitional information has been requested.
Age: 16.0
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 16 years old patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with GARDASIL (lot # J013324, expiry date: 13-FEB-2014) (dose and route if administration were not reported) that was exposed to temperature out of range (not supported by MERCK's stability data) (multiple excursion over a 24 hour period totaling 5 hours below 36 F, including three cycles below 28F, have occurred on specified date, reported as prior to the morning 23-JUN-2014). No adverse effects have been reported. This is one of several linked reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous in the abdomen (lot # and dosage not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 30-JUN-2014 the patient received a 0.5 ml MMR II (lot # H012140, expiry date: 29-JUN-2014) (manufacturer unknown) subcutaneous which was expired. No symptoms reported. At the time of report, the outcome of the event was unknown. 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 unspecified number of patients of unknown age and gender. On 23-JUN-2014 unspecified number of patients were vaccinated with RECOMBIVAXHB (dose, lot # and expiry date were not reported), that were exposed to temperature out of range (multiple excursion over a 24  hour period totaling 5 hours below 36F, including three cycles below 28F, have occurred on unspecified date reported as prior to the morning 23-JUN-2014) that were not supported by Merck's stability data. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Laboratory test, Lymphadenopathy, Pyrexia, Vaccination complication
Clinical narrative: This spontaneous report as received from the patient's mother, concerning her child of unknown age and gender. On an unknown date the patient was vaccinated with a dose of M-M-R II (lot #, dose and route not reported). Concomitant therapy was not reported. The reporter stated that on an unknown date her child had serous side effects after receiving M-M-R II. The patient had a different set of symptoms, high fever and  lymph node problems, the child underwent many tests (data not reported) and an unspecified health care professional determined that it was a reaction to the M-M-R II. The outcome of reaction to the M-M-R II, high fever and lymph nodes problems was unknown. This is one of several reports received from the same reporter: MARRS: 1407USA000508 and 1407USA000509. Additional information is not expected.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown type reporter refers to a 5 month old patient of unknown gender. On 01-APR-2014 the patient was vaccinated with a dose of ROTATEQ (lot #/batch # J012525, expiry date 09-APR-2015) dose, frequency and indication unspecified. The reporter stated that ROTATEQ was involved in temp changed. At the time of report, the outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEPAB, PPV, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Right arm swollen and redness wrapped around arm. Was not able to use arm. Lasted for about one week. Only treatment received was Tylenol.