chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report as received from a current 83 year old female patient refers to herself. The patient was allergic to anti-biotics. There was no pertinent medical history. On an unknown date the patient was vaccinated with ZOSTAVAX (0.05 ml single dose, lot# and expiration date were unknown) intramuscularly. There were no concomitant therapies. On an unknown date (reported as over a year ago) the patient developed shingles after receiving ZOSTAVAX and as a result of shingles she developed neuralgia. Over the counter medication was given for the adverse events. Blood work was performed and result was not provided. The patient did not seek for medical attention. The outcome of the events was reported as recovering/resolving. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Seen at PCP office on 09/04/14 with erythema extending to 11x15 cm on upper L arm, vesicles around injection site measuring 3.5cm x 3cm in total with one large bullar measure 12 mm x 14 mm. No shortness of breath, no throat closing, no itching of throat.
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 demographics. Patient's concurrent conditions and relevant medical history was unknown. The pharmacist reported that, on 02-SEP-2014, the patient was inadvertently vaccinated with expired dose of PNEUMOVAX23 (lot number: J004080 with expiration date of 22-AUG-2014)(dose and route unspecified). Concomitant medications were unknown. No adverse effect was reported. The outcome of the events was unknown. The causality of the event with PNEUMOVAX23 was assessed as not related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown demographics. On 02-SEP-2014 the patient was vaccinated with ZOSTAVAX 19400 PFU (plaque-forming units) (dosing regimen unspecified). No concomitant medications were reported. On 02-SEP-2014, the patient received ZOSTAVAX that was reconstituted and left in a syringe for approximately one hour at an unspecified room temperature. No adverse symptoms reported. Outcome was unknown. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Nausea, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old male patient. The patient had no pertinent medical history or drug reaction/allergies. On 19-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J014809, expiration date 20-FEB-2015, dose 0.65 ml, subcutaneous in the left arm). No concomitant medications were provided. The pharmacist stated the patient called the pharmacy stating that he developed issues approximately one week post vaccination with ZOSTAVAX (on 26-MAY-2014). Pharmacist stated the patient had joint pain, felt nauseated and rash developed on his left arm, and a little bit of rash on his right arm. Pharmacist stated the patient still had on his left arm but rash on his right arm was gone "now" (at the reporting time). No treatment was given for the events. No lab diagnostics studies were performed. The patient had sought medical attention by calling pharmacy. At time of the reporting, outcome of the events was reported as not recovered. Additional information is not expected because the reporter did not want to be contacted.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Tongue discolouration
Clinical narrative: This spontaneous report was received from a medical assistant (Healthcare worker) regarding an approximately 2 month old female patient. The pertinent medical history and drug reactions or allergies were reported as none. On 08-APR-2014, the patient was vaccinated with first dose of ROTATEQ, product lot # J008739, expiration date: 25-MAR-2015, dose 2 ml (milliliter) orally as routine vaccination, the second dose of ROTAEQ, product lot# J013625, expiration date:  31-MAR-2015, dose 2 ml orally was received on 10-JUN-2014 and on 12-AUG-2014, the third dose of ROTATEQ, product lot # K003524, Expiration date: 29-JAN-2016, dose 2 ml orally was received. On an unknown date in 2014, the patient developed a circular black spot on the top and bottom of her tongue sometime before the third dose was given. On 18-AUG-2014, the patient was in physician's office because the spot had got worse. No treatment was given, at this time they were monitoring her and ruling things out. No intervention was done to prevent serous criteria. It was reported as unknown whether the adverse event was cancer. There was no product quality complaint involved. The outcome of the event was unknown. The causality was unknown. 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 age. On 02-SEP-2014 the patient was vaccinated with PNEUMOVAX23 (lot# J007060; expiration: 28-AUG-2014), dose: 0.5 ml, intramuscular. No concomitant medications were reported. On 02-SEP-2014, PNEUMOVAX23 was administered to the patient that had expired. No adverse effect reported. The outcome of PNEUMOVAX was administered that had expired and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The reporter stated that since 06-JUL-2014 those patients were administered ZOSTAVAX (vial, 19,400 PFU (plaque-forming units), reported as unit, dose, route of administration, anatomical location, lot number were reported) which was not stored properly. No adverse effects were noted. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The reporter stated that since 06-JUL-2014, those patients were administered (Oka/Merck) PROQUAD (dose, units, route of administration, anatomical location, lot number were not reported) which was not stored properly. No adverse effects were noted. This is one of several reports from the same reporter. 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 pharmacist refers to a patient of unknown age and gender. On 29-MAR-2014 the patient was vaccinated with a first dose of GARDASIL (lot number, expiration date were not reported), 0.5ml, intramuscular. No concomitant medications were reported. On 16-AUG-2014, the patient was vaccinated with a second dose of GARDASIL (lot number, expiration date were not reported), 0.5ml, intramuscular. No adverse effects were reported. Additional information is not expected because there was no consent for follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 60 year old female patient. On an unknown date, the patient was vaccinated with ZOSTAVAX on dose, 0.65 ml, subcutaneous. On an unknown date, the patient experienced shingles. The outcome of the event was reported as improved, but it was not specified whether the patient was still recovering or has recovered fully. The reporter did not provide the causality between the event and the suspect drug. No further AE information has been provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 11 year old female patient. Patient's medical history and other previous drug allergic reactions were not reported. On 25-AUG-2014 the patient was vaccinated with GARDASIL injection (strength, dose and frequency unknown) with lot # J011272, expiry date 21-APR-2016. No concomitant medications were reported. On 25-AUG-2014, after receiving her first dose of GARDASIL the patient experienced dizziness, hotness and nausea. On 25-AUG-2014, patient visited office for medical attention to the events. The outcome of hotness, nausea and dizziness was reported as recovered/resolved. The reporter did not provide the causality of dizziness, hotness and nausea to GARDASIL. No further AE information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of 60 to 65 year old. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number lot/batch number, expiration date and route were not reported). On an unknown date, reported as months after the administration, the patient experienced shingles. No product quality complaint was involved. The outcome of shingles was unknown. The related between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in August 2014 (reported as since 14-AUG-2014) the patient was vaccinated with at least one dose of improperly stored VARIVAX (lot number, expiration date, dose and route were not reported). No concomitant medications were reported. On an unknown date in August 2014, (reported as "within two days of dose"), the patient complained of injection site pain. The outcome of injection site pain was not reported. The relatedness between injection site pain and VARIVAX was not reported. This one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to multiple unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was unknown. The nurse reported that multiple unspecified patients were administered ROTATEQ (dose, frequency and route unspecified) that were improperly stored. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ROTATEQ was not reported. Product quality issue was not involved. This case is linked to #1409USA001487, #1409USA001775 and #1409USA001776 via same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Rash vesicular, Stomatitis
Clinical narrative: Initial reaction was widespread redness and swelling at injection site.  Reaction continued with several pox breaking out on inner thighs, later on forearms and finally on torso.  Also had sores develop in mouth and tongue, and consistent headache for over a week.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Tongue ulceration
Clinical narrative: Initial reaction was widespread redness and swelling at injection site.  Reaction continued with several pox breaking out on inner thighs, later on forearms and finally on torso.  Also had sores develop in mouth and tongue, and consistent headache for over a week.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Aura
Clinical narrative: Auras.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Local swelling, Pruritus, Skin warm
Clinical narrative: localized swelling, redness, hot to touch, hard bump, itching.  Swelling and redness spread over the next week to encompass a six - eight inch area
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to multiple unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was unknown. The nurse reported that multiple unspecified patients were administered GARDASIL (dose, frequency and route unspecified) that were improperly stored. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This case is linked to #1409USA001774, #1409USA001775 and #1409USA001776 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report  as received from a pharmacist refers to a patient of unknown age gender. On an unknown date in 2010 the patient was vaccinated intramuscularly with first dose of RECOMBIVAX HB. On an unknown date in 2011 the patient was vaccinated intramuscularly with second dose of RECOMBIVAX HB. On 18-AUG-2014 the patient presented in the office to received third dose of RECOMBIVAX HB. No adverse effects were reported. No product quality complaint was involved. 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 registered nurse refers to multiple unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was unknown. The nurse reported that multiple unspecified patients were administered RECOMBIVAX HB (dose, frequency and route unspecified) that were improperly stored. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with RECOMBIVAX HB was not reported. Product quality issue was not involved. This case is linked to #1409USA001487, #1409USA001774 and #1409USA001775 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to multiple unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was unknown. The nurse reported that multiple unspecified patients were administered VAQTA (dose, frequency and route unspecified) that were improperly stored. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VAQTA was not reported. Product quality issue was not involved. This case is linked to #1409USa001487, #1409USA001774 and #1409USA001776 via same reporter link. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 62 year old patient. On 31-JUL-2014 the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, route were not reported). No concomitant medications were reported. On 02-AUG-2014, 2 days after the vaccination the patient experienced large welt at the injection site. The patient sought medical attention via office contact. The patient used Ice Pack and ibuprofen as a treatment. The outcome of welt at the injection site was reported as recovered on an unknown date in August 2014. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TDAP
Symptoms: Fall, Head injury, Loss of consciousness, Pallor, Screaming
Clinical narrative: Child was noted in male arms, after being called into lobby due to child passing out after vaccination, approx 15 mins. Nurse requested child to be placed on floor for assessment, child noted awake and alert, yelling, skin color pale. O2 administered at 3L/m x 10 mins, removed after child calmed down. Male stated, "child fell forward and hit her head." 911 called, child was transported via ambulance to hospital for assessment.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Local reaction
Clinical narrative: Localized reaction to (L) arm extending from shoulder to 2" above elbow. Firm, indurated, erythematous skin with quarter sized area vesicles at site of injection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red, swollen, itchy, instructed mom to apply cool compress and give BENADRYL, amount according to dosing chart.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had injection site reaction (injection site became red, enlarged, and warm). She took ZYRTEC, BENADRYL and never decreased by 9-3-14, so she went to doctor. Swelling hasn't gotten any larger, but it hasn't gone down. Dr told her it is an injeciton site reaction and continue BENADRYL.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9/1 pt claims when she got up the next day - below where she got flu shot - red, swelling, raised warm to touch - and puffy muscle - no fever no headache no pain. On 9/3 she came into see me and said swelling had come down - it was still red and warm to touch.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX (lot number, expiration date, dose and route were not reported). No concomitant medications were reported. On an unknown date, (reported as "within two days of dose"), unspecified number of patients complained of injection site pain. The outcome of injection site pain was not reported. The relatedness between injection site pain and (Oka/Merck) VARIVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Injection site haematoma
Clinical narrative: Significant hematoma to thigh where 2-month vaccinations were administered
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus generalised
Clinical narrative: Rash at back of arm where vaccine was given.  Also, I feel itchy all over my body.  Especially scalp and face.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Tenderness
Clinical narrative: Received annual influenza vaccine in L deltoid in the morning and by evening reported that she began to have tenderness and pain to L axilla that has progressively gotten worse.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Welt appeared around injection site.  Continued to grow and became red.  Mom treated with Benadryl.  Our nurse practitioner diagnosed with early cellulitis and prescribed a course of amoxicillin, cool compresses, and tylenol as needed.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Culture wound negative, Injection site abscess, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Leg became red, swollen and large blister/abscess developed. The blister broke was a half dollar sized wound.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram, Fatigue, Hypoaesthesia
Clinical narrative: (CIDP). Fatigue, mild cold after vaccine. 3-4 wks after vac fatigue and symptoms progressed to numbness, sleepiness, tingling, burning sensation in my legs and arms. Treatment IVIG infusions.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Nasopharyngitis, Paraesthesia, Somnolence
Clinical narrative: (CIDP). Fatigue, mild cold after vaccine. 3-4 wks after vac fatigue and symptoms progressed to numbness, sleepiness, tingling, burning sensation in my legs and arms. Treatment IVIG infusions.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. Patient's concurrent conditions and relevant medical history was unknown. On 16-MAY-2014 the patient was vaccinated with ZOSTAVAX, (0.65 ml), subcutaneously. Concomitant medications were unknown. The patient came to the pharmacy and reported that she has been experiencing arthritis type of pain in her shoulder sporadically following vaccination with ZOSTAVAX and asked if pain can be related to ZOSTAVAX. No treatment was given for adverse events. The patient sought medical attention by speaking to pharmacist. The outcome of arthritic type of pain in her shoulder sporadically was reported as not recovered/not resolved. The causality of the events with ZOSTAVAX was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Administered GARDASIL instead of Hep A vaccine.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Local swelling, Pain, Pruritus, Rash erythematous
Clinical narrative: Large plaque of erythematous rash at the injection site (right deltoid) associated with swelling in the digits of both hands, minimum pain, pruritus.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Skin plaque
Clinical narrative: Large plaque of erythematous rash at the injection site (right deltoid) associated with swelling in the digits of both hands, minimum pain, pruritus.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from Nurse practitioner refers to an adult patient of unknown age. The patient's medical history and current condition are not reported. On 06-JAN-2014 the patient was vaccinated with RECOMBIVAX HB 5 mcg/0.5 ml dose 1, intramuscularly. On 28-AUG-2014 the patient was vaccinated with RECOMBIVAX HB dose 2. It was reported that they stock the pediatric formulation of RECOMBIVAX HB so that the appropriate dosage was and will be achieved with two 5 mcg doses (pediatric formulations). No adverse effects are reported. Product quality complaint is not involved. The outcome of the events is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. On an unknown dates the patients received doses of ZOSTAVAX (dose, route of administration, lot# and expiration dates were not provided) that were exposed to temperatures outside of the proper storage range. No adverse effects reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 54 year old female patient with none medical history and none drug reactions/allergies. On an unknown date, (reported as "when the patient was a child") the patient was vaccinated with a dose of MMR II (lot number, dose and route were not reported). No concomitant medications were reported. On an unknown date reported as "recently" the patient experienced low antibody titer to one of the components of MMR II. The pharmacist did not know which of the MMR II components showed the low antibody titer. The outcome of low antibody titer to one of the components of MMR II was not reported. The relatedness between the event and MMR II was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: This spontaneous report as received from a non pregnant female patient of unknown age refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). On an unknown date the patient experienced a welt the size of "half a dime" at the injection site. She had redness and swelling at the injection site as well. Over the weekend (date unspecified) the injection site was "warm to touch". She contacted physician and was advised to take BENADRYL as a treatment. The BENADRYL cleared up her adverse events some, but not all the way. The patient was recovering from the events of a welt the size of "half a dime" at the injection site, redness and swelling at the injection site, the injection site was "warm to touch". Relatedness between all the events and ZOSTAVAX was not specified. Additional information is not expected as the patient did not want to provide any contact details.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blister, Cellulitis, Drug hypersensitivity, Injection site erythema, Injection site induration
Clinical narrative: Patient developed (R) deltoid swelling, tenderness, induration and erythema 2 days after receiving IM PNEUMOVAX 23 and FLUZONE HD in same (R) deltoid. Seen by PCP on 8/19/14 - no rash, fever or chills, severity noted as 4/10. Diagnosed as cellulitis/possible reaction to shots - treated with sulfamethoxazole/tmp DS BID x 7d. Pt subsequently had a cutaneous blistering reaction to antibiotic which lead to hospitalization.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient developed (R) deltoid swelling, tenderness, induration and erythema 2 days after receiving IM PNEUMOVAX 23 and FLUZONE HD in same (R) deltoid. Seen by PCP on 8/19/14 - no rash, fever or chills, severity noted as 4/10. Diagnosed as cellulitis/possible reaction to shots - treated with sulfamethoxazole/tmp DS BID x 7d. Pt subsequently had a cutaneous blistering reaction to antibiotic which lead to hospitalization.
Age: 37.0
Sex: M
Vaccine: HEP, MMR, TDAP
Symptoms: Erythema, Induration, Injection site pain
Clinical narrative: Tdap given on 8/28, 8/29 noted increased pain (L) upper arm. Seen on 9/2, 9 cm area of erythema with induration started on BACTRIM for possible cellulitis. Re-eval on 9/4 - sx resolved.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: 2 day post administration of vaccine patient developed induration, redness, and swelling on the left arm.
Age: 58.0
Sex: M
Vaccine: DTP
Symptoms: Ear pain, Ear swelling, Lymphadenopathy, Pain in jaw, Pruritus
Clinical narrative: Swollen glands in right side of neck, swollen left ear, pain and itching in left ear canal, swollen left jaw and pain in left jaw joint.
Age: 58.0
Sex: M
Vaccine: DTP
Symptoms: Swelling
Clinical narrative: Swollen glands in right side of neck, swollen left ear, pain and itching in left ear canal, swollen left jaw and pain in left jaw joint.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Oedema, Tenderness
Clinical narrative: Localized erythema in the left deltoid following vaccination.  Edema and tenderness.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Drooling, Feeling abnormal
Clinical narrative: 18 MIN AFTER HPV VACCINE WAS ADMINISTERED, PT STARTED SMILING AND TWISTED HER FACE AND MOM VERBALIZED THAT SHES STARTING TO HAVE A SEIZURE. NOTED SYMPTOM LASTED FOR 3 MINUTES THEN PT STARTED LOOKING SPACED OUT AND STARTED DROOLING. PT WAS PLACED ON THE FLOOR FOR SAFETY, VS RECORDED, O2 @ 3L/MIN STARTED. MANDOWN CALLED. MOM ADMINISTERED DIASTAT 2O MG/RECTUM (HER EMERGENCY SUPPLY FROM HOME) @ 6:55PM. DR RESPONDED CALL AND EVALUATED PT/CALLED PER; MANDOWN TEAM ARRIVED @ 7:10PM. PT BROUGHT TO DEM @ 7:18PM BY MANDOWN TEAM.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Insomnia, Nasopharyngitis
Clinical narrative: Change in behavior, cold/ flu like symptoms, no sleep, decrease in appetite, lots of crying.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Oropharyngeal pain, Pain, Poor quality sleep, Sinus congestion
Clinical narrative: could lift left arm >45 degrees;  body aches and malaise; pain awoke her during the night time from sleeping. A few days after that developed sore throat and sinus congestion
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discomfort, Injection site mass
Clinical narrative: She said she had bump/lump at injections site for 4 days.  She said it cause slight discomfort and she would rub it until it went away.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass
Clinical narrative: She said she had bump/lump at injections site for 4 days.  She said it cause slight discomfort and she would rub it until it went away.
Age: 20.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Eye movement disorder, Formication, Loss of consciousness, Oxygen saturation immeasurable
Clinical narrative: Patient did have reaction after receiving Hepatitis A vaccine 1st, then Typhoid vaccine 2nd. Patient became pale, slumped over in sitting position, and started having tremor of hands, and eyes rolled back for approximately 1.5 minutes. Patient did not experience fall as she was still in sitting position and LVN stood behind her, and RN stood in front of patient. Initially unable to get pulse ox read during incident, HR 50. Oxygen was administered via facemask at 10L, airway kept open. Dr. (doc of day) was alerted and CODE ALERT called. Patient became alert and oriented after 1.5min, spO2 100%, P65, R20, and states "I was dreaming". After incident, patient A&O x3, patient reports that she did not eat yet, and reports feeling of "lightheaded and dizzy after shots", states after shots she felt like "spiders crawling all over arm" and "felt blackout". Dr. assessed patient. Patient given apple juice, crackers, and water. Monitored in triage room until stable. Left clinic after 1 hour.
Age: 20.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Pallor, Posture abnormal, Tremor
Clinical narrative: Patient did have reaction after receiving Hepatitis A vaccine 1st, then Typhoid vaccine 2nd. Patient became pale, slumped over in sitting position, and started having tremor of hands, and eyes rolled back for approximately 1.5 minutes. Patient did not experience fall as she was still in sitting position and LVN stood behind her, and RN stood in front of patient. Initially unable to get pulse ox read during incident, HR 50. Oxygen was administered via facemask at 10L, airway kept open. Dr. (doc of day) was alerted and CODE ALERT called. Patient became alert and oriented after 1.5min, spO2 100%, P65, R20, and states "I was dreaming". After incident, patient A&O x3, patient reports that she did not eat yet, and reports feeling of "lightheaded and dizzy after shots", states after shots she felt like "spiders crawling all over arm" and "felt blackout". Dr. assessed patient. Patient given apple juice, crackers, and water. Monitored in triage room until stable. Left clinic after 1 hour.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red, swollen, painful  Advil and Moist heat
Age: 12.0
Sex: M
Vaccine: HPV2
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction- Pt. was given Cervarix instead of Gardasil.
Age: 11.0
Sex: M
Vaccine: HPV2
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction- pt. was administered Cervarix instead of Gardasil.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient began itching.  Developed what appeared to be hives all over trunk, then arms and neck and thighs.  She was seen the next day by physician who prescribed steroid dose pack and gave steroid injection.  Areas subsided quickly and reduced to very minimal by the following day.
Age: 11.0
Sex: M
Vaccine: HPV2
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction- pt. received Cervarix instead of Gardasil.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dizziness, Meniere's disease, Nausea, Vomiting
Clinical narrative: Severe episode of Meniere's Disease. Dizziness and vomiting all day long. Had to call 911 and was hospitalized until nausea was under control. TX with Ondansetron and ANTIVERT and VALIUM to control N and V. Dizziness persisted even after discharge. ENT referral sent me to balance therapy.
Age: 73.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Blood potassium decreased, Blood sodium decreased, Dehydration, Diarrhoea
Clinical narrative: Slight temperature 99F and cramps in the abdomen, diarrhea, muscle aches and malaise lasting over a week. I was taken to local ER and after ER physician evaluation and lab work I was given IV fluid to make up Na and K deficit and to rectify the dehydration. The ER visit was on September 1st, 2014 afternoon.
Age: 73.0
Sex: F
Vaccine: TYP
Symptoms: Electrocardiogram, Hypokalaemia, Hyponatraemia, Malaise, Myalgia
Clinical narrative: Slight temperature 99F and cramps in the abdomen, diarrhea, muscle aches and malaise lasting over a week. I was taken to local ER and after ER physician evaluation and lab work I was given IV fluid to make up Na and K deficit and to rectify the dehydration. The ER visit was on September 1st, 2014 afternoon.
Age: 73.0
Sex: F
Vaccine: TYP
Symptoms: Pyrexia
Clinical narrative: Slight temperature 99F and cramps in the abdomen, diarrhea, muscle aches and malaise lasting over a week. I was taken to local ER and after ER physician evaluation and lab work I was given IV fluid to make up Na and K deficit and to rectify the dehydration. The ER visit was on September 1st, 2014 afternoon.
Age: 14.0
Sex: M
Vaccine: HPV2
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction- pt. was given Cervarix instead of Gardasil.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Steadily increasing myalgia, chills, headache, and fever. Highest oral temperature reading was 101.6, at about 12:30 AM, 30m after treatment with ibuprofen had begun. Temperature was normal by 11:30 AM on the 30th.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse effects- pt. was given Cervarix instead of Gardasil.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Bruising, soreness around injection; hard nodule at point of injection.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness on arm around area MCV-4 was injected. Place warm compress on arm every 4 to 6 hrs PRN.
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site pruritus, Injection site rash
Clinical narrative: Right deltoid- 6.5 x 8cm pruritic rash first noticed when he woke up this morning. Reported a small lump at site of injection immediately after admin of vaccine.
Age: 1.01
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of right thigh where Daptacel was administered 24 hours later. On 6/18 redness involved the whole thigh. Pt. recovered.
Age: 12.0
Sex: M
Vaccine: HPV2
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction- pt. was given Cervarix instead of Gardasil.
Age: 13.0
Sex: M
Vaccine: HPV2
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction- pt. was given Cervarix instead of Gardasil
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eyelid oedema, Injection site erythema, Injection site urticaria, Skin warm
Clinical narrative: Right leg: upper site- red hive 1.5" long hot swollen. Right eyelid: red swollen hives.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Rash generalised
Clinical narrative: Rash on body for 3 days.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: redness, rash, itching
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Odynophagia, Pharyngeal oedema
Clinical narrative: After administration of Hep B on 6/5/14 patient reported about 30 minutes she felt like her throat was swollen and it hurt to swallow. Patient stated sensation lasted about 2 hours and resolved on its own.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature, Diarrhoea, Nausea, Rash erythematous, Rash macular
Clinical narrative: Rash, red, raised pinpoint blotchy n/v, diarrhea, temp, rash became worse.  still present on 7/17/2014
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Rash, red, raised pinpoint blotchy n/v, diarrhea, temp, rash became worse.  still present on 7/17/2014
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dysphagia, Headache, Heart rate increased
Clinical narrative: Chills, shaky, muscle weakness, trouble swallowing, fever, headache, fast hearbeat, and weakness.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pyrexia, Tremor
Clinical narrative: Chills, shaky, muscle weakness, trouble swallowing, fever, headache, fast hearbeat, and weakness.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot # and route of administration were not reported). On unknown date the reporter called to the physician's office to find out the results of unspecified specimen that she had sent on 19-AUG-2014 due to an unspecified adverse reaction that the patient developed on unknown date after receiving an unspecified product. The reporter declined to provide any information and ZOSTAVAX was documented. The outcome of the unspecified adverse reaction was unknown. Addition information is not expected due to the reporter declined to provide further information.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 34 unspecified patients of unknown age. On an unknown date, 34 unspecified patients was vaccinated with improperly stored GARDASIL (lot#, expiry date unknown) exposed to 32F for 33 days. It was also reported that one unspecified patient received improperly stored PEDVAXHIB exposed to 32F for 33 days. There was no product quality complaint. No adverse effects were reported. Outcome of the reported event was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Face injury, Fall, Lip injury, Loose tooth, Loss of consciousness
Clinical narrative: gardasil vaccine was given then a few seconds later she passed out falling off the table hitting her face on the cabinet.six stitches in her lip and her front tooth got knocked loose and a week later it needed a root canal
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Suture insertion
Clinical narrative: gardasil vaccine was given then a few seconds later she passed out falling off the table hitting her face on the cabinet.six stitches in her lip and her front tooth got knocked loose and a week later it needed a root canal
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Electrocardiogram abnormal, Pain, Pyrexia
Clinical narrative: First I want to say that I cannot remember the exact date, but I do recall it being around Christmas time. I started to get body aches later the same night I received the vaccine. I then woke up in the morning with a 102 degree fever, body aches, and chest pain. My mother, who has been an RN for almost 20 years, was concerned and took me took the doctor. I was given an ECG where my heart waves were slightly abnormal. I have never had any cardiac condition and neither has anyone in my family. The doctor said to take ibuprofen for fever and rest. He attributed my condition to the vaccination, specifically the preservatives, as this was the first year apparently that the flu shot was offered in a triple combo (influenza A, influenza B, and H1N1). He said the more viruses in the vaccine the more preservatives. I have had a flu shot every year since 1998 and never had an issue until 2010.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Erythema, Feeling hot, Local swelling, Pain, Pruritus
Clinical narrative: redness, swelling, hot. Swelling and redness extended to a patch approximately 4 inches by 8 inches on arm. Some pain, lots of itching, rash appearance.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Rash, Swelling
Clinical narrative: redness, swelling, hot. Swelling and redness extended to a patch approximately 4 inches by 8 inches on arm. Some pain, lots of itching, rash appearance.
Age: 31.0
Sex: F
Vaccine: DPP
Symptoms: Diarrhoea, Injection site pain, Vomiting
Clinical narrative: Vomiting, diarrhea, soreness at injection site
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (dose 0.5 ml subcutaneously; lot# was not reported). No adverse events were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 0.79
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Urticaria
Clinical narrative: Family arrives for child's immunizations. The "Screening Checklist for Contraindications for Children and Teens" is filled out by mother and verbally reviewed with mom. No contraindications are present. Recommended childhood immunizations are reviewed, VIS statements are provided. Mom has no questions. She consents to her child getting only the Pediarix vaccine at this time. This is child's second dose of Pediarix.Child receives Pediarix immunization IM to Right thigh. "After the shot" instructions are given and reviewed with mom and mom consents to wait in lobby for 15 minutes after vaccine administration. Staff escorts mom and child to exam room and notes four white raised areas with red borders to child's left arm above and below the elbow on the outer aspect of the arm.Lung sounds are clear. Heart rate is 120 beats per minute. Staff examines child's body for other hives, inspecting the trunk of body, arms, legs, neck, face, and behind the ears. No hives present. Child is cooing, babbling and smiling. Child is not grunting, wheezing or coughing. He does not appear to be in respiratory distress. Benadryl 0.2 ml IM to left thigh is given. Child weighs 20 pounds and 8 ounces. Lungs sounds are clear throughout. Apical pulse is 120 beats per minute. Child is babbling and cooing. Child is not grunting, wheezing or coughing. He does not appear to be in respiratory distress. No periorbital edema noted. No swelling around the mouth noted.Mom declines EMS transfer to facility. EMS and family leave the health office. At the time family leaves, the wheals on child's left arm are less raised and the redness is much less. The small raised area on child's abdomen is nearly undetectable.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Nausea, Dizziness, Sweating
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: The patient described general malaise and a low grade fever 24 hours after the immunization.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Decreased appetite, Somnolence
Clinical narrative: My daughter slept for 8 hours waking only once for feeding.  Usually would sleep no more than 1.5 hours at a time with periods of wake in between. Very sleepy and lowered appetite.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test abnormal, VIIth nerve paralysis
Clinical narrative: Bell's Palsy was diagnosed by a physician on 10/4/13. Was prescribed Valtrex. Was seen by a neurologist on approximately 10/22/2013 who confirmed Bell's Palsy
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Acarodermatitis, Anaemia, Arthralgia, Delusion, Psoriasis
Clinical narrative: I.P.V. Joint pain monthly, possible herpes. Dx / psoriasis, chronic scabies on face.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: I was informed by patient's parents that the patient had a febrile seizure the evening the vaccines were administered.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Swollen tongue
Clinical narrative: Tongue swelling after 4 mo. vaccines.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: 8cm x 10cm redness to right deltoid.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: She developed redness and swelling of her upper right arm. Some itchiness. Dr is proactively treating her for cellulitis.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt received ZOSTAVAX 8/27- The next day pt said the inj site became itchy and red- on 8/29, 2 days later, pt said it appeared to expand and continued to be itchy and red.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Pt c/o joint pain localized in knuckles on left arm where HPV administered IM. Pt advised to massage arm and monitor - pt states that relieved s/s.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash vesicular, Varicella post vaccine
Clinical narrative: 9/1/14 8:30 PM - noticed what looked like mosquito bites. 9/3/14 rash started to blister. 9/4/14 took child to Dr. who diagnosed mild case of chickenpox by sight.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician via a company representative refers to a 16 year old female patient. On 13-AUG-2014 the patient was vaccinated with GARDASIL (dose, lot # and route of administration were not reported). The last menstrual period (LMP) ans estimated date of delivery (EDD) were unknown. The pregnancy outcome was lost to f/u. I was reported that the patient was diagnosed as pregnant after receiving GARDASIL. Patient sought medical attention on unspecified date. She did not receive any treatment. Additional is not expected due to the reporter did not want to be contacted again.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pallor, Papule, Pruritus
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old male patient. On 05-AUG-2014 the patient was vaccinated with a dose of VARIVAX, lot# K002913, 0.5 ml, subcutaneous. In August 2014 the patient experienced blanching, pruritic papules on his back after receiving VARIVAX. Patient was seen in an unspecified Emergency Room on 10-AUG-2014, for an unknown reason vaccine. "The outcome of the event was unknown". The physician requested lot check. This is one of several reports received from the same reporter. K002913 is valid for VARIVAX. Additional information has been requested.