chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with a dose of GARDASIL (lot number, expiration date, dose, route were not reported). On an unknown date unspecified number of patients experienced soreness at injection site. The outcome of soreness at injection site was not reported. The relatedness between the event and GARDASIL was not reported. Additional information is not expected due to no consent for follow up.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 17 year old female patient. In October 2013 (reported as one year ago) the patient received the first dose of GARDASIL (lot#, dose and route unspecified). On 30-OCT-2014 the patient presented to office for the second dose of GARDASIL (lot#, dose and route unspecified). No adverse effects were reported. The outcome of the event was unknown. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from the nurse practitioner via company representative refers to 3 female patients, who, at the time of vaccination, all were over the age of 70 (elderly). On an unspecified date in 2014, the patients were vaccinated with a dose of ZOSTAVAX 1 single shot (dose, dose number, lot/batch number, expiration date and route of administration were not reported) in September 2014 (reported as in the last month), the patients developed shingles within one month of receiving ZOSTAVAX. The patients sought medical attention (unspecified). The outcome of shingles was reported as recovered/resolved (in approximately 2014). The relatedness between the event and ZOSTAVAX was not reported.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug dose omission, No adverse event, Product container issue
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. It was reported that the anonymous patient missed a dose of PNEUMOVAX23 (dose and lot # not reported) because the vial was broken. PQC reported for broken vial. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The reporter reported the patient received a first dose of GARDASIL (lot# was not reported) on 10-JAN-2008, a second dose of GARDASIL (lot# was not reported) on 07-APR-2008 and was in the office to receive a third dose of GARDASIL (lot# was not reported) on 22-OCT-2014. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient experienced shingles. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of shingles was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. No product quality issue was reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site reaction, Injection site swelling, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 48 years old female. Pregnancy was reported as none. Pertinent medical history included asthma, atherosclerosis, psoriasis and rheumatoid arthritis. Drug reactions/allergies were reported as none. On 15-OCT-2014, the patient was vaccinated with PNEUMOVAX23 injection 25/0.5 Y, lot # K010522, expiry date 25-FEB-2016 (dose, frequency and route were not provided). Concomitant therapies included diazepam (manufacturer unknown), HYDROCODONE, LIPITOR and unspecified "thyroid medication". On 15-OCT-2014, the patient developed red, swelling and painful rash at and around the injection site after receiving PNEUMOVAX23. Patient also developed bulbous swelling that was a "big lump" at and around the injection site. Patient was treated with BENADRYL and "icing it". No lab diagnostics studies were performed. Patient did not seek medical attention. There was no intervention to prevent seriousness Criteria. No product quality complaint (PQC) was involved. Also reported as therapy with PNEUMOVAX23 was continued. The outcome of events was not resolved. Causality was not provided. No additional information was reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Small 8 mm firm round mass at injection site with 2 cm area of redness.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Haematoma, Injection site induration, Injection site swelling
Clinical narrative: Patient received vaccine today came back to clinic with hard firm area of the (R) alteral proximal arm about 3-4 cm with swelling.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Vesicle appeared < 2 days after receiving zoster vaccine on (L) side below chin. Also site of administration red, warm, puffy, swollen, itchy. To clinic. Received valcyclovir 1 gm 3xd for 7d. Resolved. Rash size>12 mnm x 10mm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Vesicle appeared < 2 days after receiving zoster vaccine on (L) side below chin. Also site of administration red, warm, puffy, swollen, itchy. To clinic. Received valcyclovir 1 gm 3xd for 7d. Resolved. Rash size>12 mnm x 10mm.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On approximately 16-OCT-2014 (reported as "either on 15-OCT-2014 or 16-OCT-2014) the patient was vaccinated with ZOSTAVAX, (single dose (unspecified) route of administration: intramuscular). In approximately October 2014 the patient experienced pain in the shoulder and whole arm in which the ZOSTAVAX was administered. ZOSTAVAX might have been administered intramuscularly. The outcome of pain in the shoulder was reported as not recovered/not resolved. Patient sought medical attention (came to pharmacy). No lab diagnostic studies were performed. No treatment was given for adverse event. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report as received from a 53 year old female, obese patient with no drug reactions or allergies. The patient stated she had shingles three times before and in the past her physician has prescribed valacyclovir whenever the shingles reoccurred. On 28-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX injection administered in the left forearm as one single shot (strength, dose, route of administration, indication, lot # and expiry date unspecified). Concomitant therapies included BENADRYL and hydrocodone. The patient reported to her physician and pharmacist the  next morning, on 29-OCT-2014, that she felt electric shocks on her right shoulder. The electric shocks were occurring every ten minutes in between her neck and shoulder blades. The patient sought medical attention, but no treatment was given and no laboratory test were performed. The outcome of the event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the reporting healthcare professional has  not seen this patient and has no other information to provide.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Hypoaesthesia, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: "Later that evening after Tdap shot, redness, swelling, pain, hardness at injection site. Also had numbness in arm and tingling in both hands. Injection site reaction resolved but still experiencing numbness/tingling in both hands."
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Paraesthesia
Clinical narrative: "Later that evening after Tdap shot, redness, swelling, pain, hardness at injection site. Also had numbness in arm and tingling in both hands. Injection site reaction resolved but still experiencing numbness/tingling in both hands."
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (strength, dose, route and lot # unknown) injection, which underwent multiple temperature excursions. No adverse effect was reported.   Follow up information has been received from a medical assistant. Medical assistant stated that between the dates of 12-AUG-2014 through 10-SEP-2014, approximately 12-15 doses of (Oka/Merck) VARIVAX were administered to a population of 23 months old children. The reporter also stated that he lot # for (Oka/Merck) VARIVAX was K003420, expiration date 06-MAR-2016. It was reported that 5 doses had not being administer yet. This is  one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patients pertinent medical history, drug reactions/allergies were not provided.  On 30-OCT-2014, the patient was inadvertently vaccinated with dose of M-M-R II, 0.5 ml subcutaneous, lot H015829, which had expired on 24-AUG-2014. No adverse effects were reported. Additional information is not expected since no consent to contact the reporter was granted.
Age: 65.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Headache, Herpes zoster, Paraesthesia
Clinical narrative: Had tingling/pain in right side of head 4 days after vaccine. Resolved in approximately one month. No treatment.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Angioedema, Flushing, Urticaria, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old female patient with drug reactions/allergies to eggs and drug reactions/allergies to nuts. On 23-SEP-2014 the patient was vaccinated with PROQUAD. Lot number reported as K009891, expiration date unspecified. Other suspect therapies included DTAP (unspecified manufacturer) and IPV (unspecified manufacturer) date of vaccination 23-SEP-2014. Dose, route, lot number and expiration date were not reported. The physician reported that the patient left the office and while in the parking lot the patient began to vomit. The patient and her mother went back to the office and the patient then developed urticaria. The patient developed hives and angioedema and her face became flushed with the appearance similar to a sunburn (on 23-SEP-2014). The patient was given BENADRYL. Even though the patient had developed these symptoms the physician does not consider them to be life threatening. The outcome of vomiting, her face became flushed with the appearance similar to sunburn, angioedema and urticaria/hives was reported as recovered (on 23-SEP-2014). No lab diagnostics studies were performed. The patient sought medical attention. 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 certified medical assistant refers to a patient of unknown age and gender. Current conditions and other medical history were not reported. On an unspecified date in April 2014, the patient was vaccinated with the first dose of RECOMBIVAX HB (10 microgram/ml, intramuscular injection, dose 1; route, anatomical location, batch/lot and expiration date not reported). Later on, 22-OCT-2014 the patient was vaccinated with the second dose of RECOMBIVAX HB (1o microgram/ml, intramuscular injection, dose 2; route, anatomical location, batch/lot and expiration date not reported. Concomitant therapies were not reported. The reporter informed that the patient received the first dose of RECOMBIVAXHA in April 2014 and the second dose on 22-OCT-2014. No adverse effects were noted. Additional information is not expected as the reporter did not wish to be contacted for further follow up.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant), also reported as registered nurse (RN) refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On 26-AUG-2014, the patient was vaccinated with a dose of PROQUAD (Merck) injection, lot number K007158, expiration date 12-NOV-2015, 0.5 ml once, subcutaneously, that was stored at 42.9 (also reported as 43) degrees Fahrenheit for 744 hours (temperature excursion date reported as 25-AUG-2014). No adverse effects were reported. Concomitant medications were not specified. Additional information has been received from a healthcare worker (medical assistant), regarding a 4 year old patient. The reporter stated that PROQUAD was placed in the fridge and not in the freezer. At the time of the report the temperatures of the units in which PROQUAD (Merck) was stored were reported as 42.9 (refrigerator) and -11 (freezer). This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, VIIth nerve paralysis
Clinical narrative: After inquiring about side effects for the shingles vaccine and being told that there were none, I took the vaccine; shortly thereafter, I developed Bell's Palsy. My face has returned to normal, but my eye has not. Additionally, my eye is extremely light sensitive, something that was not prior to the vaccine. I went to the emergency room and was prescribed a steroid; PREDNISONE, to be taken for 10 days. I required 4 additional visits to my doctor.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On unspecified dates, an unknown number of patients were inadvertently vaccinated with VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified), that had been improperly stored. No concomitant therapies were reported. No adverse effects reported. the outcome of the events was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt c/o left arm swelling and pain, redness after receiving pneumonia vaccine one day pior. Pt took 2 (25 mg Benadryl) Full ROM in arm. Prescribed Augmentin and Prednisone. FU 24 hrs. Pt redness, pain, swelling all improved. Full ROM.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site warmth, Nausea, Pain
Clinical narrative: Nausea, vomiting, fever, headache, body aches - 7" x 9" redness and warmth (L) deltoid-lasting 3-5 days.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, fever, headache, body aches - 7" x 9" redness and warmth (L) deltoid-lasting 3-5 days.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: No adverse events reported by pt's mother.
Age: 1.27
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Area on LVL is swollen, red and looks like about 50 cent in size. This is where the PREVNAR was given.
Age: 1.36
Sex: M
Vaccine: VARCEL
Symptoms: Computerised tomogram normal, Convulsion, Laboratory test normal, Pyrexia
Clinical narrative: Approximately 24 hours after the varicella vaccine the child ran a fever and had a seizure. He was taken to the emergency room. The seizure lasted about 5 minutes. ACT scan and lab work were done. Both were normal. Dr is ordering an EEG for 12/23/14.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Pain, Pyrexia, Swelling
Clinical narrative: Pt reported swelling, chills, aches, fever 102F. She went to her doctor and told she had cellulitis and was given 2 courses of antibiotics. This was reported by pt to customer service line. Pt is improving slowly as I talked to her mother 11/7/14, 7:45 AM.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an infant patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 03-OCT-2014 the patient was vaccinated with RECOMBIVAX HB (dose, dose number, lot number and expiration date were not reported). Co-suspect and concomitant therapies were not reported. On 04-OCT-2014, the patient received another dose of the vaccine. No adverse symptoms reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Blood test, Injection site infection, Injection site swelling
Clinical narrative: Arm looked as if it was infected. Arm was swollen and had gotten worse [injected arm].
Age: 69.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Infection, Local swelling
Clinical narrative: Arm looked as if it was infected. Arm was swollen and had gotten worse [injected arm].
Age: 58.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray, Chest discomfort, Dizziness, Electrocardiogram, Enzyme level test
Clinical narrative: Tremor, tight chest within 20-30 min of shot, comes and go every 15-20 min., dizzy.
Age: 58.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Swollen tongue, Tremor
Clinical narrative: Tremor, tight chest within 20-30 min of shot, comes and go every 15-20 min., dizzy.
Age: 58.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Dizziness, Tremor
Clinical narrative: Tremor, tight chest within 20-30 min of shot, comes and go every 15-20 min., dizzy.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old male patient with allergy to fluoroquinolones. On 03-OCT-2014 the patient was vaccinated with PNEUMOVAX23 (Injection, dose number, route,  anatomical location, batch/lot # and expiration date not reported). Concomitant therapies were not reported. The pharmacist informed that since administration of PNEUMOVAX23, on 03-OCT-2014, the patient experienced soreness at the injection site. No treatment was given for the adverse event, however, the patient sought medical attention by attending pharmacy. No laboratory diagnostic studies were performed. The outcome of the event was reported as not recovered. The reporter did not provide causality for the event. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old male patient with allergy to fluoroquinolones. On 03-OCT-2014 the patient was vaccinated with PNEUMOVAX23 (Injection, dose number, route,  anatomical location, batch/lot # and expiration date not reported). Concomitant therapies were not reported. The pharmacist informed that since administration of PNEUMOVAX23, on 03-OCT-2014, the patient experienced soreness at the injection site. No treatment was given for the adverse event, however, the patient sought medical attention by attending pharmacy. No laboratory diagnostic studies were performed. The outcome of the event was reported as not recovered. The reporter did not provide causality for the event. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Blood sodium decreased, Confusional state, Diarrhoea, Hallucination, Nausea
Clinical narrative: Her sodium levels were low and she doesn't want to talk to us on this further. We came to know through CDC office that an adverse event occurred and patient hospitalized.
Age: 56.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Adverse event, Blood sodium decreased
Clinical narrative: Her sodium levels were low and she doesn't want to talk to us on this further. We came to know through CDC office that an adverse event occurred and patient hospitalized.
Age: 10.0
Sex: F
Vaccine: FLUX, HPVX
Symptoms: Dizziness, Pyrexia
Clinical narrative: Dizziness, High Fever.
Sex: M
Vaccine: DTAP, FLUX, IPV, MMR, VARCEL, IPV
Symptoms: Cellulitis, Convulsion
Clinical narrative: Initial report was received on 31 October 2014 from a non healthcare professional. A male patient had received on an unspecified date IPOL, lot number K1649, route and site of administration not reported and within 24 hours of vaccination, experienced seizure. The patient also had right side cellulitis. No further information was available at the time of the report. Outcome was  not reported. Documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Fatigue, Headache, Lethargy
Clinical narrative: Severe headache, nausea, vomiting, chills, fatigue, generalized weakness and lethargy.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Severe headache, nausea, vomiting, chills, fatigue, generalized weakness and lethargy.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Abdomen scan normal, Abdominal distension, Aortic aneurysm
Clinical narrative: On Friday, 10-17-14, she was advised that she should get a pneumonia shot before being discharged.  She had one several years ago and thought they were good for 10 years.  She feels the shot was given "improperly, either not deep enough or that the nurse hit a bone or something."  By that evening she couldn't move her right arm (where it was administered), and it has been very painful.  It didn't bother her until that night, and she had to lift that arm with her other arm.  She had to use percocet to relieve the pain in her arm, which was worse than her post-op surgical pain.  She states that from her elbow to shoulder is currently the affected area.  She's never had problems with shots before; did have a pneumonia vaccine several years ago without incident. On 10/31/14, she was able to move her right arm, but was still feeling pain and reported no change since 10/17.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, HOT, ITCHY AROUND INJECTION SITE. SLIGHTKY SWOLLEN AND PAINFUL.  PT DID NOT TAKE ANY MEDICATION FOR IT.
Age: 40.0
Sex: F
Vaccine: FLUC3
Symptoms: Blood pressure increased, Dysgeusia, Nausea, Paraesthesia oral
Clinical narrative: 15 minutes after injection, subject had weird taste in mouth, tongue got tingly, nauseated, BP increased 40 points.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: 1-2 weeks following quadravalent Flu shot, pain developed in shoulder.  Pain remains 4.5 weeks later.  It is especially painful when pressure is applied at the site of the injection, leading me to think it may be related to flu shot.  This was my first year receiving the flu shot.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Dyskinesia, Electroencephalogram normal, Eye movement disorder, Nuclear magnetic resonance imaging normal
Clinical narrative: Onset of seizures while at home child was taken to ER where work up was negative. He was discharge and on the 10/18 had another seizure and sent to another hospital for two nights and was started on Trileptal. He has follow-up apt with neurologist next week. total of 3 seizure all riding in cars activity is screams, eyes roll in head, he jerks all over for about 2-3 minutes and then sleeps after episode. Now has Diastat RX PRN.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Screaming
Clinical narrative: Onset of seizures while at home child was taken to ER where work up was negative. He was discharge and on the 10/18 had another seizure and sent to another hospital for two nights and was started on Trileptal. He has follow-up apt with neurologist next week. total of 3 seizure all riding in cars activity is screams, eyes roll in head, he jerks all over for about 2-3 minutes and then sleeps after episode. Now has Diastat RX PRN.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a physician refers to a 64 year old female patient with hypertension and asplenia and no drug allergies or reactions. In approximately 2007, 7 years ago, the patient was vaccinated with PNEUMOVAX 23 dose 1 (lot# not reported) 0.5 ml, intramuscular in right arm. On 30-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (Lot # K010466, Expiration date March 2016) dose 2, 0.5 ml, intramuscular in right arm. Other suspect therapy included unspecified influenza vaccine administered in left arm (lot#, route and dose not reported) on 30-OCT-2014. On 31-OCT-2014 the patient called the office and stated that she experienced stiffness from the shoulder extending to the elbow of the left arm. The patient was unable to move her left arm. Reflexes were intact and no other neurological damage was noted by the physician. No treatment was given for the events. No lab diagnostics studies were performed. The patient would see a physical therapist on 03-NOV-2014 and she would also be following up with a neurologist. The physician had recommended passive range of motion exercises to the patient. The outcome of the events was not recovered. The event unable to move arm was considered by the reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Oedema peripheral
Clinical narrative: This spontaneous report as received from a nurse (who is also the patient's daughter) refers to a 74 year old female patient with no known allergies. The patient's concurrent conditions included diabetes and an unspecified cardiac disorder (reported as "cardiac patient"). The patient's medical history included pacemaker insertion. On 23-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX injection administered subcutaneously in the left arm (dose, lot# and expiry date unspecified). Concomitant therapies included glipizide, metformin, COUMADIN and potassium (unspecified). The nurse reported that, on 30-OCT-2014, the patient developed red, swollen left arm, the swelling went under the armpit and "looked like Popeye". On the same date, 30-OCT-2014, the patient sought medical attention, she went to the local urgent care center and was administered an injection of steroid in her buttocks. The nurse stated the steroid injection was repeated again, since the nurse told her mother "she had bony buttocks". Patient was not hospitalized. The treatment thereafter was an unspecified oral steroid medication. The nurse stated she thought the ZOSTAVAX was administered incorrectly, by subcutaneous injection. However, it was administered subcutaneously as per the prescribing information. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the patient's events were considered to be medically significant. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Ataxia, Chest discomfort, Dyspnoea
Clinical narrative: Tightness in chest, mild difficulty breathing, mild ataxia.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC, RV1
Symptoms: No adverse event
Clinical narrative: Writer called pts father and informed him of incident.  Pts father denies pt having signs or symptoms of side effects.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Dysphagia, Dyspnoea, Headache, Ocular hyperaemia
Clinical narrative: Difficulty breathing, loss of voice, severe headache, blood red eyes, difficulty swallowing.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema
Clinical narrative: 2 days after administration, Patient developed redness in her arm which had spread from the injection site on her upper arm, down toward her forearm.  She was started on antibiotics on 11/4 for this issue in case it was infectious in nature.
Age: 71.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: 5 inch long swollen knot from site of injection down arm, 2 inch red itchy strip from site of injection across and down arm. 7-8 days for knot to disappear.
Age: 71.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: 5 inch long swollen knot from site of injection down arm, 2 inch red itchy strip from site of injection across and down arm. 7-8 days for knot to disappear.
Age: 0.24
Sex: M
Vaccine: HIBV, RV1, HIBV, RV5
Symptoms: Crying, Diarrhoea, Insomnia, Urine output decreased, Vomiting
Clinical narrative: Extreme fatigue, no sleeping, not eating, vomiting, gas, bloating, diarrhea & consequently dehydration.  Child not sleep for 10 days plus. After hours pediatrician on 10/25/14. Doctor acknowledge vaccine as probable cause of symptoms. Directed to give simethocone and watch symptoms. No improvement. Urgent care 10/31/14 rehydration instructions and pain relief for laryngomalacia irritated by other symptoms. Told to go ER if no improvement by next day for an IV.  11/1/14 started to improve.
Age: 0.24
Sex: M
Vaccine: HIBV, RV1, HIBV, RV5
Symptoms: Abdominal distension, Condition aggravated, Dehydration, Diarrhoea, Diet refusal
Clinical narrative: Extreme fatigue, no sleeping, not eating, vomiting, gas, bloating, diarrhea & consequently dehydration.  Child not sleep for 10 days plus. After hours pediatrician on 10/25/14. Doctor acknowledge vaccine as probable cause of symptoms. Directed to give simethocone and watch symptoms. No improvement. Urgent care 10/31/14 rehydration instructions and pain relief for laryngomalacia irritated by other symptoms. Told to go ER if no improvement by next day for an IV.  11/1/14 started to improve.
Age: 0.24
Sex: M
Vaccine: HIBV, RV1, HIBV, RV5
Symptoms: Fatigue, Flatulence, Insomnia, Laryngomalacia, Vaccination complication
Clinical narrative: Extreme fatigue, no sleeping, not eating, vomiting, gas, bloating, diarrhea & consequently dehydration.  Child not sleep for 10 days plus. After hours pediatrician on 10/25/14. Doctor acknowledge vaccine as probable cause of symptoms. Directed to give simethocone and watch symptoms. No improvement. Urgent care 10/31/14 rehydration instructions and pain relief for laryngomalacia irritated by other symptoms. Told to go ER if no improvement by next day for an IV.  11/1/14 started to improve.
Age: 0.24
Sex: M
Vaccine: HIBV, RV1, HIBV, RV5
Symptoms: Vomiting
Clinical narrative: Extreme fatigue, no sleeping, not eating, vomiting, gas, bloating, diarrhea & consequently dehydration.  Child not sleep for 10 days plus. After hours pediatrician on 10/25/14. Doctor acknowledge vaccine as probable cause of symptoms. Directed to give simethocone and watch symptoms. No improvement. Urgent care 10/31/14 rehydration instructions and pain relief for laryngomalacia irritated by other symptoms. Told to go ER if no improvement by next day for an IV.  11/1/14 started to improve.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema and edema at injection site.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anaemia, Anion gap, Apnoea, Blood glucose increased, Bradycardia
Clinical narrative: Seizure and subsequent apnea/bradypnea at home at 4:00 pm, bradycardia at 4:10-4-15 PM during transport by EMS to hosptial. Intubated, placed on ventilator and stabilized at primary hospital. Lab findings showed hyperglycemia, ketonuria, Diabetic ketoacidosis, anemia, leukocytosis, thrombocytopenia, dehydration, subdural hematoma. Transported to specialty hospital, weaned off of ventilator. Then suffered additional seizures and respiratory arrest- reintubated.   Hospital stay 7 days, currently on anti-seizure medication.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Bradypnoea, Carbon dioxide decreased, Convulsion, Dehydration, Diabetic ketoacidosis
Clinical narrative: Seizure and subsequent apnea/bradypnea at home at 4:00 pm, bradycardia at 4:10-4-15 PM during transport by EMS to hosptial. Intubated, placed on ventilator and stabilized at primary hospital. Lab findings showed hyperglycemia, ketonuria, Diabetic ketoacidosis, anemia, leukocytosis, thrombocytopenia, dehydration, subdural hematoma. Transported to specialty hospital, weaned off of ventilator. Then suffered additional seizures and respiratory arrest- reintubated.   Hospital stay 7 days, currently on anti-seizure medication.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Endotracheal intubation, Glucose urine present, Haematocrit decreased, Haemoglobin normal, Hyperglycaemia
Clinical narrative: Seizure and subsequent apnea/bradypnea at home at 4:00 pm, bradycardia at 4:10-4-15 PM during transport by EMS to hosptial. Intubated, placed on ventilator and stabilized at primary hospital. Lab findings showed hyperglycemia, ketonuria, Diabetic ketoacidosis, anemia, leukocytosis, thrombocytopenia, dehydration, subdural hematoma. Transported to specialty hospital, weaned off of ventilator. Then suffered additional seizures and respiratory arrest- reintubated.   Hospital stay 7 days, currently on anti-seizure medication.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ketonuria, Leukocytosis, Mechanical ventilation, Platelet count decreased, Respiratory arrest
Clinical narrative: Seizure and subsequent apnea/bradypnea at home at 4:00 pm, bradycardia at 4:10-4-15 PM during transport by EMS to hosptial. Intubated, placed on ventilator and stabilized at primary hospital. Lab findings showed hyperglycemia, ketonuria, Diabetic ketoacidosis, anemia, leukocytosis, thrombocytopenia, dehydration, subdural hematoma. Transported to specialty hospital, weaned off of ventilator. Then suffered additional seizures and respiratory arrest- reintubated.   Hospital stay 7 days, currently on anti-seizure medication.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Retinal haemorrhage, Subdural haematoma, Thrombocytopenia, Urine ketone body present, White blood cell count normal
Clinical narrative: Seizure and subsequent apnea/bradypnea at home at 4:00 pm, bradycardia at 4:10-4-15 PM during transport by EMS to hosptial. Intubated, placed on ventilator and stabilized at primary hospital. Lab findings showed hyperglycemia, ketonuria, Diabetic ketoacidosis, anemia, leukocytosis, thrombocytopenia, dehydration, subdural hematoma. Transported to specialty hospital, weaned off of ventilator. Then suffered additional seizures and respiratory arrest- reintubated.   Hospital stay 7 days, currently on anti-seizure medication.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: White blood cells urine positive
Clinical narrative: Seizure and subsequent apnea/bradypnea at home at 4:00 pm, bradycardia at 4:10-4-15 PM during transport by EMS to hosptial. Intubated, placed on ventilator and stabilized at primary hospital. Lab findings showed hyperglycemia, ketonuria, Diabetic ketoacidosis, anemia, leukocytosis, thrombocytopenia, dehydration, subdural hematoma. Transported to specialty hospital, weaned off of ventilator. Then suffered additional seizures and respiratory arrest- reintubated.   Hospital stay 7 days, currently on anti-seizure medication.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient reported to pharmacy two weeks after administration symptoms of swollen and sore arm that injection was administered in.  No report of injection site reaction.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dysstasia, Immediate post-injection reaction, Movement disorder, Pain, Renal pain
Clinical narrative: About 20 minutes after injection I had immediate onset of severe kidney pain to the point of not being able to sit or stand without assistance. Now, 2 days later, the pain has gone from a 10 to about a 6 but is still severe with movement.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cold sweat, Dizziness, Pallor, Peripheral coldness, Visual impairment
Clinical narrative: Client admitted to feeling nervous at start of the appointment. She stated feeling dizzy after 3rd/last immunization was administered; was also seeing spots. She appeared pale and her hands were cold and clammy. The mother and myself lowered client to the floor, while another nurse brought in/turned on a fan, and brought a juice box for client to sip. After drinking the juice and reclining for 10 minutes, client felt well enough to walk (with assistance) to waiting room. She no longer appeared pale, and hands were no longer clammy. She then sat with mother for approximately 10 more minutes in the waiting room until they left the building.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Reaction at injection site, swelling and painful at injection site.
Age: 72.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Back pain, Herpes zoster
Clinical narrative: 3 days after injection, constant back pain (under left shoulder blade), upper stomach pain.  Severe shingles outbreak 2wks after injection. Started Famciclovir, hydro codeine, gabapentin.  Waiting for compounded cream/lotion from pharmacy.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Convulsion, Dyskinesia, Eye movement disorder, Hyperhidrosis
Clinical narrative: I gave him the TIV flu vaccine as well as his wife. I explained to them to hang around for about 15 minutes in case they had a reaction. They sat in the waiting room and his wife comes running over to the pharmacy saying "help, he is having convulsions and not responding." I run out there and notice his eyes rolling back into his head and seemed to have lost muscle control and tone. He slid off of his chair on to the floor. I had a technician call 911. I checked for a pulse and did not notice one. I performed about 10 chest compressions and finally he slowly started to respond. He was confused and did not know how he ended up on the floor. His shirt was drenched in sweat. He appeared to be fine once the emergency crew showed up. They took him on a stretcher out of the store.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Hypotonia, Resuscitation, Unresponsive to stimuli
Clinical narrative: I gave him the TIV flu vaccine as well as his wife. I explained to them to hang around for about 15 minutes in case they had a reaction. They sat in the waiting room and his wife comes running over to the pharmacy saying "help, he is having convulsions and not responding." I run out there and notice his eyes rolling back into his head and seemed to have lost muscle control and tone. He slid off of his chair on to the floor. I had a technician call 911. I checked for a pulse and did not notice one. I performed about 10 chest compressions and finally he slowly started to respond. He was confused and did not know how he ended up on the floor. His shirt was drenched in sweat. He appeared to be fine once the emergency crew showed up. They took him on a stretcher out of the store.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Bacterial test, Dyspnoea, Influenza virus test, Oral pruritus, Paraesthesia oral
Clinical narrative: SOB, hard to breath, throat closing, tingling and itching in mouth and on lips.   Two days later ER visit with pneumonia.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Pneumonia, Throat tightness
Clinical narrative: SOB, hard to breath, throat closing, tingling and itching in mouth and on lips.   Two days later ER visit with pneumonia.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Generalised erythema, Heart rate increased
Clinical narrative: Patient presented with chest tightness, SOB, generalized pruritus and redness, increased HR & BP, peripheral swelling.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pruritus generalised
Clinical narrative: Patient presented with chest tightness, SOB, generalized pruritus and redness, increased HR & BP, peripheral swelling.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Dizziness, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Immediate dizziness, 1 hour later extreme malaise, extreme tiredness, sleepiness, extreme ill feeling.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Neck pain, Somnolence
Clinical narrative: Immediate dizziness, 1 hour later extreme malaise, extreme tiredness, sleepiness, extreme ill feeling.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Axillary pain, Back pain, Impaired driving ability, Mobility decreased
Clinical narrative: Arm and shoulder pain and weakness, radiating down arm, into armpit, into back. Very painful and movement & use impaired.  Can't lift arm.  Trouble driving and daily routines such as dressing.  Doctor said nerve may have been hit.  Chiropractor said muscles involved too.  Treatment is gentle exercises to maintain motion and NSAIDs. 18 days out, my left arm is still VERY PAINFUL, can't be used properly, and symptoms continue to worsen.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm and shoulder pain and weakness, radiating down arm, into armpit, into back. Very painful and movement & use impaired.  Can't lift arm.  Trouble driving and daily routines such as dressing.  Doctor said nerve may have been hit.  Chiropractor said muscles involved too.  Treatment is gentle exercises to maintain motion and NSAIDs. 18 days out, my left arm is still VERY PAINFUL, can't be used properly, and symptoms continue to worsen.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm
Clinical narrative: It was observed, left arm red edematous and warm to the touch.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dysgeusia, Feeling hot, Pain, Tremor
Clinical narrative: Injection at 11:00 am symptoms started approx. 3:30 pm (same day) Tuesday Oct 21, 2014. Feeling like I was burning up temp? Aching all over, shaking, bad taste in my mouth severe weakness for 4 days.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Aggression, Psychotic disorder, Self injurious behaviour
Clinical narrative: 10/30/14 at 1655-10/31 at 0600. Full psychotic break with self abuse and aggressive behavior. She was admitted after administration of multiple medications and did not return to baseline for 12 hours.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm
Clinical narrative: It was observed, left arm red, edematous and warm to the touch.
Age: 29.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 29 year old female patient with asthma. On 20-OCT-2014 the patient was vaccinated with PNEUMOVAX 23, inj (lot# and expiration date not provided) (dose not reported) in the arm. Concomitantly on 20-OCT-2014 the patient received influenza virus vaccine (manufacturer unknown) (lot# and expiration date not provided) (dose not reported), in the same arm. On unspecified date (in approximately 2014) the patient developed pain at injection site that was then radiating to her neck and that she could not move her entire arm. It was reported that the patient was going to be seen by an unspecified physician in regard to this adverse event. The outcome of "pain at injection site that is now radiating to her neck that she could not move her entire arm" and was reported as not recovered/not resolved. The relatedness between the events and therapies was not reported. Additional information has been requested.
Age: 1.82
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Injection site reaction, Rash, Urticaria
Clinical narrative: Urticarial rash started on Left leg, and then moved to body and face. Pt had similar reaction after 4 month shots, so vaccines were spread out to determine cause, and has since done fine with vaccines.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness
Clinical narrative: During injection felt sharp pain, like rn hit the bone.  She did not back out any, gave injection.  Much more painful than previous vaccinations for flu.  Tenderness at site rest of the day.  AM after rt arm was stiff- similar to previous flu vaccines.  Took Celebrex on five different days, felt pain was improved.  Took first dose about 10.20.2014. second dose 10.22.2014.  Improved then pain much worse and had to treat 3 days in a row-Took 27th-29th. Can't take ibuprofen or other anti inflammatories. Pain diminished about 48-72 hours.  Still stiffness, pain, and loss of mobility.  Unable to raise rt arm above shoulder level.  Significant sharp pain if attempts.  Disseminated achy pain to elbow.  More achy this am, painful to let rt arm Hang- it must be supported to reduce pain. Has been avoiding working out with weights. Is right handed and working with rt arms increases pain.Continued pain, worse when woke up today 11.05.2014.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt developed redness and itchy around site of injection 24-48 hours later. Recommended PO BENADRYL Q 4-6 hours. No resp. distress.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Injection site pain, Musculoskeletal pain
Clinical narrative: Painful injection and shoulder pain persisted at one month.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Ecchymosis, Local swelling, Rash
Clinical narrative: Swelling, ecchymosis, rash on arm - not near injection site.
Age: 57.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Pruritus, Rash, Skin exfoliation
Clinical narrative: Patient's skin became red and itchy. Skin began to peel. Small bumps noted to neck.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pyrexia, Urticaria, Vaccination site pain, Vaccination site swelling
Clinical narrative: Case number PHEH2014US021615 is an initial spontaneous report received from a pharmacist on 24 Oct 2014. This report refers to a 40 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly on 07 Oct 2014. It was reported that on the same day shortly after vaccination, she started experiencing hives all over her body, low grade fever, pain and swelling at the vaccination site and pain in her joints. She went to emergency room for the symptoms and also visited her personal MD on 24 Oct 2014. The events outcome was reported as unknown. The seriousness of the event was not reported, but was upgraded internally based on information available in the source documents. The causality of the events was not reported.
Age: 0.56
Sex: M
Vaccine: FLU3, RV5
Symptoms: Dermatitis diaper, Diarrhoea
Clinical narrative: Diarrhea, diaper rash.
Age: 1.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Maculopapular rash trunk, extremities, face 12 days after the vaccine.