chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Underdose, Vision blurred
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of blurred vision in a 35-year-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 8 August 2013 at 13:30 the subject received 1st dose of BOOSTRIX (0.05 ml unknown route, left arm) and experienced underdose. The indicated dose for BOOSTRIX is 0.5 ml. On the morning of 9 August 2013, 1 day after vaccination with BOOSTRIX, the subject experienced blurred vision. The nurse practitioner reported that the subject woke up with blurry vision. After some time passed, the blurry vision had not subsided. Extensive medical history was not gathered. At the time of reporting the event was unresolved.
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Local reaction, Product quality issue, Rash erythematous
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red bump at injection site in an adult female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced local reaction of red itchy bumps at injection site. The reporter had very limited information, no other details were provided. At the time of reporting the outcome of the red itchy bumps at injection site was unspecified. This is one of two reports made by the reporter, for the other case please see A1056649A. Follow up to the initial report received by GSK on 9 January 2013 and by the Quality Assurance Department on 14 February 2014. This complaint was associated with a product quality complaint. The lot number and expiry of BOOSTRIX was also provided. Follow up was received from the Quality Assurance Department on 14 February 2014. Based on results of the investigation by GSK Quality Assurance, the product complaint was assessed to be unsubstantiated.
Age: 4.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site pain, No reaction on previous exposure to drug, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of wrong vaccine administered in a 4-year-old subject of unspecified gender who was vaccinated with BOOSTRIX, (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (non-GSK); Merck; given on 6 December 2013; Varicella virus vaccine (non-GSK); Merck; given on 6 December 2013. On 6 December 2013 the subject received a dose of BOOSTRIX (.5 ml, intramuscular, left thigh) and experienced wrong vaccine administered, inappropriate age at vaccine administration and vaccine administered at inappropriate site. The nurse reported that the 4-year 5-month old subject received BOOSTRIX instead of KINRIX on 06 December 2013. The nurse stated that because "KINRIX and BOOSTRIX look so similar, someone had placed a BOOSTRIX in with the BOOSTRIX". She reported no adverse events occurred as the child subject did go home. BOOSTRIX is indicated for use in 10 years of age or older and injected into the deltoid muscle of the upper arm. Additional information received on 09 December 2013 via healthcare professional. The healthcare professional reported the 4-year-old subject was vaccinated on 06 December 2013 with a dose of BOOSTRIX (unknown) as the 5th dose in the series. On 7 December 2013, 1 day after vaccination with BOOSTRIX, the subject experienced injection site soreness. The soreness was described as a mild injection site reaction. The immunization series was not delayed or discontinued. On 8 December 2013, the injection site soreness was resolved. The healthcare professional considered the injection site soreness was probably related to vaccination with BOOSTRIX. Discrepant information regarding the sex of the subject was initially it reported as a female and follow-up indicated the subject was a male. Follow-up information was received on 15 January 2014 via healthcare professional who reported the subject was seen at a well child physical examination. The healthcare professional clarified that the subject was a 4-year-old female who developed an additional event of a quarter size redness. The events occurred on 08 December 2013 and resolved on 10 December 2013. The reporting healthcare professional associated the events with BOOSTRIX and were not considered serious. The healthcare professional attributed the events to erroneous administration in which a 4-year old subject received BOOSTRIX instead of appropriate Dtap vaccine. The subject had not received BOOSTRIX before. No action was taken with BOOSTRIX, series was not discontinued. The subject was administered the correct Dtap on 09 December 2013. At the time of the report the injection site soreness and injection site redness were resolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Chest pain, Drug administered at inappropriate site, Extensive swelling of vaccinated limb, Injection site rash, Injection site urticaria
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included PROQUAD (non-gsk); Merck; unknown; unknown given on 2 October 2013. On 2 October 2013 the subject received a dose of KINRIX (unknown details, right thigh) as the 5th dose of the DTaP series. "Late in the night" on 2 October 2013, within hours of vaccination with KINRIX, the subject experienced extensive swelling of vaccinated limb, chest pain, throat pain, vomiting, injection site rash, welt injection site, and vaccine administered at inappropriate site. The physician reported that the subject experienced a "3 by 5 inch" (76.2 by 127 millimeters) welt on the right thigh. The subject sought medical attention at the doctor's office. The preferred site of administration for KINRIX is the deltoid of the upper arm. At the time of reporting the events were resolved. No other details were provided at the time of reporting. Follow up was received from the physician on 29 October 2013. The physician documented that the subject was diagnosed with an injection reaction. Symptoms onset on 2 October 2013. The outcomes for the events were not mentioned; however, previously the physician documented that the events had resolved. The physician identified KINRIX as the suspect product. The physician did not consider this case serious. The events did not involved a congenital anomaly or birth defect. The physician noted that no subsequent doses were given at the time of this reporting. The subject had not experienced any adverse events following previous vaccinations per the physician.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included PROQUAD (non-gsk); Merck; unknown; unknown given on 2 October 2013. On 2 October 2013 the subject received a dose of KINRIX (unknown details, right thigh) as the 5th dose of the DTaP series. "Late in the night" on 2 October 2013, within hours of vaccination with KINRIX, the subject experienced extensive swelling of vaccinated limb, chest pain, throat pain, vomiting, injection site rash, welt injection site, and vaccine administered at inappropriate site. The physician reported that the subject experienced a "3 by 5 inch" (76.2 by 127 millimeters) welt on the right thigh. The subject sought medical attention at the doctor's office. The preferred site of administration for KINRIX is the deltoid of the upper arm. At the time of reporting the events were resolved. No other details were provided at the time of reporting. Follow up was received from the physician on 29 October 2013. The physician documented that the subject was diagnosed with an injection reaction. Symptoms onset on 2 October 2013. The outcomes for the events were not mentioned; however, previously the physician documented that the events had resolved. The physician identified KINRIX as the suspect product. The physician did not consider this case serious. The events did not involved a congenital anomaly or birth defect. The physician noted that no subsequent doses were given at the time of this reporting. The subject had not experienced any adverse events following previous vaccinations per the physician.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site swelling
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of swelling injection site in a 4-year-old female subject who was vaccinated with KINRIX, (GlaxoSmithKline). In "late" July 2013 the subject received a dose of KINRIX (.5 ml, unknown route, unknown thigh) and experienced vaccine administered at inappropriate site. The preferred site of administration for KINRIX is the deltoid of the upper arm. In "late" July 2013, immediately after vaccination with KINRIX, the subject experienced swelling injection site (described as injection site leg swelling). At the time of reporting the event was resolved. Per the reporter, the event resolved "3 to 4 days later". The physician considered the event was probably related to vaccination with KINRIX.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 9/17/14 - Complained of soreness in arm - going to see MD.
Age: 58.0
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Redness spread to crease of elbow and covering bicep of left arm.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Convulsion, Dyskinesia, Eye movement disorder, Irritability, Muscle rigidity
Clinical narrative: This 6 month 7 day old male presents for follow-up of the following problem(s): Seen in ER ? Seizure. Fussy all night. At 6:00 am his upper body was jerking. No leg jerking, eyes rolled up and fixed. Upper body only, mom estimates 5 minutes. Fever 100 rectal in ER. Good appetite today. He had been sleeping on a pillow when this happened. Child is brought in today by mother. He was on mothers lap and his eyes were deviated to left side and his chest and arms were moving, arms were above head jerking. He had normal color. He was not responding. His legs were rigid not moving. He felt stiff.. It lasted over 5 min. Mother called for father. It stopped just before EMS came. When seizure stopped he was alert and responsive. I reviewed records and labs from ER.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Musculoskeletal stiffness, Pupil fixed, Pyrexia, Unresponsive to stimuli
Clinical narrative: This 6 month 7 day old male presents for follow-up of the following problem(s): Seen in ER ? Seizure. Fussy all night. At 6:00 am his upper body was jerking. No leg jerking, eyes rolled up and fixed. Upper body only, mom estimates 5 minutes. Fever 100 rectal in ER. Good appetite today. He had been sleeping on a pillow when this happened. Child is brought in today by mother. He was on mothers lap and his eyes were deviated to left side and his chest and arms were moving, arms were above head jerking. He had normal color. He was not responding. His legs were rigid not moving. He felt stiff.. It lasted over 5 min. Mother called for father. It stopped just before EMS came. When seizure stopped he was alert and responsive. I reviewed records and labs from ER.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Pharyngeal oedema
Clinical narrative: Swelling of throat, flushed. HR-80. No problems breathing no wheezing. EPIPEN given (.30 mg) (L) outer thigh at 1:03pm (patient had already taken BENADRYL and CLARITIN). EMS arrived. Recommended going to ED or doctor. Patient refused EMS ride.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 25-SEP-2014 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot#, strength, dosage, frequency and route). This is one of several reports received from the same reporter. Additional information is not available.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age. On an unknown date the patient was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported) (dosage and route not reported) and later developed the chickenpox. The outcome of chickenpox was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On 06-OCT-2014, the patient purchased a dose of ZOSTAVAX at 1:30 PM from a pharmacy and she arrive at the physician's practice with the dose of ZOSTAVAX at 1:45 PM. The patient transported ZOSTAVAX to physician's office. The dose of ZOSTAVAX was administered (lot# J002693, expire date 07-JUN-2014, strength, dose, frequency and route unspecified) soon thereafter on the same day. Temperature range and timeframe of excursion, during transport to physician's office were not known. The worst case scenario would be that the dose of ZOSTAVAX was transported in a car in the 70's F outdoors, and exposed to temperatures as high as 77F or higher for less than 1 hour. The pharmacy put the vial of ZOSTAVAX in a plastic bag, and the pharmacy mislabeled the bag with the wrong expiration date, 06-OCT-2015. The dose of ZOSTAVAX was administered to the patient before the pharmacy's error was identified. There was no product quality complaint (PQC), the expiration dates not matching on the bag and the vial was the pharmacy's error. No adverse effect had been demonstrated or observed. The outcome of the events was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Next day after injection, she had redness, some swelling and warm to touch area. Following days redness seemed to spread and area turned black and blue. Pt stated said had similar rx last year, not as severe.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Rec'd 5 yr immunizations at WCE on 10/06/14. S/S began 10/07/14 evening. See in office on 10/08/14 with 10x9 cm erythema and warmth (LT) upper deltoid; Afebrile. TX: Ibuprofen q6-8 hours, warm compresses prn and return if worsening.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Crying, Discomfort, Rash, Swelling
Clinical narrative: Swelling, rash, discomfort, crying throughout night. (R) leg. Mother reports onset 10/6/14 evening, didn't report to our clinic until 10/7/14 evening. Pt seen again in office 10/8/14.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash at injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, route, lot numbers and expiration dates not reported. On an unknown dates the patients experienced redness and itching at the ZOSTAVAX injection sites. At the time of the report the outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on 07-OCT-2014 the patient was vaccinated with an expired dose of M-M-R II (lot # H018181, expiry date: 05-OCT-2014, 0.5 ml, subcutaneous, anatomical location was unknown. Concomitant medications were unspecified by reporter. No adverse effect was reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other healthcare worker refers to a patient of unknown age. Medical history and current conditions were not reported. On 19-AUG-2014, the patient was vaccinated with (Oka/Merck) VARIVAX lot # J014407, expiry: 13-NOV-2014, 0.5 milliliter, subcutaneous one for unknown indication. Concomitant medications were not reported. On 19-AUG-2014, it was reported that 5 doses of (Oka/Merck) VARIVAX were improperly stored and administered to unspecified patients. No adverse events were reported. Product quality complaint was not reported. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Injection site warmth, Vaccination complication
Clinical narrative: Pt rec'd vaccine on 10/2/14. Friday 10/3/14 site of vaccine was red and warm to touch. Patient was placed on Prednisone and Amoxicillin. Patient had allergic reaction to Flu vaccine per Dr.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Scab
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient with high cholesterol and hypertension. No drug reactions or allergies were reported. On 01-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # K006438 and expiration date 05-AUG-2015, dose 0.65 ml, subcutaneous because he had shingles years ago and his physician told him that it would be a good idea to get vaccine. Concomitant therapies included an unspecified blood pressure medication and unspecified cholesterol medication. On 02-OCT-2014, patient experienced that the back of his right arm became quite red with a red mark down quite a bit of arm and one area about the size of a quarter that looked bubbled and scabby fairly close to the ZOSTAVAX injection site. No treatment was given for the adverse events. At the time of the report the outcome of the events was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal discomfort
Clinical narrative: Pt reported possible swelling and discomfort in neck approx 5 min after immunization, blood pressure and pulse normal, medicated with 20 mL of Q-dry/12.5 mg/5mL -observed pt for > 30 min - No change, vitals normal.
Sex: F
Vaccine: MMR
Symptoms: Gastrooesophageal reflux disease, Headache, Oropharyngeal pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a "28 to 30 year old" female patient. On an unspecified day in August 2014, the patient received the first dose of M-M-R II 0.5 ml, subcutaneous and the patient did not experienced any adverse effects after the first dose. On 29-SEP-2014 (reported as "10 days ago"), the patient was vaccinated with the second dose of M-M-R II 0.5 ml, subcutaneous (lot # reported as K005110; expiration date in April 2014) and the patient experienced headache and a sore throat the day after on 30-SEP-2014 this second dose of M-M-R II was received. It was also reported that the patient experienced on an unspecified date in 2014 acid reflux after getting vaccination and her doctor gave her PRILOSEC for it. The pharmacist stated that, at the time the patient reported the headache and sore throat, she urged her to take ADVIL for her discomfort and to report her symptoms to the health care provider. The patient said, "I did not have time to do that". For this reason, the pharmacist stated that the patient was not incapacitated, nor did she seek medical attention. The reporter stated that three days after the patient first told her about her headache and sore throat, the patient was still experiencing a sore throat but still going to work every day. The outcome of acid reflux, headache and sore throat was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: An area 25 mm by 50 mm is noted on back of left arm, red and indurated. Surface slightly raised approximately 2-3 mm.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Erythema, Malaise, Pain, Pruritus
Clinical narrative: (s/s) Redness, swelling, warmth, itching, chills, pain, general malaise. Tx Elevated warm compress border drawn-start antibiotics if worsen s/s.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Skin warm, Swelling
Clinical narrative: (s/s) Redness, swelling, warmth, itching, chills, pain, general malaise. Tx Elevated warm compress border drawn-start antibiotics if worsen s/s.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Skin warm, Upper extremity mass
Clinical narrative: Mother called 10-12-14 at 10:08 am. Patient's arm had a red warm hard lump size about 3 x 3. No fever.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Pt complained of cramping and muscle spasm in left arm requiring Dr visit.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Left arm swelling, pain, induration, tenderness and warmth in 7.5 cm x 6 cm area on left upper arm lateral aspect, also had nausea.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration
Clinical narrative: Local erythema 9.0 cm x 5.0 cm and induration.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eructation, Eye pruritus, Fatigue
Clinical narrative: 5 pm - Cough - 6 pm gas - burping..Itchy eyes watery - discharge 6 pm - fatigue - shooting pain above eye. 9 pm - chills - 8 am, dried matter in eyes. 9 am - sensitive tongue - white coating - fatigue all day.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Flatulence, Glossodynia, Lacrimation increased, Pain, Tongue coated
Clinical narrative: 5 pm - Cough - 6 pm gas - burping..Itchy eyes watery - discharge 6 pm - fatigue - shooting pain above eye. 9 pm - chills - 8 am, dried matter in eyes. 9 am - sensitive tongue - white coating - fatigue all day.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Bilateral upper extremity weakness and severe pain.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site infection, Injection site necrosis
Clinical narrative: Patient got flu shot at pharmacy 9/20/14. Came in on 10/6/14 with an infected flu shot site of entry. It was black necrotic tissue about the size of a dime. Pt did not feel any pain or any other symptoms. Will go to doctor to get it checked out.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pyrexia, Urticaria
Clinical narrative: Extremity erythema/induration. Reports hives, fever 101.4 (afeb at 24). No respiratory complaints.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via representative refers to an 80 year old female patient. On 06-OCT-2014 the patient was vaccinated with her sixth dose of PNEUMOVAX23 (route, dose and lot # not reported). The dates that the other 5 doses of PNEUMOVAX23 were unspecified. No adverse effect reported. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal erythema, Pharyngeal oedema, Swelling face
Clinical narrative: Swelling of face and throat. Redness also.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX (dose, frequency, dose number, product lot #, expiry date not reported, strength reported as 1350, units reported as U) that was exposed to temperatures of 8 degrees Fahrenheit for 2 hours. There was no information on concomitant therapy. No adverse effects reported. There was no product quality complaint involved. The outcome of the event was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. Since July 2014, unspecified patients were vaccinated with improperly stored VAQTA (lot #, expiration date, route, dose not reported). No adverse effects were reported.This is one of the several report from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: Soon after the shot, my arm swelled, had him check too!! He gave the needle up high in the right area. Under the shoulder blade pain moved to the neck area still have a wk. of pain so far. Call my on call doc. office.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Medical history and current conditions were not reported.On an unknown date, the patient was vaccinated with ZOSTAVAX (404) VIAL 19400 PFU, via unknown route for unknown indication. Concomitant medications were not reported. IT was reported that patient received a dose of (Oka/Merck) VARIVAX, and then was prescribed a dose of ZOSTAVAX by the healthcare provider. The patient received this first dose of ZOSTAVAX two years ago, and this patient received another dose of ZOSTAVAX two years later. The dates of those doses of ZOSTAVAX were unspecified, and she did not specify whether or not this patient was experiencing any adverse effects. The anonymous pharmacist disconnected without taking the service request number. No product quality complaint was not reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Marked localized swelling of left upper arm 24 hours after flu vaccine administered. ? arthus reaction.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Dyspnoea, Eye irritation, Lacrimation increased, Muscle spasms
Clinical narrative: Shortness of breath, burning/watery eyes, muscle spasm, disoriented, sore throat, tightening of throat
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Throat tightness
Clinical narrative: Shortness of breath, burning/watery eyes, muscle spasm, disoriented, sore throat, tightening of throat
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Migraine, Rash
Clinical narrative: Shortness of breath, rashes, migraines/headaches.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Stiff and couldn't move arm 1 day after redness size bigger than softball and area was raised. Told patient to take BENADRYL and TYLENOL or MOTRIN. Left arm.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Facial hives - requiring ED visit -> IV steroids, IV BENADRYL and IV PEPCID. Was monitored for 2 hours in ED.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Throat irritation
Clinical narrative: Scratchy throat and T=100.5 48 hours after vaccine.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to injection site.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Loss of consciousness, Seizure like phenomena, Urinary incontinence
Clinical narrative: Employee given 14 flu vaccine. Shortly after, employee passed out falling backward and appeared to have seizure-like activity. Loss of bladder/urinated. EMS called. Patient regained consciousness. No BLS needed. Patient decided to go home with family. Employee later called and doing ok.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Dizziness, Dysgeusia, Feeling hot
Clinical narrative: Bad taste in mouth, cough, sneezing, headache, feeling of "hot" (no report of fever), dizziness, weakness. Has not had medical treatment.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Sneezing
Clinical narrative: Bad taste in mouth, cough, sneezing, headache, feeling of "hot" (no report of fever), dizziness, weakness. Has not had medical treatment.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: L deltoid erythremia 9.5 x 3.5 cm. Dx' d cellulitis and given antibiotics  (ANCEF) by Dr. Denies any previous reactions.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Injection site discolouration, Oropharyngeal pain
Clinical narrative: Flu shot given 10-12-2014. Reported 10-13-2014 headache, sore throat, diarrhea, black blue skin injection site. Symptoms ongoing at time patient called pharmacy 7PM.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Patient described arm as "hot" 1 day after shot. Recommended  ie and OTC analgesic. Proper protocol followed during admin.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Lacrimation increased, Oropharyngeal pain, Pain, Throat irritation
Clinical narrative: Watery eyes, sore throat, achy chills, throat issues within 2-3 hrs. Wheezing Took allergy medication  and contacted Dr 2 days later. Dr check her out as ok.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Watery eyes, sore throat, achy chills, throat issues within 2-3 hrs. Wheezing Took allergy medication  and contacted Dr 2 days later. Dr check her out as ok.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Unable to lift arm above shoulder height, whole arm and shoulder in pain. Unable to lift anything with right arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Paraesthesia oral
Clinical narrative: Patient reported evening of vaccine her mouth was tingling and had loss of taste for past 3 days.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Pain, Pyrexia, Rash
Clinical narrative: Day 1 following vaccine c/o low grade fever, nausea, chills and body aches. Also acquired a rash over R side of chest which has spread to full chest and back (this is day 10). Rash is somewhat itchy, using topicals for itch.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Day 1 following vaccine c/o low grade fever, nausea, chills and body aches. Also acquired a rash over R side of chest which has spread to full chest and back (this is day 10). Rash is somewhat itchy, using topicals for itch.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Muscle ache and redness at site of injection (ie left deltoid muscle), possible fever, body ache.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever 101.7 F.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Induration and swelling with erythremia on majority of inner upper Brachium L. Painful to touch. Advised cold compress, APAP, Antihistamine. Follow up post 8 days. Reduced swelling and erythremia. Resolving  (injection site rxn).
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Injection site reaction, Local swelling
Clinical narrative: Swelling and induration with erythemia on the upper brachin reported 3 days after vaccination. Cold compresses, APAP, antihistamines, suggested. Patient resolution attained. (injection site Rxn).
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Patient received  high dose flu shot in pharmacy. Relative called 10 hours later, said pt had difficulty breathing, probably going to ER.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Large bruise at injection site approximately 4" diameter also pain to the injection site.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 6 cm induration, mild swelling, redness and warmth at injection site.
Age: 25.0
Sex: U
Vaccine: FLUX
Symptoms: Middle insomnia, Pain, Pain in extremity
Clinical narrative: First couple of days arm was sore, if I raised my arm. I felt sudden sharp pain. Haven't been able to raise arm without pain and even while sleeping moving arm causes pain that wakes me. Unable to rotate arm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye discharge, Eye swelling, Pyrexia, Sinus disorder
Clinical narrative: Sinus problems, shortness of breath, fever, evening and lasting all night; morning-eyes swollen and discharge. Symptoms disappeared shortly after.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Confusional state, Eye movement disorder, Immediate post-injection reaction, Muscle rigidity
Clinical narrative: Immediately after receiving vaccines (HPV), patients eyes rolled back slight and she became rigid, lasting less than 10 seconds. No tonic-clonic movement. Was slightly confused initially then awoke and appropriate with stable vitals. Sitting up drinking water and juice and speaking appropriately. Felt fine after 15 min's and discharged home.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Had sot at 4:00 PM about 10:00 PM started getting severe chills. Didn't stop seemed to be getting worse so I called ask for nurse she said take 2 TYLENOL. I went to bed woke up at 1:30 running fever 102.1 took 2 more TYLENOL went back to bed woke up at 7:00 tem was 100.2.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Grip strength decreased, Muscular weakness
Clinical narrative: 2:30 PM Pt. returned back to clinic reporting left arm weakness which began 1 hour after receiving her flu vaccine this morning. Pt. having difficulty typing and gripping her phone. No redness, bruising, tenderness or swelling around injection site. Hand grips unequal with left grip weakness. No pain, no numbness, tingling. Good circulation. Radial pulses. Full ROM.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Lethargy, Pyrexia, Teething, Vomiting
Clinical narrative: On Sat afternoon started with fever (T-102-104.1) and vomited x1 and loose stool x1, lethargic, also teething.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia
Clinical narrative: Jerking movements of upper, lower extremities. Also, jerking movement of head.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Feeling cold, Pyrexia, Tremor
Clinical narrative: Shaking, feeling awful, cold and chilled. Fever 101.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Local swelling, Oropharyngeal pain, Pyrexia, Tremor
Clinical narrative: Swelling to her arm, sore throat, fever 101.5, chills and shaking.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Musculoskeletal stiffness, Myalgia
Clinical narrative: Within 14 hrs had muscle pain and stiffness, muscle pain and near injection site. Still w significant pain and muscles tenderness at 48 hrs.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Hypersensitivity, Ocular hyperaemia, Throat tightness
Clinical narrative: Tightness of throat, red eyes, fatigue - 3 hours post vaccine - urgent care dx allergic reaction to vaccine.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Epistaxis, Headache, Oropharyngeal pain, Pain
Clinical narrative: 10/6-Headache, 10/7-Headache, 10/8-Headache more severe, 10/9 AM -Chills, bloody nose, 10/9 PM-Full body aches, sore throat, chils, 10/9 PM-10/10- slept 18 hrs. 10/10-Aches/sore throa, 10/11-Head, chest conjestion
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: 10/6-Headache, 10/7-Headache, 10/8-Headache more severe, 10/9 AM -Chills, bloody nose, 10/9 PM-Full body aches, sore throat, chils, 10/9 PM-10/10- slept 18 hrs. 10/10-Aches/sore throa, 10/11-Head, chest conjestion
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abdominal discomfort, Feeling hot, Flushing, Urticaria
Clinical narrative: Pt reports hives, upset stomach, flushing/heat. Suggest BENADRYL for hives and watch out for worsening symptoms.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Local swelling, Nodule, Oedema peripheral, Paraesthesia
Clinical narrative: 1. Swelling on left side of  neck (knot); 2. Swelling at medical clavicle (knot) left side; 3. Arm tingling and occasional numbness (left side arm); 4. Left axillary swelling.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient had swelling, redness, and rash at and around injection site sometime (later in the day) after receiving vaccine. Patient reported event to me approximately 1 week later.
Age: 26.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypersensitivity, Urticaria, Vaccination complication, Wheezing
Clinical narrative: Systemic allergic reaction to seasonal flu vaccine. Experienced generalized hives and mild wheezing after receiving shot.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chest discomfort, Eye swelling, Pain, Rash
Clinical narrative: Patient had swelling of her eyes 1 hour after getting vaccine. Later went to ER due to developing hives, rash, pain, burning of face and heaviness of chest. Treated Kw/ prednisone, PEPCID, and hydroxyzine. She was feeling better and rash going away the next day.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient had swelling of her eyes 1 hour after getting vaccine. Later went to ER due to developing hives, rash, pain, burning of face and heaviness of chest. Treated Kw/ prednisone, PEPCID, and hydroxyzine. She was feeling better and rash going away the next day.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain
Clinical narrative: Patient experienced back pain after receiving FLUVIRIN an PNEUMOVAX. Called 911
Age: 27.0
Sex: F
Vaccine: FLUC3
Symptoms: VIIth nerve paralysis
Clinical narrative: Mild Bell's palsy.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Pt claimed pain in left arm.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3 days after vaccine pt came in with redness from inj. site almost to elbow. Mild swelling and warmth. Says started day after administration.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Pain
Clinical narrative: Body aches. Flu-like symptoms.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Dizziness resolved in 20 minutes. Shortness of breath treated with Albuterol inhaler resolved in 20 minutes.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Administered 10/10/14, went to urgent care 10/12/14 with red, swollen, warm 5 inch circle on right arm. Given 10 day course of KEFLEX on 10/12/14.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Chills, Dizziness, Pain in extremity, Vision blurred
Clinical narrative: Patient says she felt dizzy, lightheaded Kw/ blurred vision, and chills, several  hours after administration of vaccines. Along Kw/ intense right arm pain to where she couldn't put her shirt on.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site oedema, Musculoskeletal stiffness, Pain in extremity, Skin warm
Clinical narrative: After receiving vaccination (next day) noticed arm was hot and red. Look like fluid buildup between injection site and elbow. Arm stiff and sore. Was given influenza vaccine on same day but different arm. Patient brought reaction down with BENADRYL and cold compress.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Grip strength decreased, Sensory disturbance
Clinical narrative: After receiving vaccine, student stated he "couldn't feel" his (L) arm and (L) hand. Able to raise (L) arm to chest level when asked, grasp was weak. BP 98/60 P 60. Incident occurred approx 1/2 hour after shot given. After another 30 minutes pt stated he had some feeling back in hand and arm. Parent took him to MD around 2pm. At this point he had recovered feeling/sensations in (L) arm and (L) hand. No further incidents reported from pt at this time.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Mydriasis
Clinical narrative: Dizziness. Redness on feet. Dilated pupil 5 mins after admin. Paramedics came and checked vital. No special treatment given. Pt recovered in about 30 mins.
Age: 25.0
Sex: M
Vaccine: ANTH, FLUC3
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient lost consciousness immediately after administration of the Anthrax vaccine. The flu vaccine had been administered directly prior to the Anthrax vaccine. Patient was unconscious for 20 seconds.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction (redness, swelling) possible infection. Given Rx for antibiotic and prednisone 10/2/14.
Age: 1.66
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Cough, Fatigue, Sensation of foreign body
Clinical narrative: Received vaccine at 12 pm. Began getting chilled about 4 hrs later. Felt like my throat had a lump in it and started coughing. Became more chilled and very tired. Went into bed at 5 pm unable to get warm - temp. climbed to 101.2 degrees F. Slept until 8 am waking on and off. Temp. normal in morning, felt fine thereafter.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Disorientation, Malaise, Myalgia, Nausea
Clinical narrative: Seven hours after getting FLUZONE High-Dose flu vaccine I got ill - terrible chills and disoriented. Had muscle aches throughout evening. Went to bed and woke up at 5:00 am with terrible chills again and feeling nauseous.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Swelling of right deltoid (10-2-14 - 10-5-14). Shooting pains from site to right hand/fingers. Very sore to touch (10-2-14 - resolving today 10-6-14).
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth, Paraesthesia, Paraesthesia oral
Clinical narrative: Right arm: Welt - 6 1/2 x 3 1/2 ins. - scary side effect. Arm was red and hot where injection was given. Lasted for 7 days for arm to seem normal. Twinge in arm where injection given for 2 1/2 weeks. Lip and arm tingled.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: Right arm: Welt - 6 1/2 x 3 1/2 ins. - scary side effect. Arm was red and hot where injection was given. Lasted for 7 days for arm to seem normal. Twinge in arm where injection given for 2 1/2 weeks. Lip and arm tingled.
Age: 0.87
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Immediate post-injection reaction, Vomiting
Clinical narrative: Came in day after immun with vomiting (right after received flu vaccine) and next day, 1 loose stool, no fever. In daycare.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Nausea, low fever and chills - 5 hrs after injection - took BENADRYL 25mg and Sx resolved same day.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Excruciating pain on arm. Been to the hospital multiple times.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Eye swelling, Eyelid oedema, Sneezing
Clinical narrative: Left office from vaccine adm. Started sneezing as soon as outside - 10-15 min dad noted eyes swelling. 30-40 seconds later back at office - eyes swollen shut - BENADRYL given. No other symptoms. Observed for 1 1/2 hrs improved - left office.
Sex: U
Vaccine: PPV
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 04-OCT-2014 the patient was vaccinated with a second dose of PNEUMOVAX23 (dose, route, lot # and expiration date were not provided). The first dose was received approximately 1 year prior (in approximately 2013). No adverse experience reported.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a certified medical Assistant refers to a patient of unknown age and gender. On an unknown date, the PROQUAD (Merck) was improperly stored and was inadvertently administered to a patient on 09-JUL-2014 (dose and lot # were not reported). The outcome of improperly stored PROQUAD (Merck) was inadvertently administered to a patient was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. Pertinent medical history was unknown. The reporter stated that the patient was administered a dose of ZOSTAVAX (dose/frequency was reported as single dose, subcutaneous, anatomical location and lot number was unknown) on 21-APR-2014 and, inadvertently was administered another dose of ZOSTAVAX (dose, route of administration, anatomical local and lot number was unknown) on 01-OCT-2014. Concomitant medications were unspecified by reporter. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old patient. On 09-OCT-2014, the patient received an expired dose of PNEUMOVAX23 (lot # 09-OCT-2014, the patient received an expired dose of PNEUMOVAX23 (lot #J006921, expiration date: 09-AUG-2014) 0.5 ml, intramuscular. The patient has not demonstrated or reported an adverse experience. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to an unspecified number of patients of an unknown age and gender. On an unspecified dates in approximately 2014 (reported as since an unspecified date in July 2014 also reported as since the first excursion in July 2014), doses of (Oka/Merck) VARIVAX (doses, routes of administration, lot numbers and expiration dates were not reported) that have been exposed to temperatures as warm as -8C for an unspecified period of time, have been administered to an unspecified number of patients. At the time of this report, it was not known whether or not the doses of (Oka/Merck) VARIVAX were supported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL (lot, dose and route not reported). Concomitant medication was not reported. The temperature excursion for the GARDASIL was supported with in-house stability data. No adverse symptoms reported. At the time of the report, action taken regarding therapy with GARDASIL was not reported. Additional information has been requested.