chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients might have been vaccinated with GARDASIL (dose, lot and expiry date were not reported) that have been exposed to unsupported temperature excursions. No adverse effect was reported. This is 2 of 3 reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients might have been vaccinated with PEDVAXHIB (dose, lot and expiry date were not reported) that have been exposed to unsupported temperature excursions. No adverse effect was reported. This is 1 of 3 reports from same reporter. 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(s) of unknown age and gender. It was unknown if the patient(s) were vaccinated with GARDASIL (dose, concentration and lot number not reported) that had gone through a temperature excursion of 31 F. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 79 year old female patient. On 27-OCT-2013 (reported as 37 day ago) the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On 29-OCT-2013 (reported as two days later) the patient returned to the pharmacy with severe swelling in her arm the size of a grapefruit (which arm not designated). Patient did not seek medical attention and no treatment was given to patient. The outcome of severe swelling in her arm the size of a grapefruit was reported as recovered/resolved on an unknown date. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 23 year old female patient. The patient had no pertinent medical history nor drug reactions/allergies. On an unknown date the patient was vaccinated with GARDASIL (dose3, dosage, route and lot number unknown). Concomitant medication included Levothyroxine (manufacturer unknown). The medical assistant reported that a patient may have been administered 3 doses of GARDASIL at an unspecified physician's office, on unspecified dates. The medical assistant stated that patient was seen in their office on 27-NOV-2013 for a "well woman" visit. At that time the patient had a routine PAP Smear completed. The medical assistant reported that the PAP Smear results were received, on an unspecified date, and showed that HPV-16 and "HPV high risk non 16/18" were "detected". The patient received no treatment. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a female patient of unknown age, reporting on herself. On an unknown date the patient was vaccinated with GARDASIL dose 1 and 2 (route, dosage, and lot number unknown). The patient explained that she is currently 1 week past her recommended date for receiving her third shot of GARDASIL. The patient was unsure of the specific dates that she received her first and second doses. No adverse event reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a healthcare professional, concerning to a 20 month old male patient. The patient had no known pertinent medical history, drug reactions/allergies. On 30-MAR-2013, the patient was vaccinated with a dose of VARIVAX (Merck), subcutaneously, Lot # H018423 (expiry date on 08-OCT-2014). Other suspect therapies included MMR II (received in separate sites) (Lot # and expiration date were not reported). Concomitant therapies included PREVNAR. It was reported that the patient developed shingles following vaccination with VARIVAX (Merck). The reporter stated that the patient was brought to the office at the time of reporting, with a case of shingles described as patches of a vesicular rash on the right posterior buttock extending to the right posterior thigh that was painful to the touch. The healthcare worker reported that the shingles rash started about a week ago (approximately on 26-NOV-2013) and that the shingles rash was reported to have gotten worse (unspecified what worse described) over the last couple of days. The patient was treated with acyclovir cream for the event. The patient had not recovered at the time of the report, and the relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient(s) of unknown age and gender. It was unknown if the patient(s) were vaccinated with VAQTA (dose, concentration and lot number not reported) that had gone through a temperature excursion of 31 F. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient(s) of unknown age and gender. It was unknown if the patient(s) were vaccinated with RECOMBIVAX HB (dose, concentration and lot number not reported) that had gone through a temperature excursion of 31 F. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 57 year old female patient. Patient had no pertinent medical history or drug reactions/allergies. On 04-DEC-2013 the patient was vaccinated with ZOSTAVAX lot # J006832 (expiry date 14-SEP-2014), 0.65 ml (once), subcutaneous. Concomitant therapies included XYZAL and METHIMAZOLE. On 05-DEC-2013, the patient experienced redness, swelling and itching at the injection site. The nurse mentioned that the redness appeared from top of her arm to below her elbow. Lab diagnostics studies were not performed. Patient contacted the office for medical attention. The patient was given TYLENOL, antihistamin for treatment of the events. The outcome of the events was reported as recovering/resolving. Causality assessment was not provided. This is 1 of 2 cases reported (reference not provided). Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Pt claims it is difficult to move her left arm due to pain and soreness. Per pt, the pain started to bother her about 1 week ago. She has taken several doses of pain relief medication. Per pt, no bruises or swelling were observed after vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number 03655AA, expiry date 09-JUN-2012) (0.65 ml, frequency not specified) subcutaneous for prevention of shingles. The patient was administered with an expired dose of ZOSTAVAX. No adverse events were reported. No product quality issue was noted. Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Arthropod bite, Back pain, Borrelia test, Chills, Injection site pain
Clinical narrative: Experienced pain at injection site that NOC. Radiated to back, arm and back sore. Fever and chills initially but subsided. 2 days later was "in agony" seen in ER on 12/24/13. Lyme testing for recent tick bite and urine tested to R/O kidney stone. Ibuprofen, warm pads, Vicodin for pain.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia, Urine analysis
Clinical narrative: Experienced pain at injection site that NOC. Radiated to back, arm and back sore. Fever and chills initially but subsided. 2 days later was "in agony" seen in ER on 12/24/13. Lyme testing for recent tick bite and urine tested to R/O kidney stone. Ibuprofen, warm pads, Vicodin for pain.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient states she had a very sore arm and shoulder and has lost ranfge of motion since she got the flu shot. Wants it reported 12-13-13.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Eye oedema, Headache, Lacrimation increased, Lip oedema, Throat tightness
Clinical narrative: Influenza vaccine administered 12/2/13. 12/3/13 at 1AM woke up with headache, lip edema, tight throat, eye edema with watery eyes. Rx with BENADrYL at home - seen in employee health 12/5/13.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient developed redness and pain at the injection site. Treatment given was instructions to the patient to use an ice pack, take ibuprofen, and BENADRYL.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dizziness, Feeling hot, Flushing, Nausea
Clinical narrative: Had heat sensation, flushed feeling, nausea and dizziness after flu shot (same day): 2nd day increased chest pain and throat tightness and severe bilateral arms. Chest pain lasted almost a week.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Had heat sensation, flushed feeling, nausea and dizziness after flu shot (same day): 2nd day increased chest pain and throat tightness and severe bilateral arms. Chest pain lasted almost a week.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: 48 hours after receiving the vaccine, pt developed a shingles rash on left side of neck and back of scalp. Went to doctor's office 11/27/13 to receive treatment for shingles (FAMVIR, prednisone, VICODIN, gabapentin).
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Influenza like illness, Laboratory test, Pain, Pleurisy
Clinical narrative: On 8/22/13, I underwent a physical examination which included blood and lab work. Everything was considered normal. On 9/4/13, I received a senior flu shot at a pharmacy. On 9/12/13, I began suffering from flu like symptoms which included pleurisy. I took ADVIL for the pain in order to sleep. I finally saw Dr. on 10/1/13. I was examined and had an x-ray taken. He confirmed my pleurisy and prescribed an antibiotic-levofloxacin and 2 ADVIL three times a day. The following day he called and informed me that I had pneumonia.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pneumonia, X-ray
Clinical narrative: On 8/22/13, I underwent a physical examination which included blood and lab work. Everything was considered normal. On 9/4/13, I received a senior flu shot at a pharmacy. On 9/12/13, I began suffering from flu like symptoms which included pleurisy. I took ADVIL for the pain in order to sleep. I finally saw Dr. on 10/1/13. I was examined and had an x-ray taken. He confirmed my pleurisy and prescribed an antibiotic-levofloxacin and 2 ADVIL three times a day. The following day he called and informed me that I had pneumonia.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Pruritic rash occurring after vaccine was administered. Pt not allergic to eggs and did not eat any new foods or medications.
Age: 41.0
Sex: F
Vaccine: FLU3, HEPAB, PPV
Symptoms: Adverse drug reaction, Erythema, Local swelling, Pyrexia
Clinical narrative: 12/6/13 - pt complained of swollen, red arm (did not state left or right) and fever. 12/7/13 - went to doctor with same complaint, was put on antibiotics. 12/8/13 patient was admitted to the hospital for adverse reaction to antibiotics. All information reported by LPN.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Lip disorder, Mydriasis
Clinical narrative: Labial commissure deviation, unable to blink Rt eye, Rt eye mydriasis.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Pyrexia, Throat tightness
Clinical narrative: Four hours after the two vaccinations I began to feel my throat closing up inside - no swelling outside - and then developed 102F fever and felt very chilled. Fever did drop late the next day. Felt weak.
Age: 1.03
Sex: F
Vaccine: FLU3, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on stomach, chest and back - 12/8/2013. Fever - 12/3/2013 through 12/6/2013.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Blood immunoglobulin E normal, Pruritus, Rash erythematous, Rash macular
Clinical narrative: Blotchy skin, "itching" scattered small red dots 4 hours after influenza vaccine. Rx with BENADRYL every 12 hrs. Office visit x2.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 12-5-13 developed rash on trunk, face and arms with itching and developed pain redness and swelling around injection site with pain increased (L) arm - also c/o nausea and vomiting last night - works at pharmacy also and pharmacist gave her PEPCID, BENADRYL and ZYRTEC which decreased s/s some - Today presents with 3 cm red area with some induration and rash noted to face and abdomen.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Pain in extremity, Pruritus, Rash, Vomiting
Clinical narrative: On 12-5-13 developed rash on trunk, face and arms with itching and developed pain redness and swelling around injection site with pain increased (L) arm - also c/o nausea and vomiting last night - works at pharmacy also and pharmacist gave her PEPCID, BENADRYL and ZYRTEC which decreased s/s some - Today presents with 3 cm red area with some induration and rash noted to face and abdomen.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure increased, Chills, Dizziness, Dyspnoea
Clinical narrative: 11:00A received flu vaccination. 11:50A pt presents to vaccination table w/ c/o: SOB, dizziness, weakness, diaphoretic, headache, shaky hands, chills, "can't breathe good". VS 162/100 P 76 R 24. 12:07P 150/86 P 70 R20. 12:15P 148/88 P 72 R20. 12:20P Spoke to someone: instructed to give EPI PEN. Notify POC for transport to hospital. 12:22P EPI PEN given. 12:30P Spoke to someone else. 12:45P transport per EMS to hospital.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis, Tremor
Clinical narrative: 11:00A received flu vaccination. 11:50A pt presents to vaccination table w/ c/o: SOB, dizziness, weakness, diaphoretic, headache, shaky hands, chills, "can't breathe good". VS 162/100 P 76 R 24. 12:07P 150/86 P 70 R20. 12:15P 148/88 P 72 R20. 12:20P Spoke to someone: instructed to give EPI PEN. Notify POC for transport to hospital. 12:22P EPI PEN given. 12:30P Spoke to someone else. 12:45P transport per EMS to hospital.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm with 3 x 3 cm area of erythema and swelling. No induration, minimally tender, persisting for > 72 hours. Left anterior thigh with 5 x 5 cm area of swelling. No induration mildly tender, persisting for > 72 hours.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial serious report received from a non-health care professional on 05 December 2013. A 62-year-old female patient had received a Flu shot (Lot number, site of vaccination and route not reported) on an unspecified date. It was reported that the patient was involved in bad car wreck in 1995 and had received EFFEXOR that caused her to have diabetes. The patient has high blood pressure, diabetes, fibromyalgia and trouble in her feet. It was reported that the patient catches flu even though she gets flu shot. Laboratory details and corrective treatment was not reported. At the time of this report the outcome of the adverse event was unknown. Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Pruritus, Rash erythematous
Clinical narrative: 10/18/13 I received a shingles vaccine in upper left arm. Next day my arm was tingly, then by Sunday (10/20) it had a red rash (10"x3"). I took LYSINE and the itching and tingling subsided but rash has not completely gone away. Arm continues to ache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Rash papular
Clinical narrative: Local pink macular rash.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Blood immunoglobulin E, Chest discomfort, Cough, Dyspnoea, Spirometry
Clinical narrative: Reactive airway symptoms post influenza vaccine shortness of breath, chest tightness, high pitched cough. Medication prescribed MEDROL dose pack, albuterol, BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired drug administered
Clinical narrative: Pt was given an expired dose of KINRIX on 12/11/13.
Age: 19.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, painful at site of injection white border around site of injection LA back of arm.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness
Clinical narrative: Patient received vaccine on 12/11/13. Pt came back to pharmacy on 12/13/13 w/ redness on arm and arm stiffness. Advised patient to see physician.
Age: 1.27
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: < 25 lesions.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Extensive swelling of vaccinated limb, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of extensive swelling of vaccinated limb in a 35-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy. On 12 November 2013 the subject received 2nd dose of ENGERIX B (1ml/ 20 mcg, unknown, right arm). On 14 November 2013, 2 days after vaccination with ENGERIX B, the subject experienced runny nose and headache. On 20 November 2013, 8 days after vaccination with ENGERIX B, the subject experienced red, hot, swollen arm, painful six by eight inch swelling on right deltoid at injection that had pain shooting down arm site. The physician provided discrepant measurements during the report, he stated that the swelling measurements were six centimeters by seven centimeters and six by eight inches. The physician reported about a month later the subject continues to have painful six by eight inch swelling on right deltoid. The physician considered the events were disabling and clinically significant (or requiring intervention). It was unknown if the immunization series was delayed or discontinued. At the time of reporting the subject's runny nose and headache resolved; injection site redness and injection site warmth had improved. The injection site pain, pain shooting down arm and extensive swelling at vaccinated limb were worse. The lot number was reported as "AHBVC113" from the reporter; however, based on a safety lot number review, the lot number was updated to "AHBVC113AB". The physician also reported that the subject had a 'similar swelling' reaction years ago with tetanus portion of the Tdap (DTPa (with small D + P)); no further description provided. The specific details regarding the Tdap vaccination and the swelling reaction were not provided. The outcome of the swelling reaction was unknown.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Injection site warmth, Pain in extremity, Rhinorrhoea, Similar reaction on previous exposure to drug
Clinical narrative: This case was reported by a physician and described the occurrence of extensive swelling of vaccinated limb in a 35-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy. On 12 November 2013 the subject received 2nd dose of ENGERIX B (1ml/ 20 mcg, unknown, right arm). On 14 November 2013, 2 days after vaccination with ENGERIX B, the subject experienced runny nose and headache. On 20 November 2013, 8 days after vaccination with ENGERIX B, the subject experienced red, hot, swollen arm, painful six by eight inch swelling on right deltoid at injection that had pain shooting down arm site. The physician provided discrepant measurements during the report, he stated that the swelling measurements were six centimeters by seven centimeters and six by eight inches. The physician reported about a month later the subject continues to have painful six by eight inch swelling on right deltoid. The physician considered the events were disabling and clinically significant (or requiring intervention). It was unknown if the immunization series was delayed or discontinued. At the time of reporting the subject's runny nose and headache resolved; injection site redness and injection site warmth had improved. The injection site pain, pain shooting down arm and extensive swelling at vaccinated limb were worse. The lot number was reported as "AHBVC113" from the reporter; however, based on a safety lot number review, the lot number was updated to "AHBVC113AB". The physician also reported that the subject had a 'similar swelling' reaction years ago with tetanus portion of the Tdap (DTPa (with small D + P)); no further description provided. The specific details regarding the Tdap vaccination and the swelling reaction were not provided. The outcome of the swelling reaction was unknown.
Age: 54.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Myalgia, Oedema peripheral
Clinical narrative: Myalgia and injection site pain, peripheral edema. Diphenhydramine 50 mg at bedtime, prednisone 5 mg every day.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Mother of patient was notified by school of child's (L) arm w/ redness and swelling came to office for evaluation.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Myalgia. Acetaminophen 2 tab once, sodium chloride 125 ml other, ceftriaxone 1 gm once
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Malaise, Pruritus, Rash generalised
Clinical narrative: Vaccinated Monday morning. Several hours later: malaise that night and Tuesday night chills and sweats. Wednesday morning: rash involving chest, abdomen, back, arms. Itchy.
Age: 47.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Anxiety, Laboratory test, Myositis, Nasopharyngitis, Paraesthesia
Clinical narrative: Pt. states her arm where the vaccines where admin. had severe pain and she had a "cold".  She asked her friends for advice and they told her it was normal.  The pain continued.  Pt. went to ER in 10/2013 and was told her arm muscles were inflamed.  She didn't take the medication prescribed by MD.  She called into the Health Dept, where the vaccines were admin, yesterday 12/12/13.  She continues to feel pins and needles in her Left arm and has anxiety.
Age: 47.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Vaccination site pain
Clinical narrative: Pt. states her arm where the vaccines where admin. had severe pain and she had a "cold".  She asked her friends for advice and they told her it was normal.  The pain continued.  Pt. went to ER in 10/2013 and was told her arm muscles were inflamed.  She didn't take the medication prescribed by MD.  She called into the Health Dept, where the vaccines were admin, yesterday 12/12/13.  She continues to feel pins and needles in her Left arm and has anxiety.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, Angiogram, Asthenia, Computerised tomogram head normal, Headache
Clinical narrative: Global headache x 1 week needing daily NSAID w/o relief. L forearm paresthesia/subjective weakness since awakening on 12/06.  BP 140/94  Send to hospital to evaluate re TIA vs anginal equivalent.  Scanned CT + MRI/MRA + told ADEM.  Is following up w neurologist.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Photophobia
Clinical narrative: Global headache x 1 week needing daily NSAID w/o relief. L forearm paresthesia/subjective weakness since awakening on 12/06.  BP 140/94  Send to hospital to evaluate re TIA vs anginal equivalent.  Scanned CT + MRI/MRA + told ADEM.  Is following up w neurologist.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Pain, Pain in extremity, Pyrexia
Clinical narrative: PATIENT STATES THAT SHE RECEIVED THE VACCINE AROUND 1500 AND THAT NIGHT SHE FELT FINE. THE FOLLOWING DAY SHE HAD ARM PAIN, WAS ACHY AND HAD FEVER OF 99.2, BUT BY 1600 SHE CLAIMED A TEMP OF 100.1. SHE STATES SHE FELT BETTER BY 9/14/2013, BUT SHE STATED THE FEVER REMAINED FROM 99.2-99.7 UNTIL 9/28/2013. SHE STATED SHE SAW HER PCP OM 9/24/13 AND HAD BLOOD WORK DONE, BUT THE RESULTS WERE WNL.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dysphagia
Clinical narrative: Client's mother called the clinic and informed the nurse that her daughter started exhibiting difficulty swallowing about 2 hours after she left the clinic. She was given MMR and Varicella. She was encouraged to take the child to the ER to be evaluated and treated as indicated.  Follow-up: Telephone call-Parent reports she took child to the ER and client was evaluated. ER physician assessed the child's ability to swallow and gave the child orange juice. She was able to swallow without difficulty. Child stated she was okay. Parent declined x-ray and left ER. Follow-up 12/12/13 Mother reports child is having no problems with swallowing and is okay.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema
Clinical narrative: Redness 20x18 left arm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Feeling hot, Induration, Pruritus, Swelling
Clinical narrative: Very hot, swollen, feels hard, itchy. Try Motrin and Benadryl.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, IPV, PNC13, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Single dose polio was given with Pediarix.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient called County Health Department 12/12/13. Return call per RN on 12/12/13. Patient stated that shot was given in the right deltoid and became a little sore that day. States the right arm was still sore 3-4 weeks later. States he did not seek medical attention because he did not have a doctor. States right arm still sore today, 12/12/13. RN called County Health Department who coordinated a visit for this patient with the nurse practitioner on duty. RN called patient to inform him of the scheduled visit to County Health Department so someone could look at his arm.  Patient said that he was out of town and he didn't now if he would be able to make it.  RN offered the patient the telephone number so he could call and coordinate a more convenient time according to his schedule so he could see them. Patient said that he already had their number.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Malaise, Nausea
Clinical narrative: Flu-like symptoms, general malaise.  Nausea and diarrhea for 3 days about 5 days total until resolutions of symptoms.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Injection site warmth, Pain
Clinical narrative: Body aches day after injection. Soreness, knot and fever at injection site. Knot and fever at injection site sore for 6 days after injection.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX
Symptoms: Syncope
Clinical narrative: He fainted after his 2nd dose. Other shot given was Flu shot.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Sore medial right arm.
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Headache, nauseated, vomited x2 and dizziness.
Age: 39.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Skin tightness
Clinical narrative: Reddened area on back of upper right arm, itchy and tight as described by patient.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Yesterday patient received the LAIV Intranasal Flu Vaccine at School. Today patient started complaining of stomach pain at school and then threw up, no fever!
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatinine increased, Blood potassium decreased, Diarrhoea, Dizziness, Oropharyngeal pain
Clinical narrative: Diarrhea, fever then 18 days later sore throat, dizziness, vomiting.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting, White blood cell count normal
Clinical narrative: Diarrhea, fever then 18 days later sore throat, dizziness, vomiting.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint movement impairment, Injection site joint pain, Injection site pain
Clinical narrative: Patient reported that for about a week after the injection she had pain and decreased movement in left shoulder with mild tenderness at point of injection. Patient reports going to an Urgent Care with no MRI ordered. Reports improvement of ROM but still has pain. Made an appt with ortho. Stated she did not follow up sooner for medical care because she said she is a busy lawyer and did not have time to call. Offered follow up in the clinic and suggested treatments of NSAIDS OTC and warm compresses but does not wish to go this route. Attempted to have ortho appt moved up for patient and gave the patient the available ortho times.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Pruritus, Urticaria
Clinical narrative: ITCHING URTICARIA.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Started with sore arm where the shot was injected.  Then the next day had sore throat, productive cough, low grade fever, body aches, malaise, sore arm, headache.  Weakness and tiredness and head congestion.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Productive cough, Pyrexia
Clinical narrative: Started with sore arm where the shot was injected.  Then the next day had sore throat, productive cough, low grade fever, body aches, malaise, sore arm, headache.  Weakness and tiredness and head congestion.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Sinus congestion
Clinical narrative: Started with sore arm where the shot was injected.  Then the next day had sore throat, productive cough, low grade fever, body aches, malaise, sore arm, headache.  Weakness and tiredness and head congestion.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Urticaria, Vaccination site swelling
Clinical narrative: Swelling at vaccination site, became flushed, had hives on hands, face, neck, chest & body hives.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Will send follow up via email.
Age: 1.62
Sex: M
Vaccine: DTAP, MMR, PNC13
Symptoms: Rash, Vaccination complication
Clinical narrative: Rash on stomach no fever or other symptoms leading to rash as illness thus believing its a reaction to the MMR.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness swelling and burning sensation of the left arm from the injection site distally to just above the elbow.
Age: 0.66
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Autism
Clinical narrative: Autism.
Age: 55.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Muscle around the vaccination site is very swollen. Around 1.5 inches in diameter across most swollen part. Very red and raised. Patient said it was very painful all around. Patient said it started around 1 day after getting vaccine Flucelvax.
Age: 25.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Migraine
Clinical narrative: Intense migraine and pressure in head.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Pruritus
Clinical narrative: 4 yr old female c/o itchiness and swollen left arm.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling, Joint range of motion decreased, Ultrasound scan abnormal
Clinical narrative: The patient describes having immediate pain with the vaccination. Within 24 hours she had pain at the injection site and limited ROM. She was seen by a doctor 11-26-13 and presented with swelling and tenderness over humerus, glenohumeral joint.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right upper arm red and swollen. Treatment: Cool compresses, BENADRYL every 6 hours and MOTRIN. Seek medical attention for facial swelling or hard or fast breathing.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Skin tightness
Clinical narrative: 12/13/13 3:28pm Patient stated after the flu-shot was given in her left deltoid muscle she claims that 15 days after the area (site) is still hurting and she's in pain. She also stated she has problem lifting that specific arm. She stated she has taken ibuprofen 600mg. The area is tight on the left shoulder.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Hypopnoea, Muscular weakness
Clinical narrative: Patient called 12/5/13 and said that when she left she went shopping at 2 other stores and during that time she had weakness in her leg and her arm then had shallow breathing. She stated she did not go to be seen and went home and rested.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Local swelling, Panic attack, Syncope
Clinical narrative: Immediately following administration, localized swelling was noted on the left arm of the injection site. The patient stated he felt dizzy and faint. He knelt down with his head between his legs for about 1 minute and stated he felt like he was having a panic attack. The patient was monitored for an additional 15 minutes and felt fine upon leaving. Patient requested a cup of water. No other side effects were noted.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Lymph node pain
Clinical narrative: 12 hours after vaccine, pt had red round itchy patch at injection site - then over 24-36 hours she had development of tender notes - large in axilla.
Age: 0.19
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2" swelling and erythema at injection site. Self resolved over 72 hrs w/o treatment.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Emotional distress, Injection site mass, Injection site pain, Injection site urticaria
Clinical narrative: Patient sweated profusely for the two nights following vaccination, but no other symptoms developed until the second day.  Initially a lump was noticed to the upper right of injection site as severe tenderness and pain were experienced.  Site is warm to the touch and surrounded by raised flesh-toned hives.  Sudden diarrhea was experienced approximately four hours later and again later that night.  Increased irritability and emotionality (tears) were noticed.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Irritability, Night sweats, Tearfulness
Clinical narrative: Patient sweated profusely for the two nights following vaccination, but no other symptoms developed until the second day.  Initially a lump was noticed to the upper right of injection site as severe tenderness and pain were experienced.  Site is warm to the touch and surrounded by raised flesh-toned hives.  Sudden diarrhea was experienced approximately four hours later and again later that night.  Increased irritability and emotionality (tears) were noticed.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen at area of injection that spread down the arm and around- area was hot to the touch and sore.
Age: 37.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Patient described left shoulder pain around the area of the injection.  That progressed to pain localized to shoulder and then to weakness in the left shoulder over a period of several weeks.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site reaction, Listless, Oropharyngeal pain
Clinical narrative: I had a severe sore throat.  Following that, I had a low grade fever, listlessness, a welt on my arm where I had the injection.  It is now 2 days later, and I'm still not back to normal, feeling weak, tired, though better.  The sore throat is gone.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: I had a severe sore throat.  Following that, I had a low grade fever, listlessness, a welt on my arm where I had the injection.  It is now 2 days later, and I'm still not back to normal, feeling weak, tired, though better.  The sore throat is gone.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Abasia, Body temperature increased, Decreased appetite, Fatigue, Fluid intake reduced
Clinical narrative: 12/1/13 LIMPING ON SAME LEG THAT SHE RECEIVED INJECTION, CAN'T WALK, CLINGY TO MOTHER, TEMP 100.7; DEC 2 TEMP 101, LIMPING, CLINGY TO MOTHER; DEC 3 LATE AFTERNOON 100.3 OR 100.5 TEMP, 10:45 P.M. TEMP 103.5, VOMITED, CRANKY, EXHAUSTED, CLINGY, HOMEOPATHY REMEDY SILICA 30, 12 A.M. GAVE HOMEOPATHY REMEDY BELLADONNA 200C; DEC 4 7:45 A.M. HOMEOPATHIC REMEDY PULSATILLA 200C; 8:45 A.M. TEMP 102, LIMITED FOOD & LIQUID INTAKE, SIPPING WATER THROUGHOUT THE DAY WITH HOMEOPATHIC REMEDY PULSATILLA 200C, 2:30 P.M. CRANKY, CLINGY, NOT SLEEPING WELL, TEMP 101.5; DEC 5 A.M. TEMP 101.7, SOME CLINGY, GAVE SILICA 30C; DEC 6 8 A.M. SPIRITS BETTER, RASH, MOTTLED SKIN ON ENTIRE FACE & BODY, BRIDGE OF NOSE & EYES RED, NO FEVER, 9 A.M. HOMEOPATHIC REMEDY SULPHUR 30C, DIDN'T EAT WELL THROUGHOUT THE DAY, MINIMAL LIQUID INTAKE; DEC 9 EXHAUSTED THROUGHOUT THE DAY; DEC 10 TOOK HOMEOPATHIC REMEDY HIB 30C; DEC 11 BETTER ALTHOUGH STILL CLINGY
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Gait disturbance, Irritability, Livedo reticularis, Ocular hyperaemia, Poor quality sleep
Clinical narrative: 12/1/13 LIMPING ON SAME LEG THAT SHE RECEIVED INJECTION, CAN'T WALK, CLINGY TO MOTHER, TEMP 100.7; DEC 2 TEMP 101, LIMPING, CLINGY TO MOTHER; DEC 3 LATE AFTERNOON 100.3 OR 100.5 TEMP, 10:45 P.M. TEMP 103.5, VOMITED, CRANKY, EXHAUSTED, CLINGY, HOMEOPATHY REMEDY SILICA 30, 12 A.M. GAVE HOMEOPATHY REMEDY BELLADONNA 200C; DEC 4 7:45 A.M. HOMEOPATHIC REMEDY PULSATILLA 200C; 8:45 A.M. TEMP 102, LIMITED FOOD & LIQUID INTAKE, SIPPING WATER THROUGHOUT THE DAY WITH HOMEOPATHIC REMEDY PULSATILLA 200C, 2:30 P.M. CRANKY, CLINGY, NOT SLEEPING WELL, TEMP 101.5; DEC 5 A.M. TEMP 101.7, SOME CLINGY, GAVE SILICA 30C; DEC 6 8 A.M. SPIRITS BETTER, RASH, MOTTLED SKIN ON ENTIRE FACE & BODY, BRIDGE OF NOSE & EYES RED, NO FEVER, 9 A.M. HOMEOPATHIC REMEDY SULPHUR 30C, DIDN'T EAT WELL THROUGHOUT THE DAY, MINIMAL LIQUID INTAKE; DEC 9 EXHAUSTED THROUGHOUT THE DAY; DEC 10 TOOK HOMEOPATHIC REMEDY HIB 30C; DEC 11 BETTER ALTHOUGH STILL CLINGY
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Rash, Vomiting
Clinical narrative: 12/1/13 LIMPING ON SAME LEG THAT SHE RECEIVED INJECTION, CAN'T WALK, CLINGY TO MOTHER, TEMP 100.7; DEC 2 TEMP 101, LIMPING, CLINGY TO MOTHER; DEC 3 LATE AFTERNOON 100.3 OR 100.5 TEMP, 10:45 P.M. TEMP 103.5, VOMITED, CRANKY, EXHAUSTED, CLINGY, HOMEOPATHY REMEDY SILICA 30, 12 A.M. GAVE HOMEOPATHY REMEDY BELLADONNA 200C; DEC 4 7:45 A.M. HOMEOPATHIC REMEDY PULSATILLA 200C; 8:45 A.M. TEMP 102, LIMITED FOOD & LIQUID INTAKE, SIPPING WATER THROUGHOUT THE DAY WITH HOMEOPATHIC REMEDY PULSATILLA 200C, 2:30 P.M. CRANKY, CLINGY, NOT SLEEPING WELL, TEMP 101.5; DEC 5 A.M. TEMP 101.7, SOME CLINGY, GAVE SILICA 30C; DEC 6 8 A.M. SPIRITS BETTER, RASH, MOTTLED SKIN ON ENTIRE FACE & BODY, BRIDGE OF NOSE & EYES RED, NO FEVER, 9 A.M. HOMEOPATHIC REMEDY SULPHUR 30C, DIDN'T EAT WELL THROUGHOUT THE DAY, MINIMAL LIQUID INTAKE; DEC 9 EXHAUSTED THROUGHOUT THE DAY; DEC 10 TOOK HOMEOPATHIC REMEDY HIB 30C; DEC 11 BETTER ALTHOUGH STILL CLINGY
Age: 1.66
Sex: M
Vaccine: PNC13
Symptoms: Crying, Erythema, Gait disturbance, Mobility decreased, Pain
Clinical narrative: Pain, inability/refusal to move leg which he kept bent at the hip and knee, uncontrollable crying, redness, and swelling.  I gave 1 tsp Motrin at 9:00pm and then every 6 hours for 36 hrs.  He cried continuously until 4:04am when he fell asleep.  He woke at 7:40 am with a fever of 101.6° F.  He cried off and on throughout 12/12/2013.  He refused to walk for 30 hrs from onset of symptoms.
Age: 1.66
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: Pain, inability/refusal to move leg which he kept bent at the hip and knee, uncontrollable crying, redness, and swelling.  I gave 1 tsp Motrin at 9:00pm and then every 6 hours for 36 hrs.  He cried continuously until 4:04am when he fell asleep.  He woke at 7:40 am with a fever of 101.6° F.  He cried off and on throughout 12/12/2013.  He refused to walk for 30 hrs from onset of symptoms.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Nausea, Vomiting
Clinical narrative: Severe nausea, chronic vomiting. Inability to keep anything down including water, tea, broth.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Culture urine negative, Dyspnoea, Hypophagia, Laboratory test normal
Clinical narrative: Very High Fever, (100 F to 106.2 F) (Measured On temple); temperature temporarily goes down with medications then comes back up to very high fever of around 106 F. Swelling of the face, difficulty breathing, weakness. No food intake just fluids.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Swelling face
Clinical narrative: Very High Fever, (100 F to 106.2 F) (Measured On temple); temperature temporarily goes down with medications then comes back up to very high fever of around 106 F. Swelling of the face, difficulty breathing, weakness. No food intake just fluids.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Immediate pain in left shoulder. Pain continuous 24/7. Unable to use left arm. Returned to doctor's office and prescribed Ibuprofen; referred to Orthopedic specialist. MRI confirms rotator cuff tear. Surgery scheduled for 12/16/2013.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Nausea
Clinical narrative: Abdominal pain, feeling of wanting to throw up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Scab
Clinical narrative: This spontaneous report as received from a 80 year old female consumer regarding herself. The patient was not pregnant. The patient's medical history included ovarian cancer surgery and colonoscopy in 18-OCT-2012. On an unknown date in 2008 the patient was vaccinated with ZOSTAVAX dose 1 for prevention of shingles. The patient used unspecified concomitant medications. On an unknown date in November 2013 the patient experienced shingles, feels a burning sensation, blisters on her rib cage and the scabs are slowly falling away. The patient sought medical attention. Her physician thought that the episode was at the end of its course. No treatment was provided for the event. The outcome of the events was unknown. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on both arms from elbow to wrist. Patient did not report the incident to the pharmacy until 2 weeks after injection.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site streaking, Muscle spasms, Pain
Clinical narrative: This spontaneous report as received from a 63 year old male consumer regarding himself. On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX dose unknown for vaccine. The patient was on unspecified blood pressure medications. On 07-DEC-2013, the patient experienced severe back muscle spasms. On 08-DEC-2013 the patient noticed an injection site an inch long red scratch mark (reported as mark) and a half-dollar sized lump. On 08-DEC-2013 the patient experienced arm having as stinging feeling like getting smacked by a ruler. No treatment was provided. The patient sought medical attention. At the time of report the patient stated that the redness was more of a pink but it stretched from below bicep to elbow. The patient also reported that the back muscles continued to bother him. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling (localized) of administration site.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Patient developed a rash in entire body hours after receiving the Flu vaccine.  He was given to take a 50mg diphenhydramine pill to counteract the issues.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site haematoma, Injection site swelling
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 64 year old female patient with no drug reactions/allergies. On 06-DEC-2013 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # J006156, exp. date: 30-AUG-2014, 0.65 ml, one dose) for prevention of shingles, intramuscularly rather than by subcutaneous route. Concomitant therapies included omeprazole (manufacture unknown), simvastatin (manufacturer unknown), enalapril maleate, amlodipine and ubidecarenone. On 06-DEC-2013, the patient experienced small bruise (hematoma) and swelling at the injection site. It was noted that the patient returned to the office because she had forgotten her prescription, and upon returning to the office the medical assistant examined the injection site area and the swelling had gone down. The patient sought medical attention, she was seen at physician's office. No treatment was given for the adverse events. No lab diagnostic studies were performed. The outcome of the events was reported as recovering. Casual relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient (gender was not reported). On 05-DEC-2013 the patient was vaccinated intramuscularly in the right arm with a 0.5 mg dose of PNEUMOVAX23 (lot # J007059, expiration date 31-JUL-2014) in error. The child was indicated to receive a dose of PREVNAR 13. No adverse effect had been demonstrated at that time. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Hives, redness, severe swelling at inj site. Flu like sx now.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse (also reported by a health worker) refers to unspecified number of patients of unknown age. On an unknown date the patient were vaccinated with ZOSTAVAX lot # J006828, expiry date 14-SEP-2014 dose unknown. No concomitant medications were reported. The nurse reported that on an unknown date unspecified number of patients were vaccinated with improperly stored and not supported vaccine. No adverse effects were reported. Additional information has been requested.