chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Arthralgia, Asthenia, Gait disturbance, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: A few days after receiving the Tetanus vaccine, my left foot and ankle starting paining and I could not walk. Then both feet hurt and I went to an internist, then podiatrists, then back to internist trying to get back to normal. I've had chronic trouble with the left foot and ankle with pain, swelling, weakness, a fall, hospital, physical therapy, ankle foot brace, casts, medications, medical foot boot, crutches. Seems to be resulting in permanent problem. I am currently not recovered as of 12-29-14. I was vaccinated due to a cut from metal appendage at a restaurant on 6-13-13. No other vaccinations were received four weeks prior to the tetanus shot. No previous adverse events following any vaccinations in self or siblings.
Age: 68.0
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Orthosis user, Pain in extremity, Swelling
Clinical narrative: A few days after receiving the Tetanus vaccine, my left foot and ankle starting paining and I could not walk. Then both feet hurt and I went to an internist, then podiatrists, then back to internist trying to get back to normal. I've had chronic trouble with the left foot and ankle with pain, swelling, weakness, a fall, hospital, physical therapy, ankle foot brace, casts, medications, medical foot boot, crutches. Seems to be resulting in permanent problem. I am currently not recovered as of 12-29-14. I was vaccinated due to a cut from metal appendage at a restaurant on 6-13-13. No other vaccinations were received four weeks prior to the tetanus shot. No previous adverse events following any vaccinations in self or siblings.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Patient reported nausea, injection site pain, redness, swollen, hot to touch within hours of receiving PPSV23 injection. Sx resolved next day.
Age: 51.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given Flumist vaccine on 11/11/14 and didn't meet age requirements. Beyond
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Erythema, induration, mild itching locally 12 x 12 cm area of erythema/warmth over (L) thigh. Patient seen Dr 1-5-15.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: On 12/31, showed signs/symptoms of redness/soreness: on 1/2/15 pt went to MD and got steroid shot due to symptoms. On 1/3/15 came to pharmacy ro notify and took BENADRYL.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash macular, Skin warm
Clinical narrative: Sore arm, warm to touch, red blotch.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Large, swollen area at site of injection, rash at site of injection and pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 2" area of redness around injection site on (R) arm. Harder spot in center. Offered BENADRYL 25mg (pt. declined) offered ice/hot bag pt accepted. Pt. reports not painful. Physician notified 1/5/15.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Pallor, Rash erythematous, Rash generalised, Rash papular
Clinical narrative: Redness around the site of varicella vaccine. Generalized but scant red papular rash. (All blanching). No purpura.
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Peripheral swelling, Pyrexia, Wound
Clinical narrative: Pt had swollen right arm w/some fevers within 12 hrs of receiving Pneumovax and Flu in R arm, and Tdap in L arm. Pt took osome ibuprofen, sxs less today (3 days after incident). No resp difficulty. No drainage from wound.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling, Pallor
Clinical narrative: Swollen left thigh started on 12/31/14 after vaccine given on 12/30/2014. Mild redness at site; no fever, no streaking, blanching circular rash. Prescribed: Triamcinolone Acetonide cream and BENADRYL liquid.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Areflexia, CSF protein increased, Electromyogram abnormal, Guillain-Barre syndrome, Hemiplegia
Clinical narrative: Case number PHEH2014US013809, is a combined initial and follow up spontaneous report from a consumer received on 07 Jul 2014 and 10 Jul 2014 respectively and a follow up received from consumer on 19 Aug 2014, with a follow up received from physician on 08 Oct 2014. This report refers to an approximately 72 year old elderly male patient. The physician reported that the patient does not have any history of GBS or other neurological diseases or other significant medical history. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1309401, expiration date: Apr 2014) on 21 Oct 2013. On an unknown date after vaccination, he experienced Guillain-Barre syndrome and he was paralyzed on his left side and the paralysis was flaccid. It was reported that FLUVIRIN almost killed him and he was still experiencing problems due to FLUVIRIN administration. The physician stated that the onset of the event was progressive over several weeks noticing, weakness in extremities requiring hospitalization and lumbar puncture. There was no respiratory muscle involvement; no cranial nerve involvement and deep tendon reflex were absent. The electromyogram and nerve conduction studies revealed symmetric, sensory, motor axonal polyneuropathy; active denervation was seen in distal muscles in the right lower extremity and are consistent with the GBS. He had elevated protein levels found in CSF. There was no differential diagnosis. The patient was getting stronger. Treatment was rendered with intravenous immunoglobulin G and steroids intravenous. The final outcome of the events was complete recovery. The seriousness of the events was reported as life threatening, hospitalization, disability and medically significant. The physician stated that they did not administer FLUVIRIN to the patient and do not have any information about the FLUVIRIN injection itself. The physician reported that they are a neurology office that took care of the patient after he developed Guillain Barre Syndrome and believed that Guillain Barre Syndrome was due to FLUVIRIN. Non-significant follow up received from consumer on 19 Aug 2014: updated physician contact information. Follow up received from physician on 08 Oct 2014: updated patient demographics, lab data, new events, seriousness of the events, outcome of the events, treatment and other clinically relevant information in the narrative.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Muscular weakness, Nerve conduction studies abnormal, Paralysis flaccid, Peripheral sensory neuropathy
Clinical narrative: Case number PHEH2014US013809, is a combined initial and follow up spontaneous report from a consumer received on 07 Jul 2014 and 10 Jul 2014 respectively and a follow up received from consumer on 19 Aug 2014, with a follow up received from physician on 08 Oct 2014. This report refers to an approximately 72 year old elderly male patient. The physician reported that the patient does not have any history of GBS or other neurological diseases or other significant medical history. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1309401, expiration date: Apr 2014) on 21 Oct 2013. On an unknown date after vaccination, he experienced Guillain-Barre syndrome and he was paralyzed on his left side and the paralysis was flaccid. It was reported that FLUVIRIN almost killed him and he was still experiencing problems due to FLUVIRIN administration. The physician stated that the onset of the event was progressive over several weeks noticing, weakness in extremities requiring hospitalization and lumbar puncture. There was no respiratory muscle involvement; no cranial nerve involvement and deep tendon reflex were absent. The electromyogram and nerve conduction studies revealed symmetric, sensory, motor axonal polyneuropathy; active denervation was seen in distal muscles in the right lower extremity and are consistent with the GBS. He had elevated protein levels found in CSF. There was no differential diagnosis. The patient was getting stronger. Treatment was rendered with intravenous immunoglobulin G and steroids intravenous. The final outcome of the events was complete recovery. The seriousness of the events was reported as life threatening, hospitalization, disability and medically significant. The physician stated that they did not administer FLUVIRIN to the patient and do not have any information about the FLUVIRIN injection itself. The physician reported that they are a neurology office that took care of the patient after he developed Guillain Barre Syndrome and believed that Guillain Barre Syndrome was due to FLUVIRIN. Non-significant follow up received from consumer on 19 Aug 2014: updated physician contact information. Follow up received from physician on 08 Oct 2014: updated patient demographics, lab data, new events, seriousness of the events, outcome of the events, treatment and other clinically relevant information in the narrative.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Caesarean section, Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional (nurse) and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included pregnancy. The subject had one previous full-term pregnancy; however, details regarding the outcome were not reported. The subject was not using contraception and the type of conception was normal. There was no evidence of defect from prenatal testing. Maternal and paternal history which may have an impact on the outcome of this pregnancy was unknown. In 2013 the subject received a dose of FLULAVAL (.5 cc, unknown route, left deltoid) and experienced vaccine exposure during an unknown trimester of pregnancy. The gestational age and date of last menstrual period were not reported. The estimated date of delivery was reported as 1 November 2013. On an unknown date, the subject had an ultrasound examination with result of no evidence of defect from prenatal testing. At the time of reporting, the pregnancy was ongoing. The nurse reported another case with FLULAVAL. See case A1046739A for details on the other case. 11March2014: No further information provided; patient lost to follow-up. Follow-up information was received on 08 April 2014 via nurse. Concurrent medical conditions included blood pressure, depression and gastrointestinal disorder. Concurrent medications included PREVACID, TOPROL XL, ZOLOFT, prenatal vitamin, PRISTIQ. The pregnancy was by normal conception. At 39 weeks gestation age, the subject gave birth to a male live infant who was considered full term. The infant was delivered by cesarean section, weight 7 pounds 11 ounces, 19 1/2 inches in length. Head circumference and Apgar score were not provided, the report stated the mother said "he was perfect".
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, via company representative, refers to a patient of unknown age and gender. Pertinent medical history, drug reaction or allergies were not reported. On an unknown date the patient was vaccinated with several series of unspecified hepatitis A vaccine, inactivated (manufacturer unknown) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse effects were supported. The outcome of the events was unknown. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 35-year-old female subject was enrolled in a study. The subject received the 1st dose of Flu Seasonal QIV (intramuscular) .5 ml on 5th November 2014. The subject's last menstrual period was on 20th October 2014 and estimated date of delivery was 27th July 2015. The subject received Flu Seasonal QIV at week 2 of the pregnancy and during the first trimester of pregnancy. On 5th November 2014, an unknown time after receiving Flu Seasonal QIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown of the investigator considered the vaccine exposure during pregnancy to be related to Flu Seasonal QIV. Additional details provided: Called reported that she received FLUARIX QUADRIVALENT. She has received previous flu vaccines without any reactions. She denied other medications, vaccines or relevant medical history. She noted that vaccine it was given by the Nurse but she was not able to provide the HCP that oversees those. The reporter noted that she has not been given an EDD but by LMP date believes her gestation age is 8 weeks.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified number of patients of unknown age. It was reported that unspecified number of patients received improperly stored PROQUAD (Merck) on an unspecified day. No adverse effects were reported. This is one of several reports. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified number of unknown age. it was reported that unspecified number of patients received improperly stored (Oka/Merck) VARIVAX, on an unspecified day. No adverse effects were reported. This is one of several reports. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified number of patients of unknown age. It was reported that unspecified number of patients received improperly stored GARDASIL on an unspecified day. No adverse effects were reported. This is one of several reports. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients were vaccinated with VARIVAX (Merck), (strength, dose, frequency, route, anatomical location and lot number were not provided), which was improperly stored. Other suspect or concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 78 year old female patient with diabetes refers to herself. In approximately 2012 (reported as "about 2 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (route, lot#, dose and frequency unknown). Concomitant therapies included acetaminophen, TYLENOL PM, metformin and glipizide. On 18-DEC-2014 the patient experienced shingles, which was treated with Valacyclovir hydrochloride. She sought medical attention via office visit. The outcome of the shingles was reported as not recovered/not resolved. The relationship of the shingles and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patients with unknown age and sex. On unknown dates, since 02-OCT-2014 patients were vaccinated with GARDASIL (lot#, route and dose unknown) which had been exposed to temperatures outside of the recommended range. No adverse experience had been reported. It was not specified if patients sought for medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patients with unknown age and sex. On unknown dates, since 02-OCT-2014 patients were vaccinated with PNEUMOVAX23 (lot#, route and dose unknown) which had been exposed to temperatures outside of the recommended range. No adverse experience had been reported. It was not specified if patients sought for medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was inadvertently vaccinated with a second dose of ZOSTAVAX (lot number and exp. date not provided) (strength, dose, frequency and route not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patients with unknown age and sex. On an unknown date patients were vaccinated with VARIVAX (Merck) (lot#, route and dose unknown) which had been exposed to temperatures above 5 Fahrenheit. No adverse experience had been reported. It was not specified if patients sought for medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patients with unknown age and sex. On unknown dates patients were vaccinated with PROQUAD (Merck) (lot#, route and dose unknown) which had been exposed to temperatures above 5 Fahrenheit. No adverse experience had been reported. It was not specified if patients sought for medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Dyspnoea, Feeling abnormal, Feeling hot, Headache
Clinical narrative: 10/31/14 received Flu vax, received tetanus vax in 2010 with no reaction. 15 minutes after vaccine had strange tingling in head and headache. 30 minutes after vaccine felt like detached from body did not have difficulty breathing. At one point felt very hot but was hydrating all day. Warmth felt like a rush which took a couple of hours to step down and then repeated again. Took almost 24 hours to resolve. Took TYLENOL at one point for back pain. It was an idiosyncratic reaction. Arm kept hurting until this morning. Couldn't use it to much, feeling better today. Call vax administrator and family doctor; vax administrator asked pt to come by the office.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Idiosyncratic drug reaction, Pain in extremity, Paraesthesia
Clinical narrative: 10/31/14 received Flu vax, received tetanus vax in 2010 with no reaction. 15 minutes after vaccine had strange tingling in head and headache. 30 minutes after vaccine felt like detached from body did not have difficulty breathing. At one point felt very hot but was hydrating all day. Warmth felt like a rush which took a couple of hours to step down and then repeated again. Took almost 24 hours to resolve. Took TYLENOL at one point for back pain. It was an idiosyncratic reaction. Arm kept hurting until this morning. Couldn't use it to much, feeling better today. Call vax administrator and family doctor; vax administrator asked pt to come by the office.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper
Clinical narrative: Upper gastric abdominal pain. Pain intensity 9/10. Time course: 5 minutes.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received via Poison and Drug Center from a pharmacist refers to a female patient of unknown age. The patient's relevant medical history and past drug history were unknown. The pharmacist reported that on 01-JAN-2015, she administered an expired dose of M-M-R II subcutaneously at a dose of 0.5 ml "because she needed a 2nd dose a couple of months ahead of time for work" (expiry date: 01-AUG-2014; strength, frequency and lot# unspecified). It was unknown if the patient took any concomitant medications, neither if the patient had any relevant lab work performed. As of 01-JAN-2015, the patient would not continue on the M-M-R II vaccine and the outcome of receiving an expired vaccine was unknown. The pharmacist did not have a lot number or other information for the report as she did not have that information with her. The event occurred at the pharmacy. The address provided by the caller was her own home address and not for the pharmacy. She did not wish to provide the address for the pharmacy because she did not work there on a regular basis. The reporter considered the event as non-serious. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients was vaccinated with ROTATEQ, (strength, dose, frequency, route, anatomical location and lot number were not provided), which was improperly stored. Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site erythema, Injection site induration, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via representative refers to a female patient of unknown age. On 18-DEC-2014 the patient was vaccinated with ZOSTAVAX (lot # K000330, expiration date in March 2015) (dose and route unspecified) in the left arm. In December 2014 the patient experienced redness at the injection site on her left arm described as "it resembled a mosquito bite or a bug bite", she felt "hardness" and it was "welt" where the injection was given. The pharmacist stated the patient's back started to hurt after ZOSTAVAX vaccination. The patient had sought medical attention. No treatment was given. The events outcome was unknown. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Thi spontaneous report was received from a pharmacist refers to a 41 year old female patient. The patient's medical history included unspecified gastrointestinal (GI) issues. On 29-DEC-2014 the patient was vaccinated with PNEUMOVAX23 lot # K004148, expiry date 10-MAY-2015, 0.5 ml, subcutaneous in the left arm. Concomitant therapies included AMBIEN and probiotics (unspecified). On 29-DEC-2014, later in the evening the patient called the pharmacist and reported itching at the injection site (left arm). The pharmacist recommended that the patient take BENADRYL, for her symptoms. On 30-DEC-2014, the patient called the pharmacist again and reported that her injection site was swollen to the size of a soft ball with pain and redness present. The pharmacist recommended application of ice to the injection site. There were no lab diagnostic studies performed. The patient sought medical attention by calling the pharmacist. There was no product quality complaint involved. The outcome of injection site was swollen to the size of a soft ball with pain and redness present and itching at the injection site was reported as not recovered at the time of the report. The causality of the events was unknown. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a 72 year old male consumer referring on himself. Patient's medical history included penicillin allergy. On 26-DEC-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported), intramuscular. Concomitant therapies included DIOVAN. The patient called in to ask about pain he is having at the site of injection of the ZOSTAVAX vaccine which was administered intramuscular. The patient stated that he has been experiencing pain that is running from the left elbow that radiates toward the torso. He stated that this pain has not gone away since the administration of the vaccine on 26-DEC-2014. Patient didn't sought medical attention. The outcome of pain that is running form the left elbow that radiates toward the torso and pain he is having at the site of injection of ZOSTAVAX vaccine which was administered intramuscular was reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician's wife refers to a patient of unknown age. On 29-DEC-2014 the patient was inadvertently vaccinated with ZOSTAVAX, subcutaneous (lot # unknown) that had expired on 26-DEC-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No relevant medical history of the patient was reported. Approximately in July 2014, reproted as six months ago, the patient was vaccinated with ZOSTAVAX dose 1, 0.65 ml once, subcutaneous (lot number and expiry dates were not reported) (the patient received the second dose mix months after the first dose). No concomitant medications were reported. There were no adverse effect reported. There was no product quality complaint (PQC) reported. The outcome was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Pt states that a rash appeared the day after pt was given the PNEUMOVAX injection; pt had been treating a different rash prior to injxn and was not certain if injxn was cause of current rash.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Injection site rash, Pruritus, Rash, Swelling
Clinical narrative: Vaccinated Thursday 12-4-14-rash after shots ok Friday-Sat. rash and central swelling and itch. No fever, SOB, tenderness, pustules, N or V. Rash slowly expanded upper (R) th. office visit 12/8.
Sex: U
Vaccine: HEPA, IPV, TDAP, TYP
Symptoms: Pain in extremity, Swelling
Clinical narrative: Patent called at 3:00 pm on 12/29/14 with complaints of sore right arm and swelling. Advised to make an appt. with physician immediately.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient describes redness surrounding injection site in a 6 inch ring around site. No pain or itching; no other adverse effects at this time. No treatment applied. Reported Friday morning. Injection given Wed. (time unknown).
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site swelling, Pain, Pyrexia
Clinical narrative: Chills, fever, achy, swelling of arm site.
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a consumer refers to her daughter. On 02-OCT-2008 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # 659199/1541U, expiration dates 26-JUN-2009). On an unknown date the patient had unspecified levels drawn and the patient's levels showed that she developed low antibodies to PNEUMOVAX 23. The reporter reported that the patient had developed low antibodies to every vaccine (unspecified of which vaccines but the reporter did mention PREVNAR) she had received on unspecified dates due to an unspecified chronic medical condition that the patient was born with. The patient was going to be receiving immunoglobulin therapy on an unspecified date for the unspecified chronic medical condition that the patient was born with. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product packaging confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Nurse reported she administered VARIVAX (Merck) to a patient as directed (in approximately 2014), then she was supposed to administer M-M-R II. On 22-DEC-2014 nurse inadvertently administered PROQUAD (Merck) subcutaneously (dose and lot# were not reported) instead of the ordered dose of M-M-R II. Nurse stated the error occurred because the green color of the boxes of PROQUAD (Merck) and M-M-R II were similar. Nurse also reported she did not completely read the names on the product labels, specifically she did not notice the word "varicella" on the PROQUAD (Merck) box. No adverse effect reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient. On 11-DEC-2014 the patient was vaccinated with one dose of ZOSTAVAX (lot # K010732, exp 10-OCT-2015, 0.65 ml, subcutaneous). The patient had no drug reactions/allergies. On 12-DEC-2014, the patient experienced a red, warm, hard area at the site of injection. The patient sought medical attention via coming to pharmacy. The outcome of the events was reported as not recovered/not resolved. The relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On an unknown date the patient was received a booster dose of RECOMBIVAX HB (lot#, expiry date, dose, strength and route unspecified) after presumed exposure to hepatitis B virus from a razor blade cut. The patient with exposure had completed hepatitis B series (name and manufacturer of vaccine unspecified but RECOMBIVAX HB could not be ruled out) on unspecified date in the past. No adverse effects reported. No PQC involved. Additional information is not expected as contact with physician was not allowed.
Sex: F
Vaccine: VARCEL
Symptoms: Chest X-ray abnormal, Computerised tomogram thorax abnormal, Lung infiltration, Pulmonary fibrosis, Tuberculin test positive
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient's medical history included asthma and aneurysm in her head. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot#, exp and dose/frequency were unknown). Concomitant therapies included sitagliptin phosphate (manufacturer unknown), EXCEDRIN, DEPAKOTE, omeprazole, nortriptyline, amlodipine, calcium citrate, DULERA and fluconazole. On an unknown date the patient experienced a low varicella titer of "0.9". In May 2014, the patient had a Computed Axial Tomography (CAT) scan which showed "an old nodular infiltrate and scarring on her right lower lobe." On an unknown date, the patient had a positive "PPD" test (purified protein derivative test) and an X-ray was done in June 2014 which also showed "an old nodular infiltrate and scarring on her right lower lobe." The patient did not have an active case of tuberculosis ("TB"). The patient did not seek for medical attention. The outcome of adverse events was not recovered. No treatment was given for the adverse events. The relationship between the events and VARIVAX (Merck) was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient's medical history included asthma and aneurysm in her head. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot#, exp and dose/frequency were unknown). Concomitant therapies included sitagliptin phosphate (manufacturer unknown), EXCEDRIN, DEPAKOTE, omeprazole, nortriptyline, amlodipine, calcium citrate, DULERA and fluconazole. On an unknown date the patient experienced a low varicella titer of "0.9". In May 2014, the patient had a Computed Axial Tomography (CAT) scan which showed "an old nodular infiltrate and scarring on her right lower lobe." On an unknown date, the patient had a positive "PPD" test (purified protein derivative test) and an X-ray was done in June 2014 which also showed "an old nodular infiltrate and scarring on her right lower lobe." The patient did not have an active case of tuberculosis ("TB"). The patient did not seek for medical attention. The outcome of adverse events was not recovered. No treatment was given for the adverse events. The relationship between the events and VARIVAX (Merck) was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 05-DEC-2014 the patient was vaccinated with an expired dose of GARDASIL, 0.5 ml, intramuscular. (Dose number, lot# were not reported). Expiration date: 21-NOV-2014. Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 03DEC2014 from a certified medical assistant who reported that two patients (see MARRS # 1412USA001870 for second patient) received improperly stored RECOMBIVAX HB 10/1.0 mcrg/ml (lot # K011239 expiration 11JUN2016) which was exposed to 48 degrees Fahrenheit for 108 hours on 01DEC2014. No adverse effects were reported. No further information was provided. Additional information is expected.
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 02DEC2014 from a certified medical  assistant who reported that two patients (see MARRS #1501USA000647 for second patient) received improperly stored RECOMBIVAX HB 10/1/0 mcrg/ml (lot # K011239 expiration 11JUN2016) which was exposed to 48 degrees Fahrenheit for 108 hours on 01DEC2014. No adverse effects were reported. No further information was provided. Additional information is expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified number of patients of unknown age. It was reported that unspecified number of patients received improperly stored RECOMBIVAX HB, 2.5 microgram/0.5 milliliter, on an unspecified day. No adverse effects were reported. This is one of several reports. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: 11 x 6.5 cm erythema, warmth, mild edema, pruritus (R) deltoid. Tx with BENADRYL and KEFLEX for local reaction. Resolved on follow up on 1/2/15.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical laboratory assistant professional refers to a patient of unknown age and gender with unknown indication. On 10-DEC-2014 the patient was vaccinated with RECOMBIVAX HB 1 DF, intramuscular, lot number unknown. The medical laboratory assistant reported that on 10-DEC-2014, a patient inadvertently received a dose of RECOMBIVAX HB which expired on 17-SEP-2014 and there were no adverse event. The outcome of inadvertently received a dose of RECOMBIVAX HB which expired and no adverse event is not available. Action taken with the therapy drug were not reported. No additional information were provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patients with unknown age and sex. Since 02-OCT-2014 patients were vaccinated with VAQTA (lot#, route and dose unknown) which had been exposed to temperatures outside of the recommended range. No adverse experience had been reported. It was not specified if patients sought for medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patients with unknown age and sex. Since 02-OCT-2014 patients were vaccinated with oral, ROTATEQ (lot#, route and dose unknown) which had been exposed to temperatures outside of the recommended range. No adverse experience had been reported. It was not specified if patients sought for medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender and age. On 12-MAR-2014 the patient was administered her first dose of PNEUMOVAX 23 0.5 ml, intramuscular, and was inadvertently administered a second dose of PNEUMOVAX 23 on 19-DEC-2014. No adverse effects reported. Additional information is not expected because the nurse did not allow us to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to an unspecified number of patients of unknown ages and gender. On unknown dates the patients received 4th dose of GARDASIL (dosage, lot# and route unknown). No adverse effects were reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest pain, Dyspnoea, Hyperhidrosis, Palpitations
Clinical narrative: Case number PHHY2012US111095 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 465454) on 04 Dec 2012 with a follow up information received from the quality assurance department (QA reference number: 210168) on 30 May 2014. This case refers to 51-year-old female patient. The patient's medical history included asthma, diabetes and high blood pressure. Concomitant medications included enalapril and hydrocodone/APAP. The patient was vaccinated with FLUVIRIN (batch number: 1204701, expiry date: May 2013) intramuscularly in left arm on 12 Sep 2012. On 12 Sep 2012, approximately 10 minutes after the vaccination, the patient complained of heart palpitation, diaphoresis, chest pain and difficulty breathing. She had to sit down and try to relax. The emergency medical technician (EMT) arrived within 5-10 minutes after which the patient felt better. The EMT concluded that patient needed to be transported to the hospital. EMT also reported that patient had increased blood pressure. The outcome of the events was reported as condition unchanged as of 12 Sep 2012. The causality of the events was not reported. Upon follow up receipt from the quality assurance department (reference number: 210168), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 30 May 2014: Batch summary and expiry date updated.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia, Tachycardia
Clinical narrative: Case number PHHY2012US111206 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 465588) web site on 04 Dec 2012 with a follow up report received from the Quality Assurance department (QA reference number: 210158) on 30 May 2014: This report refers to a 59 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1204401, expiry date: 31 May 2013) intramuscularly on to left arm on 19 Sep 2012. On the same day within 15 to 30 minutes after vaccination, she reported tachycardia with a heart rate of 115 beats per minute, lightheadedness and numb and tingly feet. She was taken to the emergency room. Her oxygen saturation was 96 percent and there was no complains of dyspnea. Her blood pressure value was 157/76 and heart rate became 109 later. The outcome of the event was reported as condition unchanged. Based on the review performed, it was concluded that this batch of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 210158) on 30 May 2014. The expiry date, labeling and the batch review report were updated.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Induration, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2012US111221, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 466642) website on 04 Dec 2012 and a follow up received from Quality Assurance Department (QA, reference number: 210160) on 09 Jan 2014: This report refers to 66-years-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: 1203801) intramuscularly in the left arm and PNEUMOVAX (other manufacturer, batch number H010515) intramuscularly in the left arm on 06 Sep 2012. On 07 Sep 2012, she experienced arm very painful, felt nauseous, faint, diaphoretic, upper arm became hard and swollen. The outcome of the events was reported as condition unchanged as of 27 Sep 2012. The causality and seriousness of the events was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1203801) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 210160) on 09 Jan 2014:  Updated batch review report.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Syncope
Clinical narrative: Case number PHHY2012US111221, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 466642) website on 04 Dec 2012 and a follow up received from Quality Assurance Department (QA, reference number: 210160) on 09 Jan 2014: This report refers to 66-years-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: 1203801) intramuscularly in the left arm and PNEUMOVAX (other manufacturer, batch number H010515) intramuscularly in the left arm on 06 Sep 2012. On 07 Sep 2012, she experienced arm very painful, felt nauseous, faint, diaphoretic, upper arm became hard and swollen. The outcome of the events was reported as condition unchanged as of 27 Sep 2012. The causality and seriousness of the events was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1203801) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 210160) on 09 Jan 2014:  Updated batch review report.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Chest discomfort, Dyspnoea, Feeling abnormal, Immediate post-injection reaction, Influenza like illness
Clinical narrative: Case number PHHY2013US000714 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471009) website on 02 Jan 2013, and with a follow up report received from QA department (QA reference: 209037) on 14 May 2014. This report refers to a 67-year-old female patient. Her medical history included gingivitis and low grade fevers which were off and on for the past few years. She was vaccinated with FLUVIRIN (batch number: 1206201) intramuscularly in the right arm on 21 Oct 2012. The patient also received PNEUMOVAX (batch number: 1947AA, other manufacturer) intramuscularly on the right arm on the same date. On the same date, immediately after both the vaccinations the patient grabbed chest. She said it felt like air went out and felt funny like she cannot breathe. She grabbed EPI-PEN. The patient felt nauseous at that moment and after 17 mins her color and skin temperature returned. The patient seated and felt that the chest was tight and had no air. The patient followed up at 5:55 pm on the same date, she was at home and resting. The patient had 100 degrees fever and arm swollen. Patient said honestly that she felt as though she had flu with temp of 100. Patient called the MD who told her that this was not serious and not to be worried. The seriousness, outcome and causality of the events were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1206201 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department (QA reference: 209037) on 14 May 2014. Batch review report updated.