chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to patients of unknown age and gender. Concurrent or historical condition was not provided. On an unknown date the unspecified number of unspecified patients were administered improperly stored dose of ROTATEQ (lot # L008054 with expired date of 30-NOV-2016, strength, dose and frequency unknown) orally. Concomitant therapy was not provided. The vaccine was stored under 33.4F for 41 minutes. Previous temperature excursion included 73F for 1 hour 29 minutes, 34.1F for 2 hours 3 minutes and 34.3F for 1 hour 29 minutes. Data logger was involved. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to a patients of unknown demographics. The patients pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were administered with unidentified Merck human papillomavirus (HPV) vaccine, intramuscular (name, dosage information and lot number not provided). It was reported that, some patients received unspecified vaccines concomitantly. On 28-JUN-2016, the nurse reported that patients passed out after the vaccination with GARDASIL (not specifically specified if the product was GARDASIL 9), however company representative explained that practice only carries GARDASIL 9. The outcome of event was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site swelling, Pain, Skin tightness
Clinical narrative: (L) upper arm localized swelling - tightness - pain.  Shot was not given in the deltoid (visible shot mark close to shoulder).
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash
Clinical narrative: Rash two days after vaccines. Observed in creases of elbows and knees. No fever.
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a female patient who received BEXSERO (batch number 151401, expiry date 30th December 2016). On 15th June 2016, the patient received the 1st dose of BEXSERO. On 17th June 2016, 2 days after receiving BEXSERO, the patient experienced injection site swelling, injection site induration and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site induration and injection site warmth were unknown. It was unknown if the reporter considered the injection site swelling, injection site induration and injection site warmth to be related to BEXSERO. Additional details were provided as follows: This case was reported by a medical assistant. The age at vaccination was not reported. The patient experienced swelling, hotness and induration (hardness) at the injection site. The sales representative called to report this adverse event and his call was solely to report the adverse event. The sales representative stated that, the healthcare professional did not need to be contacted, as she did not have any medical information questions.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 12 month old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 28-JUN-2016, the patient was vaccinated with a dose of PROQUAD and a dose of VARIVAX (overdose). The lot #, expiry date, dose, frequency and route was not reported for the two vaccines. No adverse effects were reported. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Patient described it as muscle aches starting in opposite arm (left arm) as injection arm (right arm) and all over muscle aches. Vaccine was given in 11/2015 and she still has problem with left arm. Can't raise it all the way.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Decreased appetite, Malaise, Skin burning sensation
Clinical narrative: No appetite, left side of face burning up, bruised right arm, no fever. Pt got vaccine on 6/22/16. Pt felt symptoms on 6/25/16. Pt feels sick.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a 14 year old female patient. No medical history and no concurrent conditions were reported. On 04-MAY-2016, the patient was exposed during pregnancy to VARIVAX, GARDASIL, VAQTA injection and MENACTRA (lot number, expiration date, dosage and route of administration were not provided for all vaccines). No concomitant therapies were reported. At the time of vaccine administration, the physician did not known that the patient was pregnant and was not aware of it until the patient's mother called the office after vaccines were given. The patient's pregnancy information was reported as "5 months pregnant", therefore the last menstrual period (LMP) was estimated as approximately January 2016, however, gestation has not been confirmed by a physician yet. Additionally, delivery date has been estimated as October 2016, therefore the pregnancy outcome was pending. No adverse event was reported. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema multiforme, Rash, Rash vesicular, Skin lesion
Clinical narrative: 43 yo developed exanthem with onset 12 days after vaccine receipt; seen in ER day 14 (IHB contacted by CDC): Initially papular with appearance consistent with nonviral pustulosis, day 15 progressed to significant vesicular lesions on erythematous base, discrete lesions coalescing then progressed to impetiginous honey crusted, more vesicular lesions, with several larger bullous lesions and erythematous patches. Appearance was not consistent with nonviral pustulosis, benign acral papulovesicular eruption, Autoinoculation or generalized vaccinia. Sites included both axilla, adjacent to inoculation site, low back and R abdomen across belt line and hip. Differential diagnosis includes atypical form of erythema multiforme minor (no mucosal lesions), id reaction (auto-and eczematization) or some other Immune-mediated dermatoses related to his recent vaccination. Reviewed with derm and treated as Immune mediated dermatosis with secondary infection with doxycycline, ibuprofen and cetirizine: improvement at day 17, but still significant dermatitis. Treated then with prednisone 40 x5 days. Now on day 26, most lesions fully resolved except mild residual to his back. Symptoms: Rash, oth nonspecific skin eruption.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Injection 6/28 pm. (L) arm subsequently swelled/red. No constitutional signs reported. Pt declined consultation in office. Got PREVNAR in 2015.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 87 year old female patient with hypertension, COPD and arthritis. The patient's medical history included drug reactions or allergies to ZYBAN and Sulfa. On 20-SEP-2008, the patient was vaccinated with ZOSTAVAX injection, 1 shot, subcutaneously (exact dose, dose number, anatomical location, lot # and expiration date were not provided). Concomitant therapies included benzonatate, carvedilol, DETROL, gabapentin, lorazepam, losartan potassium (manufacturer unknown), metaxalone, simvastatin (manufacturer unknown), NAMENDA and carbidopa (reported as "carbodopa"). On 01-JUN-2015, the patient was diagnosed with an outbreak of shingles and later in the same month she was also diagnosed with postherpetic neuralgia. She was given LIDODERM patches to use for 12 hours a day, as a treatment. The outcome of the events was reported as recovered/resolved, on unknown dates. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On an unknown date (reported as "several days ago") the patient received ZOSTAVAX (strength, dose, frequency, Lot # and route unknown). Concomitant therapy was not provided. The patient was now beginning prednisone therapy (20mg daily for 5 days) for an unspecified reason. The outcome of adverse event was unknown. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Chills, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a male patient who received BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced vomiting, tingling, chills and fever. On an unknown date, the outcome of the vomiting, tingling, chills and fever were not recovered/not resolved. It was unknown if the reporter considered the vomiting, tingling, chills and fever to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, she would be able to obtain information related to vaccination dates, lot numbers and expiration dates at a later time, but she wanted to talk to a medical information scientist urgently, as the patient was actively experiencing symptoms at the time of the call. This case has been linked with US2016088237 reported by the same reporter for the same patient.
Sex: F
Vaccine: HPV9
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: Information has been received from a pharmacist via a company representative concerning a female young teenager (age not specified). Information regarding concurrent condition, medical history and concomitant therapy was not reported. The reporter stated she heard from an unspecified healthcare provider that the patient received the first dose of an unspecified HPV vaccine (manufacturer unknown, dose and route not reported) on an unknown date. Then on an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS). The pharmacist was not sure but she thought the HPV vaccine that the patient had received was GARDASIL 9. It was also unknown if the patient had received any further doses of the HPV vaccine. The outcome of postural orthostatic tachycardia syndrome was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date the patient was administered M-M-R II (dose, frequency and lot number were unknown) intramuscularly. No adverse effect was reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPVX
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report has been received from the patient's husband concerning this 31 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was supposed to get "Tdap" but received unidentified Merck HPV vaccine (name and lot number not provided, one shot, once, route reported as one vaccine shot) instead (wrong drug administered). The reporter was unsure if she received vaccinated with GARDASIL or GARDASIL 9. The patient had not experienced any adverse effect from the vaccination. The patient became pregnant with last menstrual period (LMP) of 18-NOV-2015 and estimated delivery date (EDD) of 24-AUG-2016. At this time of reporting, the outcome of pregnancy was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV9, MEN, MENB, TDAP
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a 15 to 16 year old male patient. The patient's pertinent medical history and drug reactions of allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 INJ 1 dose (also reported as first shot) (dose number and lot number unknown) intramuscularly. Concomitant therapies included TRUMENBA, DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE) (TDAP) MCV4. On an unknown date, the patient was feeling woozy, like he was about to faint but did not faint. The patient sought medical attention- the doctor let patient sit and wait until the feeling subsided. No treatment was given for the event. The outcome of the event was considered as recovering/resolving. Causality assessment was not provided by the reporter. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple, unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (strength, frequency and route not reported, lot # was reported as L048466 with expiration date 02-DEC-2017). The vaccines were exposed to 2.4 degree Celsius for 20 hours. There was no previous temperature excursion. The temperature was back in range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple, unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II (strength, frequency and route not reported, lot # L032044 with expiration date 24-AUG-2017). The vaccines were exposed to 11.7 degree Celsius for 84 minutes. There was no previous temperature excursion. The temperature was back in range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple, unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (strength, frequency and route not reported, lot # L040458 and Expiration date 04-FEB-2018, another lot # was reported as M009377 with expiration date 17-JUN-2017). The vaccines were exposed to 11.7 degree Celsius for 84 minutes. There was no previous temperature excursion. The temperature was back in range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 month old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was inadvertently administered a dose GARDASIL 9 intramuscularly, lot # L024993, expiration date 17-OCT-2017 (dose  was not reported). It was confirmed by medical assistant that this was not due to product confusion. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-APR-2016, the patient was vaccinated with a dose of improperly stored VAQTA 25 U/0.5 ml, lot # L004743 with expiration date: 01-JUN-2017, via intramuscular route (dose was not reported). Administered dose of VAQTA underwent temperature excursion at 31.1 Fahrenheit degrees, for 82 hours. There was no previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. 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 healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were  not reported. On 12-APR-2016, the patient was vaccinated with improperly stored VAQTA 250U/0.5 ml, lot # L004743 with expiration date: 01-JUN-2017, via intramuscular route (dose not reported).  Administered dose of VAQTA underwent temperature excursion at 31.1 Fahrenheit degrees, for 82 hours. There was no previous temperature excursion. There was no adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse referring to a 69 year old female patient. The patient's concurrent conditions included seasonal allergy, chronic obstructive pulmonary disease, hypertension, hyperlipidaemia, osteoporosis and allergic to codeine. On 14-MAY-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L048680, expiration date June 2017, intramuscular in the right deltoid, dose unknown). Concomitant therapies included amlodipine, atorvastatin, citalopram, hydralazine, hydrochlorothiazide (+) losartan potassium, metoprolol, pantoprazole and budesonide (+) SYMBICORT. On 14-MAY-2016, the patient experienced an injection site reaction. Upon assessing the reaction in office on 15-MAY-2016, the site was red, swollen and painful. The physician suggested cool compresses, topical cortisone, BENADRYL as well as ALEVE for the pain. The events outcome was reported as not resolved. The reporter did not provide the causality. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of pediatric patients of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patients were administered with GARDASIL 9 (Lot# L026602, Expiration date 19-OCT-2017, therapy type rHA, dose, route and frequency not reported). The vaccine was undergoing a possible (but not verifiable) second temperature excursion at 30.8 degree Fahrenheit for 15 hours. It was noted that the reading of "30.8" was based on a handwritten record that was not clear. It was strongly believed by the reporter that the vaccines instead remained in range at 38.8 degree Fahrenheit and that the reading "30.8" was based on a clerical error (handwriting legibility issue). The vaccines involved previously underwent an excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Redness, rash, fever.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: Patient injected with 5ml of anthrax vaccine.  10x normal dose (.05ml).  Patient experiencing significant pain at injection site.  Continuing to monitor.
Age: 0.17
Sex: F
Vaccine: DTPIHI, IPV, RVX
Symptoms: Crying, Headache, Pyrexia, Seizure, Unresponsive to stimuli
Clinical narrative: Vomiting, fever, high pitched cry for hours, headache, seizures 3 days later, unresponsiveness.
Age: 0.17
Sex: F
Vaccine: DTPIHI, IPV, RVX
Symptoms: Vomiting
Clinical narrative: Vomiting, fever, high pitched cry for hours, headache, seizures 3 days later, unresponsiveness.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection on left bicep Was slightly itchy with minimal redness through 07/01/2016 Took off pajama shirt at 11:30 AM 07/02/2016 to reveal appearance Swelling dark red warm to touch size of his entire bicep Itchy, highly bothersome prescribed OTC Benadryl and a prescription. He was given a total of 6 injections in one day in the 2 in each bicep and one in the thigh. One was chicken pox.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient stated arm had small red itchy area day of injection. Today, 9 days later most of outer upper arm reddened and a little itchy.
Age: 30.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Neck pain, Paranasal sinus discomfort, Rash, Spinal pain
Clinical narrative: Bad neck and lower spine pain, headache, and sinus pressure. No symptoms prior to the 29th. No redness or rash at the injection site but from elbow to wrist on arm used for the injection patient has a rash similar to a heat rash.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash and swelling around bicep of left arm.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Back pain, Injection site bruising, Injection site pain, Musculoskeletal pain
Clinical narrative: Pain & bruising at injection site. Pain in both shoulders, neck, hips & low back. Still painful as of 07/02/2016.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Neck pain
Clinical narrative: Pain & bruising at injection site. Pain in both shoulders, neck, hips & low back. Still painful as of 07/02/2016.
Age: 55.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Axillary pain, Injection site induration, Injection site warmth, Nodule
Clinical narrative: Pt came in and showed me a large knot/mass under her arm-- the arm in which the vaccine was administered. Immunization site was warm to the touch and hard. Pt stated that knot under her arm was painful.
Age: 50.0
Sex: F
Vaccine: TYP
Symptoms: Arthralgia, Headache, Influenza like illness, Joint range of motion decreased, Joint swelling
Clinical narrative: It began with Joint pain, headache, body aches, nausea, swollen lymphnodes/glands. Later that day, joints severely swollen. Knees swollen so badly, can't bend them, hands swell up intermittently. Headaches continue. The swelling goes down in about ten days. Flu like symptoms, body aches, mild fever, nausea continues for at least three weeks. My glands are still swollen, hands and knees swell up intermittently, still experiencing some headaches and nausea.
Age: 50.0
Sex: F
Vaccine: TYP
Symptoms: Lymphadenopathy, Nausea, Pain, Peripheral swelling, Pyrexia
Clinical narrative: It began with Joint pain, headache, body aches, nausea, swollen lymphnodes/glands. Later that day, joints severely swollen. Knees swollen so badly, can't bend them, hands swell up intermittently. Headaches continue. The swelling goes down in about ten days. Flu like symptoms, body aches, mild fever, nausea continues for at least three weeks. My glands are still swollen, hands and knees swell up intermittently, still experiencing some headaches and nausea.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Activities of daily living impaired, Asthenia, Cardiopulmonary exercise test abnormal, Chronic fatigue syndrome, Cystitis interstitial
Clinical narrative: My entire body felt heavy, like lead filled my body and it was difficult to lift my arms and legs. My legs were so heavy and I was so weak so I had to crawl and there is an aching from my bones out similar to what one experiences with the flu that has left me suicidal in order to escape the pain! It is managed with narcotics now, but I remain at all times. I had a sore throat that has not gone away in the past six years. My white blood cell count was down at 2 to 3 verses normal 5 to 12. I remain unable to process information or recall things from my short-term memory, I could not watch a television show, read or do math. I was incapable of any complex activities like paying bills or filling my pillbox and had no strength to even get up and do my own toileting and hygiene. I had photophobia and difficulty regulating my body temperature with my hands and feet becoming extremely cold and purplish colored intermittently. I developed interstitial cystitis. My doctor later told me I had post viral syndrome also known as chronic fatigue syndrome and to remain hopeful but as the years passed she explained some people never get well.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Discomfort, Gait disturbance, Influenza like illness, Limb discomfort, Malaise
Clinical narrative: My entire body felt heavy, like lead filled my body and it was difficult to lift my arms and legs. My legs were so heavy and I was so weak so I had to crawl and there is an aching from my bones out similar to what one experiences with the flu that has left me suicidal in order to escape the pain! It is managed with narcotics now, but I remain at all times. I had a sore throat that has not gone away in the past six years. My white blood cell count was down at 2 to 3 verses normal 5 to 12. I remain unable to process information or recall things from my short-term memory, I could not watch a television show, read or do math. I was incapable of any complex activities like paying bills or filling my pillbox and had no strength to even get up and do my own toileting and hygiene. I had photophobia and difficulty regulating my body temperature with my hands and feet becoming extremely cold and purplish colored intermittently. I developed interstitial cystitis. My doctor later told me I had post viral syndrome also known as chronic fatigue syndrome and to remain hopeful but as the years passed she explained some people never get well.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Memory impairment, Mental impairment, Mobility decreased, Oropharyngeal pain, Peripheral coldness
Clinical narrative: My entire body felt heavy, like lead filled my body and it was difficult to lift my arms and legs. My legs were so heavy and I was so weak so I had to crawl and there is an aching from my bones out similar to what one experiences with the flu that has left me suicidal in order to escape the pain! It is managed with narcotics now, but I remain at all times. I had a sore throat that has not gone away in the past six years. My white blood cell count was down at 2 to 3 verses normal 5 to 12. I remain unable to process information or recall things from my short-term memory, I could not watch a television show, read or do math. I was incapable of any complex activities like paying bills or filling my pillbox and had no strength to even get up and do my own toileting and hygiene. I had photophobia and difficulty regulating my body temperature with my hands and feet becoming extremely cold and purplish colored intermittently. I developed interstitial cystitis. My doctor later told me I had post viral syndrome also known as chronic fatigue syndrome and to remain hopeful but as the years passed she explained some people never get well.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Photophobia, Post viral fatigue syndrome, Skin discolouration, Suicidal ideation, Temperature regulation disorder
Clinical narrative: My entire body felt heavy, like lead filled my body and it was difficult to lift my arms and legs. My legs were so heavy and I was so weak so I had to crawl and there is an aching from my bones out similar to what one experiences with the flu that has left me suicidal in order to escape the pain! It is managed with narcotics now, but I remain at all times. I had a sore throat that has not gone away in the past six years. My white blood cell count was down at 2 to 3 verses normal 5 to 12. I remain unable to process information or recall things from my short-term memory, I could not watch a television show, read or do math. I was incapable of any complex activities like paying bills or filling my pillbox and had no strength to even get up and do my own toileting and hygiene. I had photophobia and difficulty regulating my body temperature with my hands and feet becoming extremely cold and purplish colored intermittently. I developed interstitial cystitis. My doctor later told me I had post viral syndrome also known as chronic fatigue syndrome and to remain hopeful but as the years passed she explained some people never get well.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: White blood cell count decreased
Clinical narrative: My entire body felt heavy, like lead filled my body and it was difficult to lift my arms and legs. My legs were so heavy and I was so weak so I had to crawl and there is an aching from my bones out similar to what one experiences with the flu that has left me suicidal in order to escape the pain! It is managed with narcotics now, but I remain at all times. I had a sore throat that has not gone away in the past six years. My white blood cell count was down at 2 to 3 verses normal 5 to 12. I remain unable to process information or recall things from my short-term memory, I could not watch a television show, read or do math. I was incapable of any complex activities like paying bills or filling my pillbox and had no strength to even get up and do my own toileting and hygiene. I had photophobia and difficulty regulating my body temperature with my hands and feet becoming extremely cold and purplish colored intermittently. I developed interstitial cystitis. My doctor later told me I had post viral syndrome also known as chronic fatigue syndrome and to remain hopeful but as the years passed she explained some people never get well.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash erythematous
Clinical narrative: 2 weeks after receiving shingles vaccine, patient broke out in red rash on chest that progressively became worse (large, red, raised areas all across chest. The dermatologists determined patient had had an allergic reaction to shingles vaccine based on presentation and prescribed patient a prednisone. Patient still using prednisone taper started taper on 6/28/16.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea with severe abd pain.
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Patient's left arm was red and showed some signs of swelling with redness extending on forearm for several inches.
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's left arm was red and showed some signs of swelling with redness extending on forearm for several inches.
Age: 50.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity
Clinical narrative: I received a Tdap vaccine on 6/23/2016.  I needed to show proof of vaccine for admission to school and had not received a tetanus shot in several years. The day after the shot my upper left arm ached, which I expected and day two I noticed the pain was a bit worse. By day three the pain was noticeably worse and then by that night I awoke to severe pain and could not lay on my left side. I realized something might be up with vaccine because I had not done anything physical to injure myself.  From that day to present, I cannot reach across my body from left to right without shooting pains. I cannot reach above my head without same pains, I cannot remove a shirt over my head at all. I continue to ache inside my shoulder and my shoulder near where the injection was is very sore to the touch.  When I lean on my elbow, sharp pain radiates back up my arm into my shoulder and down to my hand. I contacted my dr this past Friday late afternoon and he said to talk to the pharmacy which gave me the shot and to come in and see him if my pain doesn't improve.  The pharmacists were concerned and I explained all of my pains, but said that perhaps a nerve was hit and that I should try and get pain meds and wait it out. The pharmacy I believe made a VAERS report as well. I don't understand why this happening to me and I just hope the pain goes away, but it doesn't seem right that 10 days post shot that my pain continued to ge worse to where it is today.
Age: 50.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: I received a Tdap vaccine on 6/23/2016.  I needed to show proof of vaccine for admission to school and had not received a tetanus shot in several years. The day after the shot my upper left arm ached, which I expected and day two I noticed the pain was a bit worse. By day three the pain was noticeably worse and then by that night I awoke to severe pain and could not lay on my left side. I realized something might be up with vaccine because I had not done anything physical to injure myself.  From that day to present, I cannot reach across my body from left to right without shooting pains. I cannot reach above my head without same pains, I cannot remove a shirt over my head at all. I continue to ache inside my shoulder and my shoulder near where the injection was is very sore to the touch.  When I lean on my elbow, sharp pain radiates back up my arm into my shoulder and down to my hand. I contacted my dr this past Friday late afternoon and he said to talk to the pharmacy which gave me the shot and to come in and see him if my pain doesn't improve.  The pharmacists were concerned and I explained all of my pains, but said that perhaps a nerve was hit and that I should try and get pain meds and wait it out. The pharmacy I believe made a VAERS report as well. I don't understand why this happening to me and I just hope the pain goes away, but it doesn't seem right that 10 days post shot that my pain continued to ge worse to where it is today.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site pain, Malaise, Pyrexia, Rash, Urinary incontinence
Clinical narrative: Fever, malaise, pain at injection site, vomiting, rash on face. Loss of urinary continence.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Vomiting
Clinical narrative: Fever, malaise, pain at injection site, vomiting, rash on face. Loss of urinary continence.
Age: 0.7
Sex: M
Vaccine: PNC13
Symptoms: Crying, Hypophagia, Insomnia, Lethargy, Pyrexia
Clinical narrative: Vomiting, lethargy, high fever for 2 days. Inconsolable crying, refusal to eat, weight loss, difficulty sleeping for following 2 weeks.
Age: 0.7
Sex: M
Vaccine: PNC13
Symptoms: Vomiting, Weight decreased
Clinical narrative: Vomiting, lethargy, high fever for 2 days. Inconsolable crying, refusal to eat, weight loss, difficulty sleeping for following 2 weeks.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 28 hours after injected with Shingles Vaccine, red swollen area 2"x2" noticed at injection site. Area tender and warm to touch. In next 24 hours, area grew to 7"x6" with more swelling, redness, hot to touch, requiring ice packs, antihistamines and antibiotics.
Age: 27.0
Sex: M
Vaccine: TD
Symptoms: Decreased appetite, Dizziness, Dysphagia, Dyspnoea, Fatigue
Clinical narrative: Fatigue, pain in finger tips and feet, tingling in left hand and both feet, dizziness, shortness of breath, neausea, loss of appetite, difficulty swallowing, headache. I can't report outcomes because it's still ongoing.
Age: 27.0
Sex: M
Vaccine: TD
Symptoms: Headache, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Fatigue, pain in finger tips and feet, tingling in left hand and both feet, dizziness, shortness of breath, neausea, loss of appetite, difficulty swallowing, headache. I can't report outcomes because it's still ongoing.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Fever up to 101.4 measured in urgent care office. Lymphadenopathy in the neck was also noted.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site reaction
Clinical narrative: Patient rec'd vaccine 6/28/16 and developed injection site reaction that covered from injection down to her elbow and was about 4 inches wide. Patient took pain medications, iced and elevated arm to relieve the pain and inflammation.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: 6 days s/p vaccine to (R) deltoid - 6 cm by 6 cm erythema and warmth, localized to vaccine injection site w/ subsequent satellite lesion just medial to vaccine localized reaction - 2 cm by 4 cm. Pt started on KEFLEX for concern of concurrent cellulitis w/ associated anterior axillary lymph node erythema. Pt otherwise well appearing.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Lymphadenopathy, Vaccination complication
Clinical narrative: 6 days s/p vaccine to (R) deltoid - 6 cm by 6 cm erythema and warmth, localized to vaccine injection site w/ subsequent satellite lesion just medial to vaccine localized reaction - 2 cm by 4 cm. Pt started on KEFLEX for concern of concurrent cellulitis w/ associated anterior axillary lymph node erythema. Pt otherwise well appearing.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient came in the pharmacy said he has numbness/tingling in his arm. He did not specify how soon it started but it is ongoing.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chest discomfort, Erythema, Headache, Injection site erythema
Clinical narrative: Hot, red injection site measuring 1.5 x 3 inches. Prickly itchy feeling on torso, head and arms. Woke up to a larger area of redness and headache and achy joints.  As the next day progressed the redness increased to 3" x 5" and chest felt tight.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Paraesthesia, Pruritus
Clinical narrative: Hot, red injection site measuring 1.5 x 3 inches. Prickly itchy feeling on torso, head and arms. Woke up to a larger area of redness and headache and achy joints.  As the next day progressed the redness increased to 3" x 5" and chest felt tight.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: CUSTOMER STATES THAT THE ARM FEELS NUMB OR "ASLEEP". THIS HAPPENED A FEW WEEKS AGO BUT DID NOT KNOW HOW THE SHOT AFFECTED HER ARM.
Age: 28.0
Sex: M
Vaccine: DTAP
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site induration, Injection site swelling, Pain
Clinical narrative: Immediate swelling at injection site. Soreness and swelling for 2 days after. 4 days later and there is a large bruise around injection site and even larger area around that is hard and swollen.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site began early morning of 07/03/16 and is continually worsening. Currently 2 inches by 3 inches large. Painful at the site.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Discomfort, Erythema, Hyperaesthesia, Pain
Clinical narrative: Initial soreness then development of two 2-3 inch red areas below injection site. Subsequent joint pain in ensuing days, severe hives in response to scratching red areas on6/20/16. Treated with benadryl gel and took benadryl, subsided over night. Red areas remained for about 10 days. Developed acute pain in knee/leg that seemed to be triggered by initial joint pain. Largely disappeared by July 1. Note that discomfort, soreness became cyclical on a diurnal basis. Disappeared at night, increased upon rising and then decreased in evening.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: Initial soreness then development of two 2-3 inch red areas below injection site. Subsequent joint pain in ensuing days, severe hives in response to scratching red areas on6/20/16. Treated with benadryl gel and took benadryl, subsided over night. Red areas remained for about 10 days. Developed acute pain in knee/leg that seemed to be triggered by initial joint pain. Largely disappeared by July 1. Note that discomfort, soreness became cyclical on a diurnal basis. Disappeared at night, increased upon rising and then decreased in evening.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, lot #, expiration date were not reported). On the same day after returning home, the patient passed out in the bathroom. The outcome of the event and the relatedness between the event and GARDASIL 9 were not reported. Upon internal review the event of "passed out" was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (lot #, dose, and route were not provided). On unknown dates, the patients passed out after administration of GARDASIL 9. The outcome of the event was unknown. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of "passing out" was considered to be medically significant. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Adverse event, Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Information has been received from a nurse practitioner referring to a 24 year old female patient. The patient had no concurrent or historical condition. The patient intramuscularly received the first and second doses of GARDASIL 9 (strength, dose, lot number and expire date unknown) on 04-MAY-2016 and 16-JUN-2016, respectively. Concomitant therapy included XULANE. On 16-JUN-2016, the patient experienced an adverse event while on GARDASIL 9 therapy. Prior to receiving the second dosage, she was given a urine test to ascertain pregnancy, and after receiving the vaccine, then it was discovered that she was pregnant. The last menstrual period (LMP) and estimated due date (EDD) were not provided. The outcome of events was unknown. The causality was not provided. Additional information has been requested.
Age: 30.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received from a nurse referring to a 30 years old patient of unknown gender. The patient received both first and second doses of GARDASIL (dose, route, lot # and expiration date unspecified) in 2006 (at 21 years old). On 08-JUN-2015 the patient received the third dose in series of GARDASIL (lot # K010574, expired on 08-APR-2017), 0.5 ml intramuscularly at 30 years of age. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 17-JUN-2016, the patient was inadvertently vaccinated subcutaneously with one dose of M-M-R II (lot # K024824 and expiration date 02-DEC-2016, albumin status therapy type was not reported) that went through a temperature excursion. The nurse reported that there were no adverse effects from the administered product. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a female physician of unknown age (who also was the patient) via a field representative referring to herself. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient's sister was vaccinated with ZOSTAVAX (dose, route and lot# were not reported. The patient's concomitant therapy included prednisone (manufacturer unknown). On an unspecified date, after her sister received ZOSTAVAX, the patient was in the car with her sister "for a couple hours", the patient developed shingles (secondary transmission), which was diagnosed by herself. The patient's sister did not develop shingles after receiving ZOSTAVAX. Unspecified treatment was given for the adverse event. The outcome of the event was reported as recovering. The causality assessment between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 13-JUN-2016, 0.65 ml of improperly stored ZOSTAVAX (lot # M001746, expiration date 07-APR-2017, subcutaneous) was administered. No adverse effects were noted. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 67 year old female patient via company representative refers herself. In 2009 the patient was vaccinated with an unspecified dose of ZOSTAVAX (route, lot number not reported). On an unspecified date of 2016, the patient had a mild case of shingles. The patient did not seek medical attention. No treatment was given for the event. At time of this reporting, the patient was recovered from the shingles. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 03-JUN-2016, the patient was vaccinated with improperly stored ROTATEQ (dose and frequency were not reported). The reporter did not know which dose from which lot was administered to the patient and the possible ROTATEQ lot# administered was: lot # L029618 (expiry date: 20-MAY-2017), L038534 (expiry date: 19-AUG-2017) and/or M004508 (expiry date: 29-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the two reports from the same reporter. Additional information has been requested.