chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Urticaria, Vomiting
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of hives in a female patient who received Influenza vaccine Quadrivalent unspecified. The patient's past medical history included hernia repair, nasal septum deviation, tonsillectomy, vaginal reconstruction, endometriosis and scar. Concurrent medical conditions included asthma, tendon disorder (congenitally loose tendons or joints or ligaments), post-traumatic stress disorder, bipolar disorder, major depression (with psychotic features), fibromyalgia, hypothyroidism, migraine, irritable bowel syndrome, irregular menstrual cycle (bleeding issues), ichthyosis vulgaris, fatty liver, nearsighted, hearing loss, metabolic disorder, obsessive-compulsive disorder, anemia, premenstrual dysphoric disorder, mood disorder NOS, nausea, vitamin B12 decreased, sleep apnea, brain disorder NOS, neuropathy, tooth impacted, meniscus tear, arthritis, blood potassium decreased, drug allergy (Baclofen, Etodolac, Aspirin, Generic ZYPREXA), food allergy (mushrooms, fresh milk products, sweeteners, shellfish or fish, vegetables or fruits, a lot of processed foods), allergy to molds (Mildew), pollen allergy, allergy to chemicals (Perfumes, Orange or Citrus Scents, most smelly chemicals) and insect bite allergy. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine Quadrivalent unspecified, the patient experienced hives, diarrhea and vomiting. On an unknown date, the outcome of the hives, diarrhea and vomiting were unknown. It was unknown if the reporter considered the hives, diarrhea and vomiting to be related to Influenza vaccine Quadrivalent unspecified. Additional details were provided as follows: The age at vaccination was not reported. This case has been linked with case US2016GSK005647, reported by the same reporter for same patient.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Altered state of consciousness, Blindness, Deafness, Dizziness
Clinical narrative: Patient says she couldn't see or hear, then felt faint and laid herself to the ground because she felt like she was going to pass out.  I called and checked on her about 45 minutes after the immunization was administered and she said she was feeling good.
Age: 28.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Chills, Confusional state, Headache, Joint range of motion decreased, Mobility decreased
Clinical narrative: Body aches, chills, fever, headache at base of neck, confusion lasting for 4 days. Unable to move arm for 5 days, extreme pain, lost full ROM.
Age: 28.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches, chills, fever, headache at base of neck, confusion lasting for 4 days. Unable to move arm for 5 days, extreme pain, lost full ROM.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Patient became weak, fatigued, softball size red area and golf ball size hard knot/swelling at injection site, inj site hot to touch, and fever for several days after injection. On 3/8/2017 pt still has hard knot at injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Patient became weak, fatigued, softball size red area and golf ball size hard knot/swelling at injection site, inj site hot to touch, and fever for several days after injection. On 3/8/2017 pt still has hard knot at injection site.
Age: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None known.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left thigh had pain, redness and swelling from PREVNAR injection (#4). Also running low grade temp and non weight bearing per mother.  Mother took patient to ED where a dx of cellulitis was given along with abx treatment. S/SX cleared within 3 doses per mother and 10 course was completed.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Weight bearing difficulty
Clinical narrative: Left thigh had pain, redness and swelling from PREVNAR injection (#4). Also running low grade temp and non weight bearing per mother.  Mother took patient to ED where a dx of cellulitis was given along with abx treatment. S/SX cleared within 3 doses per mother and 10 course was completed.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Fever and SOB.
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Swelling face, Urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of generalized urticaria in a 19-month-old female patient who received HARVIX. Co-suspect products included INFANRIX, PEDVAXHIB and PREVNAR. On 6th February 2017, the patient received HAVRIX, INFANRIX, PEDVAXHIB and PREVNAR. On 7th February 2017, 1 days after receiving HAVRIX, INFANRIX and PREVNAR, the patient experienced generalized urticaria. On 8th February 2017, the patient experienced facial swelling. The patient was treated with MOTRIN, BENADRYL, DECADRON, dexamethasone and prednisone. On an unknown date, the outcome of the generalized urticaria and facial swelling were unknown. The reporter considered the generalized urticaria and facial swelling to be probably related to HARVIX and INFANRIX. Additional details were provided as follows: This case was previously reported to manufacturer. The reporter, pharmacy operations manager, stated that the patient received all four of the vaccines at the same time. The next day, the patient broke out into hives. On 7th February 2017, the patient had hives all over the body and on the head. He was taken to the emergency room and was treated with MOTRIN, BENADRYL, DECADRON and prednisolone and was released. On 8th February 2017, 2 days after receiving HARVIX, the patient had hives again as well as swelling in the face and hence was taken back to the emergency room and was treated with BENADRYL and dexamethasone. The patient was improving once again with treatment. The patient did not have a fever and was discharged. Before the patient left the emergency room, she was able to eat and drink.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Viral test positive
Clinical narrative: Shingles diagnosed 3/3/17 at urgent care on right shoulder. Doxycycline 100 mg 1x/day and Valacyclovir HCL 1 gm 3x/1day prescribed.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness extending from injection site down to elbow.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, drug reactions or allergies or concomitant medications were not reported. On an unspecified date, the patient may have been vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, frequency and route were not reported) lot # M022077 with expiration date of 10-MAR-2019, for prophylaxis. No adverse effects were reported. The temperature excursion of the RECOMBIVAX HB was between 32 F and 36 F, for a time frame of 72 hours. No previous temperature incursion was reported and no data logger was involved. No product quality complaint was involved (PQC).  This is one of several reports received from the same reporter.   Additional information has been requested.; Sender's Comments:  US-009507513-1702USA010330: US-009507513-1702USA010334:
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Information was received from a physician via a company representative concerning an unspecified patient who was "greater than 65 years old." Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot number, dosage, and route of administration not provided). The physician reported that at an unspecified time after the patient received PNEUMOVAX 23, the patient developed "a large lump, swelling and redness at injection site that got worse" (clarifying information not provided). The patient was seen at an emergency room on an unspecified date in regards to the reaction and was given unspecified steroids as treatment.  It was not specified if the patient was admitted to the hospital. The patient recovered from the large lump, swelling and redness at injection site. Causality was not assessed by the reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concomitant therapy, concurrent condition, historical condition and drug reaction were not provided. On 21-FEB-2017 the patient was vaccinated with an expired supported dose of ZOSTAVAX (strength and dose unknown, lot # L046293, expiration date 17-FEB-2017) subcutaneously for prophylaxis (expired vaccine used). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored. The site and route of VARIVAX administration were not reported. The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours. There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 22-FEB-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA001788.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored.  The site and route of VARIVAX administration were not reported.  The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours.  There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 23-FEB-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001788:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Pain, Rash erythematous
Clinical narrative: Body aches and red rash to left upper arm.
Age: 41.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Urticaria
Clinical narrative: Hep B, first shot, no prior Hep B vaccination;  Hives on face, hands, abdomen; minor case so treated with only Benadryl; resolved at 72-96h.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse reaction, Mass, Musculoskeletal pain, Neck pain, Skin warm
Clinical narrative: "Hot to touch, feels like lump, can't sleep on that side, feels sore up into neck and throughout left shoulder blade" "no temp".
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder
Clinical narrative: "Hot to touch, feels like lump, can't sleep on that side, feels sore up into neck and throughout left shoulder blade" "no temp".
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Patient was given an extra dose of Hep B rather than Hepatitis A vaccine.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Red arm from shoulder to elbow, hot to touch, sore.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Severe localized redness and swelling entire upper arm.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Injection site pain, Injection site swelling
Clinical narrative: Arm soreness, swelling at injection site, headache.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with the first and the second dose of GARDASIL (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis.  It was stated that if the patients began the human papillomavirus (HPV) series with GARDASIL then, on an unknown date, they received GARDASIL 9 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis in order to finish the human papillomavirus (HPV) series. No adverse effects were reported.  Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from the patient's mother concerning to her 7 months female daughter. The patient had not concomitant medication, medical history or drug allergies. On an unknown date (reported as "a couple of days ago"), the patient was vaccinated for mistake with GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported) for prevention of HPV. At the time of the report, the patient seemed alright and there were no known occurring side effects. The patient did not received any treatment and an unspecified physician said "keep an eye on the patient" The patient did not see medical attention. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored.  The site and route of VARIVAX administration were not reported.  The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours.  There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 22-FEB-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001788: US-009507513-1703USA001788: US-009507513-1703USA003630: US-009507513-1703USA003631: US-009507513-1703USA003633: US-009507513-1703USA003638: US-009507513-1703USA003634: US-009507513-1703USA003635: US-009507513-1703USA003632: US-009507513-1703USA003636: US-009507513-1703USA003637:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored. The site and route of VARIVAX administration were not reported. The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours. There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 27-FEB-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA001788.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored.  The site and route of VARIVAX administration were not reported.  The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours.  There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 27-FEB-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001788:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored. The site and route of VARIVAX administration were not reported. The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours. There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 28-FEB-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA001788.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored.  The site and route of VARIVAX administration were not reported.  The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours.  There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 28-FEB-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001788:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored.  The site and route of VARIVAX administration were not reported.  The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours.  There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 01-MAR-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001788:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 07-MAR-2017, the patient was vaccinated with an unspecified expired dose of M-M-R II for prophylaxis (lot # K024038 with an expiration date of 26-NOV-2016) (dosage, route and  anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported.  On 06-MAR-2017, the patient was vaccinated with an unspecified expired dose of PNEUMOVAX23  for prophylaxis (lot # L014458 with an expiration date of 11-FEB-2017) (dosage, route and  anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported.       Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Irritability, Sleep disorder, Vomiting
Clinical narrative: Was fussy all night, slept fitfully but began vomiting at 11:30 am. By time of consult at 3:40pm he had vomited 5 times already; afebrile; irritable but consoled by mom and fell asleep within 10 mins in clinic; exam: normal exam, pupils normal; fontanelles normal.
Age: 1.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: LEFT THIGH RED, SWOLLEN, HOT.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Erythema, Headache, Nausea, Pain
Clinical narrative: 65yr female presents for reported poor reaction to pneumococcal vaccination (PSV 13) on 23Jan2017.  She notes pain, erythema, swelling, itching, subjective fevers, headache, nausea and diarrhea after getting the immunization.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Pyrexia, Swelling, Vaccination complication
Clinical narrative: 65yr female presents for reported poor reaction to pneumococcal vaccination (PSV 13) on 23Jan2017.  She notes pain, erythema, swelling, itching, subjective fevers, headache, nausea and diarrhea after getting the immunization.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Local swelling, Vaccination site induration
Clinical narrative: Localized Sweeling, Redness,hard to touch left thigh at Vaccine site. Mar 02 Treatment In ER Motrin, Benadryl and HCTC Cream
Age: 27.0
Sex: M
Vaccine: MEN, MMR, TYP, YF
Symptoms: Alopecia areata, Skin discolouration
Clinical narrative: Alopecia areata (Hair loss spots)on front and back of head, 2 spots. 5 white spots have also appeared on my arm. Both conditions have lasted over a year now and only one of the hair loss spots have gone away.
Age: 2.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Gait disturbance, Irritability, Local reaction, Petechiae, Serum sickness-like reaction
Clinical narrative: Had large local reaction start on 3/4 which resolved by 3/5. Seemed fine and then 3/8 work up very fussy refusing to walk and with mild petechial rash. Diagnosed with likely serum sickness like reaction.
Age: 2.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Erythema, Local swelling, Myositis, Pain, Skin warm
Clinical narrative: Had large local reaction start on 3/4 which resolved by 3/5. Seemed fine and then 3/8 work up very fussy refusing to walk and with mild petechial rash. Diagnosed with likely serum sickness like reaction.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 10.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: About 24hrs after vaccines, pt w/ redness, warmth and tenderness increased redness 12 cm x6 cm, and came to clinic on 3/3, started on Keflex 500 mg 1000mg bid x 10 days.
Age: 70.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Rash
Clinical narrative: Rash of left arm, back, and both inner thighs.  Doctor prescribed methylprednisolone for presumed reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site rash, Injection site swelling
Clinical narrative: ZOSTAVAX administered 1/17/17. Presented 1/19/17 with swelling, seeping rash at injection site. Physician did not recommend exam. Advised cold compresses, ZOSTRIN for symptoms.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Rash x 5 days after administration at injection site.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Pain, Paraesthesia
Clinical narrative: Pt received PNEUMOVAX 23 on his right arm on 2/23/17. He is complaining of tingling pain and not being able to lift the arm. His MD prescribed KEFLEX, Naproxen, a TYLENOL w/codeine today. I will follow up with him in 3 days.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Patient had fever starting on 3-7-17 at 6:00 pm. His whole body started shaking lasting 10 minutes. Bottom of his mouth was quivering. Parents clothed him more and this stopped the shaking movement.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity
Clinical narrative: BENADRYL, cold compresses.
Age: 60.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea and nausea vomiting.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Injection site rash, Pyrexia, Rash, Respiratory viral panel
Clinical narrative: 2-13-17 fever, febrile seizure, rash occurring 9 days after vaccine administered. RVP (respiratory viral serial negative) Rash localized around MMR site administration and extend to torso.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Viral test negative
Clinical narrative: 2-13-17 fever, febrile seizure, rash occurring 9 days after vaccine administered. RVP (respiratory viral serial negative) Rash localized around MMR site administration and extend to torso.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Back pain, Chest pain
Clinical narrative: Pt states she has pain (chest) and then radiates to back and this occurs on and off since last month. Advise pt to see doctor and go to ER if cannot get hold of doctor.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Chest pain, Spinal pain
Clinical narrative: Pt states she has pain (chest) and then radiates to back and this occurs on and off since last month. Advise pt to see doctor and go to ER if cannot get hold of doctor.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Discomfort, Erythema, Skin warm, Swelling
Clinical narrative: Redness (size of half dollar) "hot" to touch and with discomfort, minimal swelling visible.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Influenza like illness, Injection site erythema
Clinical narrative: Sickness, flu-like symptoms, dizziness, light fever, aches, fatigue, stomach pain. Red, itchiness and swelling around injection site.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: Sickness, flu-like symptoms, dizziness, light fever, aches, fatigue, stomach pain. Red, itchiness and swelling around injection site.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash generalised
Clinical narrative: Patient got all over body rash 2 weeks after vaccine, requiring multiple courses of steroids.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Diplopia, Fatigue, Guillain-Barre syndrome, Ophthalmoplegia
Clinical narrative: Guillain Barre-Ocular Palsy/Diplopia fatigue.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urticaria
Clinical narrative: 3/07/17 was seen for severe hives, was given SOLU-MEDROL 40mg/mL. Administered 0.5 mL in office. Prescribed prednisolone 15mg/5mL solution: Take 2.5mL twice a day by oral route for 5 days.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Vaccination site oedema
Clinical narrative: Redness and edema on left deltoid around vaccination site, edema and redness is circular about 6 inches big, no tenderness to touch. Ibuprofen and Diphenhydramine HCI were prescribed.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Hypopnoea, Loss of consciousness, Stridor
Clinical narrative: Case number PHHY2015US014110 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551564) on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 350963) on 10 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 350963) on 11 Mar 2015. This report refers to an 18 years old female patient. Her current condition included diabetes and cough. Her concomitant medications were levothyroxine; LANTUS SOLOSTAR, omeprazole, HUMALOG Mix, Acetaminophen and metformin. She was vaccinated with MENVEO (batch number: M14056 and expiry date: Aug 2015) in the right arm and FLUARIX QUADRIVALENT (other manufacturer, batch number: 34MM3) in the left arm; both vaccines administered on 22 Oct 2014. On 22 Oct 2014, she experienced shallow breathing, stridor and loss of consciousness. She was hospitalized for 2 days and was treated with EPIPEN 3 mg intramuscularly in the right thigh by doctor at 12:14 pm. The outcome of event reported as complete recovery. The event was reported as serious. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M14056) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 350963) on 10 Feb 2015: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 350963) on 11 Mar 2015: Updated MENVEO vaccine batch review report. On 20th February 2017, after GSK internal review, the suspect vaccine FLUARIX was changed into FLUARIX QUADRIVALENT.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2015US117231, is  an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 558941) received on 10 Sep 2015. This report refers to an 11-year-old male patient. Historical conditions were none. Concomitant medication was none. The patient was vaccinated with MENVEO (batch number: M14042) intramuscularly into the right arm along with GARDASIL (batch: K04205) intramuscularly into the left am and FLUARIX QUADRIVALENT (batch number: 9954H) intramuscularly into the right arm on 17 Dec 2014. On 18 Dec 2014, the patient experienced redness and swelling on right deltoid. Final outcome of the events was not recovered. The events were reported as non-serious and causality was not reported. On 20th February 2017, after GSK internal review, the suspect vaccine FLUARIX was changed into FLUARIX QUADRIVALENT.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Middle insomnia, Poor quality sleep, Psychomotor hyperactivity, Speech disorder
Clinical narrative: UNABLE TO SLEEP WELL, WAKING UP MORE OFTEN THAN NORMAL AT NIGHT, EXTREMELY HYPERACTIVE AND MUMBLING MORE THAN NORMAL.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13, FLUX, PNC13
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 27-Feb-2017. This case involves a 69 years old female patient who was vaccinated with a dose of INFLUENZA VACCINE in buttock (reported as butt) and PREVENAR 13 in right arm (dose, dose in series, batch number, expiry date, route of administration were not reported for both) on 24-Oct-2016. Medical history reported as the patient was too fat. Any other vaccinations within four weeks of vaccinations were none. On an unknown date and month of 2016, following the vaccination, the patient experienced joint pain in both knees and in both thumbs. It was also reported that joint pain began a week to 10 days. Patient went for doctor visit with her concern. It was also reported that patient received INFLUENZA VACCINE (Flu vaccine) in the past. Laboratory investigations were none. Patient took Diclofenac Sodium- 75 mg tablet twice a day for four days. The outcome of the event was reported as not recovered as pain came back within couple of days. It was also reported as improved as she was feeling better. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: DTAP, HEPAB, TDAP
Symptoms: Ear swelling, Urticaria
Clinical narrative: Patient felt flushed 1-2 days after receiving vaccines but did not take temperature. Late in day 3 (approximately 80 hours after receiving vaccines) she developed a temperature of 101.3 and hives. She called the Health Dept the next morning and was instructed to start BENADRYL which she already had done and to go to her Dr for evaluation. She was seen at an ER clinic and was given a steroid shot and a steroid pack to take home. She developed problems while on the steroid pack and was further instructed by the ER clinic staff to stop taking the pack and only take BENADRYL for the hives.
Age: 40.0
Sex: F
Vaccine: DTAP, HEPAB, TDAP
Symptoms: Body temperature increased, Flushing, Urticaria
Clinical narrative: Patient felt flushed 1-2 days after receiving vaccines but did not take temperature. Late in day 3 (approximately 80 hours after receiving vaccines) she developed a temperature of 101.3 and hives. She called the Health Dept the next morning and was instructed to start BENADRYL which she already had done and to go to her Dr for evaluation. She was seen at an ER clinic and was given a steroid shot and a steroid pack to take home. She developed problems while on the steroid pack and was further instructed by the ER clinic staff to stop taking the pack and only take BENADRYL for the hives.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Blood test normal, Computerised tomogram normal, Crying, Drooling
Clinical narrative: Post 24 hour my baby received the 2 mos. scheduled vaccine she is becoming lethargic, excessive drooling, secretions, difficulty swallowing, high pitched cry and absence of fever. At present she is becoming more lethargic, increased secretions and having multiple diagnosis from the doctors in which they keep on telling us the cause or origin is unknown and my baby's illness is rare.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dysphagia, Intussusception, Lethargy, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Post 24 hour my baby received the 2 mos. scheduled vaccine she is becoming lethargic, excessive drooling, secretions, difficulty swallowing, high pitched cry and absence of fever. At present she is becoming more lethargic, increased secretions and having multiple diagnosis from the doctors in which they keep on telling us the cause or origin is unknown and my baby's illness is rare.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Salivary hypersecretion, Spinal cord abscess, Ultrasound abdomen abnormal
Clinical narrative: Post 24 hour my baby received the 2 mos. scheduled vaccine she is becoming lethargic, excessive drooling, secretions, difficulty swallowing, high pitched cry and absence of fever. At present she is becoming more lethargic, increased secretions and having multiple diagnosis from the doctors in which they keep on telling us the cause or origin is unknown and my baby's illness is rare.
Sex: F
Vaccine: HPVX
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report has been received from the patient's mother referring to her currently 16 years old daughter. The patient did not have pertinent medical history, drug reactions, allergies, concurrent conditions or concomitant therapies. In approximately 2016, reported as "about a year ago" the patient received the three doses regimen of GARDASIL or GARDASIL 9 intramuscular, (strength, dose, frequency, lot#, expiration date and anatomical location were not provided) for prevention on HPV. The reporter was not sure which vaccine her daughter received. The reporter stated that she received a call from the primary physician stating that the batch of GARDASIL or GARDASIL 9 was involved in a temperature excursion and for that reason her daughter would have to return to the physician's office to receive the regimen again. At the time of reporting the patient did not receive the additional doses of GARDASIL or GARDASIL 9. The patient did not seek medical attention. Neither, no laboratory diagnostics studies were performed or treatment any was given. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a currently 5-year-old patient of an unknown gender. There was no information about the patient's medical history, concurrent conditions, concomitant therapies and drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of PROQUAD lot number: M031568, expiration date: 24-DEC-2017 (strength, dose, frequency, route, and anatomical location were not reported) for prophylaxis. The vaccine was exposed to a temperature that remained between -15 and - 10 Celsius degrees, for 60 minutes due to a data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of three reports from the same source. There was no product quality complaint involved. Additional information has been requested.; Sender's Comments: US-009507513-1703USA002316: US-009507513-1703USA002315:
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 22-year-old, female patient with scoliosis and abnormal Papanicolaou smear (PAP). The patient had no relevant medical history or products taken prior to or during her pregnancy. She had not been pregnant before. On 08-NOV-2016, the patient was vaccinated with a dose of GARDASIL 9 injection (intramuscularly in her right deltoid; lot # M028323, expiration date: 26-SEP-2018). On an unknown date, the patient became pregnant (confirmed by an urine pregnancy test performed on 09-SEP-2017) with last menstrual period (LMP) of 15-OCT-2016 and Estimated Date of Delivery (EDD) of 22-JUL-2017 (calculated based on LMP). The pregnancy outcome was unknown at the time of the report (the outcome was pending). Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Diarrhoea, Incorrect product storage, Injection site pain, Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of PROQUAD (lot # M031566, expiration date 24-DEC-2017; lot # M038862, expiration date 13-MAR-2018 or lot # M037652, expiration date 28-FEB-2018) (dose, route and frequency were not reported) or the improperly stored dose of VARIVAX (lot # M032493, expiration date 06-JUL-2018; lot # M037642, expiration date 01-SEP-2018; lot # M033213, expiration date 13-JUL-2018; lot # M030138, expiration date 15-JUN-2018; lot # M035687, expiration date 10-AUG-2018 or lot # M038857, expiration date 14-SEP-2018) (dose, route and frequency were not reported), both for prophylaxis. The reporter mentioned that multiple unspecified patients had experienced vomiting, diarrhea or soreness at the injection site (vaccination site pain) after receive any vaccine. Administered doses of vaccines experienced the following temperature excursion: greater than 5 but less than 14 degrees Fahrenheit for 2 hours; greater than 5 but less than 14 degrees Fahrenheit for 2 hours; greater than 5 but less than 14 degrees Fahrenheit for 3 hours; greater than 5 but less than 14 degrees Fahrenheit for 3 hours, greater than 5 but less than 14 degrees Fahrenheit for 4 hours, greater than 5 but less than 14 degrees Fahrenheit for 4 hours; greater than 5 but less than 14 degrees Fahrenheit for 4 hours; greater than 5 but less than 14 degrees Fahrenheit for 4 hours; greater than 5 but less than 14 degrees Fahrenheit for 2 hours. The last temperature excursion was greater than 5 but less than 14 degrees Fahrenheit for 3.5 hours. Data logger was involved. The outcome of vomiting, diarrhoea, and vaccination site pain was unknown. The causality between vomiting, diarrhoea, and vaccination site pain with PROQUAD and VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided.      From November 2016 to 23-FEB-2017, improperly stored doses of VARIVAX (dose, strength, frequency and route were unknown, lot # L015048, expiration date 29-APR-2017) were each administered to the unspecified patients for immunization. The VARIVAX was exposed -4.3 Celsius for a time frame of 1 hour 18 minutes. The previous temperature excursions of the VARIVAX are a range between -10 Celsius and 8 Celsius in 10 hours 40 minutes and a range between -15 Celsius and -10 Celsius  in 3 hour 59 minutes. A data logger was in use. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.  ; Sender's Comments: US-009507513-1703USA003154:
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old patient. The nurse reported on 17-FEB-2017, the patient inadvertently received first dose in M-M-R II (injection, lot # L036851, EXP 23-SEP-2017, subcutaneous, dose and frequency were not reported) and PROQUAD (injection, lot#M017336, EXP 05-OCT-2017, dose, route and frequency were not reported) dose series concomitantly. The nurse reported one vaccine administered in upper right arm and other vaccine administered in upper left arm. The nurse reported that there had been no call back regarding any adverse effects from the parents. 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 medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported for the patient. On an unspecified date, the patient may have been vaccinated with an improperly stored dose of ROTATEQ (dose, frequency and route were not reported) lot # M025563 with expiration date of 06-NOV-2017, for prophylaxis.  No adverse effects were reported. The temperature excursion of the ROTATEQ was between 32 F and 36 F, for a time frame of 72 hours. No previous temperature incursion was reported and no data logger was involved. No product quality complaint was involved (PQC). This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA010330: US-009507513-1703USA000331:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a currently 4-year-old patient of an unknown gender. There was no information about the patient's medical history, concurrent conditions, concomitant therapies and drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of PROQUAD lot number: M031568, expiration date: 24-DEC-2017 (strength, dose, frequency, route, and anatomical location were not reported) for prophylaxis. The vaccine was exposed to a temperature that remained between -15 and - 10 Celsius degrees, for 60 minutes due to a data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of three reports from the same source. There was no product quality complaint involved. Additional information has been requested. Sender's Comments: US-009507513-1702USA004244: US-009507513-1703USA002316.