chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No date of time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Eye swelling, Influenza like illness, Oedema mouth
Clinical narrative: Flu like symptoms, mouth and eye swelling.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Axillary pain, Chills, Decreased appetite, Disturbance in attention
Clinical narrative: Swelling and severe pain in left arm (injection in L deltoid), swollen and painful left armpit, pain on weakness, and fatigue, severe pain in left arm and entire left side could not lay on left side, swollen aching neck glands, unable to concentrate or think, brain very "foggy" and forgetful, nausea, no appetite, chills, occasionally dizzy.  It is 12/5/14 and I am still having these symptoms.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Fatigue, Feeling abnormal, Flank pain, Lymph node pain
Clinical narrative: Swelling and severe pain in left arm (injection in L deltoid), swollen and painful left armpit, pain on weakness, and fatigue, severe pain in left arm and entire left side could not lay on left side, swollen aching neck glands, unable to concentrate or think, brain very "foggy" and forgetful, nausea, no appetite, chills, occasionally dizzy.  It is 12/5/14 and I am still having these symptoms.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Memory impairment, Mental impairment, Nausea, Oedema peripheral
Clinical narrative: Swelling and severe pain in left arm (injection in L deltoid), swollen and painful left armpit, pain on weakness, and fatigue, severe pain in left arm and entire left side could not lay on left side, swollen aching neck glands, unable to concentrate or think, brain very "foggy" and forgetful, nausea, no appetite, chills, occasionally dizzy.  It is 12/5/14 and I am still having these symptoms.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Swelling and severe pain in left arm (injection in L deltoid), swollen and painful left armpit, pain on weakness, and fatigue, severe pain in left arm and entire left side could not lay on left side, swollen aching neck glands, unable to concentrate or think, brain very "foggy" and forgetful, nausea, no appetite, chills, occasionally dizzy.  It is 12/5/14 and I am still having these symptoms.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness, Paraesthesia
Clinical narrative: Decreased use of arm and hand. ED visit ? Ulnar palsy. Still having arm weakness 12/1/14. At onset shooting electrical shock like sensation  weakness. Had Extra strength Vaccine for >65yr. Given at a pharmacy.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Malaise, Walking aid user
Clinical narrative: Around the 20-22nd of November, the patient began feeling ill and weak. These symptoms progressed to the point that she needed to use a walker to ambulate. She sought medical attention in the emergency department on the 24th of November.
Age: 73.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Pruritus generalised
Clinical narrative: At 11.30 am patient stated to feel itching on the neck which progressed to her arms, back and then on the whole body. Patient had red streaks on the arms and breast during the visit (at 2.10 pm) at our Medical Center. Treatment: Benedryl 50 mg tablet administered on the spot and provided the prescription.
Age: 49.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: TDaP injection site swelling measuring 3 x 2 1/2 inches, pain/tenderness, redness, and warmth.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient received her Pneumovax 23 vaccination, 8+ weeks after receiving Prevnar 13.  She has a hx of breast cancer and had a bilateral mastectomy in Sept 2014.  She did not notice any immediate adverse reactions, but by the evening of 12/04/2014 she noticed increased pain and redness.  On 12/05/2014, the pain was worse and the skin around the injection site was red and swollen.  She had some limited range of monitor in her arm, due to the pain.  She denied any itching and the reaction was localized to an area about 6 inches or so around the injection area.  She did state that she reviewed her vaccination information sheet and saw that 60% of patients experience pain and 1 in 3 may have redness/swelling.  She asked me (a pharmacist at the hospital) to report her reaction.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Tenderness, Urticaria
Clinical narrative: Patient came back to the pharmacy on 11/30/14. Her upper post-lateral arm had a 2 inch raised, red welt, and surrounding redness that stretched 2 to 3 inches in all directions. Patient said it was hot and sore to the touch. The surrounding redness continued to spread so she went to her physician on 12/1/14 and received a Medrol dosepak and doxycycline.  The patient was contacted on 12/3/14 by the administering pharmacist. The patient said she was doing much better with most of the redness completely gone. She still had the middle red, raised welt, however.  She was in good spirits and felt fine otherwise.
Age: 0.79
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever of 105 degrees Fahrenheit.
Age: 28.0
Sex: F
Vaccine: YF
Symptoms: Abdominal pain upper, Anaphylactic reaction, Dyspnoea, Vaccination site swelling
Clinical narrative: Patient noticed swelling around vaccination adminsitration site and began to experience stomach pain. She then notified a staff nurse who took her to the acute care area and notified the duty doctor. She then began feeling a minor difficulty in breathing, and was treated for anaphylaxis.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Fatigue, Hypersomnia, Muscular weakness, Nausea
Clinical narrative: Rapid onset of a fever of 103.7 degrees Fahrenheit and severe weakness in the arms and legs. Nauseated and drowsiness occurred and swelling of the throat. Severely confused and tired slept from 4:30 pm on 11/19/2014 until the following day at 6:00 pm.  Fever broke around that time as well.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pyrexia, Somnolence
Clinical narrative: Rapid onset of a fever of 103.7 degrees Fahrenheit and severe weakness in the arms and legs. Nauseated and drowsiness occurred and swelling of the throat. Severely confused and tired slept from 4:30 pm on 11/19/2014 until the following day at 6:00 pm.  Fever broke around that time as well.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, pain, itching, swelling at the injection site.
Age: 58.0
Sex: F
Vaccine: FLUR3
Symptoms: Arthralgia, Drug administered to patient of inappropriate age, Fatigue, Headache, Malaise
Clinical narrative: Fatigue, malaise, joint aches, muscle aches, headaches, neck aches, overall symptoms seemingly similar to fibromyalgia which were not being experienced before the flu vaccine was administered. (Flublok was administered even though I was out of the realm of the approved age range of 18-49). This vaccine was administered per employment requirements, if I had not had the vaccine I would have been suspended, ultimately terminated "fired" from my workplace.
Age: 58.0
Sex: F
Vaccine: FLUR3
Symptoms: Myalgia, Neck pain, Pain
Clinical narrative: Fatigue, malaise, joint aches, muscle aches, headaches, neck aches, overall symptoms seemingly similar to fibromyalgia which were not being experienced before the flu vaccine was administered. (Flublok was administered even though I was out of the realm of the approved age range of 18-49). This vaccine was administered per employment requirements, if I had not had the vaccine I would have been suspended, ultimately terminated "fired" from my workplace.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain, Pruritus
Clinical narrative: LOCALIZED REDNESS AND SWELLING, PAIN, SOME ITCHING.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Oropharyngeal pain, Rash, Throat irritation
Clinical narrative: Difficulty breathing in the middle of the night, rash on trunk discovered in AM upon waking, feeling of "a rash in throat" and throat pain.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Eye irritation, Eye pruritus, Malaise, Musculoskeletal pain, Neck pain
Clinical narrative: Extreme pain in left arm, shoulder and neck, all over itching, especially left appendages, itching and burning eyes, general malaise.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Pruritus generalised
Clinical narrative: Extreme pain in left arm, shoulder and neck, all over itching, especially left appendages, itching and burning eyes, general malaise.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reported arm soreness that occurred within 5 days of vaccine, worst symptoms involved inability to move arm, experienced 30 days after vaccine.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date since 08-NOV-2014, an unspecified number of patients were vaccinated with a dose of ROTATEQ (lot #, expiration date and dose were not reported) orally, that was exposed to supported temperature excursions. No adverse experience has been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Joint range of motion decreased, Mobility decreased, Muscle spasms, Muscular weakness
Clinical narrative: Sore left arm that improved briefly then started hurting and being somewhat weak. Got steroid injection which helped a little briefly. I am doing physical therapy but symptoms continue. Upper arm pain, muscle spasms, reduced ROM. Arm pit pain too.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Sore left arm that improved briefly then started hurting and being somewhat weak. Got steroid injection which helped a little briefly. I am doing physical therapy but symptoms continue. Upper arm pain, muscle spasms, reduced ROM. Arm pit pain too.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Red bump developed above elbow, 8 inches from injection site. Redness gone but a tiny nodule still remains. Itches once in a while but its been 5 weeks.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Ovarian cancer
Clinical narrative: Left upper arm red and swollen and painful and warm 2 days after PNEUMOVAX - c/o pain and tenderness.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: At approximately 2 pm on 12/5/2014 a single 0.5 mL dose of FLUARIX was administered to the patient. While sitting in the waitiung area, the customer began to lose consciousness. Customer passed out and after a minute or so regained consciousness.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Varicella
Clinical narrative: Patient reported chicken pox rash confirmed by family doctor 12/5/14.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Blood creatine phosphokinase, Blood creatinine, C-reactive protein, Fatigue
Clinical narrative: She started feeling tired/weakness and itchy and rash to arm.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Liver function test, Pruritus, Rash, Urine analysis
Clinical narrative: She started feeling tired/weakness and itchy and rash to arm.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Injection site swelling
Clinical narrative: Mom noticed swelling to (R) thigh in the evening? Brought un to see dr 12-3-14. (R) thigh with swelling 3x2x2 inches. 12-3-14 (Tx) pt was given KEFLEX 250mg/5ml = 2 1/2 mls po tid x 10 days.
Age: 1.37
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site swelling
Clinical narrative: 12-3-13 vac given. Mom noticed swelling (L) thigh 12-4-14. 12-5-14 brought in to see MD. ZYRTEC 5m/5ml tx 2 1/2 ml PQ Q24 hours PRN 12-5-14 KEFLEX 250 mg/5mL-Txc 2 1/2 mls PQ TID x 10 days
Age: 84.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest pain, Injection site pain
Clinical narrative: Pt. reported pain, soreness on side of body (chest) and arm where vaccine was administered. Pain lasted approximately one week, but now they are feeling OK with no pain or discomfort.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt developed urticaria - extensive coverage of body/extr's /face - within 24 hrs of vaccine.
Age: 16.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Pain, Syncope
Clinical narrative: Fainting spell after vaccination of Tdap, MCV4, FLUMIST and HPV. Without conscious loss. ADVIL given by mouth for pain and vital sign monitoring for 30 mins.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Malaise, Pain in extremity
Clinical narrative: Vaccine given 11-19-14 (FLUZONE HD) patient reported feeling sick and short of breath and sore arm (given tizanidine by MD 11-29-14). Patient reported still sick and short of breath and received cefuroxime from MD 12-1-14. Patient reported dismissed from hospital 12-5-14.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the patients were vaccinated with ROTATEQ (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, ROTATEQ was improperly stored for an unspecified amount of time and administered to an unspecified number of patients. No adverse effects reported. The outcome was unknown. Product quality complaint was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates the unspecified number of unspecified patients were vaccinated with unspecified doses of improperly stored GARDASIL (lot number not provided) injection (strength, dose, frequency and route not provided). No adverse effect was reported. The outcome of event was not reported. This one of several reports received from the same source. Additional information has been requested.
Age: 0.22
Sex: M
Vaccine: HEP
Symptoms: Erythema, Injection site erythema
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site redness in a 11-week-old male patient who received ENGERIX B (batch number 9423K, expiry date 3rd February 2016). Concomitant products included PREVNAR, Rotavirus, ZANTAC and erythromycin. On 13th August 2014, the patient received ENGERIX B (injection) .5 ml. On 13th August 2014, Less than a day after receiving ENGERIX B, the patient experienced injection site redness. On an unknown date, the outcome of the injection site redness was recovered/resolved. The reporter considered the injection site redness to be possibly related to ENGERIX B. Additional information received: Other vaccine given the same day: PENTOPHIL (Sanofi Pasteur: C4683AA; 07 August 2015). No known drug allergy. No previous reactions. Pediatric patient experienced redness from the knee to the top of the thigh of both legs after vaccinations were given. Issue had resolved at time of reporting.
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: Seroconversion test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old male patient, who was also a dentist, with hyperlipidemia. On an unknown date ("many years ago") the patient was vaccinated with a dose of RECOMBIVAX HB (dose, lot # not reported). The patient was probably vaccinated when the vaccine was first released. However, physician states he was not sure if the vaccine administered was RECOMBIVAX HB. Physician states an antibody titer was drawn for the patient on 17-NOV-2014. The result was patient failed to seroconvert; the test was non reactive and was less than 3.1. The causality was not reported. Physician stated he would probably revaccinate this patient. Additional information is not expected because the physician gave no consent to be contacted.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of "high school age". On 03-DEC-2014 the patient was vaccinated with the second dose of GARDASIL (route, dose, frequency and lot # not reported). It was reported that on 03-DEC-2014 (also reported as today) the patient did not eat breakfast or lunch and fainted after being administered her second dose of GARDASIL. It was reported that the therapy with GARDASIL was continued. The patient recovered fully on 03-DEC-2014 while at the office and was released. The patient sought medical attention and was in the office at that time. The relatedness between the event and GARDASIL was not reported. Additional information is not expected as there is no consent to contact physician.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date since 08-NOV-2014, an unspecified number of patients were vaccinated with a dose of GARDASIL (lot #, expiration date, dose and route of administration were not reported) that was exposed to supported temperature excursions. No adverse experience has been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date since 08-NOV-2014, an unspecified number of patients were vaccinated with a dose of RECOMBIVAX HB (lot #, expiration date, dose and route of administration were not reported), that was exposed to supported temperature excursions. No adverse experience has been reported. This is one of several reports from the same reporter. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date since 08-NOV-2014, an unspecified number of patients were vaccinated with a dose of VAQTA (lot #, expiration date, dose and route of administration were not reported), that was exposed to supported temperature excursions. No adverse experience has been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date since 08-NOV-2014, an unspecified number of patients were vaccinated with a dose of M-M-R II (lot #, expiration date, dose and route of administration were not reported), that was exposed to supported temperature excursions. No adverse experience has been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On 25-MAY-2013 the patient was vaccinated with GARDASIL 0.5 ml, intramuscular. The patient did not receive her second dose until 07-JUN-2014, and third dose on 19-AUG-2014 (inappropriate dosing schedule). The physician reported that the patient did not experience an adverse event. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Pt has Tdap 2 days later he developed rash on both hands, extensor side involving 4 distals. Parents applied topical ointment. One month later, he developed rash behind both ears. No fever. To ER for evaluation.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Vaccine positive rechallenge
Clinical narrative: Information was received from the father of a female patient, age unknown. On unknown dates, the patient was vaccinated with GARDASIL (dosage and route of administration not provided). The patient experienced severe erythema after her first dose of GARDASIL, and less severe erythema after her second dose of GARDASIL. The third dose of GARDASIL has not yet been administered. The outcome of the severe erythema and less severe erythema was not provided. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cyst
Clinical narrative: Vaccine administered on 11/17/2014. Pt started noticing yellowish cyst/blister start about 10 days ago.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Redness and swelling, hard know at injection site that did not go away after 3 days.
Age: 0.01
Sex: F
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse (via MARRS # 1411USA002261) refers to a 3 day old female patient who on 21-OCT-2014 was vaccinated with improperly stored M-M-R II lot # J008153 (dose and route of administration were not reported). The outcome of the events (incorrect product storage and inappropriate schedule of vaccine administration were unknown). This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Pyrexia, Skin warm, Swelling, Vomiting
Clinical narrative: Fever, swelling, redness, warm to touch, vomiting.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Pain in extremity, Rash
Clinical narrative: (L) arm pain, weakness, rash on truck about 48 hours (ibuprofen). Persisten arm pain.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Sore, red raised left lower arm 2 days post MMRX VARIVAX vaccine.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Sore, red raised left lower arm 2 days post MMRX VARIVAX vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse (via MARRS # 1411USA002261) refers to a 11 year old female patient who on 28-OCT-2014 was vaccinated with improperly stored GARDASIL lot # H020901, expiration date: 05-JUL-2015 (dose and route of administration were not reported). The outcome of the event was unknown. This is one of several reports from the same reporter. 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 physician refers to unspecified number of unknown age. Current conditions and medical history was not reported. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX injection (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, (Oka/merck) VARIVAX was improperly stored for an unspecified amount of time and administered to an unspecified number of patients. No adverse effects reported. The outcome was unknown. product quality complaint was not reported. No further information provided. This is on of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the patients were vaccinated PNEUMOVAX23 (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On unknown date, PNEUMOVAX23 was improperly stored for an unspecified amount of time and administered to an unspecified number of patients. No adverse effects reported. The outcome was unknown. Product quality was not reported. No further information provided. 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: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. Current conditions and medical history was not reproted. On an unknown date, the patients were vaccinated with M-M-R II (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, M-M-R II was improperly stored for an unspecified amount of time and administered to an unspecified number of patients. No adverse effects reported. The outcome was unknown. Product quality complaint was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a registered nurse via company representative regarding a 61 year old female patient with asthma, hypertension and coronary heart disease. On 12-NOV-2014, the patient was vaccinated with PNEUMOVAX23 (dose, route, lot number were not reported). On 12-NOV-2014, the patient experienced a large extended rash. On 13-NOV-2014, the patient had an appointment at doctor's office and was treated with unspecified antibiotics. The outcome of a large extended rash was not reported. The relatedness between the event and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Asthenia, Maternal exposure before pregnancy, Vomiting
Clinical narrative: This spontaneous report as received from a consumer. The patient is a 26 year old female patient with drug allergies to VICODIN, morphine, codeine, and COMPAZINE. Concomitant therapies included PULMICORT. On 02-OCT-2014, the patient was vaccinated with a second dose of GARDASIL. The patient reported that she experienced feeling weak for 20 to 30 minutes after GARDASIL injection. The patient reported that one week after receiving GARDASIL she found out she was pregnant. The patient reported that she has been vomiting and sick to her stomach since her pregnancy diagnosis. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown demographics. The patient's pertinent medical history was not reported. On an unknown date in JULY-2014 the patient was vaccinated with the first dose of VARIVAX (Merck) (unknown strength and doe) and now like to receive her second dose. No adverse symptoms were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown dates, in 2014 (reported as "since October 2014") the patients were vaccinated with improperly stored GARDASIL (dose, route, lot# and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was reported. This is the 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: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown dates, in 2014 (reported as "since October 2014") the patients were vaccinated with improperly stored RECOMBIVAX HB, (therapy type, dose, route, lot# and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is the one of several reports received from the same reporter. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Heart rate increased, Immediate post-injection reaction, Vaccine positive rechallenge
Clinical narrative: Ten to twenty minutes after receiving vaccination, employee experienced SOB and rapid HR. The first MMR she experienced this but it was a few days later. This time it was immediately.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown dates, in 2014 (reported as "since October 2014") the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Electromyogram, Injection site pain, Periarthritis
Clinical narrative: After having Tdap administered in (L) arm, pt. started with pain and aching of the (L) upper arm, deltoid area then developed frozen shoulder.
Age: 65.0
Sex: F
Vaccine: FLUX, IPV, TYP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: After completing 4th dose, patient developed Solid Red and itchy skin rash on Neck, torso and leg.
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age who were enrolled in study. Pertinent medical history was unknown. The reporting physician stated that they also given PNEUMOVAX 23 (dose, route of administration and anatomical location was unknown) to smokers under 65. Concomitant medications were unspecified by reporter. The outcome of the event was unknown. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning an 11 year old patient of unknown gender. On 21-OCT-2014 the patient was vaccinated with GARDASIL (lot # J010668, expiration date 29-APR-2016) (dose and route not reported). There was no concomitant medication reported. The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, route, lot# and expiration date were not reported). No adverse events were reported. No PQC (product quality complaint) was involved. This is the one of several reports received from the same reproter. 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 nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (dose, route, lot# and expiration date were not reported). No adverse events were reported. No PQC (product quality complaint) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with PROQUAD (Merck) and a dose of VARIVAX (Merck) (dose, route and lot number were not provided) on the same day. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. BENADRYL cream and TYLENOL provided to patient.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Peripheral swelling
Clinical narrative: Patient said she had a small local reaction (red and swollen) which has gotten much larger in the last 2 days. The swelling appears to cover about 5 inches of her arm now.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Periarthritis
Clinical narrative: Diagnosed with frozen shoulder that lasted until March 2013.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Gait disturbance, Muscle spasms
Clinical narrative: Severe back spasms began on the evening of 10/20 that came back intermittently for several days and interfered with normal daily activities.  Severe leg cramps in left calf began on the morning of 10/21 and lasted for 36 hours before relaxing.  I was unable to walk without a limp for almost a month. I had never had leg cramps prior to this event.  General back and leg problems continued off and on until January.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Significant pain in Right shoulder down arm.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Arm is sore at site still but no swelling or redness the patient has complained of persistent, localized pain with no abscess, hematoma, or neuropathy, no structural injury or allergic reaction.
Age: 45.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports large red area on arm, baseball size swelling and soreness.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: CSF white blood cell count increased, Headache, Malaise, Meningitis, Spinal pain
Clinical narrative: Malaise, headache, spinal pain resulting in hospitalization and spinal tap consistent with meningitis.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness neurosensory, Deafness unilateral
Clinical narrative: Unilateral right hearing loss, total.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Rash developed on left side of body covering neck and torso; fever around 102 for 3 days and fits of vomiting. I probably should have gone to the doctor but I suffered through it with fluids and ibuprofen.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Eye irritation, Eye pruritus, Foreign body sensation in eyes, Headache, Pyrexia
Clinical narrative: Scratchy throat; itchy, burning eyes, slight fever, severe headache   Lasted for 24 hours. Took Benedryl. Eyes felt like pieces of glass were in them.  Severe headache lasted 24 hours.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Throat irritation
Clinical narrative: Scratchy throat; itchy, burning eyes, slight fever, severe headache   Lasted for 24 hours. Took Benedryl. Eyes felt like pieces of glass were in them.  Severe headache lasted 24 hours.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Ultrasound scan
Clinical narrative: Patient reports a 10/10 pain radiating from deltiod down entire length of left brachium. Patient also reports decreased range of motion of left arm.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Angiogram abnormal, Asthenia, Balance disorder, Dysarthria, Hypoaesthesia
Clinical narrative: Slurred speech, unbalanced, numbness, weak, mini stroke.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging brain, Scan with contrast, Transient ischaemic attack
Clinical narrative: Slurred speech, unbalanced, numbness, weak, mini stroke.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Contusion, Erythema, Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient said he arm bruised immediatly after administration, site became painful later same day. Over next couple of days patient said bruising and redness got worse. Presented to pharmacy on 12/6/2014 and I referred her to urgent care. Diagnosed with cellulitis and prescribes 7 day course of Keflex.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Sharp shooting pains are injection site, recommended that patient see clinic.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Pain in arm where shot was given and in muscle. It hurt to lift arm. Chills, mild fever, tiredness, headache & sore joints.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Pain in arm where shot was given and in muscle. It hurt to lift arm. Chills, mild fever, tiredness, headache & sore joints.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, protrusion and itch at site of injection and down side of arm.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Swelling, redness, protrusion and itch at site of injection and down side of arm.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Hypoaesthesia, Musculoskeletal pain, Nuclear magnetic resonance imaging normal
Clinical narrative: Extreme pain in rt shoulder, arm & hand (10 out of 10) Numbness in rt forearm and hand. Went to ER 9:00 AM.  Sent home w/norco. Not effective returned to ER on 10/31/2014.  Follow up w/PCP. Still unresolved at present.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Ultrasound scan normal, X-ray normal
Clinical narrative: Extreme pain in rt shoulder, arm & hand (10 out of 10) Numbness in rt forearm and hand. Went to ER 9:00 AM.  Sent home w/norco. Not effective returned to ER on 10/31/2014.  Follow up w/PCP. Still unresolved at present.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Erythema, Herpes zoster, Rash pustular
Clinical narrative: Pt reports single pustular lesion on an erythematous base on her face / non tender / her hx of zoster in her past with non tender lesions on her face x 2 / I treated her with antiviral medication suspecting lesion zoster due to time near to vaccine administration.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Musle pain at injection site-unresolved since injection admin. Throbbing pain at injection site upon strenuous use of muscle. Muscle pain at injection site when arm is lifted to head level.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Received IM injection in left deltoid muscle. Pt complaining of muscle pain in arm of injection site and soreness not allowing pt to lift arm up all the way even after 6 weeks from receiving vaccination.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Hypersensitivity, Lip swelling, Paraesthesia, Urticaria
Clinical narrative: Pt called at 5 pm, approximately 7 hours after vaccine admin. about allergic rxn consisting of hives on head, swollen lips, and tingling in hands. I instructed pt to take BENADRYL - he had taken 2 tablets at 4 pm and reported improved/improving symptoms.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown ages and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot#, strength, dosage, frequency and route unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified child patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. The unspecified amount of children were vaccinated with improperly stored M-M-R II from an unknown date in October 2014 to 25-NOV-2014. No adverse effects were reported. No product quality complaint (PQC) was reported for M-M-R II. Additional information is not expected as the reporter did not wish to contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the patients were vaccinated with GARDASIL (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, GARDASIL was improperly stored for an unspecified amount of time and administered to an unspecified number of patients. No adverse effects reported. The outcome was unknown. Product quality complaint was not reported. No further information provide. This is one of several reports received from the same reporter. 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 physician refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the patients were vaccinated with VAQTA (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, VAQTA was improperly stored for an unspecified amount of time and administered to an unspecified number of patients. No adverse effects reported. The outcome was unknown.. Product quality complaint was not reported. No further information provided. 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: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, RECOMBIVAX HB was improperly stored for an unspecified amount of time and administered to an unspecified number of patients. No adverse effects reported. The outcome was unknown. Product quality complaint was not reported. No further information provided. This is one of several reports received from the same reproter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: This spontaneous report as received from a health care worker refers to a 55 year old female patient. The patient was allergic to latex. The patient's pertinent medical history was unspecified. On 21-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (Dose 0.5 ml) (lot # K007826, expiry date: 03-FEB-2016) in an unspecified arm. Concomitant therapies included prednisolone (manufacturer unknown), ACTIVELLA, LATISSE, levothyroxine sodium (manufacturer unknown), PAXIL, SINGULAIR, ULTRAM, WELLBUTRIN and RESTASIS. On the night of 21-NOV-2014 the patient developed fever of 102 F, felt achy all over, her arm swelled from the shoulder to the elbow and it was bright red and tender to the touch. The patient sought medical attention and no treatment was provided (also reported as treatment given was unspecified). The patient called the physician's office on 21-NOV-2014 to report the adverse experience, but she was not seen in the office. The outcome of the events was unknown. The causality of the events was not provided. No product quality complaint was reported for PNEUMOVAX 23. Lot check was requested. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 8 year and three quarters old male patient. The patient's pertinent medical history was not reported. On an unknown date the patient was vaccinated with 1st dose of GARDASIL (dose, frequency and route were not reported). The patient received GARDASIL before his 9th birth day. No adverse effects reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from consumer via other refers to a 17 year old male patient. The patient's current and historical conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL (lot # K009482 and expiry date was unknown) that has been exposed to temperatures outside of the required temperature range. The efficacy of the GARDASIL outside the temperature range has not been established. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Viral test, Viral titre decreased
Clinical narrative: This spontaneous report as received from a 29 year old female pharmacist who is also a patient. The patient's medical history and current condition was not reported. Approximately in 1997 (reported as at the beginning of 12 years of age) the patient was vaccinated with VARIVAX (Merck) (unknown strength, dose, frequency and lot number). Other concomitant medication includes prenatal vitamins (unspecified). It was reported that initially her titers showed immunity, titers drawn in JUNE-2014 or JULY-2014 showed no immunity to varicella. Lab test includes serological testing for immunity to VARIVAX (Merck). Cancer and overdose was not reported. The outcome of the event was unknown. Additional information has been requested.