chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. The patient was administered the first dose of RECOMBIVAX HB three-dose series on 03-JUN-2014 and had come back to pharmacy on 11-NOV-2015 (today) to be administered second dose of the series. This dosing schedule was outside the labeled recommendations of RECOMBIVAX HB prescribing information. No adverse effects were reported. There was no product quality complaint involved. 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 health care professional refers to multiple unspecified patients of unknown demographics. In 2015 (also reported as multiple unspecified dates ranging from 01-OCT-2015 through 03-NOV-2015) the patients were vaccinated with improperly stored multiple unspecified doses of ROTATEQ suspension 2, lot # L000571; 26-Jul-2016, expiry: and L008574; expiry: 22-NOV-2016 (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 06-NOV-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # L000453 with expiration date of 06-JAN-2017, dose, strength and route unknown) that was improperly stored. No adverse effects reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Headache, Influenza like illness, Oropharyngeal pain
Clinical narrative: 2 days after vaccine administered extremely sore arm, Flu like sx's, armpit and arm sore to touch. 3 days after vaccine fever, H/A small red streak - 1" away from injection site, sore throat. 4 day after vaccine all above sx's resolved except slight red streak. 5 day after vaccine red streak resolved.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 2 days after vaccine administered extremely sore arm, Flu like sx's, armpit and arm sore to touch. 3 days after vaccine fever, H/A small red streak - 1" away from injection site, sore throat. 4 day after vaccine all above sx's resolved except slight red streak. 5 day after vaccine red streak resolved.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. No information about their medical history, concurrent conditions or concomitant drugs was provided. On an unknown date, only two months after the second dose, the patient was vaccinated with the third dose of GARDASIL (site and route of administration, lot# and expiration date not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. In December 2013, the patient received their first dose of GARDASIL (dose, route, lot# and expiration date were not provided). On 04-OCT-2015, the patient received their second dose of GARDASIL (dose, route, lot# and expiration date were not provided). No adverse effect was reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Pain, Sensation of foreign body, X-ray limb normal
Clinical narrative: One week after injection the right arm (place of injection) was painful to try to reach over the shoulder to the back. To lift anything; felt like a needle broke off in the injection area. Complained to Medical they said that was normal and that no needle broke off. Had xrays (twice taken - showed no foreign item in arm) still the same today.
Age: 83.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Activities of daily living impaired, Arthralgia, Gait disturbance, Injection site pain, Laboratory test normal
Clinical narrative: 10-14-15 To doctor for annual wellness checkup. Lab report came back normal. Received my annual influenza shot and my third pneumonia vaccine. 10-15-15 Noticed severe soreness in both upper arms. Checked temperature - subnormal (97). 10-17-15 Had mild pain in hip joints (not in spine or coccyx region) so, at night I applied medicated "Equate" pads and "ICY HOT", a topical  medication. This has continued through present. However, my usual activities were curtailed, such as walking up and down stairs and around 5-acre apartment complex. 10-25-15 Attended church (drove car) but could not walk as briskly as before. As pain increased, I cancelled dental appointment for next week (11-02); and, since then cancelled 11-09 but have 11-16 scheduled if better by then. 10-26-15 Increasing pain. Went to a massage therapist. Had to roll off the table. No better. Continued self treatment; drank sufficient water.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Ice was applied to the injection site on 11/5/15. After removing ice the following were noted: swollen area w/a spilled milk design; the area was red, blue/purple and later became warm to touch. Later that day I saw a Dr. in local urgent care who diagnosed me with allergic reaction to flu shot injection and I was prescribed prednisone 5 mg 1 twice a day, redness subsided bit area that was red is now black.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Feeling abnormal, Laboratory test normal, Loss of consciousness, Pyrexia
Clinical narrative: Mother states child began running fever of 102 by 5:30 on 9/29, took child to see PCP the next day; says child has "felt bad" all week, but today had to take child to ER due to her "blacked out" at school; tests were run, all returned back good. Rxn thought to be related to child getting a 4th dose of HPV4 vaccine.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Nausea, Pruritus generalised, Urticaria
Clinical narrative: Generalized itching, hives, increased HR, nausea.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site induration, Injection site mass, Injection site swelling, Musculoskeletal pain
Clinical narrative: Patient contacted reporter at the Employee flu clinic on 11/03/15. He reported swelling and a hard bump at the injection site that was observed on 10/28/15. He currently has a purple skin discoloration at the injection site, swelling, bump size decreasing and sore arm. Recommend seek medical care if pain continues. 11/6 PHN call to EMS. Patient moving up to upper arm and shoulder. Recommend see healthcare provider.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient contacted reporter at the Employee flu clinic on 11/03/15. He reported swelling and a hard bump at the injection site that was observed on 10/28/15. He currently has a purple skin discoloration at the injection site, swelling, bump size decreasing and sore arm. Recommend seek medical care if pain continues. 11/6 PHN call to EMS. Patient moving up to upper arm and shoulder. Recommend see healthcare provider.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain, radiating down arm to palm.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Acoustic stimulation tests abnormal, Audiogram, Computerised tomogram normal, Deafness neurosensory, Ear pain
Clinical narrative: Fever 101-102, nasal congestion/runny nose earache right. Decreased hearing right. Permanent sensory neural hearing loss right ear.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Ear, nose and throat examination, Hypoacusis, Nasal congestion, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: Fever 101-102, nasal congestion/runny nose earache right. Decreased hearing right. Permanent sensory neural hearing loss right ear.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinorrhoea, Tympanometry abnormal
Clinical narrative: Fever 101-102, nasal congestion/runny nose earache right. Decreased hearing right. Permanent sensory neural hearing loss right ear.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site infection
Clinical narrative: Infection on injection site. Treatment by MD; cephalexin 500mg 2 bid for 10d. On injection site on PREVNAR 13 - (R) delt.
Sex: U
Vaccine: FLU3
Symptoms: Death
Clinical narrative: Initial unsolicited report received from a physician on 05 November 2015. This case was linked to 2015SA179115 and 2015SA179116 (same reporter). This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series and site of administration were not reported) intramuscularly on an unspecified date in 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not reported. On an unspecified date in 2015, following the vaccination, the patient died. Relevant diagnostic tests/laboratory data and corrective treatment was not reported. The outcome was fatal. List of documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Chills, Fatigue, Hyperhidrosis, Malaise
Clinical narrative: Arm so painful it was immobilized.  Rash spreading into armpit like fingers; General feeling of unwell, very tired, nausea, chills, sweats, 104 degree fever.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Nausea, Pain in extremity, Pyrexia, Rash
Clinical narrative: Arm so painful it was immobilized.  Rash spreading into armpit like fingers; General feeling of unwell, very tired, nausea, chills, sweats, 104 degree fever.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: Arm so painful it was immobilized.  Rash spreading into armpit like fingers; General feeling of unwell, very tired, nausea, chills, sweats, 104 degree fever.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, HEP, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: See Dr Note.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nerve injury, Neuropathy peripheral
Clinical narrative: Posterior of arm was erythematous all along the triceps with an area of redness that looked like it pooled at the elbow. I had a mild ulnar neuropathy for 2 days that resolved. Suspect injection hit nerve sheath.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash erythematous, Rash macular
Clinical narrative: About 1 hour after vaccine was administered, employee started itching on scalp, palms of hands and soles of feet. At 6:00PM that night he continued to have symptoms so he showered and took Benadryl 25mg PO. During the night itching continued and he developed a red splotchy rash on palms of hands, soles of feet, under arms and groin area. He took another Benadryl 25mg PO. 11/6/15 - Symptoms were not relieved with previous medications and began a Medrol dose pack. By day 3 all symptoms were resolved.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: GROSS SWELLING, PAIN, REDNESS, PRURITUS WITH INDURATION WITH 7CM DERMACATION LOCALLY ON LEFT DELTOID. TREATED WITH COLD COMPRESS FOR 1st 48HRS AND TYLENOL FOR PAIN.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Soreness and pain in the muscle at the injection site 3 weeks after received shot.  Initially hurt for 3 days after injection then felt better.
Age: 0.42
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: No problems.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Computerised tomogram, Headache, Hypoaesthesia, Lumbar puncture, Nausea
Clinical narrative: Extreme Headache front left behind eye. Some numbness in extremities. Nausea on 11/08/15. Headaches continue through date of report, 11/16/15. Not constant but severe.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Her arm was sore later that afternoon that she received the vaccine. Today every time she touches it, that same area is sore. The soreness has not resolved from the Prevnar vaccine in her right deltoid.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscle strain, Myalgia, Neuralgic amyotrophy
Clinical narrative: Pt reports muscle soreness and some trouble moving arms in certain positions (stated she could not reach to her back).  Pt mentioned symptoms at a PCP visit.  Pt PCP, diagnosed pt with muscle strain and Parsonage-Turner syndrome.  Pt was referred by PCP for followup care with a chiropractor.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Injection site rash, Injection site swelling
Clinical narrative: Shoulder swelling, Rash around site and extreme fatigue/Dazed.
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain, Exposure during pregnancy
Clinical narrative: A report has been received from a health professional (registered nurse) concerning a female patient. Relevant medical history or concomitant medication was not reported. The patient, who was 30 weeks pregnant, received FLUMIST (intranasal) by her general practitioner on 02-Nov-2015. Shortly following the administration, she experienced abdominal pain. She was brought back and it was concluded that the abdominal pain was not contractions. On 03-Nov-2015 the abdominal pain had subsided. The action taken of FLUMIST was unknown. The outcome of the event of pregnant and received drug was unknown. The reporter assessed the event of pregnant and received drug to be serious with serious criteria of important medical event. The company physician has been identified and captured the event of abdominal pain from the source document and assessed it as non serious.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Joint range of motion decreased, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Upper arm pain with limited movement. Activities of daily living hindered. It started at about 2 hours after administration. Took Ibuprofen, but has not had much of an impact on pain. I am unable to sleep on my side or lift my arm. ROM is limited. I continue to be in pain.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test negative, Anaphylactic reaction, Cardiac stress test, Electrocardiogram, Enzyme level test
Clinical narrative: Itching of eyes, ears, nose & throat, followed by mild anaphylatic episodes.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Hypersomnia, Malaise, Pain, Palpitations
Clinical narrative: Itching of eyes, ears, nose & throat, followed by mild anaphylatic episodes.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat irritation
Clinical narrative: Itching of eyes, ears, nose & throat, followed by mild anaphylatic episodes.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: Fever, weakness, headache for four days after administration.
Age: 31.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Chills, Nausea
Clinical narrative: Intense nausea and stomach pain, chills - stomach cramps after send dose of pill oral typhoid as well, stopping treatment early now.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Warm, firm, swollen, area on her posterior left arm where her shingles vaccination was administered.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: Fever, shaking chills, headache, sore arm.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Abdominal tenderness, Decreased activity, Enema administration, Laboratory test, Lethargy
Clinical narrative: Decreased appetite for one day. Bilious emesis times one in the evening of the same day. Tender abdomen. Lethargy. Treatment included an air enema in radiology for reduction.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Decreased appetite for one day. Bilious emesis times one in the evening of the same day. Tender abdomen. Lethargy. Treatment included an air enema in radiology for reduction.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with the first dose of ROTATEQ orally (dose, lot# and expiration date were not reported). On an unknown date, within one week, the patient had "a short episode: of bloody stools. On an unknown date, the patient was vaccinated with the second dose of ROTATEQ orally (dose, lot# and expiration date were not reported). The physician mentioned the patient had the same experience of bloody stools. The patient was sent to the emergency room for evaluation on an unspecified date after the second dose. The patient sought medical attention via office visit. The outcome of the event was reported as recovered/resolved on an unknown date. The relatedness between he event and ROTATEQ was not reported. Additional information is not expected.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency and route were not reported) (lot# K010215 and expiration date 05-MAY-2017) and confirmed not GARDASIL. MMR II and PNEUMOVAX 23 appeared on the product list, because stability questions were asked about these products and no doses of improperly stored MMR II and PNEUMOVAX 23 were administered. No adverse effects were reported. No Product Quality Product (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 05-NOV-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date were unknown, 0.65 ml) subcutaneously. On 10-NOV-2015, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX (lot#, expiration date, dose and route were unknown) at an unspecified clinic. No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at injection site with additional swelling below injection site.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Left arm pain radiating from shoulder down to forarm. Constant ache in arm and sharp pains with movemnet. Started day after vaccine administration and has worsened since.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, X-ray normal
Clinical narrative: Patient reported to pharmacy on 11/16/15 extreme arm pain and arm movement limitation one hour after vaccine administration on 10/30/15. Patient contacted pharmacy where vaccine was administered 16 days after injection. Patient reported seeing Primary Care physician on 11/2/15 complaining of right shoulder pain. Xrays didn't show anything so patient was given steroid injection. On 11/9/15 patient again contacted PCP complaining of arm soreness and pain and then mentioned they had Flu and Pneumonia vaccine. Reported arm soreness to pharmacy on 11/16/15.
Age: 33.0
Sex: F
Vaccine: FLU4, HEPAB, TDAP, TYP
Symptoms: Activities of daily living impaired, Chills, Hyperhidrosis, Injection site pain, Injection site swelling
Clinical narrative: 10/14/15, 3PM, significant swelling and pain left upper arm, chills/diaphoresis. 10/15: no chills/diaphoresis. Pain increased, pt unable to lift arm or perform ADLs for 4 days. Significant improvement by 10/20.
Age: 33.0
Sex: F
Vaccine: FLU4, HEPAB, TDAP, TYP
Symptoms: Mobility decreased
Clinical narrative: 10/14/15, 3PM, significant swelling and pain left upper arm, chills/diaphoresis. 10/15: no chills/diaphoresis. Pain increased, pt unable to lift arm or perform ADLs for 4 days. Significant improvement by 10/20.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Left Bell's palsy.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash macular, Skin lesion
Clinical narrative: Generalized red macular discrete lesion on face, arms, legs, abdomen, groin and back. No hives noted.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Woke up in middle of night with very sore, red arm.  Continued to get worse red and swollen all to way around the arm.  Saw doctor on Wed Nov 4th who determined it to be cellulitis and started tx with abx.  Pt still recovering and taking abx as of Nov 16.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Soreness of the arm for more than 3 weeks.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired driving ability, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Slight soreness 1 day after injection, however, on 11/15/15 experienced complete Left Arm soreness in which she could not lift her arm or pick anything up. She cannot drive either.
Age: 64.0
Sex: M
Vaccine: TD
Symptoms: Joint range of motion decreased, Pain, Periarthritis, X-ray
Clinical narrative: Normally expected soreness did not go away. Pain became progressively worse, and limited range of motion (left shoulder) developed over next several weeks. Orthopedist diagnosed "frozen shoulder" also known as adhesive capsulitis.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Pt came to clinic on 11/13/15 for follow-up.  MD ordered pneumococcal conjugate 13-valent vaccine (Prevnar 13) and nurse gave the 0.5ml vaccine IM in the left deltoid at 1149 per documentation (Wyeth-Ayerst lot # M13068, NDC # 0005-1971-01.  Patient returned to clinic on 11/16/2015 for follow-up and nurse noted mild redness at the injection site.  Pt reported that it has been red for several days with mild reaction.  Pt stated that she had no fever or chills.  The site was not warm or painful to touch on 11/16/15.
Sex: U
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history and concurrent condition was not reported. On an unknown date, the patient was vaccinated with MMR II. No information on concomitant medications was provided. On an unknown date, the patient developed rash on an unspecified part of the body during an unknown period of time after receiving MMR II. The outcome of the event and the relatedness of the event with the suspect drug was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event, Product quality issue
Clinical narrative: This spontaneous report has been received from a physician and refers to three unspecified patients of unspecified gender and age. The patient medical history and concurrent conditions were not reported. The physician stated that the three unspecified patients were delayed in receiving start of therapy with MMR II (dosage, frequency, lot number not reported) because the carton the office received was empty. A product quality complaint was filed. No adverse event symptoms were reported. Additional information has been requested.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Itching.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Rash
Clinical narrative: Rash on lower left arm - lasted almost 7 days. Tingling and numbness is still going on randomly each day.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 62-year-old female patient who received FLUARIX. In October 2015, the patient received FLUARIX .5 ml. On 11th October 2015, less than a month after receiving FLUARIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was recovered/resolved. The reporter considered the vesicular rash to be probably related to FLUARIX. Additional details were provided as follows: This case was previously reported to a doctor. The doctor reported that the patient blistering red rash after receiving the vaccination. The date of vaccination and batch number of the vaccine was unknown. The doctor was unsure of the injection site and vaccine administration site was not available.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response, Product quality issue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of therapy non-responder in a 58-year-old female patient who received ENGERIX B adult (batch number 995J5, expiry date 6th February 2017). This case was associated with a product complaint. Co-suspect products included ENGERIX B adult (batch number 995J5, expiry date 6th February 2017) and ENGERIX B adult (batch number 9937B, expiry date 2nd October 2017). On 20th January 2015, the patient received the 1st dose of ENGERIX B adult. On 20th February 2015, the patient received the 2nd dose of ENGERIX B adult. On 17th July 2015, the patient received the 3rd dose of ENGERIX B adult. On 15th September 2015, 238 days after receiving ENGERIX B adult, 207 days after receiving ENGERIX B adult and 60 days after receiving ENGERIX B adult, the patient experienced therapy non-responder. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder and pharmaceutical product complaint were unknown. The reporter considered the therapy non-responder to be possibly related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details provided were as follows: This case was one of the seven reports reported by an occupational nurse for patients tested negative for hepatitis B titers following vaccination with ENGERIX B (see cases US2015135763, US2015GSK136757, US2015GSK136759, US2015GSK136760, US2015GSK136761 and US2015GSK136762). The caller reported that, they had their laboratory equipment recalibrated and the tests were rerun and results were same or even lower titers. The patient concerned in this case received 1st dose of ENGERIX B adult vaccine on 20th January 2015. On 20th February 2015, the patient received the 2nd dose. On 17th July 2015, the patient received the 3rd dose. On 15th September 2015, 238 days after receiving 1st dose of ENGERIX B adult, 207 days after receiving 2nd dose of ENGERIX B adult and 60 days after receiving 3rd dose of ENGERIX B adult, the patient underwent test for hepatitis B antibodies and it was found to be negative with value of 2.4, causing the patient to be a non-responder to the therapy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around site of immunization on right thigh. Treated with AUGMENTIN BID for 10 days.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pain
Clinical narrative: Family called on 11/11/15. Redness and swelling noted on 11/11/15 (L) deltoid region. Mild pain flu shot given 2 days earlier. No problems with post flu shots. Exam: 6 x 9 cm pinkness, induration, mild tenderness (L) upper arm 21 cm circumference (R) upper arm 19.5 cm circumference. No systemic findings.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Injection site area was hot, red, blotchy and painful. Patient sought care with physician's office and was prescribed antibiotics. Physician told the patient she had cellulitis.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: Injection site area was hot, red, blotchy and painful. Patient sought care with physician's office and was prescribed antibiotics. Physician told the patient she had cellulitis.
Age: 34.0
Sex: F
Vaccine: FLU3, HEPA, MMR, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Visit 11/13/15 arm redness and swelling 5 1/2" x 3". Thickened red area in center of larger swollen area. Warm and tender to touch. Client states swelling began day 1 after vaccination in right arm. She received Tdap and flu shot. Unaffected arm received (left arm) Hep A and MMR. 11/13 saw Dr at office, no Rx - sent client to an urgent care for MD f/u if nec. Diagram of erythema 8 1/2" -> 11/16 called pt, states getting a little better, size smaller.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pallor, Rash pruritic
Clinical narrative: Right shoulder down 27 cm is a blanching rash with mild erythema that is same temp as other arm. Mainly outer arm and rash is pruritic but not painful. Treatment: Continue BENADRYL or CLARITIN and follow up if worse.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Significant pain at injection site and shoulder has continued x 1 month and treatment through chiropractor and taking ibuprofen -> othopedic physician 11/16/15.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Heart rate decreased, Syncope
Clinical narrative: Two brothers came in to get shots. Older brother (18) went first did fine. 15 year old went second said he was okay and fine. Ask him several times. He said okay walked away couple of steps fainted blood pressure, heart rate dropped low called ambulance. He was taken to ER gave steroids released. Called 8:25 fine. Called same day fine. Released. Everything was fine when released blood pressure and heart rate resolved talke to mom twice.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Pruritus, Urticaria
Clinical narrative: 11/12/15 955A flu vaccination quadrivalent FLUZONE given. No prior rxn, allergies or concerns. On 11/13 919A pt RTC with concern for hives, external itch to (B) axilla and (B) medial thigh beginning at 11pm 11/12/15 and then resolving overnight now with (B) feet tingling - more internal that has resolved. T 98.4 122/74, HR 60 RRR, RR 105 at 98 RA exam NL lungs CTA, no lesions, NVD, hives or angioedema noted to keep PMD FU today.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient on 11/15/15 reported to store manager for the first time he was experiencing pain in the arm that he got the vaccine. It continued for more than 3-4 days. Visited family MD.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Participant advised nurse of dull pain at injection site, following numbness in fingers and hand and also swelling of hand. approx 1hr 20 min later reporting inability to lift arm.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Influenza, Influenza like illness, Pain
Clinical narrative: Flu like symtoms, flu, and general soreness.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site infection, Injection site rash, Injection site swelling
Clinical narrative: PT CAME IN WITH SWOLLEN LIKE RASH AT INJECTION SITE-- STARTING TO GET INFECTED. TOLD PT TO KEEP AN EYE AND APPLY TOPICAL ABX, NEXT DAY IN THE PM BECAME ALOT WORSE AND LARGER-- SENT PT TO URGENT CARE -PT THEN RECIEVED ORAL ABX.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Ear pain, Injected limb mobility decreased, Injection site pain, Neck pain
Clinical narrative: Injection site soreness..trouble lifting arm...pain from right under left ear, back of neck to elbow and under arm. Tingling in left hand & fingertips.  One month later, all except injection site soreness is still present.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: Injection site soreness..trouble lifting arm...pain from right under left ear, back of neck to elbow and under arm. Tingling in left hand & fingertips.  One month later, all except injection site soreness is still present.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Asthma, Ear infection, Eczema, Intussusception, Pneumonia
Clinical narrative: Intussusception, asthma, ear infections, pneumonia, eczema.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Blood test, Chest X-ray, Electroencephalogram normal, Febrile convulsion, Nuclear magnetic resonance imaging normal
Clinical narrative: 15-20 min complex febrile seizure requiring hospitalization and administration of midazolam intranasal by paramedics to break seizure. MRI and EEG obtained and were normal.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Vomitting, chills, fever and body aches. Went to Hospital.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Child birthday was 10/18/15 baby turned three and was given a two year old dose, mother notified and will bring child in for second half asap.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Red macular patch rash right below injection site, denied pain, pruritus, fever, chills. Did not try any treatments prior to seeing me.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Chills, Headache, Hypotension, Nausea
Clinical narrative: Tremors, chills and increased Blood pressure (190/60). No fever.  Headache and nausea.  Later in evening and overnight blood pressure low: 44/23 and 77/54 before recovering in morning to 125/86. Recommended that patient seek medical attention immediately.  Do not know outcome.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Tremors, chills and increased Blood pressure (190/60). No fever.  Headache and nausea.  Later in evening and overnight blood pressure low: 44/23 and 77/54 before recovering in morning to 125/86. Recommended that patient seek medical attention immediately.  Do not know outcome.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pt states had the expected soreness after the vaccine, then had shooting pain to the shoulder area starting on 11-11-2015 while playing basketball. Shooting pain continued if pt moves arm. At rest there is no pain. Region where the shot was given looks normal per pt. Pt states no history of unexpected reactions getting previous flu vaccines or any other vaccines.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Injection site was "black". 11/15/2015: Patient started feeling itch/pain (1 week after administration on 11/9/15). Patient put ice packs, swelling went down. Area felt warm to the touch. Patient was consulted to visit with physician on 11/16/2015 and is willing to comply.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Pruritus, Rash
Clinical narrative: Vaccine was given on 11/11/2015. One hour later patient was dizzy and sweaty. That same night patient broke into a rash. Patient took Benadryl by mouth, which helped a little bit but was still really itchy. Patient is going to doctor and still has rash and itch.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Hypersensitivity, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient awoke next day Left Arm red & painful, applied ice and took regular anti-inflammatory. Went to doctors on 10/9/15 arm red, sore, swollen, unable to use, swollen from armpit to elbow. Nurse called said patient had allergic reaction to either Fluarix quad or Pneumovax-23 which were both given in left arm. Given prescription for Benadryl and reaction was resolved by 10/12/15.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Gastric disorder, Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain in Left arm (site of injections), gastric distress.  Diagnosised as cellulitis
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Polymyalgia rheumatica
Clinical narrative: Stiffness in arms, legs. Unable to bend arms and legs.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal pain, Pain, Polymyalgia rheumatica
Clinical narrative: Stiffness in arms, legs. Unable to bend arms and legs.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Large hard lump that was hot to the touch at the injection site. Injection site very tender. Severe chills followed by fever. The following two days- general malaise.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Large hard lump that was hot to the touch at the injection site. Injection site very tender. Severe chills followed by fever. The following two days- general malaise.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Myalgia, Vomiting
Clinical narrative: All night had chills, shivering, muscle aches, head ache, vomiting (one time in the middle of the night.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Injection-site pain/soreness/tenderness/ swelling/induration.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash--started small and then spread towards elbow.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Laboratory test normal, Migraine
Clinical narrative: Severe persistent migraine headaches.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Patient complains of soreness after shot was received on 11/3/2014. Lingered on for 2-4 weeks, or more especially when applying pressure or leaning on arm that shot was received. Soreness has subsided but still is experiencing some irritating pain when leaning on the arm. Have spoke to her PCP for treatment.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain occurring during injections.  Pain did not subside after.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Muscle twitching
Clinical narrative: Patients states that once in a while he gets muscle twitching at the injection site and that it shock like pain.  The pain comes and goes.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Left shoulder pain, inability to raise above head.
Age: 0.24
Sex: M
Vaccine: 6VAX-F, PPV, RVX
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Swelling legs. Redness in skin on legs and stomach.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Imaging procedure, Mobility decreased, Pain, Rotator cuff syndrome, Sleep disorder
Clinical narrative: Patient could not lift up arm.  It has been 3 weeks still in a lot of pain and cannot sleep due to pain.  Has been to internist, orthopedic and physical therapy.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Blister, Fatigue, Headache, Herpes zoster, Paraesthesia
Clinical narrative: Shingles - Headache, fatigue started 11/7, tingling 11/9, shingles blisters 11/12/15.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Discomfort, Immediate post-injection reaction, Pain, Spinal pain
Clinical narrative: I immediately experienced discomfort and chills and pain up & down my spinal column. I have been in extreme pain since I received the vaccine. This pain was instant & immediate!! And it has never stopped. I'm in pain night & day!!!
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia
Clinical narrative: Patient's wife came into pharmacy stating that patient was having pain in the left arm where the shot was given. There is no redness nor bruising according to patient's wife however they complained of muscle pain still on 11/16/15.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia
Clinical narrative: Patient returned to the pharmacy on 11/16/15 stating she was still having pain in her left arm where the shot was given. There is no redness nor bruising but she was still complaining of muscle pain on 11/16/15.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Scar, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician and healthcare worker and referring to a 5 year old female patient. The patient had no pertinent medical history, drug reactions or allergies. On 01-MAR-2011, the patient was vaccinated with one dose of VARIVAX (Merck) (dose, frequency, route of administration and indication were not reported, lot number reported as 1054Z). There were none concomitant therapies. On 28-OCT-2015 (reported as "about 2 weeks ago"), the patient developed chickenpox. The reporter stated the patient visited an unspecified emergency room, but she was uncertain whether the patient was admitted to the hospital. In 2015, the patient recovered from the chickenpox, but now has "scars all over her body" where the chickenpox lesions were. No treatment was given for the events. The outcome of scar was not reported. The physician reported that due to the length of time between receipt of VARIVAX (Merck) and the development of chickenpox, she did not feel the chickenpox could have been a vaccine-related rash and must have been caused by wild-type varicella. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Blood glucose decreased, Blood test normal, Decreased appetite, Diarrhoea, Intensive care
Clinical narrative: Day 1: Fever in evening. Day 2: Lost appetite, could not keep down TYLENOL, had severe diarrhea. Day 3: Patient given IMMODIUM by spouse. Day 4: 911 called; Blood sugar was 17; Taken to ER and waited 7 hours. Now in ICU for Sepsis.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia, Sepsis, Staphylococcus test positive, Vomiting
Clinical narrative: Day 1: Fever in evening. Day 2: Lost appetite, could not keep down TYLENOL, had severe diarrhea. Day 3: Patient given IMMODIUM by spouse. Day 4: 911 called; Blood sugar was 17; Taken to ER and waited 7 hours. Now in ICU for Sepsis.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pulse absent, Respiratory arrest
Clinical narrative: This 6-7 wk old child was given his 2 mo vaccines on 11-5-15. He was found without resp or pulse the morning of 11-6-15 in Mother's home not sure if he was in a crib or mother's bed.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Demyelination, Electromyogram abnormal, Guillain-Barre syndrome, Quadriplegia, Respiratory failure
Clinical narrative: Guillain Barre with quadriplegia and respiratory failure.
Age: 82.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Sore, inflamed right arm at injection site - son is reporting event.
Age: 83.0
Sex: U
Vaccine: FLU3
Symptoms: Respiratory tract congestion, Sinus congestion
Clinical narrative: Per patients daughter, soon after the vaccine she had very bad congestion both sinus and chest.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The patient is a healthy 7 yo male received FLUARIX (lot # not documented) on 19 Oct 2015. Mother states he received IIV and 3 days later noted a large area at the injection site of erythema, edema and warmth to touch from shoulder to 2/3 of upper arm. She thinks it might have been tender but he did not specifically complain. She noted no pruritus. She treated it with warm soaks and it resolved in approximately 3 days. There were no vesicles, urticaria, macules, papules or scaling. She states he has not received IIV since he was a baby and consistently has done well with FLUMIST.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: Still has slight pain (L) upper arm and shoulder intermittently (at site and in joint).
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Joint range of motion decreased, Pain, Peripheral swelling
Clinical narrative: Received Hep B shot 11/4/15. Noticed soreness not improving within 3-4 days. Swelling in arm noticed Thurs 11/12/15. Decreased ROM noticed on 11/10/15. Not improving.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Abnormal faeces, Faeces discoloured, Gait disturbance, Pyrexia, Vomiting
Clinical narrative: Fever 102.2 3.5 hours after 15 mo vaccines, would not walk for 1.5 days, vomited x 1 4 hours after vaccines, loose green smelly stool x 1, fussiness x 3 days. Treatment Acetaminophen and Ibuprofen. Fever on and off x 3 days.
Age: 66.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Erythema, Feeling hot, Immediate post-injection reaction, Pruritus, Pyrexia
Clinical narrative: Immediately arm started itching then redness and fever began. Called doctor 5 days later who recommended BENADRYL. BENADRYL controlled itching but redness and heat continued. On 11/14 went to ER confirmed that it was a reaction and gave her ranitidine and prednisone; seems to have helped but it made her hyper - a side effect. ER doctor noticed that redness spreading down arm. Today will call doctor to follow-up and see if antibiotic required.
Age: 66.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Vaccination complication
Clinical narrative: Immediately arm started itching then redness and fever began. Called doctor 5 days later who recommended BENADRYL. BENADRYL controlled itching but redness and heat continued. On 11/14 went to ER confirmed that it was a reaction and gave her ranitidine and prednisone; seems to have helped but it made her hyper - a side effect. ER doctor noticed that redness spreading down arm. Today will call doctor to follow-up and see if antibiotic required.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Rash
Clinical narrative: This spontaneous report was received from a female consumer of unknown age regarding herself. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23, (dose, anatomical location, route, lot number and expiration date were not reported). There was no concomitant medication reported. The reported stated that after she was vaccinated with PNEUMOVAX23 she broke out (adverse event), the patient did not specify what she meant by broke out. The patient also mentioned that she had an unspecified injection site reaction after being vaccinated. At the time of the report, the outcome of the broke out and the unspecified injection site reaction after being vaccinated was unknown. The relatedness between the event and therapy with PNEUMOVAX23 was not reported. Additional information is not expected because no contact details were available.