chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain
Clinical narrative: Information has been received via facility from a 55 year old female nurse referring to herself with asthma, sinus infection and migraine. The patient's medical history included separated shoulder. The patient received a flu shot and a tetanus shot in the past. Concomitant therapies included baclofen for migraine and unknown medications for asthma. On 03-MAR-2017 at about 16:30, the patient was vaccinated with PNEUMOVAX23, one dose (lot # and expiration date unknown), intramuscularly in her upper left deltoid one time for prophylaxis. On the same day, since receiving the vaccine, the patient was experiencing muscle pain that was spreading to her shoulder, pectoral muscle in her chest, muscles in her lower neck, the front and back of her rhomboid muscle from her shoulder to her spine. She also had pain in her deltoid and armpit. The pain was so severe she could not abduct or lift her arm and she felt like she had a separated shoulder or a sprained shoulder. She reported she could not lift anything or move her arm to the point that she could not reach behind herself to put on a shirt or bra. She also was experiencing severe pain under her collar bone. The pain was significant enough to cause her to need to brace her arm against her body. She could not get comfortable or sit down. The pain was spreading. Relevant laboratory data for the events was unknown. As of the reporting time, the patient no longer received PNEUMOVAX23 and the events persisted (not resolved). The causality between and PNEUMOVAX23 was not provided. The reporter considered the events to be medically significant. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA002496.
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient. There were no patient's concurrent conditions, medical history nor concomitant therapies. On 15-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming unit (PFU) with lot number M026874 and expiration date of 19-JUL-2017 (dose, route of administration and anatomical location were unknown) for prophylaxis. On 04-MAR-2017 (reported as "3 days ago"), the patient developed a cold sore on an unspecified location. The patient was seen by an unspecified physician and that physician prescribed him an unspecified dose of acyclovir to treat the event. There were no laboratory diagnostics studies performed. At the time of reporting, the patient was not recovered from the event. The causality between ZOSTAVAX and oral herpes was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection lot# L027733, expiration date: 13-SEP-2017, lot# L039660, expiration date: 04-FEB-2018, lot# M000442, expiration date: 03-MAR-2018 (dose and route of administration were not reported). The temperature excursion ranged between 32 and 36 degrees Fahrenheit and lasted 72 hours. There was no previous temperature excursion. Digital data logger was not used. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005129: US-009507513-1703USA005128: US-009507513-1703USA000842: US-009507513-1703USA005127:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection, lot# M001811, expiration date: 04-NOV-2018, lot# M014927, expiration date 18-FEB-2019 (dose and route of administration were not reported). The temperature excursion ranged between 32 and 36 degrees Fahrenheit and lasted 72 hours. There was no previous temperature excursion. Digital data logger was not used. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005129: US-009507513-1703USA005128: US-009507513-1703USA005126: US-009507513-1703USA000842.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site pain
Clinical narrative: SEVERE PAIN AT THE SITE (RIGHT DELTOID) OF MENACTRA VACCINE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site discolouration, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: The day (day 2) after vaccinated child had bruising at injection sites the size of a 50 cent piece.  At 2:30 am child woke his mother c/o of his leg "aching".  Day 3 he had "whelps 3 inches in diameter with a white center all the way to the bone".  The "thigh was so swollen his pants won't go over the leg".  The thigh was hot to touch, but child did not have a fever.  Day 4 he c/o itching.  Day 5 he was better.  Mother was giving Bendryl since Day 1.  Day 10 child has dark marks at the injection site and has been doing fine for the past 6 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Urticaria
Clinical narrative: The day (day 2) after vaccinated child had bruising at injection sites the size of a 50 cent piece.  At 2:30 am child woke his mother c/o of his leg "aching".  Day 3 he had "whelps 3 inches in diameter with a white center all the way to the bone".  The "thigh was so swollen his pants won't go over the leg".  The thigh was hot to touch, but child did not have a fever.  Day 4 he c/o itching.  Day 5 he was better.  Mother was giving Bendryl since Day 1.  Day 10 child has dark marks at the injection site and has been doing fine for the past 6 days.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Erythema, Mobility decreased, Myalgia, Nausea
Clinical narrative: This is a spontaneous report from a contactable nurse.   A 18-year-old female received TRUMENBA (NDC number: 0005-0100-10; Lot Number: M77282;Expiry date: Jun2017), on 01Mar2017 around noon, at 0.5 ml single for immunisation. Medical history included rheumatoid arthritis. Concomitant medications included ibuprofen for rheumatoid arthritis. On 01Mar2017 patient's arm was red, swollen  and hot, she had a fever of 100, was real achy, nauseated and had chills and muscle ache and could not raise her arm.On  02Mar2017 patient's arm was warm and swollen, there was no redness and patient can only raise it half way. Events muscle ache , could not raise her arm and arm swollen improved but were still ongoing. All other events completely recovered on an unknown date.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse.   A 18-year-old female received TRUMENBA (NDC number: 0005-0100-10; Lot Number: M77282;Expiry date: Jun2017), on 01Mar2017 around noon, at 0.5 ml single for immunisation. Medical history included rheumatoid arthritis. Concomitant medications included ibuprofen for rheumatoid arthritis. On 01Mar2017 patient's arm was red, swollen  and hot, she had a fever of 100, was real achy, nauseated and had chills and muscle ache and could not raise her arm.On  02Mar2017 patient's arm was warm and swollen, there was no redness and patient can only raise it half way. Events muscle ache , could not raise her arm and arm swollen improved but were still ongoing. All other events completely recovered on an unknown date.
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (mother). A 19 year old female patient received the first dose of TRUMENBA on 26Aug2016; the second dose on an unspecified date and the third dose on 05Mar2017, all at single dose, for immunization. Relevant medical history was unknown. Concomitant medications were none. On an unspecified date, the patient experienced flu like symptoms and her arm was sore after the administration of the first dose of TRUMENBA and only her arm hurt after the second and the third dose. Clinical outcome of the events was unknown at time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pruritus
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer Sales representative. A patient of unknown age and gender received PREVNAR 13) at single dose for immunization via unspecified route on unknown date. Medical history and concomitant medication were not reported. The patient experienced itching at the injection site.  No follow-up attempts are possible. No further information is expected.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Movement disorder, Seizure like phenomena
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of dyskinesia in a 6-month-old female patient who received PEDIARIX (batch number M9L74, expiry date 18th November 2018). Concomitant products included PEDVAXHIB, PREVNAR and ROTATEQ. On 21st February 2017 17:00, the patient received the 3rd dose of PEDIARIX (intramuscular) .5 ml. On 21st February 2017, several hours after receiving PEDIARIX, the patient experienced dyskinesia (serious criteria hospitalization and other: As per reporter). On an unknown date, the outcome of the dyskinesia was unknown. It was unknown if the reporter considered the dyskinesia to be related to PEDIARIX. Additional details were provided as follows: The patient had no known allergies and no medically significant medical history. The patient had symptoms of seizure like disorder a few hours after the vaccines. The patient was taken to the emergency room and was admitted. She was evaluated by a neurologist in the hospital who diagnosed her with benign paroxysmal movement disorder, per reporting physician. On 2nd March 2017, the patient was discharged from the hospital. The reported batch number for PEDIARIX (M91L74) did not exist and was updated to M9L74 as per sales data sheet.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site oedema, Injection site swelling
Clinical narrative: Patient developed localized swelling at the site of her DAPTACEL vaccination on her left upper arm which gradually became edematous leading to a 3 cm difference in circumference. 18 1/2 cm right arm/21 1/2 cm left arm. Otherwise well. Using BENADRYL orally.
Age: 27.0
Sex: F
Vaccine: YF
Symptoms: Paraesthesia oral
Clinical narrative: Pt received YF VAX for travel plans at 12:25. Had Pt stay for observation 45 mins. At 1:00 pm tongue tingle. 10 mins later mouth tingle. 911 called and ambulance ride 1:15 PM.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Full blood count, Influenza virus test positive, Injection site reaction, Pyrexia, Rash macular
Clinical narrative: Rash-splotchy hive like one leg where shot was given from knee to foot fever 103.4 started midnight same day vomited once 3/8/17.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria, Vomiting
Clinical narrative: Rash-splotchy hive like one leg where shot was given from knee to foot fever 103.4 started midnight same day vomited once 3/8/17.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient noticed next day redness and swelling and soreness from injection site. Site described as left upper inner arm. Wednesday swelling and redness was enlarged. She come to pharmacy and showed me. I told her it looked infected and go see MD of clinic. She saw primary care MD who prescribed KEFLEX and MEDROL Dose Pack.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Pt. was given expired vaccine (DTAP) lot # below only to see this happened after I administered it. Call Sanofi Pasteur got CDC recommendations, notified doctor then called mom on phone to notify her.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle and joint pain, mostly in upper body, that started about one week after injection. Treating with ibuprofen and massage. Symptoms still present but not worsening.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Influenza like illness, Pain in extremity, Pain of skin, Peripheral swelling
Clinical narrative: Fever - 3 to 4 days - joints ached, arm swollen, given on 2/20/17 hurt for 1 week sore, felt like had the flu, skin sore.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever - 3 to 4 days - joints ached, arm swollen, given on 2/20/17 hurt for 1 week sore, felt like had the flu, skin sore.
Age: 1.25
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Injection site rash, Injection site reaction, Rash maculo-papular
Clinical narrative: Rash erupted on (R) upper thigh 10-11 days after vaccination; 5 maculopapular lesions on (R) upper thigh; non-vesicular; non-pruritic; mom states that 1% HC cream helps.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Fall, Injection site nodule, Peripheral swelling
Clinical narrative: Patient states that her arm was swollen and had a "small knot" at immunization site. She took ALEVE and applied ice pack to affected area and now her arm is much better. Patient also mentioned that she has suffered a fall since she received immunization.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Severe soreness in left arm after shot. Next day, soreness was followed by severe aches in shoulders and shooting down to wrist. Discussed the aches with Dr, who was treating my right shoulder due to a fall in August. He prescribed pt. symptoms continue.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Vision blurred
Clinical narrative: Patient developed blurred vision and a headache right after receiving Hep A vaccine. These symptoms continued the next day. This lasted for 3 days.
Age: 57.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Bone marrow oedema, Injected limb mobility decreased, Injection site swelling, Iontophoresis
Clinical narrative: Severe pain x 2 months; moderate pain x 4 months. Swelling and restricted ROM (L) shoulder, weakness. Trtmt: Prednisone, ultrasound, Iontophoresis with dexamethasone, elect. stim., PROM.
Age: 57.0
Sex: F
Vaccine: RAB
Symptoms: Muscle electrostimulation therapy, Nuclear magnetic resonance imaging abnormal, Pain, Ultrasound scan
Clinical narrative: Severe pain x 2 months; moderate pain x 4 months. Swelling and restricted ROM (L) shoulder, weakness. Trtmt: Prednisone, ultrasound, Iontophoresis with dexamethasone, elect. stim., PROM.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Unevaluable event
Clinical narrative: GAVE DOSE OF PPSV23.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Cerebral infarction, Computerised tomogram head abnormal, Confusional state, Encephalopathy, Full blood count normal
Clinical narrative: Pt developed encephalopathy of unclear etiology, and was hospitalized.  Found to have low grade UTI, possible old stroke findings on head Ct VS new small infarcts, h/o alcoholism confounding the picture as well. Hospitalized 2/28/2017 through 3/3/2017, still requires cane, still confused, needs PT and also cognitive and speech therapy.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Metabolic function test normal, Urinary tract infection, Urine analysis abnormal, Walking aid user
Clinical narrative: Pt developed encephalopathy of unclear etiology, and was hospitalized.  Found to have low grade UTI, possible old stroke findings on head Ct VS new small infarcts, h/o alcoholism confounding the picture as well. Hospitalized 2/28/2017 through 3/3/2017, still requires cane, still confused, needs PT and also cognitive and speech therapy.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: No adverse event, however this was the 2nd dose with the previous one administered 2/23/2016.  This dose of pneumococcal vaccine should have been PPSV23.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Peripheral swelling, Pyrexia
Clinical narrative: Patient complained of swelling and fever in the arm..says it did not happen right away. Several days later?? She seemed unsure of onset. Had trouble lifting arm for a few days. Talked to patient on 3/6/2017. Reported adverse event to pharmacist on duty Sat. March 4.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 15-AUG-2009, the patient was vaccinated with GARDASIL fist dose, when she was 10 years old (route, dose, frequency, lot # and expiration date were unknown) for prophylaxis. Subsequently, on 31-JUL-2009, 11 months 17 days after the first dose the patient was vaccinated with the second dose of GARDASIL (route, dose, frequency, lot # and expiration date were unknown) for prophylaxis. The medical assistant stated that the patient at the time of the report was on the office to received the third dose of GARDASIL. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular, Rash pruritic, Skin haemorrhage
Clinical narrative: This spontaneous report was received from a 36-year-old female consumer regarding herself with double bypass surgery and drug reaction or allergies to acetaminophen, propoxyphene napsylate (DARVOCET) and penicillin. The patient's concomitant therapies included rosuvastatin calcium(CRESTOR), aspirin(manufacturer unknown) and isosorbide. On 13-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX, intramuscularly, (dose, anatomical location, lot number and expiration date were not reported) for prevention of shingles. On the same day, the patient was experiencing bumps on her arms and legs that were bleeding and itchy. The patient was unaware if they were bleeding because she was scratching them (skin haemorrhage, rash papular and rash pruritic). The patient sought  medical attention and the physician prescribed prednisone (manufacturer unknown) for the events, no laboratory diagnostics studies were performed. At the time of the report, the patient stated that "it got a little better" but she did not recovered from the skin haemorrhage, rash papular and rash pruritic  and when she ran out the medication, the symptoms fully returned. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Expired product administered, Influenza like illness
Clinical narrative: This spontaneous report was received from a 65-year-old female consumer regarding herself with high blood pressure, osteoporosis, aortic insufficiency and hypothyroidism and sensitive to narcotics. The patient's concomitant therapies included losartan potassium (+) hydrochlorothiazide (manufacturer unknown). On 15-FEB-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 route reported as injection, lot number reported as 013428 with expiration date 03-FEB-201, (dose and anatomical location were not reported) to prevent pneumococcal disease. On the same day, the patient experienced "chills" the evening after being vaccinated with PNEUMOVAX 23, she felt "like she was getting the flu" but she did not have high temperature. The patient sought medical attention by calling the nurse prescriber when she learned that the PNEUMOVAX 23 was expired but the office had not called back as of the time of this report. None laboratory diagnostics were performed and no treatment was prescribed for the events, although the patient self-medicated with ADVIL at 6 pm on the same day she was vaccinated with PNEUMOVAX 23 and again at 2 am in the following morning. At the time of the report, the patient recovered from the chill and influenza on unspecified date in 2017. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received on 03-MAR-2017 from a pharmacist refers to an 85 year old male patient with papilloma viral infection. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 01-MAR-2017 the patient was vaccinated with an expired dose of GARDASIL 9 lot # L001312 expiration 24-FEB-2017, intramuscular related to the "off label indication" of treatment of a HPV (papilloma viral infection) spot on his eyelid. No adverse effects reported. The pharmacist inquired about revaccination if the patient received an expired dose of GARDASIL 9 with no previous temperature excursion. No further information was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Herpes zoster, Pain, Tenderness
Clinical narrative: Information has been received from a currently 67 year old female patient reporting on herself. The patient's medical history included: shingles in 2004 (13 years ago), in her back; an unspecified cancer; 2 lumpectomies; brain bleed and stroke. The patient's concomitant medications included: diltiazem hydrochloride (CARDIZEM), linagliptin (GLYXAMBI), gabapentin, metformin, anastrozole and simvastatin (VASTATIN). Her drug reactions/allergies included drug reactions to codeine, acetaminophen + hydrocodone bitartrate (NORCO) and an unspecified derivative of Penicillin. On an unknown date, the patient was vaccinated with ZOSTAVAX in the left arm (dose, strength, route of administration, lot# and expiration date were not provided), for prevention of shingles. On unknown dates the patient experienced shingles (herpes zoster). The patient reported that she had shingles six times since she received the ZOSTAVAX vaccine. After the first episode of shingles experienced 13 years ago, she received the ZOSTAVAX vaccine. She did not remember when she received the vaccine. She reported that she had Shingles on her leg six times after she received the vaccine. The outbreak "looked like a circle" that caused pains when she wore slacks and "it rubed against it". She did not remember when she experienced any of the six outbreaks. She stated that the first time that she had shingles, after receiving the vaccine, on her leg she went to the doctor. The doctor gave her "a cream to put on it". She stated that "the time between breakouts had been shorter" and "this last time it was only a month and a half in between outbreaks". This outbreak began "Saturday", it was really painful and "the pain was not lessening". She did not remember when any of the above mentioned events took place. Additionally, she reported that she was tired from Shingles and that it "zaps" her energy. The patient's outcome and the causality assessment between ZOSTAVAX  and the adverse events was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative, Rubella antibody positive, Therapy non-responder
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 35-year-old patient of unknown gender who was allergic to penicillin. There was no concomitant medication reported. On 24-FEB-2017, the patient was vaccinated with a dose of M-M-R II lot number M001200 with expiration date 28-FEB-2016, (dose, route and anatomical location were not reported) for prophylaxis. The patient came to the pharmacy on 08-MAR-2017 (reported as today) and was unable to recall any vaccination in childhood. It was reported that on an unknown date, the patient postvaccination titer showed negative titer to mumps "0.9" (units not provided) (therapy non-responder) and rubella titer was positive at "2.0" (units not provided). The patient was advice by an unspecified resource to be revaccinated with a second dose of M-M-R II based on this low titer for mumps result. At the time of the report, the outcome of the therapy non-responder was unknown. The relatedness between the event and therapy with M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to an infant patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, intramuscular injection (lot # and expiry date were not reported) for prophylaxis. Other co-suspect or concomitant medications were not reported. The infant received a dose of GARDASIL, which was not indicated for patients under the age of 9 (drug administered to patient of inappropriate age). The patient did not experience any effects from receiving the GARDASIL vaccine injection (no adverse event). The outcome of drug administered to patient of inappropriate age and no adverse event was unknown. Additional information is not expected; as no consent to obtain follow up was provided.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX23 for prophylaxis (route, lot # and expiration date were not reported). It was stated that the temperature was between 47 to 77 Fahrenheit degrees with a time frame of 5 days. No previous temperature excursions were reported. No adverse effects were reported in the patient. A product quality complaint was not involved. Additional information is not expected because the reporter refused additional contact.
Age: 53.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain, Skin exfoliation, Skin warm, Swelling
Clinical narrative: Redness, swelling, pain, warmth, skin peeling.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Lethargy, Vomiting
Clinical narrative: Per mother, states child became lethargic 2 hours after vaccine, vomited 6 times on 03/01/17 with continued lethargy-no fever- resolved on 03/01/17 in evening.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Decreased activity, Decreased appetite, Erythema, Hypersomnia, Infantile spitting up
Clinical narrative: Red cheeks, fever of 101°F, gave Tylenol,  decreased appetite, excessive spitting up, continuous red cheeks,  fever 102.5, excessive sleeping throughout day, continued Tylenol and alternating ibuprofen, much less active than usual.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: Red cheeks, fever of 101°F, gave Tylenol,  decreased appetite, excessive spitting up, continuous red cheeks,  fever 102.5, excessive sleeping throughout day, continued Tylenol and alternating ibuprofen, much less active than usual.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb mass, Pruritus
Clinical narrative: I had the shingles vaccination and now have an itchy lump on the back of my arm that's lasted 5 days.
Sex: M
Vaccine: FLU3
Symptoms: Epicondylitis
Clinical narrative: 3/7/2017 patient came to the pharmacy and said that week after his flu shot he got tennis elbow.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local reaction pt. waited 30 min due to pt.  having a local reaction to Varicella vaccine on right thigh.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Drug administered at inappropriate site, Ligament injury, Mobility decreased, Muscle injury, Pain in extremity
Clinical narrative: Received Rabies #3, arm sore that evening (Feb 1 2017) fine next week. Wisdom teeth removed 2-10-17 and on pain med. Started pain medication after the next week about 2-17-17. Noticed pain and decreased movement. Went to MD 3-1-17. Told ligament and muscle damaged and started PT 3-6-17. MD thinks shot too high. Pt concerned.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Wisdom teeth removal
Clinical narrative: Received Rabies #3, arm sore that evening (Feb 1 2017) fine next week. Wisdom teeth removed 2-10-17 and on pain med. Started pain medication after the next week about 2-17-17. Noticed pain and decreased movement. Went to MD 3-1-17. Told ligament and muscle damaged and started PT 3-6-17. MD thinks shot too high. Pt concerned.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mass, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Received injection on 3/8/17. Sore, painful red lump appeared morning of 3/9/17. Difficult to move arm from pain all day. Night of 3/9/17 101 degree fever. 3/10/17 Redness got larger. Took ibuprofen for fever and pain in arm/Per Dr. use cold compresses and BENADRYL and IBU.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Received injection on 3/8/17. Sore, painful red lump appeared morning of 3/9/17. Difficult to move arm from pain all day. Night of 3/9/17 101 degree fever. 3/10/17 Redness got larger. Took ibuprofen for fever and pain in arm/Per Dr. use cold compresses and BENADRYL and IBU.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Injection site rash, Injection site swelling, Pruritus
Clinical narrative: Pt. had severe rash that had tripled in size since he received the vaccination - starting at the injection site and going down into the armpit - slight swelling - pt. very itchy and not comfortable - no swelling of lips or throat. Given 50 mg of BENADRYL.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Chest pain
Clinical narrative: Chest pains, symptoms started about 3 hrs after injection, lasted for about 10 minutes.
Age: 0.58
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None reported.
Age: 18.0
Sex: M
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Deafness bilateral
Clinical narrative: Emailed me on 2/8/17, beginning on 3/3/17 "feeling of deafness" in (R) ear, which then changed to (L) ear and then went back to (R) ear. No other symptoms or illness. Still waiting to hear back.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Hemiparesis, Muscle contractions involuntary
Clinical narrative: Pt received Varicella vaccine 3 days ago; now having sudden onset of involuntary fasciculations to (R) side with muscle weakness. Sx are worsening; getting stronger. Urgent referral to neurology has been sent for further eval.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm - elbow to shoulder is red, swollen, warm, itching.
Age: 1.75
Sex: F
Vaccine: FLU4, HEP
Symptoms: Wrong drug administered
Clinical narrative: Child came to office for Hepatitis A vaccine and influenza vaccine. She was given Hepatitis B vaccine by mistake.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt received vaccine 2/27/16. Pt called 3/1/17 the injection site looked red and was itchy. BENADRYL was recommended. Follow up on 3/6/17. Pt was doing better.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm swelling and redness.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Seen by MD on 8/21/16 for treatment of cellulitis with cephalexin 500mg 1 QID x 7d. Complains of not be able to life arm without pain.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itchy rash over abdomen.
Age: 32.0
Sex: M
Vaccine: YF
Symptoms: Erythema, Feeling hot, Pruritus, Throat tightness, Tongue pruritus
Clinical narrative: Approximately 30 minutes after the Yellow Fever vaccine was administered, the patient noted itching on his scalp, felt his throat was closing up and his tongue was itching.  He also noted that his face appeared red and he felt hot.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Chills, Erythema, Flushing, Lethargy
Clinical narrative: He woke up at midnight throwing up and having chills. He went back to bed and ate breakfast in the morning. At 9:30 am he threw up again.  Claimed he hurt all over. Has a fever of 101.8 and his cheeks are red and flush. He has no energy, tried to get up and ended up laying on the ground. His lower lip is red and swollen. His tounge he said feels normal.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Lip discolouration, Lip swelling, Pain, Pyrexia, Vomiting
Clinical narrative: He woke up at midnight throwing up and having chills. He went back to bed and ate breakfast in the morning. At 9:30 am he threw up again.  Claimed he hurt all over. Has a fever of 101.8 and his cheeks are red and flush. He has no energy, tried to get up and ended up laying on the ground. His lower lip is red and swollen. His tounge he said feels normal.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Patient awoke and had redness, warmth, soreness, and swelling on the backside of the arm (under the arm, near the axilla, which is the opposite side of arm where vaccine was given). There were no other likely causes of these symtoms besides the vaccine given 2 days prior, according to the patient.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Pruritus, Pyrexia
Clinical narrative: Swollen red, feverish slightly painful with itching. It's is hard to the touch and the skin is so tight that it feels like an orange peel. I have taken Benadryl every night with Zyrtec. Applied hydrocortisone ointment QID. With little results of decreased reaction.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin tightness, Swelling
Clinical narrative: Swollen red, feverish slightly painful with itching. It's is hard to the touch and the skin is so tight that it feels like an orange peel. I have taken Benadryl every night with Zyrtec. Applied hydrocortisone ointment QID. With little results of decreased reaction.
Age: 17.0
Sex: F
Vaccine: MENB, MNQHIB
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on throat.  Rash still there at time of this report - almost 24 hours later.  Cold Ice, hydrocortozone, allegra used for treatment.  Will take benedryl tonight if still persists.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Hyperhidrosis, Hypotonia, Lethargy, Pallor
Clinical narrative: Patient had either syncopal vs seizure episode. Mom states patient became limp, pale, diaphoretic, and lethargic.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Eye movement disorder, Fall, Feeling abnormal, Musculoskeletal stiffness, Pallor
Clinical narrative: Went into seizure minutes after having this vaccine! Complained of not feeling good, then immediately fell sideways onto desk ,eyes rolled back in head, body was stiff and shaking, lost color to skin. Patient couldnt talk, hear or had any awareness.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Seizure, Tremor, Unresponsive to stimuli
Clinical narrative: Went into seizure minutes after having this vaccine! Complained of not feeling good, then immediately fell sideways onto desk ,eyes rolled back in head, body was stiff and shaking, lost color to skin. Patient couldnt talk, hear or had any awareness.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Laboratory test normal, Pain in extremity, Peripheral swelling
Clinical narrative: Vaccine given 3/8/17. Pt. went to gym and was fine 1st hr., 2nd class arm starting hurting and swelling. Went home and applied ice/heat. Stopped by PHR 3/9/17 to ask if should have avoided exercise. Swelling (above elbow, not inj. site). Advised continue treatment. Fri. p.m., arm worse and M.D. marked to rule out blood clot. Diagnosis cellulitis. M.D. to phone in antibiotic.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Fall, Gait disturbance, Lumbar puncture
Clinical narrative: Patient got the flu shot on Oct. 3rd 2016. Patient started falling on Monday Oct. 24, 2016. Then he couldn't run or barely walk on Friday night Oct. 28th 2016. We took him to the ER on 10/24/16.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Ultrasound scan
Clinical narrative: Patient got the flu shot on Oct. 3rd 2016. Patient started falling on Monday Oct. 24, 2016. Then he couldn't run or barely walk on Friday night Oct. 28th 2016. We took him to the ER on 10/24/16.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Crying, Musculoskeletal stiffness, Tremor
Clinical narrative: Unconsolable crying for over 24 hours, body shakes, muscle stiffness.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Polyarthralgias located in left arm (injection site), lumbar-sacral spinal area, bilateral thigh area and  bilateral leg area. Polyarthralgias still ongoing 5 months after injection.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Patient came back about 15 minutes after immunization (appx. 10:45am) and said she felt fine but that her arm itched. The injection site was warm to touch, red, and had mild swelling about one inch in diameter. one teaspoon of diphenhydramine 12.5mg/5ml was administered at that time. Patient did not want to wait in pharmacy for further monitoring, but retuned again at 11:30. She reported that the itching had subsided but upon examination of injectio site, it was found that the local smptoms were about the same. Another 12.5mg dose of diphenhydramine was administered at that time for a total dose of 25mg diphenhydramine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Redness around injection site, pt seen at urgent care for possible cellulitus in injection site arm.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Muscular weakness
Clinical narrative: Begin to fell fatigue during physical training and muscles weakness.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Condition aggravated, Decreased appetite, Syncope, Vertigo
Clinical narrative: VOMITING, FAINT, INTENSIFIED MY BACK PAIN SIGNIFICANTLY, HEAD WAS SPINNING, LOSS OF APPETITE. 2 DAYS LATER, THE SAME.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: VOMITING, FAINT, INTENSIFIED MY BACK PAIN SIGNIFICANTLY, HEAD WAS SPINNING, LOSS OF APPETITE. 2 DAYS LATER, THE SAME.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Itchy Rash.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: My arm swelled to three times its size at the site of the injection and radiating about 5 inches out in each direction. The area was red and warm to touch. The swelling, redness and warmth lasted for 6 days.  On day 8, the swelling has gone down but I still have redness radiating about 1 inch in all directions from the site of injection and bruising.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Vesicular rash on the back of patient's arm where the Varicella vaccine had been administered about one week ago.
Age: 43.0
Sex: M
Vaccine: TTOX
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Body wide aches, pains, fever, chills, headache, nausea.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain, Peripheral swelling
Clinical narrative: Pt stated that late 03/11 he experience painful large read swelling of entire upper arm and underarm.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Hypoaesthesia, Joint lock, Paraesthesia
Clinical narrative: I noticed that my vision gets blurry looking at things and I'm lightheaded with no energy. My body feels weak and my legs feel numb. My knees lock up from time to time with a tingling sensation running down from my lower back to my legs. I also noticed I have hives near both of my elbows and I keep hearing a sharp ringing sound in my ears.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Tinnitus, Urticaria, Vision blurred
Clinical narrative: I noticed that my vision gets blurry looking at things and I'm lightheaded with no energy. My body feels weak and my legs feel numb. My knees lock up from time to time with a tingling sensation running down from my lower back to my legs. I also noticed I have hives near both of my elbows and I keep hearing a sharp ringing sound in my ears.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13, RV1
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: On 12/6/16 Hep A was documented in EMR that was given to a 6 month old. Time out sheet was not used. MA states that it was Hep B and documented wrong vaccine. No reaction or side effects. 3rd Hep B was given on 3/1/17 when attending saw in records Hep A was documented at 6 mos old and felt pt needed 3rd Hep B.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site oedema, Injection site pain, Musculoskeletal pain
Clinical narrative: Patient reported erythema, soreness, and edema on her left deltoid beginning 24 hours after vaccination.  By 48 hours after the vaccination she reported the symptoms spreading across the back of her neck and to her right shoulder. The symptoms have since receded to a 6x7cm area on her left deltoid over the following 48 hours.  She reported no fever.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Neck pain, Oedema
Clinical narrative: Patient reported erythema, soreness, and edema on her left deltoid beginning 24 hours after vaccination.  By 48 hours after the vaccination she reported the symptoms spreading across the back of her neck and to her right shoulder. The symptoms have since receded to a 6x7cm area on her left deltoid over the following 48 hours.  She reported no fever.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abasia, Arthralgia, Dysphagia, Influenza like illness, Myalgia
Clinical narrative: Sat. 3/4/17 Flu like SX. Sun 3/5/17 Trouble swallowing (golf ball feeling in throat). Mon - Sat 3/11/17 Muscle pain/joint pain patient stated they cannot walk.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Sensation of foreign body
Clinical narrative: Sat. 3/4/17 Flu like SX. Sun 3/5/17 Trouble swallowing (golf ball feeling in throat). Mon - Sat 3/11/17 Muscle pain/joint pain patient stated they cannot walk.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV2, MNQ, TDAP, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US019964 is an initial spontaneous report received from a nurse on 03 Oct 2014, and with a follow up report received from nurse on 11 Nov 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medications were not reported. Concomitant vaccines included tetanus diphtheria acellular pertussis vaccine (other manufacturer, batch number: 4EK53) 0.5 ml IM; varicella zoster vaccine (other manufacturer, batch number: 5007727) 0.5 ml subcutaneous; human papilloma vaccine (other manufacturer, batch number: K006095) 0.5 ml IM  and hepatitis A vaccine (other manufacturer, batch number: GX2LA) 0.5 ml IM on 02 Oct 2014. She was vaccinated with MENVEO (batch number: M13046) 0.5 ml intramuscularly, into right deltoid on 02 Oct 2014. It was reported that she received MenA lyophilized component reconstituted with sterile diluent instead of MenCYW-135 liquid component. She was advised to repeat vaccination with MENVEO. No adverse event was reported following the maladministration. Follow up report received from nurse on 11 Nov 2014. Updated patient details (height and weight), site of MENVEO and all concomitant vaccines. Upon internal review, varicella vaccine has been corrected to a non GSK product (no license). On 20th February 2017, after GSK internal review, the suspect BOOSTRIX (previously captured as DTPa), HPV vaccine, Varicella vaccine and Hepatitis vaccine was changed into concomitant vaccine. The concomitant vaccine according to batch number Diphtheria tetanus acellular pertussis was changed into BOOSTRIX.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 71 year old female patient with rheumatoid arthritis and no drug reactions/allergies. The patient's medical history and concomitant medications were not reported. On 13-FEB-2017, the patient was vaccinated with PNEUMOVAX 23 through her bursa or shoulder joint, in her right arm (the pharmacist could not determine the route of administration), for prophylaxis. On an unspecified date in February 2017, the patient experienced a horrible soreness in her entire right arm. The reporter stated that the patient had went to visit the doctor on 15-FEB-2017 for the soreness in her right arm and she was suggested to treat it with LODINE, ASPERCREME or morphine being the last resort. No laboratory diagnostics studies were performed. The outcome of the event was reported as recovering and the causal relationship between it and PNEUMOVAX 23 was not informed. No product quality complaint was involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 71 year old female patient with rheumatoid arthritis and no drug reactions/allergies. The patient's medical history and concomitant medications were not reported. On 13-FEB-2017, the patient was vaccinated with PNEUMOVAX 23 through her bursa or shoulder joint, in her right arm (the pharmacist could not determine the route of administration), for prophylaxis. On an unspecified date in February 2017, the patient experienced a horrible soreness in her entire right arm. The reporter stated that the patient had went to visit the doctor on 15-FEB-2017 for the soreness in her right arm and she was suggested to treat it with LODINE, ASPERCREME or morphine being the last resort. No laboratory diagnostics studies were performed. The outcome of the event was reported as recovering and the causal relationship between it and PNEUMOVAX 23 was not informed. No product quality complaint was involved. Additional information has been requested.