chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth, Oropharyngeal pain
Clinical narrative: Right after vaccine as walking from one room in the facility to other eyes felt flurry confusion. When arrive to other room doctor took vitals and were ok. Felt lightheaded, kept blinking because couldn't see at distance. 3 hours later at home headache started for 36 hours. Took TYLENOL, helped a little. Stayed in bed because had upset stomach. 3 days later still had little headache. Injection site was aching, itchy, hot, hard. Today had sore throat.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Visual acuity reduced
Clinical narrative: Right after vaccine as walking from one room in the facility to other eyes felt flurry confusion. When arrive to other room doctor took vitals and were ok. Felt lightheaded, kept blinking because couldn't see at distance. 3 hours later at home headache started for 36 hours. Took TYLENOL, helped a little. Stayed in bed because had upset stomach. 3 days later still had little headache. Injection site was aching, itchy, hot, hard. Today had sore throat.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Computerised tomogram head normal, Head injury, Pyrexia, Syncope
Clinical narrative: Patient fainted the following morning and was seen in the emergency room at hospital after hitting her head when fainting. Also had a slight fever post-vaccination.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PREVNAR 13 shot given; redness and swelling in area upper arm; took 10 days CIPRO 500 mg; swelling and redness lasted 1 1/2 months. Ok now.
Age: 52.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red. Swollen. Painful. Hot at injection site.
Age: 67.0
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: Red break outs on the arm, where injection was given, from wrist to shoulder. There was 4 and they were red circles that turned into bullseyes.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Discomfort, Irritability, Pyrexia, Rash
Clinical narrative: 4 days after receiving vaccines child developed an intermittent fever and irritability that lasted for 2 to 3 days. Child also developed a rash on abdomen that spread to shoulders and this lasted for 3 weeks. Rash caused discomfort. Decreased appetite for 3-4 days.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt got redness and hardening areas around the injection site for 2 weeks. (It was about 2 inches radius).
Age: 37.0
Sex: M
Vaccine: TYP, YF
Symptoms: Diarrhoea, Headache, Myalgia
Clinical narrative: Pt called to report, diarrhea, headache and muscle pains.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Zoster vaccination was given instead of MMRV which was ordered by physician.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site discharge, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother relates child had a quarter size or > red raised area at varicella site 8/26/15 by bedtime. 8/27/15 the area was baseball size and had fever, site warm to touch. Instructed to use cool moist cloths and see M.D. asap. 8/31/15 follow up call-child was referred to a surgeon and the site was opened to drain. No further problems reported. Had f/up appt. 9/1/15 with surgeon was given AUGMENTIN and clindamycin.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # K023157, expiration date 23-JUL-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. An unspecified number of doses of improperly stored PROQQUAD (Merck) lot # L019997 exp. 02-DEC-2016, lot # L016394 exp. 08-NOV-2016, lot # L017140 exp. 13-NOV-2016, (route of administration and dose were not reported) were administered to an unspecified number of unspecified patients by an unspecified physician on unspecified dates. There was no adverse events reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Injection site rash, Rash generalised
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 (dose, route and lot# were not reported). Concomitant therapies included VAQTA. On an unknown date, the patient experienced injection site rash and rash throughout their body. The patient sought medical attention by an office visit and was treated with BENADRYL (dosage unknown). On an unknown date, after treatment with BENADRYL the events was resolved. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant and nurse via a company representative and refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapies were reported. On 28-AUG-2015, the patient was vaccinated with expired dose of MMR II lot # J009382, expiration date 08-AUG-2015 (dose, route of administration and anatomical location were not reported). No symptoms were reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report was received from a consumer, referring to himself, a 60 and a half year old male patient. The patient's medical history included celiac disease. Concurrent conditions were not reported. On an unspecified date in February 2015, the patient was vaccinated with one dose of ZOSTAVAX (lot number, expiration date, dose and route of administration were not reported) in the left arm for prevent shingles. Concomitant medication was not reported. The patient stated that, on an unspecified date in 2015, about 2 weeks after he got the ZOSTAVAX vaccine, he developed itchy, half inch, hives. He stated they are primarily on his face, but also on neck, chest, and arms. the patient sought medical attention and was treated with steroids. The outcome and causality of the hives were unknown. There were product quality complaints reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history and drug allergy were not reported. On 11-AUG-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K010215 with expiration date of 05-MAY-2017, dose and strength unknown, intramuscular). No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning 7 patients of unknown age and gender. There was no pertinent or drug reactions/allergies reported. Since 06-JUL-2015, each of the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K009472 and expiration date: 03-JAN-2016; route and frequency unspecified) (incorrect product storage). No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to a female patient of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The nurse reported that on 28-AUG-2015, the patient was vaccinated with a dose of GARDASIL gluteal intramuscular injection (dose, strength, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Full blood count normal, Immediate post-injection reaction, Rash, Urticaria
Clinical narrative: Immediately after she received MMR, Varicella, IPV, DTaP vaccines she broke into a urticarial rash to cheeks and around eyes. She was given 12.5 mg oral BENADRYL and rash resolved within 15 minutes. Child was observed for 1 hour in the office and no distress noted at discharge.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Patient states swelling, itching, pain, rash, and redness was experienced in site of administration immediately after administration of HPV#1 vaccine. This happened on 08-27-2015, but patient did not return for treatment until 8-31-2015. Patient described prednisolone 15mg/5mL, and cetirizine 1mg/1mL.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site swelling
Clinical narrative: Patient states swelling, itching, pain, rash, and redness was experienced in site of administration immediately after administration of HPV#1 vaccine. This happened on 08-27-2015, but patient did not return for treatment until 8-31-2015. Patient described prednisolone 15mg/5mL, and cetirizine 1mg/1mL.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Immediate (L) deltoid area pain 8/6/15, continued pain then after 2 weeks tingling over (L) thumb up to lateral antecubital area, no swelling or redness or fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema
Clinical narrative: Erythema no fever - large over anterior right tricep (one half).
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Muscular weakness, Myalgia
Clinical narrative: Night of vaccination - redness and swelling below injection of PNEUMOVAX 3" x 4" and warm to touch. Pt also began experiencing severe muscle aches in both legs and weakness in legs.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient returned to the pharmacy with a rash at the intramuscular injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Patient describes having a local reaction of itchiness, redness, swelling around site of where she received her ZOSTAVAX injection. She says reaction has decreased noticeably after BENADRYL and ice applied.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3 x 3 1/2 cm slightly raised, reddened, warm area on upper (R) arm. Seen in office 8-14-15 for reaction.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Somnolence
Clinical narrative: Spotty rash. Somnolence. 10 days after vaccine. No treatment.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Patient fainted with tonic-clonic activity of extremities lasting less than 10 seconds. After laying down and resting 20-30 minutes after he recovered.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Paraesthesia
Clinical narrative: Pt c/o tingling and difficulty raising arm/moving arm that injection was given in.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever highest temp 104.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: Onset of fever, chills and cough the evening after receiving vaccine.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Had 12 mo vaccines on 9-3-15. Tongue swelling (mild per mom) and hives following morning.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness at site of injection. Warm to the touch.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 18-JUN-2015, the patient was vaccinated with MMR II (lot number, status of rHA, expiration date, dose, route of administration and strength were not reported). Concomitant medication was not reported. The reporter stated that the patient received less than the recommended dosage of the vaccine administered. No adverse effects were reported. Follow up information has been received from the Registered Nurse on 27-AUG-2015, concerning a 12 month old (also reported as 14 month old) female patient, with no known pre-existing allergies, birth defects or medical conditions. On 18-JUN-2015 at 11:30, the patient vaccinated with the first dose of MMR II, (lot number reported as 1003859, no expiration date reported) unknown dose, subcutaneous, in the left thigh. On the same date, the patient was also vaccinated with the first doses of VARIVAX (Lot number reported as 1004654, no expiration date reported) unknown dose, subcutaneous, in the left thigh, and HAVRIX (lot number 4235D) intramuscular in the right thigh (dose not reported). The reporter stated that the syringe of the MMR II vaccine was drawn up in a malfunctioned during the administration of the vaccine, so that most of the dose was sprayed outside the patient. The dose was repeated because the patient did not receive most of the first one. Additional information is not expected as all correspondence was received. General, Patient, Product, Event and Narrative were updated.
Age: 0.1
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from an office manager via a company representative refers to a 5 week old male patient. Concurrent conditions and medical history were not reported. The reporter stated that on 01-SEP-2015, the physician vaccinated by accident to the patient with a dose of GARDASIL (lot # K010215,e expiration date May 2017) 0.5 ml (Route and dose were not provided). Concomitant medication was not reported. No information was provided on the vaccine the baby was supposed to receive on 01-SEP-2015. No adverse effects are being reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, IPV, MEN
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative, regarding an 11 year old female patient. No concurrent or historical condition was reported. On 26-AUG-2015, the patient was vaccinated with the first dose of GARDASIL, Lot number, expiration date, dose, route and anatomical location were not reported. Concomitant medications included unspecified polio vaccine and an unspecified meningococcal vaccine. ON 26-AUG-2015, the patient had syncope after receiving the first dose of GARDASIL. The patient sought medical attention at physician's office. No further information was reported. At the time of the report the outcome of syncope was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No concurrent or historical condition were reported. On 22-JAN-2015 the patient was vaccinated with the first dose of ZOSTAVAX (Lot number and expiration date not provided) dose, route, anatomical location were unknown, and a second dose of ZOSTAVAX (Lot number and expiration date not provided) dose, route, anatomical location were unknown, was inadvertently administered on 01-SEP-2015. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 03-SEP-2015, the patient was inadvertently vaccinated with an expired dose of GARDASIL (lot # H020901, expiration ate 05-JUL-2015) (route, strength and route of administration were not reported) (expired product administered). The patient was vaccinated by a nurse practitioner. There was no concomitant medication reported. Additionally, no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant, referring to an unspecified number of patients of unknown demographics. No medical history nor concurrent conditions were reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaints were reported. This is one of three reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant, referring to an unspecified number of patients of unknown demographics. No medical history nor concurrent conditions were reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # J005078, expiration date 20-SEP-2015) (strength, dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaints were reported. This is one of three reports from the same source. 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 Certified Medical Assistant, referring to an unspecified number of patients of unknown demographics. No medical history nor concurrent conditions were reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ (lot # reported as K013408, expiration date 20-FEB-2016) (strength and dose were not reported) orally taken. No concomitant medications were reported. No adverse effects were reported. No product quality complaints were reported. This is one of three reports from the same source. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Chronic gastritis, Fatigue, Hypoaesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of joint pain in a 43-year-old male patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult. Previously administered products included ENGERIX B adult (1st dose in August 2013). Concurrent medical conditions included vitamin D deficiency, eczema, triglycerides high and genital warts. Concomitant products included MVI and vitamin D. In December 2013, the patient received the 2nd dose of ENGERIX B adult. In May 2014, the patient received the 3rd dose of ENGERIX B adult. In December 2013, an unknown time after receiving ENGERIX B adult and not applicable after receiving ENGERIX B adult, the patient experienced drug dose administration interval too long. In April 2015, the patient experienced vitamin B12 deficiency. In May 2015, the patient experienced joint pain, gastritis atrophic, fatigue, neck pain, shoulder pain, arthritis and numbness of extremities. The patient was treated with vitamin B12. On an unknown date, the outcome of the joint pain, vitamin B12 deficiency, gastritis atrophic, fatigue, neck pain, shoulder pain, arthritis, numbness of extremities and drug dose administration interval too long were unknown. The reporter considered the joint pain, vitamin B12 deficiency, gastritis atrophic, fatigue, neck pain, shoulder pain, arthritis and numbness of extremities to be possibly related to ENGERIX B adult. Additional details were provided as follows: In December 2013, the patient received 2nd dose of ENGERIX B, leading to lengthening of vaccination schedule. In May 2014, the patient receive the 3rd dose of ENGERIX B adult. In April 2015, the patient experienced vitamin B12 deficiency. In May 2015, the patient developed some symptoms which included neck and shoulder pain, arthritis, numbness in feet and fingers, generalized joint pain, atrophic gastritis and fatigue. The events were possibly related to vaccination with ENGERIX. No lot numbers or expiration dates of vaccines were available. The patient had been worked up for multiple sclerosis, but did not have it. No further information was available at the time of reporting.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Musculoskeletal pain, Neck pain, Vitamin B12 deficiency
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of joint pain in a 43-year-old male patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult. Previously administered products included ENGERIX B adult (1st dose in August 2013). Concurrent medical conditions included vitamin D deficiency, eczema, triglycerides high and genital warts. Concomitant products included MVI and vitamin D. In December 2013, the patient received the 2nd dose of ENGERIX B adult. In May 2014, the patient received the 3rd dose of ENGERIX B adult. In December 2013, an unknown time after receiving ENGERIX B adult and not applicable after receiving ENGERIX B adult, the patient experienced drug dose administration interval too long. In April 2015, the patient experienced vitamin B12 deficiency. In May 2015, the patient experienced joint pain, gastritis atrophic, fatigue, neck pain, shoulder pain, arthritis and numbness of extremities. The patient was treated with vitamin B12. On an unknown date, the outcome of the joint pain, vitamin B12 deficiency, gastritis atrophic, fatigue, neck pain, shoulder pain, arthritis, numbness of extremities and drug dose administration interval too long were unknown. The reporter considered the joint pain, vitamin B12 deficiency, gastritis atrophic, fatigue, neck pain, shoulder pain, arthritis and numbness of extremities to be possibly related to ENGERIX B adult. Additional details were provided as follows: In December 2013, the patient received 2nd dose of ENGERIX B, leading to lengthening of vaccination schedule. In May 2014, the patient receive the 3rd dose of ENGERIX B adult. In April 2015, the patient experienced vitamin B12 deficiency. In May 2015, the patient developed some symptoms which included neck and shoulder pain, arthritis, numbness in feet and fingers, generalized joint pain, atrophic gastritis and fatigue. The events were possibly related to vaccination with ENGERIX. No lot numbers or expiration dates of vaccines were available. The patient had been worked up for multiple sclerosis, but did not have it. No further information was available at the time of reporting.
Age: 54.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Injection site erythema
Clinical narrative: Pt (R) arm red from shoulder to elbow (anterior), no swelling, no drainage or heat. Pt denies pain. Methylprednisolone 6, 5, 4, 3, 2, 1 dose pak tab every day.
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. The patient's medical history, concurrent conditions and concomitant medications were not provided. Nurse stated an unspecified dose of GARDASIL 9 series was the only vaccine administered that was improperly stored. Nurse stated GARDASIL 9, Lot # L007495, expiry date 25-FEB-2017, was administered to the patient on 27-AUG-2015. No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 11-AUG-2015, the patient was vaccinated with a dose of ROTATEQ, oral (dose, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. The reporter stated that the patient immediately vomited once after receiving the dose of ROTATEQ (on 11-AUG-2015). The nurse reported that the patient fully recovered after vomiting once. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring a patient of unknown age and gender. Pertinent Medical History and Drug Reactions/Allergies were not reported. On 09-AUG-2015, the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # H017304, expiration date: 11-JUL-2015) (dose and route not reported). No concomitant therapies were reported. No symptoms reported. Additional information has been requested (correspondence containing a request from additional information is scheduled).
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and allergies were not reported. The reporter stated that on an unknown dates the patient was vaccinated with the first and second dose of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were not reported) on time. Then, on an unknown date, (reported as "four to five weeks early"), the patient was vaccinated with the third dose of GARDASIL (strength, dose, route, anatomical location. lot number and expiration date were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 25-AUG-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (intramuscularly, lot # K004542, expiration date 25-AUG-2015). Concomitant medication was not provided. This pharmacist also noted this was only dose of PNEUMOVAX 23 this patient had ever been administered. No adverse effect reported. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Bone pain, Chronic obstructive pulmonary disease, Dizziness, Fatigue, Myalgia
Clinical narrative: Extreme bone pain and muscle aches, fatigue, worsening overnight, dizziness when lying down, fever of 101.3 when felt well enough to sit up and take temp. Bone pain was worse primarily in legs and arms hurt to move or not to move. At time of this report temp is finally down to 99 and able to sit up at 3 am on 9/5/15 took Excedrin to alleviate bone pain prior to taking temperature.
Age: 47.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Extreme bone pain and muscle aches, fatigue, worsening overnight, dizziness when lying down, fever of 101.3 when felt well enough to sit up and take temp. Bone pain was worse primarily in legs and arms hurt to move or not to move. At time of this report temp is finally down to 99 and able to sit up at 3 am on 9/5/15 took Excedrin to alleviate bone pain prior to taking temperature.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was red, tender to touch, and raised (~1cm). Site was also warm to touch, but pt reported she was otherwise afebrile. Pt stated full resolution in about 96 hours.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Severe pain, unable to lift arm. Have had two steroid injections, physical therapy and to this day still have pain.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Dizziness, Pyrexia
Clinical narrative: 103.1 Fever. Joint aches. Dizziness.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, X-ray limb normal
Clinical narrative: Within hours of vaccine I had terrible pain and unable to use my arm for two weeks. Still having pain and lkimited use of arm. Saw my doctor again, went to the ER and had x rays. No Help for problem and pain.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever to 102.2 F rectal.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness around injection site and itching the day of vaccine, redness around injection site but no itching day 2 and 3 after vaccine.
Age: 0.66
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Culture urine negative, Cyanosis, Dyskinesia, Febrile convulsion, Pyrexia
Clinical narrative: Subjective fever @ 8 pm, 102 F @ home, then 103.1 F shortly afterward; abnormal mouth movements; perioral cyanosis; presumed febrile seizure.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chest X-ray normal, Chills, Feeling cold, Myalgia
Clinical narrative: Approximately one hour after receiving the vaccine, patient complained of chills and feeling cold. He called the pharmacy and was instructed to monitor his temperature and seek medical care for high fever or severe symptoms. He was contacted the next morning by the pharmacist and he indicated he did seek medical care at a local urgent care. He reported a peak temperature of 102.6 degrees, chills and muscle aches. Urgent care did several tests including throat swab for strep test, urinalysis and chest X-ray and could not find a conclusive cause for the fever. It was determined the fever and corresponding symptoms were a result of the influenza vaccine administered several hours prior. He was given Tylenol to lower the fever and sent home with instructions to monitor fever and seek medical care with any worsening of symptoms. The following morning he reported his fever had broken overnight and he was feeling much better approximately 16 hours post vaccination.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Streptococcus test negative, Urine analysis normal
Clinical narrative: Approximately one hour after receiving the vaccine, patient complained of chills and feeling cold. He called the pharmacy and was instructed to monitor his temperature and seek medical care for high fever or severe symptoms. He was contacted the next morning by the pharmacist and he indicated he did seek medical care at a local urgent care. He reported a peak temperature of 102.6 degrees, chills and muscle aches. Urgent care did several tests including throat swab for strep test, urinalysis and chest X-ray and could not find a conclusive cause for the fever. It was determined the fever and corresponding symptoms were a result of the influenza vaccine administered several hours prior. He was given Tylenol to lower the fever and sent home with instructions to monitor fever and seek medical care with any worsening of symptoms. The following morning he reported his fever had broken overnight and he was feeling much better approximately 16 hours post vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Crying, Disorientation, Dyskinesia, Emotional distress, Fatigue
Clinical narrative: About a half an hour after the shots, she vomited violently. Called Dr.'s office they said she was probably upset because of the shots and that was why she threw up. She wasn't nervous or upset, though- she barely cried when she got them. Right before vomiting she remarked on how tired she was and wanted me to pick her up. When we got home she spiked a fever of 102.5 which went down after children's Tylenol. She seemed ok although lethargic the next day, but then at bedtime spiked another fever, this time of 103.2, which also was corrected with the Tylenol. She then woke up screaming a high pitched scream sitting straight up in the middle of the night. She was terrified, hallucinating, disoriented. Her legs were jerking in an involuntary way, like a seizure. She was seeing things that weren't there even after upon waking. She was holding onto me tighter than she ever has. She was inconsolable. This is not anything that has ever happened before. She said "The black" was coming for her. This happened three times throughout the night. In the interims, I watched her while sleeping and she was twitching and jerking a lot. She did NOT have a fever during any of these episodes of "night terrors".
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Hallucination, Lethargy, Muscle twitching, Pyrexia, Screaming
Clinical narrative: About a half an hour after the shots, she vomited violently. Called Dr.'s office they said she was probably upset because of the shots and that was why she threw up. She wasn't nervous or upset, though- she barely cried when she got them. Right before vomiting she remarked on how tired she was and wanted me to pick her up. When we got home she spiked a fever of 102.5 which went down after children's Tylenol. She seemed ok although lethargic the next day, but then at bedtime spiked another fever, this time of 103.2, which also was corrected with the Tylenol. She then woke up screaming a high pitched scream sitting straight up in the middle of the night. She was terrified, hallucinating, disoriented. Her legs were jerking in an involuntary way, like a seizure. She was seeing things that weren't there even after upon waking. She was holding onto me tighter than she ever has. She was inconsolable. This is not anything that has ever happened before. She said "The black" was coming for her. This happened three times throughout the night. In the interims, I watched her while sleeping and she was twitching and jerking a lot. She did NOT have a fever during any of these episodes of "night terrors".
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Seizure like phenomena, Sleep terror, Vomiting
Clinical narrative: About a half an hour after the shots, she vomited violently. Called Dr.'s office they said she was probably upset because of the shots and that was why she threw up. She wasn't nervous or upset, though- she barely cried when she got them. Right before vomiting she remarked on how tired she was and wanted me to pick her up. When we got home she spiked a fever of 102.5 which went down after children's Tylenol. She seemed ok although lethargic the next day, but then at bedtime spiked another fever, this time of 103.2, which also was corrected with the Tylenol. She then woke up screaming a high pitched scream sitting straight up in the middle of the night. She was terrified, hallucinating, disoriented. Her legs were jerking in an involuntary way, like a seizure. She was seeing things that weren't there even after upon waking. She was holding onto me tighter than she ever has. She was inconsolable. This is not anything that has ever happened before. She said "The black" was coming for her. This happened three times throughout the night. In the interims, I watched her while sleeping and she was twitching and jerking a lot. She did NOT have a fever during any of these episodes of "night terrors".
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blood pressure fluctuation, Cough, Dyspnoea, Lung disorder, Oxygen saturation decreased
Clinical narrative: Approximately around 10:30 too 11 PM, patient experianced shortness of breath and cough and change in colors (expressed as purple), patient called 911 and EMS arrived in 3 minutes. According to the patient, oxygen saturation was low around 82 and blood bressure was up and down, at times the systolic was 220. EMS gave her oxygen and took patient to hospital where she was treated with oxygen and discharged around 3 am.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Skin discolouration
Clinical narrative: Approximately around 10:30 too 11 PM, patient experianced shortness of breath and cough and change in colors (expressed as purple), patient called 911 and EMS arrived in 3 minutes. According to the patient, oxygen saturation was low around 82 and blood bressure was up and down, at times the systolic was 220. EMS gave her oxygen and took patient to hospital where she was treated with oxygen and discharged around 3 am.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Patient is reporting soreness around injection site with pain and movement since date of vaccination.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: Muscle soreness, stiffness, pain in arm/shoulder lasting 4 weeks.
Age: 1.27
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fever, vomiting, rash.
Age: 86.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hypoaesthesia
Clinical narrative: Pts whole left arm went numb and the numbness has only gotten worse the last 2 days. Pt came in today (9/5/2015) and reported the problem to me.  Pt said she was going to urgent care to have a doctor look at her arm.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Cough, Eye pruritus, Headache, Influenza like illness, Influenza virus test negative
Clinical narrative: Patient had flu-like symptoms including fever, sore throat, cough, headache, itchy eyes and itchy ears, aches. This resulted in an office visit to physician who confirmed a negative flu test.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Oropharyngeal pain, Pain, Pruritus, Pyrexia
Clinical narrative: Patient had flu-like symptoms including fever, sore throat, cough, headache, itchy eyes and itchy ears, aches. This resulted in an office visit to physician who confirmed a negative flu test.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenopia, Chills, Cough, Headache, Injection site pain
Clinical narrative: Patient had flu-like symptoms including fever, sore throat, cough, headache, itchy eyes and itchy ears, aches. This resulted in an office visit to physician who confirmed a negative flu test.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Patient had flu-like symptoms including fever, sore throat, cough, headache, itchy eyes and itchy ears, aches. This resulted in an office visit to physician who confirmed a negative flu test.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Toothache
Clinical narrative: Patient had flu-like symptoms including fever, sore throat, cough, headache, itchy eyes and itchy ears, aches. This resulted in an office visit to physician who confirmed a negative flu test.
Age: 75.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Significant redness, swelling, and warmth of injection site.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Rash, Rash erythematous
Clinical narrative: Patient had bruise and red rash over large area of upper arm.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Musculoskeletal discomfort, Musculoskeletal pain, Swelling
Clinical narrative: Upper shoulder discomfort, swelling, and pain pt used Ibuprofen and ice the next day to help with pain. Pt believes the discomfort was due to improper placement of the injection too high on the deltoid muscle possibly hitting the bursa in the shoulder.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Injection site pain, Mobility decreased, Myalgia
Clinical narrative: Severe arm pain at site of injection that limited mobility, vomiting, fever, dizziness, myalgia, headache.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Severe arm pain at site of injection that limited mobility, vomiting, fever, dizziness, myalgia, headache.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles, ongoing Rash.
Age: 29.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Headache, Injection site reaction, Myalgia, Pyrexia
Clinical narrative: Subjective fever and headache < 1 hour after vaccine administration; muscle ache at the vaccine site (R arm) radiating to the R elbow and chest ~ 8 hours after administration. Level of pain and the fact that the symptoms were significantly worse than those that occurred on previous administrations of the vaccine (this is the 8th time Pt has received the anthrax vaccine) prompted an ED visit the following morning. Patient discharged with return precautions and analgesia.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site which lasted over 1 week.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Arm was stiff and pain was shooting down into her hand. Took ALEVE in the morning and the pain resolved, she had difficulty lifting her arm in the evening but by morning it was resolved.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chest X-ray abnormal, Cough, Injection site erythema, Pain, Pyrexia
Clinical narrative: Fever of 103 degrees F and aches. Redness at injection site was normal. Cough went to Dr. and had chest xray. Lower left lobe cloudy in otherwise healthy adult. In bed for 2 days after. Better but non-productive cough on day 4 in the afternoon.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Hard, swollen (about 5" diameter-slightly raised and firm) spot at injection site of PREVNAR-13 inj.-area red and warm started 3 days after inj. began to resolve 4-5 days later also large bruising area about 4" x 5" and below by 4" of FLUVIRIN injection on opposite arm-may or may not be from flu shot.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Sore, painful, red huge area around injection site armpit sore, swollen lymph node, warm to the touch, very painful, very irritating to patient.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Sore, painful, red huge area around injection site armpit sore, swollen lymph node, warm to the touch, very painful, very irritating to patient.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Inflammation, Peripheral swelling, Rash, Underdose
Clinical narrative: Patient arm began swelling/inflammation rapidly before injecting a fraction of the vaccine. I withdrew syringe before injecting more and observed rash spreading approximately 2 cm. I quickly gave her 2 BENADRYL 25mg and water. She reported no SOB or palpitations, etc or spreading of rash after 20 minutes, so I refunded her and let her go home.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Temp of 101-102 degrees F for about 10 hours follow by low grade temp for 4 days. 4 days of injection site being swollen, red, hot to touch with hard knot at location site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Temp of 101-102 degrees F for about 10 hours follow by low grade temp for 4 days. 4 days of injection site being swollen, red, hot to touch with hard knot at location site.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Lymphadenopathy, Malaise, Migraine
Clinical narrative: This spontaneous report as received from a physician regarding his wife's relative via company representative refers to a 17 year old non pregnant female patient. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with first dose of GARDASIL (strength, route unspecified) and experienced migraines, swollen lymph nodes, malaise and fatigue on an unknown date. It was reported that the adverse effects continued for ten days (dates unspecified) and the patient was feeling better and was recovering from the events reported. The patient had not sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to an unspecified number of patients of an unknown age. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with more than one dose of PNEUMOVAX 23. No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to two unspecified patients of an unknown age and gender. The patients concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX and developed shingles on an unspecified date. The outcome of the event was unknown. The reporter did not provide the relatedness of the event with ZOSTAVAX. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 7 month old patient. The patient's concurrent conditions and medical history were not reported. On 26-AUG-2015, the infant was vaccinated with VARIVAX (lot # L009205, expiry date 17-MAR-2017) and MMR II (lot # K020189, expiry date 11-SEP-2016) in error. The patient did not demonstrate an adverse experience. Additional information has been requested.