chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: FLUX, MMR
Symptoms: Urticaria
Clinical narrative: We were against the MMR and tried to avoid giving it to him but our School forced us, no MMR shot no school! So Doctor gave him the first MMR shot AND the FLU Shot at the same time. I would NEVER would have let him give both shots, only MMR. Pretty stupid choice from Dr!!!Awoke with chills, super wet, super high fever 105.2. Red bumps, hives, sore throat. We soaked him in the bath with room temp water until the fever came down. It is now 11/24/2012 and we have been giving patient 2 tsp doses of Motrin since 11/17/2012, every 6 to 8 hours. If we stop his fever jumps back up to 103 to 104.8. Took him back to Doctor, asking for blood work to be done, and was told that we should wait until Sunday 11/25/2012. If his fever doesn't break by then to bring him in for blood work. This is why I refused as I knew that this would not turn out well!
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Body temperature fluctuation, Chills, Dizziness, Full blood count normal
Clinical narrative: Approximately 2 hours after getting the shot I began to get very dizzy. I was unable to walk, I was even dizzy laying down with my eyes closed. I was taken to my family doctor where they checked my out. While I was there I began having severe tremors or what they called rigors. When I first got there I told them that the nurse at work took my blood pressure where it was 96/60 (mine usually runs quite low) but when I got th the doctors office my heart rate went up to 140. They also took my temp right when I got there and it was 97 degrees (mine again runs low) after the rigors started they took temp again and it was 100 degrees. They took blood and my CBC was normal. They watched me for a while and by the time I left my blood pressure was normal as well as my temperature. The dizziness continued for the rest of the day but otherwise everything else stopped. The next day I was back to normal.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Approximately 2 hours after getting the shot I began to get very dizzy. I was unable to walk, I was even dizzy laying down with my eyes closed. I was taken to my family doctor where they checked my out. While I was there I began having severe tremors or what they called rigors. When I first got there I told them that the nurse at work took my blood pressure where it was 96/60 (mine usually runs quite low) but when I got th the doctors office my heart rate went up to 140. They also took my temp right when I got there and it was 97 degrees (mine again runs low) after the rigors started they took temp again and it was 100 degrees. They took blood and my CBC was normal. They watched me for a while and by the time I left my blood pressure was normal as well as my temperature. The dizziness continued for the rest of the day but otherwise everything else stopped. The next day I was back to normal.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Injection site pain, Pyrexia, Somnolence, Vomiting
Clinical narrative: Appetite gone, fever, sleepy, sore arm site of injection, vomiting.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort
Clinical narrative: Patient called and said she was still having discomfort in the arm, 2 weeks after her flu shot. I told her I thought that was a long time and suggested she call her MD.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Gradually increasing pain, redness, induration at injection site.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Very sore shoulder, especially when using arm overhead or removing shirt.  This has continued since then (7 weeks so far).
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Gait disturbance, Headache, Injection site swelling, Migraine, Muscle swelling
Clinical narrative: Severe swelling to the injection site. Muscle swollen and inflammed in an aprox. 6" square around injection site. Trouble walking (pain). Severe migraine. Stiff neck/shoulder (right side). High Temperature, as high as 102.5. Signs and Symptoms have lasted for 3 days and continue to persist. Tried to treat at home with aspirin, Excedrin migraine. Finally sought doctor care at an urgent care facility (date 11/23/12), given a toradol shot for pain and given butalbital/acetminophine/caffiene for headache. Having to take them every 4 hours to gain any relief.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Myositis, Pain, Pyrexia
Clinical narrative: Severe swelling to the injection site. Muscle swollen and inflammed in an aprox. 6" square around injection site. Trouble walking (pain). Severe migraine. Stiff neck/shoulder (right side). High Temperature, as high as 102.5. Signs and Symptoms have lasted for 3 days and continue to persist. Tried to treat at home with aspirin, Excedrin migraine. Finally sought doctor care at an urgent care facility (date 11/23/12), given a toradol shot for pain and given butalbital/acetminophine/caffiene for headache. Having to take them every 4 hours to gain any relief.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives all over body.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Pain, Rash
Clinical narrative: Patient came into store on 11/24/12 and complained of rash and pain. Rash is about 3-4 inches above injection site. I told patient to check with physician. Also noticed rash around elbow area but not around injection site.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Swelling, Urticaria
Clinical narrative: Slightly raised, red "red as a lobster" rash/hives that itched. Began 11-20-12, lasting until at 11-24-12.
Age: 95.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fluid retention, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Trouble moving her left arm started hurting same day continued to hurt went to walk in clinic. She has fluid in her arm.
Sex: F
Vaccine: HPV4
Symptoms: Aphagia, Injection site pain, Injection site swelling, Nausea
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a female patient of unknown age. Approximately 1 month ago on 20-OCT-2012, the patient was vaccinated with dose 1 GARDASIL (lot#, expiry, dose, route not reported). No concomitant medications were reported. Approximately in October 2012, the patient experienced pain and swelling at the injection site. The patient also experienced nausea and was unable to eat because of nausea. No treatment information was reported. The Patient had sought medical attention (office visit). The outcome of unable to eat, nausea, pain and swelling at the injection site was reported as not recovered. The relatedness for pain and swelling at the injection site, unable to eat and nausea and was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEP, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. The nurse is reporting that an unknown number of patients may have been administered GARDASIL (lot #, expiry, dose and route not reported) and RECOMBIVAX HB (lot #, expiry, dose and route not reported) since August 2012 that had been improperly stored. No concomitant medications were reported. No adverse effects were reported. No treatment information was reported. It was unknown if the patients had sought medical attention. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Bordetella test positive, Polymerase chain reaction
Clinical narrative: Child diagnosed positive pertussis by PCR on 11-23-12. Treated with Z-pack.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Poor quality sleep
Clinical narrative: Soreness, radiating pain up to shoulder, neck persistent for one week. Pain is constant and prevents a restful sleep. Taking TYLENOL 500mg 1 by mouth every 6 hours for pain.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Insomnia, Pain
Clinical narrative: Soreness, radiating pain up to shoulder, neck persistent for one week. Pain is constant and prevents a restful sleep. Taking TYLENOL 500mg 1 by mouth every 6 hours for pain.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. On 20-NOV-2012, the patient was vaccinated with a dose of expired ZOSTAVAX (lot # 671144/1269AA, expiry: 05-NOV-2012). No concomitant medications were reported. No adverse effect was reported. No treatment information was reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a 74 years old male patient. The patient's medical history included shingles on an unspecified date in the past. On 11-NOV-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX(lot#, expiry, dose not reported). No concomitant medications were reported. On 19-NOV-2012, the patient had developed a rash on his back after receiving the ZOSTAVAX. No treatment was given for the rash. The pharmacist advised the patient to see his physician for treatment. The outcome of rash on his back was reported as not recovered. The relatedness for rash on his back was unknown for ZOSTAVAX. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Pain in back of left thigh. The next two nights pain was in both thighs (and much more severe on third night).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Audiogram, Balance disorder, Condition aggravated, Deafness
Clinical narrative: On 10/8/12, 2 days post flu vax, developed, Menieres attack (h/o Menieres), this episode, severe, veritgo, tinnitus, hearing loss/moderate drop, nausea, double vision. Needed one week off work. Was not treated with Prednisone, as was in previous Menieres episodes as caution of autoimmune reaction to flu vax. Meniere episode, strongest one since 2009, lasting with residual effects approx. 3 weeks, tinnitus, imbalance, nausea, left ear hearing drop.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia, Meniere's disease, Nausea, Tinnitus, Vertigo
Clinical narrative: On 10/8/12, 2 days post flu vax, developed, Menieres attack (h/o Menieres), this episode, severe, veritgo, tinnitus, hearing loss/moderate drop, nausea, double vision. Needed one week off work. Was not treated with Prednisone, as was in previous Menieres episodes as caution of autoimmune reaction to flu vax. Meniere episode, strongest one since 2009, lasting with residual effects approx. 3 weeks, tinnitus, imbalance, nausea, left ear hearing drop.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Oropharyngeal pain, Pyrexia, Sinusitis
Clinical narrative: Rash at injection site, followed by sore throat, fever, and sinus infection.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain, Sleep disorder
Clinical narrative: Very painful, stiff left shoulder where vaccine administered. Painful to lift arm away from body, overhead, or across chest. Painful to sleep/pull covers up.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: Rash all over body with itching, hives, urticaria, steroids and antihistamine given by MD.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Infection, Musculoskeletal stiffness, Oedema peripheral, Pain in extremity
Clinical narrative: Received shot at flu clinic on 10/12/12.  On 10/13/12 complained of sore arm, mom gave Tylenol.  On 10/14/12 arm swollen from elbow to shoulder, warm, stiff, red.  Mom took to ER, MD treated as infection and gave Bactrim x 7 days.  Arm is better now.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Received shot at flu clinic on 10/12/12.  On 10/13/12 complained of sore arm, mom gave Tylenol.  On 10/14/12 arm swollen from elbow to shoulder, warm, stiff, red.  Mom took to ER, MD treated as infection and gave Bactrim x 7 days.  Arm is better now.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Extreme toe, arch, top of foot and calf cramps both legs, but predominantly in the left leg same side as the immunization that lasted for approx 3 - 5 minutes and continues.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's Palsy.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Pain, Pain in extremity
Clinical narrative: Small bruise at injection site. Entire upper arm very sore. Soreness began evening of 13th and got progressively worse on 11-15. Movement of arm is painful. Patient reports that her mother is a nurse and that her mother said injection given approximately 3 inches too high. Patient has had multiple influenza vaccinations in past without pain (but with occasional bruising).
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia
Clinical narrative: Last year I had a very severe case of shingles and have PHN. About 24 hrs after vaccine my neuralgia became very intense and painful around the waist area - I had not had this level of pain in over 6 mos. This lasted about 2 1/2 days.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance, Muscular weakness, Pain in extremity
Clinical narrative: I am very active, healthy person & within 6-7 hrs of flu shot, had significant pain and muscle spasms from (R) hip to mid lower (R) leg. Could not walk without holding on, knee would buckle without warning. Was not able to exercise (treadmill, swimming). After 6 wks sxs slowly resolving but still debilitating at times.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncope immediately after influenza vaccine 0.5 IM.
Age: 37.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Differential white blood cell count, Full blood count, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 37 years old female patient with asthma, allergy to bactrim and sulfa. The patient was vaccinated with PNEUMOVAX 23 (0.5 ml, Intramuscular, lot # was reported as H013399, expiration date was 07-MAR-2014) along with BOOSTRIX (route, dose and lot # were unknown) in the same arm on 05-NOV-2012. Concomitant medications included RETIN-A, clindamycin, benzoyl peroxide, ACANYA, SINGULAIR, VENTOLIN and escitalopram. On 06-NOV-2012 the patient experienced redness and tenderness at the injection site, a fever and was diagnosed with cellulitis on 08-NOV-2012. The outcome of the events were reported as recovered/resolved. The patient had sought unspecified medical attention. Treatment of "ibuprofen and cephalexin for 7 days" were given for adverse events. Lab Diagnostics Studies Performed: "CBC" and result was unknown. This is one of the three cases (other cases in SR# 1-5751424938 (MARRS # 1211USA007581), SR# 1-5751424995 (MARRS # 1211USA007578) by this nurse concerning adverse events from the same lot number for PNEUMOVAX 23. Lot check is being requested by the nurse. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 37 years old female patient with asthma, allergy to bactrim and sulfa. The patient was vaccinated with PNEUMOVAX 23 (0.5 ml, Intramuscular, lot # was reported as H013399, expiration date was 07-MAR-2014) along with BOOSTRIX (route, dose and lot # were unknown) in the same arm on 05-NOV-2012. Concomitant medications included RETIN-A, clindamycin, benzoyl peroxide, ACANYA, SINGULAIR, VENTOLIN and escitalopram. On 06-NOV-2012 the patient experienced redness and tenderness at the injection site, a fever and was diagnosed with cellulitis on 08-NOV-2012. The outcome of the events were reported as recovered/resolved. The patient had sought unspecified medical attention. Treatment of "ibuprofen and cephalexin for 7 days" were given for adverse events. Lab Diagnostics Studies Performed: "CBC" and result was unknown. This is one of the three cases (other cases in SR# 1-5751424938 (MARRS # 1211USA007581), SR# 1-5751424995 (MARRS # 1211USA007578) by this nurse concerning adverse events from the same lot number for PNEUMOVAX 23. Lot check is being requested by the nurse. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Cellulitis, Full blood count, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 37 years old female patient with asthma, allergy to bactrim and sulfa. The patient was vaccinated with PNEUMOVAX 23 (0.5 ml, Intramuscular, lot # was reported as H013399, expiration date was 07-MAR-2014) along with BOOSTRIX (route, dose and lot # were unknown) in the same arm on 05-NOV-2012. Concomitant medications included RETIN-A, clindamycin, benzoyl peroxide, ACANYA, SINGULAIR, VENTOLIN and escitalopram. On 06-NOV-2012 the patient experienced redness and tenderness at the injection site, a fever and was diagnosed with cellulitis on 08-NOV-2012. The outcome of the events were reported as recovered/resolved. The patient had sought unspecified medical attention. Treatment of "ibuprofen and cephalexin for 7 days" were given for adverse events. Lab Diagnostics Studies Performed: "CBC" and result was unknown. This is one of the three cases (other cases in SR# 1-5751424938 (MARRS # 1211USA007581), SR# 1-5751424995 (MARRS # 1211USA007578) by this nurse concerning adverse events from the same lot number for PNEUMOVAX 23. Lot check is being requested by the nurse. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Feeling abnormal, Headache
Clinical narrative: Headache, stomach ache immediate & continuous daily to regular now. Fatigue & weakness. Localized weakness as well to injection sites. Out of sorts.
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site reaction
Clinical narrative: Headache, stomach ache immediate & continuous daily to regular now. Fatigue & weakness. Localized weakness as well to injection sites. Out of sorts.
Age: 11.0
Sex: M
Vaccine: MMR, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Appetite disorder, Asthenia, Condition aggravated, Constipation
Clinical narrative: Headache, stomach ache, nausea, immediately & continues regularly as well as day 1 & 2 fatigue & weakness. Continued with return of eczema & skin lesions that all above are reoccurring. Allergies began soon after year round sinusitis without relief. Constipation. Difficulty with emotional control & sleep. Appetite fluctuations.
Age: 11.0
Sex: M
Vaccine: MMR, MNQ, TDAP, VARCEL
Symptoms: Eczema, Emotional disorder, Fatigue, Headache, Hypersensitivity
Clinical narrative: Headache, stomach ache, nausea, immediately & continues regularly as well as day 1 & 2 fatigue & weakness. Continued with return of eczema & skin lesions that all above are reoccurring. Allergies began soon after year round sinusitis without relief. Constipation. Difficulty with emotional control & sleep. Appetite fluctuations.
Age: 11.0
Sex: M
Vaccine: MMR, MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Insomnia, Nausea, Skin lesion
Clinical narrative: Headache, stomach ache, nausea, immediately & continues regularly as well as day 1 & 2 fatigue & weakness. Continued with return of eczema & skin lesions that all above are reoccurring. Allergies began soon after year round sinusitis without relief. Constipation. Difficulty with emotional control & sleep. Appetite fluctuations.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain upper, Anxiety, Constipation, Diarrhoea, Dizziness
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 12 year old female patient with no medical history or drug reactions/allergies. The patient was vaccinated with dose 1 GARDASIL (date, dose, route, lot # and expiration date not reported). The patient also received MENACTRA and ADACEL at the same visit. Medical assistant reported that the patient became "a little dizzy" after her first vaccination with GARDASIL. The patient was vaccinated with dose 2 GARDASIL (date, dose, route, lot # and expiration date not reported). After the patient's 2nd vaccination with GARDASIL, she became dizzy and passed out. Since the 2nd vaccination the patient has developed nausea, stomach pains, anxiety and did not want to go to school. The patient's mom stated her daughter had had two of the three series of shots for GARDASIL and was experiencing nausea, diarrhea, constipation, stomach aches, tears in the morning on the way to school, dizziness, and when she ate it got worse. The patient contacted office to seek medical attention. The patient was treated with ZANTAC. No lab tests were performed. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Loss of consciousness, Nausea, Tearfulness
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 12 year old female patient with no medical history or drug reactions/allergies. The patient was vaccinated with dose 1 GARDASIL (date, dose, route, lot # and expiration date not reported). The patient also received MENACTRA and ADACEL at the same visit. Medical assistant reported that the patient became "a little dizzy" after her first vaccination with GARDASIL. The patient was vaccinated with dose 2 GARDASIL (date, dose, route, lot # and expiration date not reported). After the patient's 2nd vaccination with GARDASIL, she became dizzy and passed out. Since the 2nd vaccination the patient has developed nausea, stomach pains, anxiety and did not want to go to school. The patient's mom stated her daughter had had two of the three series of shots for GARDASIL and was experiencing nausea, diarrhea, constipation, stomach aches, tears in the morning on the way to school, dizziness, and when she ate it got worse. The patient contacted office to seek medical attention. The patient was treated with ZANTAC. No lab tests were performed. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 34.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 34 years old patient. The patient was inadvertently administered with ZOSTAVAX (subcutaneously, Lot #, dose unspecified) on 19-NOV-2012. No adverse effects reported. No treatment information was reported. The outcome was unknown. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a 67 years old patient. The patient did not have any drug reactions/allergies. The patient was vaccinated with the first dose of PNEUMOVAX 23 (0.5 ml, Intramuscular, lot # were unknown) in 2009 and the second dose of PNEUMOVAX 23 (0.5 ml, Intramuscular, lot # 671555/1314AA, expiration date was 05-MAY-2013) on 14-NOV-2012. No other co-suspects were reported. Concomitant medications included omeprazole and FLONASE. On 14-NOV-2012 the patient experienced swelling at the injection site after receiving PNEUMOVAX 23 and swelling was moving down toward her right armpit and down to elbow along with pain and redness. Ibuprofen and BENADYRL were given for adverse event. The outcome of event was unknown. The patient had sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not provided) "two weeks ago", approximately on 25-OCT-2012 and vaccinated with another dose on 08-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Muscle spasms, Muscle twitching, Pain
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 69-year-old male patient with no pertinent medical history and drug reactions/allergies. On 15-OCT-2012 the patient was vaccinated with 0.5 milliliter (ml) PNEUMOVAX 23 (lot # 1947AA), expiration date 20-OCT-2013) intramuscularly (IM). Concomitant medications included unspecified blood pressure medication. Patient experiencing stinging, soreness and pain at the injection site after receiving PNEUMOVAX 23 on 15-OCT-2012. Pharmacist also reported that the patient stated that he had been experiencing cramping in the left arm where he received the injection of PNEUMOVAX 23 and that the cramping moved down from his shoulder to his hand and is described as quick cramps or a twitching feeling. No treatment was given for the events. No lab diagnostic studies were performed. The patient sought medical attention by contacting the pharmacist. The events did not resolve at the time of this report. No further information is available. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a other health professional refers to a 28 years old male patient. The patient was vaccinated with, 1 DF MMR II. No other co-suspects were reported. No concomitant medications were reported. On 14-NOV-2012 the patient experienced patient's titer for measles was low. No treatment information was reported. The outcome of patient's titer for measles was low is unknown. The relatedness for patient's titer for measles was low is unknown for MMR II> Additional information has been requested./Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL, DTAPIPV, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: This report was received from GlaxoSmithKline was assigned manufacturer report number A00990329A. This was originally reported from a physician, via sales representative, concerning 4 years old male patient with no adverse events following previous vaccinations. The patient did not have any relevant medical history. On 10-JUL-2012, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # 1909AA) (route and dose unknown). Other suspect therapies included on 10-JUL-2012, the first dose of KINRIX (lot # AC20B187AA) (dose unknown; route administration: left thigh). No concomitant medications were reported. On 10-JUL-2012, the patient experienced injection site cellulitis of the left thigh. On 12-JUN-2012, two days after vaccination with VARIVAX (Merck) and KINRIX, the patient experienced an allergic reaction in addition to previously reported injection site cellulitis. No treatment information was reported. It was also reported that the patient was vaccinated at inappropriate site with KINRIX, the preferred site for KINRIX is the deltoid muscle of the upper arm instead of the left thigh. On 18-JUL-2012, the events of injection site cellulitis and allergic reaction were resolved. The reporting investigator considered the events of injection site cellulitis of the left thigh and hypersensitivity were probably related to vaccination with VARIVAX (Merck) and KINRIX. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL, DTAPIPV, VARCEL
Symptoms: Drug administered at inappropriate site, Hypersensitivity, Injection site cellulitis
Clinical narrative: This report was received from GlaxoSmithKline was assigned manufacturer report number A00990329A. This was originally reported from a physician, via sales representative, concerning 4 years old male patient with no adverse events following previous vaccinations. The patient did not have any relevant medical history. On 10-JUL-2012, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # 1909AA) (route and dose unknown). Other suspect therapies included on 10-JUL-2012, the first dose of KINRIX (lot # AC20B187AA) (dose unknown; route administration: left thigh). No concomitant medications were reported. On 10-JUL-2012, the patient experienced injection site cellulitis of the left thigh. On 12-JUN-2012, two days after vaccination with VARIVAX (Merck) and KINRIX, the patient experienced an allergic reaction in addition to previously reported injection site cellulitis. No treatment information was reported. It was also reported that the patient was vaccinated at inappropriate site with KINRIX, the preferred site for KINRIX is the deltoid muscle of the upper arm instead of the left thigh. On 18-JUL-2012, the events of injection site cellulitis and allergic reaction were resolved. The reporting investigator considered the events of injection site cellulitis of the left thigh and hypersensitivity were probably related to vaccination with VARIVAX (Merck) and KINRIX. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL, DTAPIPV, VARCEL
Symptoms: Drug administered at inappropriate site, Injection site cellulitis
Clinical narrative: This report was received from GlaxoSmithKline was assigned manufacturer report number A00990329A. This was originally reported from a physician, via sales representative, concerning 4 years old male patient with no adverse events following previous vaccinations. The patient did not have any relevant medical history. On 10-JUL-2012, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # 1909AA) (route and dose unknown). Other suspect therapies included on 10-JUL-2012, the first dose of KINRIX (lot # AC20B187AA) (dose unknown; route administration: left thigh). No concomitant medications were reported. On 10-JUL-2012, the patient experienced injection site cellulitis of the left thigh. On 12-JUN-2012, two days after vaccination with VARIVAX (Merck) and KINRIX, the patient experienced an allergic reaction in addition to previously reported injection site cellulitis. No treatment information was reported. It was also reported that the patient was vaccinated at inappropriate site with KINRIX, the preferred site for KINRIX is the deltoid muscle of the upper arm instead of the left thigh. On 18-JUL-2012, the events of injection site cellulitis and allergic reaction were resolved. The reporting investigator considered the events of injection site cellulitis of the left thigh and hypersensitivity were probably related to vaccination with VARIVAX (Merck) and KINRIX. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abdominal discomfort, Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 46 years old male patient with diabetic, hypertension and hyperlipidemia no drug reactions or allergies. On 07-NOV-2012, the patient was vaccinated in arm intramuscularly (IM) with a 0.5 ml dose of PNEUMOVAX23 (lot number H013399, expiration date:07-MAR-2014). On the same date, the patient also was vaccinated with FLUZONE(dose, route, lot # and expiration date not reported) in the same arm. Concomitant medications included metformin, aspirin, PRILOSEC, LYRICA and tramadol hydrochloride. On 08-NOV-2012, the patient experienced swelling and pain at the injection site, stomach upset, fever, chills and was diagnosed with cellulitis. The patient sought unspecified medical attention and was treated with ciprofloxacin and prednisone (manufacturer unspecified). On an unknown date, the patient recovered from cellulitis. The relatedness for the adverse event of cellulitis was unknown for PNEUMOVAX23. This one of several report received from same source. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abdominal discomfort, Cellulitis, Chills, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 46 years old male patient with diabetic, hypertension and hyperlipidemia no drug reactions or allergies. On 07-NOV-2012, the patient was vaccinated in arm intramuscularly (IM) with a 0.5 ml dose of PNEUMOVAX23 (lot number H013399, expiration date:07-MAR-2014). On the same date, the patient also was vaccinated with FLUZONE(dose, route, lot # and expiration date not reported) in the same arm. Concomitant medications included metformin, aspirin, PRILOSEC, LYRICA and tramadol hydrochloride. On 08-NOV-2012, the patient experienced swelling and pain at the injection site, stomach upset, fever, chills and was diagnosed with cellulitis. The patient sought unspecified medical attention and was treated with ciprofloxacin and prednisone (manufacturer unspecified). On an unknown date, the patient recovered from cellulitis. The relatedness for the adverse event of cellulitis was unknown for PNEUMOVAX23. This one of several report received from same source. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 46 years old male patient with diabetic, hypertension and hyperlipidemia no drug reactions or allergies. On 07-NOV-2012, the patient was vaccinated in arm intramuscularly (IM) with a 0.5 ml dose of PNEUMOVAX23 (lot number H013399, expiration date:07-MAR-2014). On the same date, the patient also was vaccinated with FLUZONE(dose, route, lot # and expiration date not reported) in the same arm. Concomitant medications included metformin, aspirin, PRILOSEC, LYRICA and tramadol hydrochloride. On 08-NOV-2012, the patient experienced swelling and pain at the injection site, stomach upset, fever, chills and was diagnosed with cellulitis. The patient sought unspecified medical attention and was treated with ciprofloxacin and prednisone (manufacturer unspecified). On an unknown date, the patient recovered from cellulitis. The relatedness for the adverse event of cellulitis was unknown for PNEUMOVAX23. This one of several report received from same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 years old female patient with no pertinent medical history and no drug reactions or allergies. On 16-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX23 lot number reported as H013394, exp. date 05-MAR-2014 (dose and route were not reported). Other suspect therapy administered concomitantly in the same arm (on an approximately 16-NOV-2012) included a dose of FLUZONE (dose, route and lot number were not reported). There was no concomitant medications. Pharmacist reported that on 17-NOV-2012, the patient's arm was "extremely swollen" around the injection site after receiving a dose of PNEUMOVAX23 and dose of FLUZONE concomitantly in the same arm. It was reported that the patient sought unspecified medical attention (contacted the pharmacist). There was no treatment given for the patient's event. No laboratory tests were performed. At the time of report, the patient's outcome was unknown. The relatedness for patient's event was not reported for PNEUMOVAX23 and FLUZONE. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Swelling and rash around injection site (lower deltoid), fever, flu-like symptoms, 105 degree fever. Tx with CIPRO in hospital (11/22/12) and had follow-up with PCP (11/24/12).
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence, Unresponsive to stimuli
Clinical narrative: Customer was sleepy, not respond to husband call, breathing was ok, later she opened her eye talked some words to husband. 911 was called, took her to hospital.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Urticaria
Clinical narrative: LARGE RED WELTS ON LEFT CHEST, SHOULDER AND LEFT SIDE OF NECK. DR. DIAGNOSED AS SHINGLES WHEN SEEN AGAIN ON FRI. (11/23/2012) PRESCRIBED ANTI VIRALS, VICODIN, IBUPROFEN, GABAPENTIN.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Electromyogram normal, Hemiparesis, Hypoaesthesia, Injection site pain
Clinical narrative: On 05 Oct 2012 recd Flu vaccine in (L) deltoid (IM injection). Experienced pain during shot that increased in severity over the following week. On 12 Oct went for routine previously scheduled med. exam with primary care physician who became concerned with symptoms (pain, muscle weakness (L) side; face numb (L) side. Hospitalized 12-13 Oct 2012. Symptoms resolved in approximately 2 weeks. Can never take Flu shot again.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test normal, Neurological examination normal, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: On 05 Oct 2012 recd Flu vaccine in (L) deltoid (IM injection). Experienced pain during shot that increased in severity over the following week. On 12 Oct went for routine previously scheduled med. exam with primary care physician who became concerned with symptoms (pain, muscle weakness (L) side; face numb (L) side. Hospitalized 12-13 Oct 2012. Symptoms resolved in approximately 2 weeks. Can never take Flu shot again.
Age: 42.0
Sex: F
Vaccine: FLU3, MNQ, PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 42 years old female patient. The patient had allergies to soy isoflavone and latex. On 13-OCT-2012 the patient was vaccinated in her left deltoid by intramuscular injection with a single dose of 0.5 ml PNEUMOVAX23 (lot # H010661, expiration date reported as 02-FEB-2014). Concomitant medications included FLUVIRIN (Novartis) and MENACTRA (Sanofi), both of which were vaccinated in the patient's right arm during the same visit, on 13-OCT-2012. The patient developed a case of cellulitis, described as "very large" and a fever described as "greater than 102 degrees Fahrenheit" at an unspecified time following vaccination. Pharmacist reported that this was the patient's third lifetime dose of PNEUMOVAX23 and the patient had experienced similar, though milder reactions following prior doses of PNEUMOVAX23 (lot # not reported). Pharmacist did not know the patient's prior medical history, but stated that the patient reported that her healthcare providers had urged her to get PNEUMOVAX23 every 5-10 years. The patient sought for unspecified medical attention. Antibiotics and oral steroids were given as treatment. Lab diagnostics studies performed were reported as none. The patient recovered on an unspecified date. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Headache, Musculoskeletal pain, Nodule, Pain in extremity
Clinical narrative: Initial report was received from a health care professional on 15 November 2012. A female patient (age and date of birth not reported) had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH731AB, on 08 October 2012. On 01 November 2012, the patient developed left shoulder pain and arm pain to hand, left ear pain and knots behind left ear that got progressively worse and a headache. Treatment included steroids and anti-inflammatories. The patient continued to complain of symptoms. Cervical spine and left shoulder x-ray were within normal limits (WNL). The patient had no known allergies (NKA) and no illness at the time of vaccination. Outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Spinal X-ray normal, X-ray limb normal
Clinical narrative: Initial report was received from a health care professional on 15 November 2012. A female patient (age and date of birth not reported) had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH731AB, on 08 October 2012. On 01 November 2012, the patient developed left shoulder pain and arm pain to hand, left ear pain and knots behind left ear that got progressively worse and a headache. Treatment included steroids and anti-inflammatories. The patient continued to complain of symptoms. Cervical spine and left shoulder x-ray were within normal limits (WNL). The patient had no known allergies (NKA) and no illness at the time of vaccination. Outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: DTP
Symptoms: Allergy to vaccine, Convulsion
Clinical narrative: Initial report was received from a consumer through another manufacturer on 13 November 2012 under service request number 1-5724965661. A female patient (age not reported) received an injection of Diphtheria, Tetanus and Pertussis Vaccine (lot number, route, site, and date of vaccination not reported) and an unspecified amount of time later experienced a seizure. The patient said she was allergic to the pertussis portion of the vaccine. The patient's outcome was not reported. Documents held by sender: None.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Rash generalised
Clinical narrative: Initial report was received from a health care professional on 28 September 2012. An 84-year-old male patient, whose medical history and concomitant medications were not reported, had received FLUZONE HD vaccine, (lot number: U4490AA site of administration was not reported) intramuscularly on 23 September 2012. It was reported that on 23 September 2012, after receiving FLUZONE HD vaccine, the patient experienced "bumps/rash" all over body and patient had self-treated with BENADRYL which had provided only slight relief. The laboratory investigations were not reported. As of 28 September 2012, the patient not recovered from the event. Follow-up information was received 19 November 2012 from a health care professional. Based upon new information received, this case now meets seriousness criteria, and has been upgraded from nonserious to serious. The patient received FLUZONE HIGH-DOSE in the left arm. According to the reporter, the patient had a rash and blisters all over. BENADRYL was the only medication prescribed as corrective treatment. The patient had no illness at the time of vaccination and no other medications reported on "VAR" form. The patient recovered around 30 September 2012. Documents held by sender: None.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Vaccination site reaction
Clinical narrative: Initial report was received 12 November 2012 from a health care professional which involved a cluster of two patients. The other patient has been captured in case number 2012-10633. A 94-year-old female patient who had a history of allergy to sulfa and shellfish and no concurrent illness, had received a left deltoid intramuscular injection of FLUZONE, lot number UH752AB on 15 October 2012 and two days later, she developed shingles on her left arm, back, and on her left arm at the vaccination site. Laboratory and diagnostic data was reported as "none". The patient received treatment (not specified) and recovered. Documents held by sender: None.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Polymerase chain reaction
Clinical narrative: Initial report was received on 13 November 2012 from a healthcare professional. This case was originally part of a cluster of approximately 17 patients (six elderly patients, two adolescent patients and approximately nine unidentified patients) who tested PCR positive for INFLUENZA A/H3N2. The two adolescent patients were captured in case number 2012-05659 and the ten unidentified patients (previously reported as nine patients) were captured in case numbers 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06071, 2012-06072, 2012-06073. In addition this case was previously part of the six elderly patient's case 2012-05658. The other elderly patient cases have been captured in case numbers 2012-10691, 2012-10692, 2012-10693 and 2012-10695. An 89 year-old female patient had received on 11 October 2011 a dose of FLUZONE, lot number UH454AC (route and site of administration not reported). The patient participated in an influenza surveillance program. The patient's approximate treatment date and "collection date" was 29 February 2012. According to the reporter, the type of influenza was flu A and the subtype of influenza was H3N2. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Migraine, Nausea, Rash, Somnolence
Clinical narrative: Case number PHEH2012US021252, is an initial spontaneous report received from a pharmacist on 18 Oct 2012, with a follow up on 18 Oct 2012 with a follow up information received on 20 Nov 2012. This report refers to 32 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: UH745AA, expiry date: May 2013) 0.5 ml intramuscular on 08 Sep 2012. About 30 minutes after vaccination the patient noticed spots and experienced nausea, vomiting, migraine and headache. The next day the patient was groggy and had vomiting. Event outcome, seriousness and causality assessment was not reported. Follow up received on 18 Oct 2012. Expiry date added. Follow up information received on 20 Nov 2012: Patient demographics (height and weight), batch number, dose and vaccination date updated and events (migraine).
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Case number PHEH2012US021252, is an initial spontaneous report received from a pharmacist on 18 Oct 2012, with a follow up on 18 Oct 2012 with a follow up information received on 20 Nov 2012. This report refers to 32 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: UH745AA, expiry date: May 2013) 0.5 ml intramuscular on 08 Sep 2012. About 30 minutes after vaccination the patient noticed spots and experienced nausea, vomiting, migraine and headache. The next day the patient was groggy and had vomiting. Event outcome, seriousness and causality assessment was not reported. Follow up received on 18 Oct 2012. Expiry date added. Follow up information received on 20 Nov 2012: Patient demographics (height and weight), batch number, dose and vaccination date updated and events (migraine).
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Oedema peripheral, Pruritus generalised, Urticaria
Clinical narrative: Case number PHHY2012US105247 is an initial spontaneous report received from a pharmacist on 19 Nov 2012: This report refers to a 42-years-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: not reported) on 15 Nov 2012. After vaccination on the next day, he complained that, he woke up in the middle of the night with hives and itching all over trunk, arms and legs. He was treated with BENADRYL. On 17 Nov 2012, he also experienced lips and hands swelled up. The outcome and causality of the events was not reported.