chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: I received the flu shot vaccine on 10/22/13 around 0800 in my left arm. The flu shot was administered by a facility employee. I noticed she gave the shot very high in the arm, and I remember this being odd because she asked me to roll up my cap sleeve shirt before she gave me the shot. My shoulder was very sore the remainder of the day. The following morning (10/23/14) I woke up in extreme pain and with extremely limited mobility in my left arm/shoulder. The pain was so bad while trying to put my clothes on, I got light-headed and felt I was going to pass out and had to lay back down. I assumed the pain would go away, but over the next several weeks the pain kept getting worse and the mobility in my left arm/shoulder became more and more limited. On 11/8/13 I called a local orthopedic office to schedule an appointment. This office specializes in upper extremity orthopedics and I had previously seen them about an unrelated hand issue. I scheduled an appointment to see Dr. on 11/12/13. On 11/12/13, Dr. checked my left arm/shoulder and recommended orthopedic therapy (OT) 1-2 times per week onsite for 3 weeks and he wanted to see me for a follow-up on 12/5/13. I had my OT evaluation on 11/18/13 and did an OT session following the evaluation. I was also given OT to do at home between onsite OT sessions, which I did as instructed. I had additional onsite OT sessions on 11/21/13, 11/25/13, 12/2/13, 12/5/13, 12/12/13. I continued OT daily at home during and after the onsite OT sessions. During the 12/5/13 follow-up appointment with Dr. he administered a cortisone shot since the pain in my arm was still so strong and my mobility was still extremely limited. Dr. hoped that cortisone shot would take care of the problem and he instructed me to call back if the shoulder didn't get better. After receiving the cortisone shot, the pain was much better, but the mobility was still limited. Around the end of January the pain began coming back so I called the doctor and set up an appointment to see Dr. on 3/13/14. During the 3/13/14 appointment Dr. checked my shoulder again (still in pain and still limited mobility) and then administered another cortisone shot. Dr. said to call if the pain/limited mobility continued and if so we would do an MRI at that time. The pain continued along with the limited mobility so dr. sent me for an MRI on 7/10/14. I went back to see Dr. on 7/17/14 to review the MRI results which showed fluid in my bursa. Essentially there is nothing else that can be done to ease my pain or increase my mobility unless I want to get yet another cortisone shot. My shoulder mobility is still very limited. It even hurts to sleep on my left shoulder at night. When I reach certain directions she shoulder pops and shoots extreme pain down the arm. I am still doing OT at home as of 9/17/14 while I am writing this.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 50 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose were not reported) subcutaneous. No concomitant medications were reported. On an unknown date the patient experienced redness at injection site. The patient sought medical attention, she went to see the pharmacist. The outcome of redness at injection site was reported as recovered on an unknown date. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Respiration abnormal, Rhinorrhoea, Swollen tongue
Clinical narrative: Patient went to facility on 9/12/14 morning for a PE and received a flu shot. 3 hours later, he returned with complaints of tongue swelling and abnormal breathing sensations. He was instructed to go the ER. Since arrival to the ED, patient was feeling fine but complaint of a runny nose and sore throat.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse and healthcare worker (reported also as: Health Department Employee) refers to an unspecified patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On an unknown date unspecified patients were vaccinated with M-M-R II (dose, route of administration, anatomical location, lot#, expiration date not reported) that was improperly stored on 27-APR-2014. No product quality complaint (PQC) was reported. Concomitant medications were not reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMR, VARCEL
Symptoms: Epistaxis
Clinical narrative: Per parent, pt had nosebleeds occurring twice in 9/16 and once on 9/17. Each episode stopped after 5 min. No previous history of nosebleeds.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Lip swelling
Clinical narrative: Localized swelling upper and lower lips.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site abscess, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 64 year old patient of unknown gender. On 10-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (route, lot # and expiration date were not provided). On 11-SEP-2014, the patient developed redness and tenderness at the injection site. The patient called the office and was advised to take BENADRYL. On 12-SEP-2014, the patient went to the office and was diagnosed with an abscess at the injection site. On approximately 12-SEP-2014, the area of the abscess had a line of blisters. The patient was prescribed an unspecified antibiotic medication. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. On 17-SEP-2014 the patient was vaccinated with a expired dose of ZOSTAVAX (lot # J000444, expiration date:11-APR-2014), (dose, route were not reported). No concomitant medications were reported. No adverse effects were reported. Additional information is not expected due to no consent for follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse and healthcare worker (reported also as: Health Department Employee) refers to an unspecified patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On an unknown date unspecified patients were vaccinated with ROTATEQ (dose, route of administration, anatomical location, lot#, expiration date not reported) that was improperly stored on 27-APR-2014. No product quality complaint (PQC) was reported. Concomitant medications were not reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse and healthcare worker (reported also as: Health Department Employee) refers to an unspecified patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On an unknown date unspecified patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, anatomical location, lot#, expiration date not reported) that was improperly stored on 27-APR-2014. No product quality complaint (PQC) was reported. Concomitant medications were not reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse and healthcare worker (reported also as: Health Department Employee) refers to an unspecified patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On an unknown date unspecified patients were vaccinated with VAQTA (dose, route of administration anatomical location, lot#, expiration date not reported) that was improperly stored on 27-APR-2014. No product quality complaint (PQC) was reported. Concomitant medication were not reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse and healthcare worker (reported also as: Health Department Employee) refers to an unspecified patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On an unknown date unspecified patients were vaccinated with GARDASIL (dose, route of administration, anatomical location, lot#, expiration date not reported) that was improperly stored on 27-APR-2014. No product quality complaint (PQC) was reported. Concomitant medications were not reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 70 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose were not reported) subcutaneous. No concomitant medications were reported. On an unkonwn date the patient experienced redness at injection site. The patient sought medical attention, she went to see the pharmacist. The outcome of redness at injection site was reported as recovered on an unknown date. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site pain, Injection site pruritus, Urinary tract infection
Clinical narrative: This spontaneous report as received from a 67 year old female patient refers to herself. The patient's medical history included drug reaction/allergies to sulfonamide (also reported as sulfa). On 20-AUG-2014, the patient was vaccinated with ZOSTAVAX 1 injection (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included TOPROL XL TABLETS, SYNTHROID, ZOCOR and PREVACID. On 20-AUG-2014, the patient experienced redness "about the size of a quarter" after being administered the ZOSTAVAX. The patient also had itching at the injection site along with pain and a headache. As a treatment of adverse events the patient received TYLENOL. On 22-AUG-2014, at the end of the same week, the patient also experienced a urinary tract infection which was treated with CIPRO. The outcome of the events was unknown. The relatedness between the events and vaccination with ZOSTAVAX was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 month old patient of an unknown gender. On 12-SEP-2014, the 2 month old patient was mistakenly administered a dose of VAQTA (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This spontaneous report received from a pharmacist refers to a 88 year old female patient. On 16-SEP-2014 the patient was vaccinated with ZOSTAVAX (vial, lot # K007548, expiry date: 23-AUG-2015, subcutaneous) for vaccination. Concomitant therapies included prednisone (manufacturer unknown). On 16-SEP-2014 after receiving ZOSTAVAX the patient experienced dizziness. The patient did not seek medical attention. It was reported that no treatment was given for adverse event and no lab diagnostic was performed. The outcome of dizziness was reported as not recovered. The relatedness between ZOSTAVAX and dizziness was not reported. Additional information is not expected because there is no consent to contact the physician.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Client passed out after giving vaccine, pale, dizzy but alert when coming to, client laid down for a few min. Gave water, BP 102/76, O2 98%, HR 81.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Pt reported dizziness after receiving zoster vaccine. No swelling or shortness of breath.
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 year old patient of unknown gender. The reporter stated that on 12-SEP-2014 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous) instead of VARIVAX. Pertinent medical history and concomitant medications were unspecified by reporter. No adverse effects were reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 22 year old female patient. On 29-AUG-2014 the patient was vaccinated with GARDASIL lot # J015378, expiration date 09-APR-2016, intramuscular. The nurse reported to the representative, "the patient developed a lump on her neck on an unspecified date after receiving GARDASIL." Physician clarified that lymph node was not related to GARDASIL. It was related to upper respiratory infection. She stated patient did not have a reaction to GARDASIL. The outcome of lymph node/lump on neck and upper respiratory infection was reported as not recovered/not resolved. The patient sought medical attention. No treatment was given for the adverse events. No lab diagnostics studies were performed. Additional information is not expected. Physician declined any further contact regarding this report.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Eye pain, Fatigue, Headache, Muscular weakness, Pain in jaw
Clinical narrative: 2 days after immunization, developed headache, eye pain, fatigue, fevers. Had UTI that day and soreness in her jaw. Then on 9/12 developed weakness in l leg, now normal exam.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Urinary tract infection
Clinical narrative: 2 days after immunization, developed headache, eye pain, fatigue, fevers. Had UTI that day and soreness in her jaw. Then on 9/12 developed weakness in l leg, now normal exam.
Age: 1.04
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Pt. presented with mom for rash on trunk and fever x 1 week. Skin confluent maculopapular rash mostly on trunk. Rash on side of face and behind ears. Given Calamine lotion BID PRN.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Case number PHEH2014US018199 is an initial spontaneous report received from a nurse on 10 Sep 2014. This report refers to a 17 years old male patient. He had no known allergies to any vaccines and never had syncope with vaccines in the past. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: not reported) intramuscularly on 04 Sep 2014. It was reported that on the same day he experienced syncope for less than one minute after MENVEO administration. The nurse reported that he was not anxious and did not experience pain. When he woke up, his blood pressure and heart rate were within the normal limits. He was not cyanotic during the syncope and did not experience jerking movements. When he woke up he was grinning, very relaxed and not disoriented. He was not hospitalized, but the physician kept the patient lying on the table for some time before he was allowed to leave. The event outcome was reported as complete recovery on 04 Sep 2014. The seriousness and causality was not reported.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site and upper arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large raised, red, and swollen area around injection site with some itching.  Hot to touch.  Started clearing up Saturday morning.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Headache
Clinical narrative: Headache for two days now. 6 months pregnant.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Erythema, Pain, Pyrexia
Clinical narrative: High feaver, aching body, general overall discomfort, still some feaver, now 2 days later. Red patch below injection site, about 3 inches square.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Erythema, Headache, Injection site erythema, Injection site pain
Clinical narrative: Swelling, redness, pain at local site (right deltoid) and regional area (chest and trapezius) area, headache.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Local swelling, Pain
Clinical narrative: Swelling, redness, pain at local site (right deltoid) and regional area (chest and trapezius) area, headache.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash, Urticaria
Clinical narrative: CHILD WOKE UP FROM NAP WITH HIVE LIKE RASH ON ABDOMEN, CHEST AND BACK. CALLED THE PHYSICIANS OFFICE 09/18/14 AT 1:31 PM TO REPORT RASH AND TO SEE IF BENADRYL WAS OKAY TO GIVE. APPT. WAS OFFERED TO PARENT THAT DECLINED IT PHYSICIAN NOTIFIED.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Face injury, Fall, Laceration, Malaise, Presyncope
Clinical narrative: After receiving flu vaccine returned back to office training room. States not feeling well returned to room where injections given, sat at table and has a possible vaso vagal response fell from chair to floor. Hit chin on table causing laceration. EMS activated and sent to ER for evaluation.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Anaphylactic shock, Blood pressure decreased, Chills, Cough, Discomfort
Clinical narrative: Presented with symptoms of anaphylactic shock soon after receiving vaccines. Symptoms included throat constriction, cough, trouble breathing, hives, redness, itchiness, and significant discomfort. Patient received an injection of epinephrine (Auvi-Q), oral albuterol, and 1 tsp of Benadryl at the doctor's office (3:00 pm). Was then transferred to the ER where he received Benadryl and Pepcid intravenously (4:11 PM). He also suffered from a drop in blood pressure, loss of skin color, chills, and fever. Was observed for six hours for biphasic reaction.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Dyspnoea, Erythema, Pallor, Pruritus, Pyrexia
Clinical narrative: Presented with symptoms of anaphylactic shock soon after receiving vaccines. Symptoms included throat constriction, cough, trouble breathing, hives, redness, itchiness, and significant discomfort. Patient received an injection of epinephrine (Auvi-Q), oral albuterol, and 1 tsp of Benadryl at the doctor's office (3:00 pm). Was then transferred to the ER where he received Benadryl and Pepcid intravenously (4:11 PM). He also suffered from a drop in blood pressure, loss of skin color, chills, and fever. Was observed for six hours for biphasic reaction.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Throat tightness, Urticaria
Clinical narrative: Presented with symptoms of anaphylactic shock soon after receiving vaccines. Symptoms included throat constriction, cough, trouble breathing, hives, redness, itchiness, and significant discomfort. Patient received an injection of epinephrine (Auvi-Q), oral albuterol, and 1 tsp of Benadryl at the doctor's office (3:00 pm). Was then transferred to the ER where he received Benadryl and Pepcid intravenously (4:11 PM). He also suffered from a drop in blood pressure, loss of skin color, chills, and fever. Was observed for six hours for biphasic reaction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient had redness and tenderness at the site on injection. The site was red, approximately 2 inch in diameter, oblong in shape, and raised. The patient states she feels fine. The other pharmacist on duty, and I advised the patient to contact her doctor. The patient stated that she would. I will follow-up with patient on Monday.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: Pt. presented to her PCP with swelling in the left axilla region (approx. diameter 10mm). She was prescribed a steroid and an antibiotic.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Fainted after shot was administered.  Patient was not in any distress before, directectly after or the next day.
Age: 26.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: 100 degree temperature at 4:00 pm.  Had fever since morning. Swollen, tender, painful lump that extends from top left shoulder to top of left collarbone.  Itchy, feverish, swollen rash at  Varicella injection site. Body aches.
Age: 26.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Pain, Pyrexia
Clinical narrative: 100 degree temperature at 4:00 pm.  Had fever since morning. Swollen, tender, painful lump that extends from top left shoulder to top of left collarbone.  Itchy, feverish, swollen rash at  Varicella injection site. Body aches.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm was red and swollen below the site of the vaccination, was also warm to the touch.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted and recovered.  No additional adverse events to report.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Redness of area around injection site extending down towards elbow.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus generalised, Rash generalised
Clinical narrative: Pt experienced local itching at injection site, -within 5 minutes of receiving the vaccine, at 01:10pm itching/rash became generalized-both upper arms, EMS notified, pt monitored, by 1:25pm symptoms were no longer progressing, pt given 50mg oral diphenhydramine at 1:37, escorted to the clinic in the same building, by 2:05 pm pt symptoms resolved and released to home.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site cellulitis, Mass, Pain in extremity
Clinical narrative: Patient called today to report cellulitis at the site of injection (given Zostavax). Patient reported a lump under the skin and some pain up to the arm pit on the arm.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Lethargy, Nervousness
Clinical narrative: Patient is complaining of feeling lethargic, hot, and shaky about 25 minutes after vaccine. Symptoms lasting about 30 mintues with hot and shaky but is now resolved at 5:45 pm. Still is feeling lethargic about 1 hour later.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Dizziness, Eye pain, Oropharyngeal pain, Pain
Clinical narrative: Fever, chills, aches, pains, soreness in eyes, sore throat. Hands and arms trembling, dizziness. Everything lasted about 3 hours.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever, chills, aches, pains, soreness in eyes, sore throat. Hands and arms trembling, dizziness. Everything lasted about 3 hours.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Oropharyngeal pain, Pyrexia, Swollen tongue, Tremor
Clinical narrative: Fever, chills, aches, pains, soreness in eyes, sore throat. Hands and arms trembling, dizziness. Everything lasted about 3 hours.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: PT RECEIVED HIVES ON RIGHT ARM WHERE VACCINE WAS GIVEN AND SPREAD TO RIGH LEG. PT ALSO COMPLAINED OF ITCHINESS.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Myalgia, Pruritus, Skin warm, Swelling
Clinical narrative: Pt reported swollen, red, warm, itchy, painful muscle.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, muscle aches.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient had a large golf ball type swelling close to injection site on her arm.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included Prednisone and VYVANSE. On 27 August 2014, the subject received a dose of BOOSTRIX (route unknown, left arm). On 27 August 2014, 30 minutes after vaccination with BOOSTRIX, the subject's entire arm was red, hot and swollen. This extended across the upper back and over to the right arm. No tightness in throat or trouble breathing. It was confined to both upper arms and upper back. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL and ZYRTEC. On 28 August 2014, the events were resolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Skin warm
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included Prednisone and VYVANSE. On 27 August 2014, the subject received a dose of BOOSTRIX (route unknown, left arm). On 27 August 2014, 30 minutes after vaccination with BOOSTRIX, the subject's entire arm was red, hot and swollen. This extended across the upper back and over to the right arm. No tightness in throat or trouble breathing. It was confined to both upper arms and upper back. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL and ZYRTEC. On 28 August 2014, the events were resolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: 2 days after immunization patient returned to report very red arm in area of the injection extending down towards elbow, warm to touch, mild fever.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with VAQTA dose 1 (dosing details and lot number unknown). On an unknown date the second dose of VAQTA was administered, 4 months after the first dose (sooner than 6 months). No adverse effects were reported. It was queried if a third dose should be given. Outcome of 'administration of second dose of VAQTA 4 months after the first dose of VAQTA' was not reported. No product quality complaint (PQC) was reported. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 20 year old female patient. Pertinent medical history, drug reactions or allergies were unspecified. On 11-AUG-2011 the patient was vaccinated with (Oka/Merck) VARIVAX first dose to prevent chickenpox (dose, route, anatomical location, lot number and expiration date were not reported). No concomitant therapies were reported. On an unknown date the patient experienced had negative titers after receiving the vaccine. The outcome of negative titers was unknown. The relatedness between the event and (Oka/Merck) VARIVAX was not reported. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. On unspecified dates, an unknown number of patients had been inadvertently administered (Oka/Merck) VARIVAX (dose, route, lot # and expired date were not reported) and ZOSTAVAX, vial, (dose, route, lot # and expired date were not reported), that had been improperly stored. Concomitant therapy was not reported. No adverse effects reported. Follow up information received from pharmacy manger on 11-SEP-2014. The reporter stated that the (Oka/Merck) VARIVAX that had the temperature issue was not used on a patient. However, one dose of the ZOSTAVAX vial, (dose, route, lot # and expired date were not reported) was administered to a patient yesterday (approximately on 10-SEP-2014). No adverse experiences were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus generalised, Rash generalised
Clinical narrative: This spontaneous report was received from a female consumer of unknown age regarding herself. There was no pertinent medical history. On an unknown date in the year 2008, the patient was vaccinated with ZOSTAVAX strength 19400 units reported as PFU (Plaque-forming unit), (dose, units, product Lot#, expiry date, route not reported) for shingles prevention. There was no concomitant therapy. On an unknown date in 2013 (reported as about a year ago), the patient experienced a mild case of shingles after receiving the ZOSTAVAX vaccine. The patient experienced a rash over her body and itchiness. She was seen at the physician's office but no treatment was given. There was no product quality complaint involved. The outcome of event mild case of shingles was unknown and events rash over her body and itchiness was recovered on an unknown date (reported as the symptoms went away after two or three weeks). The causality was unknown. Additional information has been requested.
Age: 47.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse refers to a 47 year old patient of an unknown gender. Medical history was not reported. On 08-SEP-2014 the patient was vaccinated with the third dose of RECOMBIVAX HB injection (10/1.0 mcrg/ml) 1 ml, intramuscular, lot # J008505 dose, expiration date: 07-FEB-2016, which was improperly stored. No adverse effects reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose normal, Dizziness, Dyspnoea, Hyperhidrosis, Tremor
Clinical narrative: Approx 1 1/2 - 2 m after vaccine - pt became shaky and sweaty, dizzy. Pt vs checked and placed in supine position. These symptoms began to worsen and Dr to assess pt. 911 called. Pt blood glucose 93. Pt then c/o difficulty breathing. HOB up and 10L 02 mask placed on pt and then EMS arrived - IV and BENADRYL given by EMS and transported to hospital.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Chest pain, Feeling hot, Hyperhidrosis, Pain
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 23 year old female patient with asthma, allergy to benzonatate and allergy to wheat. On 08-JUL-2014 the patient was vaccinated with the first dose of GARDASIL (intramuscular injection, batch/lot #, expiration date, route not reported). On 09-SEP-2014 the patient was vaccinated with the second dose of GARDASIL batch/lot # J015378, expiration date 09-APR-2016, also reported as 01-APR-2016, dose 2, route not reported). Concomitant therapies included naproxen, NASONEX, budesonide, SYMBICORT, ATROVENT, PROAIR and LO LOESTRIN FE. On 10-SEP-2014, the patient developed body aches, joint pain and chest pain, after the second dose of GARDASIL. The patient also felt warm and sweaty and reported a body temperature of 99 F. The patient sought medical attention by contacting the nurse practitioner, but did not receive treatment for the adverse events. The outcome of the events was reported as not recovered/not resolved. Causality was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and unkonwn gender. Pertinent medical history, drug reactions or allergies were unspecified. On an unspecified dates, since 10-JUN-2014, an unspecified number of patients were vaccinated with M-M-R II (that were exposed to a supported temperature excursion on 10-JUN-2014). No adverse experience had been reported. No concomitant therapies were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. On 15-SEP-2014 the patient was inadvertently vaccinated with a dose of PROQUAD, injection, subcutaneous, (dose was not reported, lot # was reported as "K009890", expired date was reported as "11-JAN-2016"), which was improperly stored. Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. On an unknown date, the patient, at her 18 weeks gestation, was inadvertently administered with a dose of VARIVAX (Merck). The patient's last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. No adverse effects reported. The patient sought medical attention by office visit and the physician did not have the patient's chart available at the time of the report. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Throat tightness.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Throat tightness
Clinical narrative: Facial swelling and throat tightness. Took 25mg BENADRYL and was alright. No loss of work.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker via a representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of M-M-R II (lot#, strength, dosage and route unknown). No adverse effect reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Throat tightness and shortness of breath.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness where vaccine was given.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, swelling and pain to touch.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Chills, vomiting, redness at injection site (saucer-size), swelling injection site. First symptoms started after injection.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse and health care worker (reported also as: Health Department Employee) refers to an unspecified patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On an unknown date unspecified patients were vaccinated with RECOMBIVAX HB (dose, route of administration, anatomical location, lot#, expiration date not reported) that was improperly stored on 27-APR-2014. No product quality complaint (PQC) was reported. Concomitant medications were not reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pruritus, Injection site swelling
Clinical narrative: Itches, bruise, swollen around injection site.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Pt reported severe vertigo, dizziness, and nausea worsened by riding in a car. These symptoms started 2 days after the vaccine was given. No hx of this in the past.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Pt reported tingling and weakness in both arms approx 24 hours after flu shot, plus pain in right thumb. Symptoms resolved completely and spontaneously approximately 24 hours after onset. Pt states she is completely fine now.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Pt called, then came in. Location of PNEUMOVAX: swelling at above injection site around whole arm. Started by evening of injection, had on 17th, improving. ZOSTAVAX: painful and itchy to start, then red dot that has continued to grow. Currently measures 3 1/2" diameter and raised approx 1/2". She had just taken BENADRYL and we marked around the area to be better able to judge worsening/improving of the welt. She is seeing her son/MD tomorrow and will follow up with her as well.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Urticaria
Clinical narrative: Pt called, then came in. Location of PNEUMOVAX: swelling at above injection site around whole arm. Started by evening of injection, had on 17th, improving. ZOSTAVAX: painful and itchy to start, then red dot that has continued to grow. Currently measures 3 1/2" diameter and raised approx 1/2". She had just taken BENADRYL and we marked around the area to be better able to judge worsening/improving of the welt. She is seeing her son/MD tomorrow and will follow up with her as well.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Mobility decreased, Pain, Tenderness
Clinical narrative: Hard to lift arm. Bruising, very tender, hurting.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Got flu shot IM on 8-17-14 - left deltoid. The arm was sore for couple of days. Then OK. Then after 20 days developed pain in arm radiating to shoulder. The Dr treating the pt thinks the pain may be due to flu shot.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Cold sweat, Pallor
Clinical narrative: Pale, weak, cold and clammy. Vaccine given at 4:15. Symptoms developed 5-10 minutes after vaccine was administered.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pain, Pain in extremity, Pyrexia, Vaccination site swelling
Clinical narrative: Vaccine received 10AM 9/17/14 - pt started feeling sore/achy by 3PM. Achy legs and arms. Site near vaccination became red and swelled. Spread to inside of arm. Pt went to doctor on morning of 9/18/14. Running a fever. Dr. gave pt antibiotic but instructed her to wait until further notice to take.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus, Swollen tongue, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Started itching, throat felt full and funny, tongue started to swell, hives.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Pruritus, Swelling
Clinical narrative: Started itching, throat felt full and funny, tongue started to swell, hives.
Age: 45.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm 6" x 4" oblong circle of red, warm, swollen, painful around site of injection.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Decreased appetite, Nausea, Vomiting
Clinical narrative: Pt received FLUARIX Quad 2014-15 yesterday (9-17) at approx 14:30. She called today (9-18) at 12:39 reporting vomiting, shivering, nausea and decreased appetite. She was going to f/u w/ MD.
Age: 1.28
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Patient developed hives on entire body within 24 hours of receiving vaccines. BENADRYL was administered.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash macular
Clinical narrative: 1 1/2 hours after administration on 9/17/14 - pruritus began and blotchiness on entire body. Used OTC BENADRYL and had relief.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Pruritus, Rash, Wheezing
Clinical narrative: Itching, rash, shortness of breath, wheezing. Treated with steroids, epinephrine (SQ), antihistamines /w bronchodilators emergently in office with Rxs for steroids and antihistamines.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Injection site joint movement impairment, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Left shoulder pain and immobility; MRI; Physical therapy.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Blister, Body temperature increased, Rash
Clinical narrative: Vaccinations given on 9/10/14. Came to clinic on 9/16/14 with blister/rash on cheek and nose and streaking up her face. Temp 100 degrees. Treated with acyclovir.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Blood glucose normal, Presyncope
Clinical narrative: Vasovagal episode after FLUMIST administration at 1:15pm.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Tdap (ADACEL) vaccine at visit 9/15/14, patient called in 9/17/14 complaining of red, swollen, hot to touch and painful injection site.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: Student received MMR vaccine on 9/4/14 for college entry. Last menses reported as 8/25-8/30/14 TC from pt 9/9/14 - (+) home preg test. Referred to medical group as intends to proceed with pregnancy.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Local swelling, Pruritus, Scab
Clinical narrative: 9/8/14 Pt received MMR vaccine s.c. right arm (upper). 9/9 hand was red and swollen and itchy. Used ice and Ibuprofen. 9/10 hand back to normal - sev small scabs on fingers noted on OV 9/15/14.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm red, swollen, hot touch. Given BENADRYL oral and cool compress.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Lymphadenopathy, Oedema peripheral
Clinical narrative: Swollen lymph node. Swollen armpit/very painful. No rashes/no redness. MD prescribed antibiotic 9/18/14. Pain/hurts x3 days.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Injection site reaction. Hot, red, tender. Localized reaction only.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Blood test normal, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This consumer report (initial receipt 10-Sep-2014) concerns a 60 year old female patient who had a medical history of hypertension, fibromyalgia and shingles (twice). The patient had experienced an adverse reaction/allergy to sulfa drugs, nortriptyline, morphine and was allergic to tape. Concomitant medications included duloxetine, pregabalin, ampicillin, 'vesylate', benazepril, oxycodone/paracetamol, simvastatin, pantoprazole, alprazolam. On the 16-Aug-2014, the patient received the influenza virus vaccine (manufacturer and batch number not reported) and concomitantly received the ZOSTAVAX vaccine 1 injection via the subcutaneous route. Both vaccines were given in the same arm. The patient felt like the vaccinations were given in a strange location, near her underarm on the underside of her arm. On the 16-Aug-2014, the patient developed a headache, got really hot, red and swollen at the injection site. By the next night (17-Aug-2014), the injection site had swollen to the size of an egg and the swelling migrated down her arm. The patient went to an Emergency Room (ER) where she was treated and sent home. Her symptoms started to clear up. On the Saturday morning (date unspecified), she woke up feeling paralysed on the right side of her face. She went back to the hospital and was hospitalised overnight. She was diagnosed with Bell's Palsy. Treatment included valacyclovir tablets. Lab diagnostic showed normal bloodwork. Outcome was unknown.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Local swelling, VIIth nerve paralysis
Clinical narrative: This consumer report (initial receipt 10-Sep-2014) concerns a 60 year old female patient who had a medical history of hypertension, fibromyalgia and shingles (twice). The patient had experienced an adverse reaction/allergy to sulfa drugs, nortriptyline, morphine and was allergic to tape. Concomitant medications included duloxetine, pregabalin, ampicillin, 'vesylate', benazepril, oxycodone/paracetamol, simvastatin, pantoprazole, alprazolam. On the 16-Aug-2014, the patient received the influenza virus vaccine (manufacturer and batch number not reported) and concomitantly received the ZOSTAVAX vaccine 1 injection via the subcutaneous route. Both vaccines were given in the same arm. The patient felt like the vaccinations were given in a strange location, near her underarm on the underside of her arm. On the 16-Aug-2014, the patient developed a headache, got really hot, red and swollen at the injection site. By the next night (17-Aug-2014), the injection site had swollen to the size of an egg and the swelling migrated down her arm. The patient went to an Emergency Room (ER) where she was treated and sent home. Her symptoms started to clear up. On the Saturday morning (date unspecified), she woke up feeling paralysed on the right side of her face. She went back to the hospital and was hospitalised overnight. She was diagnosed with Bell's Palsy. Treatment included valacyclovir tablets. Lab diagnostic showed normal bloodwork. Outcome was unknown.