chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site pain, Sleep disorder
Clinical narrative: Initial unsolicited report received from a Physician on 10 February 2016. This Case Linked with 2016SA027336 (same reporter). This case involves a 75-year-old male patient who was vaccinated with an intramuscular dose of Fluzone (batch number UI430AA (invalid lot number), expiration date, dose, dose in series was not reported) in left deltoid on 28 October 2015. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On 29 October 2015, one day following the vaccination, the patient experienced an erythematous area at the injection site on left deltoid. The redness was lessened at the end of the day. It returned the next day and could not be relieved. The redness spread down the arm into the elbow and the elbow joint was sore.The elbow and the bicep were sore. The arm was still sore and it interfered with his sleep. It was reported that patient received many previous doses. Patient required emergency room or doctor visit. Lab data and corrective treatments were not reported. The patient was not recovered from events. List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Injection site paraesthesia, Injection site swelling
Clinical narrative: Injection site swelling and tingling ("like I hit my funny bone"). According to treating provider, swelling may be pushing on ulnar nerve. Dr placing on employee on prednisone.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4, MENB
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode.
Age: 49.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling of arm around where injection was given.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Presyncope
Clinical narrative: Near syncope episode.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: SHINGLES INFECTION.
Age: 82.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site cellulitis, Nausea, Purulent discharge
Clinical narrative: Cellulitis of left upper arm in shich TDAP was given.  Some pus was drained.  Chills, nausea.  Treatment:  clindamycin and heparin injection and vancomycin IV overnight.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Anaphylactic reaction, Dyspnoea, Pyrexia, Throat tightness
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A 18-year-old female patient of an unspecified ethnicity received TRUMENBA at 0.5 ml single and MENACTRA at 1 dosage form single, both via an unspecified route of administration on an unspecified date at the same time/visit. Medical history and concomitant medications were not reported. After the vaccination, the patient had to go to the emergency room with a fever and her throat was closing up, she could not breathe, so, it was like an anaphylactic response. The outcome of the events was unknown. Follow-up (05Feb2016): Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Red, swollen area, hot area.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Not aware of it. Patient didn't present themselves at the pharmacy.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Varicella 0.5mL SQ injection on 1/28/16 (recommended by reproductive endocrinologist prior to pregnancy) and developed a tennis ball-sized redness/swollen area around injection site that was warm to the touch. Provider notified - reaction resolved with ice, BENADRYL and ADVIL over next few days per patient.
Sex: F
Vaccine: FLUN4, MENB
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable registered nurse (RN) through a Pfizer sales representative. A female patient received TRUMENBA at 0.5 ml single and FLUMIST, both on 08Nov2015. Medical history and concomitant medications were not provided. On 08Nov2015 the patient felt lightheaded, so the nurse let her lay down for 15 minutes, put her feet up and gave her something to drink and she was fine. The patient mother said that they had a family history of getting lightheaded when they receive injections. The patient recovered from the event on 08Nov2015. Follow-up (08JAN2016): Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: FLUN4, MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous report from a contactable physician via sales representative. A 15 year-old male patient of unspecified ethnicity received on 23Nov2015 TRUMENBA (lot number M37314 expiry date Apr2017) intramuscularly on the left arm at 0.5 ml single and FLUMIST via an unspecified route of administration at 1 dosage form single. Relevant medical history and concomitant medications were not reported. On an unspecified date in Nov2015, the patient experienced left arm red, swollen quite a bit, warm to touch and the arm hurt really bad like somebody had punched in it. All events lasted for at least 4 days but the outcome of the events was unknown. Follow-up (22JAN2016): Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: M
Vaccine: FLUX, HPVX, MENB, FLUX, HPVX, MENB
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A 16-year-old male patient received TRUMENBA at 0.5 ml single in the right arm, human papilloma virus (HPV) at 1 DF single in the right arm, Flu vaccine at 1 DF single in the left arm, all via an unspecified route of administration on 20Nov2015. The patient medical history and concomitant medications were not reported. On 21Nov2015, the patient experienced fever 101 degrees F, muscle pain and body ache with outcome of unknown. Follow up (07Dec2015): New information reported included: vaccination site for HPV and Flu vaccine changed. Follow-up (30JAN2016): Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Cognitive disorder, Hypoaesthesia, Pain in extremity, Pallor, Syncope
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18-year-old female patient of an unspecified ethnicity received first dose of TRUMENBA (Lot# J28923, Exp date 30Jun2016), intramuscular in the left arm, on 28Dec2015 at 11:00 am, at 0.5 ml single. Relevant medical history was not reported. Concomitant medication included second dose of Flu vaccine (Lot# U5321AB), intramuscular in left arm, at 0.5 ml, on 28Dec2015. Previously the patient received first dose of influenza vaccine. On 28Dec2015, the patient experienced very pale, fainted approximately 10 minutes post vaccination, cognitively out of it, impairment. Also she developed numbness and arm was sore on an unspecified date. The patient underwent lab tests and procedures on 28Dec2015 which included: blood pressure measurement: was ok. The outcome of the events was unknown. The reporter considered that the events were related to TRUMENBA. Follow-up (29Jan2016): New information received from a contactable other health professional on behalf of the nurse includes: vaccination details, concomitant details, past vaccine history, causality assessment. Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Back pain, Headache, Myalgia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 02Dec2015 at 0.5, single and Flu vaccine, via an unspecified route of administration on 02Dec2015 at 0.5 ml. Medical history and concomitant medications were not reported. The nurse stated that the patient did not have any other medical condition and did not underwent any kind of lab work. The patient experienced severe muscle ache of the arms and leg, headache and lower back pain on 02Dec2015. The nurse mentioned that the patient's mother gave her the MOTRIN to the patient as treatment. The outcome of the events was unknown. The nurse believed that these side effects was because of TRUMENBA. Follow-up (16JAN2016): Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea- morning x2; diarrhea- morning x2; vomiting- morning x2.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Cough, Impaired driving ability, Influenza like illness, Injected limb mobility decreased
Clinical narrative: PAIN IN LIFTING MY LEFT ARM, PAIN IN MOVEMENT OF MY LEFT ARM. DIFFCULTY IN WRITING, AND DOING EVERYDAY THINGS, (BATHING, DRIVING, EATING, ETC.) IN NOVEMBER SEVER FLU LIKE SYMPTOMS WHERE THERE I TOOK TIME OFF AND HAVING TO DEAL WITH THE ABOVE ISSUES. MEDICATING FOR PAIN AND FLU LIKE SYMPTOMS WERE TAKING TO HELP COMFORT AND TAKE AWAY THE PAIN AND TO BE AT EASE.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: PAIN IN LIFTING MY LEFT ARM, PAIN IN MOVEMENT OF MY LEFT ARM. DIFFCULTY IN WRITING, AND DOING EVERYDAY THINGS, (BATHING, DRIVING, EATING, ETC.) IN NOVEMBER SEVER FLU LIKE SYMPTOMS WHERE THERE I TOOK TIME OFF AND HAVING TO DEAL WITH THE ABOVE ISSUES. MEDICATING FOR PAIN AND FLU LIKE SYMPTOMS WERE TAKING TO HELP COMFORT AND TAKE AWAY THE PAIN AND TO BE AT EASE.
Age: 0.38
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Crying, Pyrexia, Screaming
Clinical narrative: Abnormally high fever 103-104, constant screaming and inconsolable crying had to take ambulance to the hospital were they said she had an adverse reaction to her 4 month immunizations so we are unsure exactly which one she reacted to so now we are going to space out her vaccines but I am very worried and concerned about another adverse reaction for her 6 month visit.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Swelling, hurt - could not touch the area, and itching badly.
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: Abdominal pain upper, Dizziness, Dyspnoea, Injection site pain, Vomiting
Clinical narrative: Patient states she vomited, felt dizzy and SOB. Pain in the stomach and at injection site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dependent rubor, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: (L) arm swelling, pain, rigor, difficulty lifting arm.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Drug administered at inappropriate site, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a consumer on 12 February 2016. This case involves 41-year-old female patient who was vaccinated with injection of Fluzone tiv mdv (batch number not reported) intramuscularly on right deltoid on 28 October 2015. The patient's medical history includes vaccination with many doses of Fluzone tiv mdv vaccine and illness at the time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergy. The patient's concomitant medications were not reported. On 28 October 2015, eight hours following the vaccination, the patient's right arm was on fire, bright red, raised and lumpy. On 29 October 2015 (reported as next day), one day following the vaccination, the patient's arm was very sore and redness was going up to neck and face. It was reported that, the injection was given up to high on deltoid. The patient required ER/doctor visit. Laboratory data was not reported. The patient had received steroids (unspecified) as corrective treatment. The patient was recovered from events (3 weeks) on an unspecified date. List of documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Upper extremity mass
Clinical narrative: Initial unsolicited report received from a consumer on 12 February 2016. This case involves 41-year-old female patient who was vaccinated with injection of Fluzone tiv mdv (batch number not reported) intramuscularly on right deltoid on 28 October 2015. The patient's medical history includes vaccination with many doses of Fluzone tiv mdv vaccine and illness at the time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergy. The patient's concomitant medications were not reported. On 28 October 2015, eight hours following the vaccination, the patient's right arm was on fire, bright red, raised and lumpy. On 29 October 2015 (reported as next day), one day following the vaccination, the patient's arm was very sore and redness was going up to neck and face. It was reported that, the injection was given up to high on deltoid. The patient required ER/doctor visit. Laboratory data was not reported. The patient had received steroids (unspecified) as corrective treatment. The patient was recovered from events (3 weeks) on an unspecified date. List of documents held by sender: none.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Severe ongoing pain in the arm vaccine was given.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Severe ongoing pain in the arm vaccine was given.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Immune thrombocytopenic purpura, Petechiae, Platelet count decreased, Rash
Clinical narrative: Pt evaluated in clinic on 12/7/15 for rash. Petechiae had been present and increasing for 3 days. He was found to have platelets of 20,000 and was referred to Hemo/Onc for further evaluation and management. He has been followed by hematology and diagnosed with ITP. His platelet counts are slowly improving but not fully recovered.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient with complaint of nausea, dizziness, fever, vomiting on 2/21/15. Symptoms lasted on and off for 6 hours. Symptoms improved after taking a dose of TYLENOL and Fluids.
Age: 11.0
Sex: M
Vaccine: HPV4, MENB, MNQ, TDAP
Symptoms: Erythema, Loss of consciousness, Nausea, Pain in extremity, Syncope
Clinical narrative: Syncope and collapse - loss of consciousness. Nausea and vomiting. Pt was admitted for observation and fluids. Lt arm red and painful - Pt to see pediatric neurology. Pt discharged in stable condition. Lt arm is still red.
Age: 11.0
Sex: M
Vaccine: HPV4, MENB, MNQ, TDAP
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Syncope and collapse - loss of consciousness. Nausea and vomiting. Pt was admitted for observation and fluids. Lt arm red and painful - Pt to see pediatric neurology. Pt discharged in stable condition. Lt arm is still red.
Age: 0.45
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on trunk and upper thighs.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: I received the vaccine and my left arm was sore and it is still sore today with pain and left arm cannot move it to the back with some pain and cannot lay on the left side either. I have received vaccines for many years and this year it bothers me.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: I received the vaccine and my left arm was sore and it is still sore today with pain and left arm cannot move it to the back with some pain and cannot lay on the left side either. I have received vaccines for many years and this year it bothers me.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure, Streptococcus test positive
Clinical narrative: 5-10 minute seizure requiring neurology consult.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: CSF glucose normal, CSF protein increased, CSF white blood cell count negative, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillain Barre with 30 day hospitalization. Diagnosed with lumbar puncture and CSF findings. Treated with IVIG x5 doses. Inpatient and outpatient rehabilitation.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Guillain Barre with 30 day hospitalization. Diagnosed with lumbar puncture and CSF findings. Treated with IVIG x5 doses. Inpatient and outpatient rehabilitation.
Age: 16.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, TD, VARCEL
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: After patient received vaccines, went to the waiting room to wait for 15 minutes while guardian made follow-up appointment and she fainted.  Patient was pale, drank some water, and gave patient some crackers.  Checked patient's blood pressure at 94/60.  Patient stated she was feeling dizzy when she fainted.  Patient's color came back and she stated she felt better.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anger, Crying, Dysphagia, Oropharyngeal pain, Urticaria
Clinical narrative: After receiving immunizations child became very upset and was crying. Told mom he had difficulty swallowing and c/o of sore throat. Developed hives on face and subsequently spread to other areas of his body. Lungs were clear and no wheezing noted. Given 25mg Benadryl IM.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient had fever on Tuesday following vaccination on Monday. Site was red, swollen, hot to touch, and described as "splotchy." Also noted, itching at site and irritable. Parent treated with Tylenol. Clindamycin prescribed 02/26/2016 for possible cellulitis.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Irritability, Pyrexia, Rash macular
Clinical narrative: Patient had fever on Tuesday following vaccination on Monday. Site was red, swollen, hot to touch, and described as "splotchy." Also noted, itching at site and irritable. Parent treated with Tylenol. Clindamycin prescribed 02/26/2016 for possible cellulitis.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Pt returned to pharmacy about 5 days later with a red itchy rash, fist size, located below the area the vaccine was administered (above elbow).  Both pharmacists on duty consulted and told pt to go to physician for further evaluation. Pt stated she felt fine, just rash was itchy.  She has since been back to the pharmacy several times and is doing good, still has small rash on her upper arm.  She is begin evaluated regularly by her physician.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Pt returned to pharmacy about 5 days later with a red itchy rash, fist size, located below the area the vaccine was administered (above elbow).  Both pharmacists on duty consulted and told pt to go to physician for further evaluation. Pt stated she felt fine, just rash was itchy.  She has since been back to the pharmacy several times and is doing good, still has small rash on her upper arm.  She is begin evaluated regularly by her physician.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza A virus test positive
Clinical narrative: Tested positive for influenza type A strain despite receipt of vaccine.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient's father returned to the pharmacy to report that patient was having soreness in her arm with sudden movements and that he thought it should have gone away at this point.  I agreed and told him that he may advise her to see a doctor if the pain continues.  Denies that it may be "in her head" as a result of her fear of needles.  Says it is causing her trouble when playing volleyball.  Despite her being an adult, he reported the adverse event to me because he was "going to be in pharmacy" so he told her he would ask for her.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Client pregnant 36 weeks at time of administration.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT PRESENTED TO THE PHARAMCY ON 02/24/16 WITH REDNESS AND SWELLING FROM SHOULDER TO ELBOW ON LEFT ARM.  PATIENT SAID THAT HE WENT TO A REGULAR PHYSICIAN APPOINTMENT AND THE DOCTOR PRESCRIBED CLINDAMYCIN TO TREAT ON 2/24/2016.  HE TOLD THE PATIENT THAT IF THE ANTIBIOTIC DID NOT HELP, HE SHOULD FOLLOW UP.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Influenza like illness, Pain
Clinical narrative: This was from the first Gardasil shot. Aches in different areas of the body at different times. Acne outbreak other flu like symptoms I never related to the vaccine. I have all of my medical records.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Arthralgia, Influenza like illness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: I never associated my side effects to this vaccine. I thought I was over worked or just sick from something else. I woke very stiff with joint pain, shoulder, wrist, neck, hip, traveling through my legs and ankle. I thought I had the flu again. The pain increased into my hands and wrists. Everything felt swollen. The pain would come and go. I also thought I was over worked again. I had acne pretty bad but thought that was my age issue.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling
Clinical narrative: I never associated my side effects to this vaccine. I thought I was over worked or just sick from something else. I woke very stiff with joint pain, shoulder, wrist, neck, hip, traveling through my legs and ankle. I thought I had the flu again. The pain increased into my hands and wrists. Everything felt swollen. The pain would come and go. I also thought I was over worked again. I had acne pretty bad but thought that was my age issue.
Age: 3.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Lethargy, Pyrexia, Rhinorrhoea, Tremor
Clinical narrative: Pt. with shaking, fever, lethargy, runny nose. Seen at emergency department.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Mobility decreased, Musculoskeletal pain, Pyrexia
Clinical narrative: Immobile shoulder because of pain being a 10 on scale, slight fever, sick feeling, lasting 48 hours, pain at 7 next day, 4 the third day.
Age: 61.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Induration, Injection site pain, Skin warm
Clinical narrative: 2/23/2016 soreness, warm to touch. 2/24/2016 soreness at site/ pain to touch, hard, red, warm to touch. 2/26/2016 evaluated by doctor and antibiotic ordered. Shingles vaccine admin route of IM instead of SC.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Pt received vaccines for 6 months plus seasonal flu on 2-24-16. Mom noticed localized papular, non fluid filled rash to injection sites on both legs on 2-25-16. Rash spreading from hip to knee on 2-26-16.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Circumstance or information capable of leading to medication error, Immediate post-injection reaction, Injection site bruising, Peripheral swelling
Clinical narrative: Patient jumped a bit on administration, bruise noted immediately, arm swelled more. Left arm at meningococcal vaccine.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: (L) arm/(L) shoulder pain after flu shot. Within a week of receiving flu shot noticed significant pain in (L) shoulder. Basic movements that involve lifting arm above head cause significant pain - removing clothes, toweling off, and sometimes when washes hair. Can't sleep on (L) side - shoulder hurts too much. If rolls onto (L) side hand becomes tingling and numb. Took Rx ALEVE and over the counter MOTRIN - helps but pain persists. Did ice and heat application. Pain specific to spot about 1/2" below shoulder joint.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: (L) arm/(L) shoulder pain after flu shot. Within a week of receiving flu shot noticed significant pain in (L) shoulder. Basic movements that involve lifting arm above head cause significant pain - removing clothes, toweling off, and sometimes when washes hair. Can't sleep on (L) side - shoulder hurts too much. If rolls onto (L) side hand becomes tingling and numb. Took Rx ALEVE and over the counter MOTRIN - helps but pain persists. Did ice and heat application. Pain specific to spot about 1/2" below shoulder joint.
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a pharmacist referring to an adult Asplenic patient of unknown age and gender. No other relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with PEDVAXHIB (lot#, expiration date, dose and route were not reported) (inappropriate schedule of drug administration). Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration, No therapeutic response
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 57-year-old male patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult, ENGERIX B adult and ENGERIX B adult (batch number 9L2LK, expiry date 21st October 2017). In January 2014, the patient received the 1st dose of ENGERIX B adult. In February 2014, the patient received the 2nd dose of ENGERIX B adult. In June 2014, the patient received the 3rd dose of ENGERIX B adult. In October 2015, the patient received the 4th dose of ENGERIX B adult 1 ml. In June 2014, not applicable after receiving ENGERIX B adult, ENGERIX B adult and ENGERIX B adult and an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too long. In October 2015, the patient experienced drug dose administration interval too long. In January 2016, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long and drug dose administration interval too long were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B adult, ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details were provided as follows: In June 2014, the patient received 3rd dose of ENGERIX B adult, which led to lengthening of the vaccination schedule. In October 2015, the patient received 4th dose of ENGERIX B adult, which led to lengthening of the vaccination schedule. In January 2016, 3 months after receiving the 4th dose of ENGERIX B adult, the patient underwent laboratory test, which revealed 3 mIU/ml (less than 10 mIU/ml) i.e. no antibodies against hepatitis B antigen leading the patient to be a therapy non-responder. It was reported that, the laboratory test for testing the efficacy of the vaccine technically should have been performed 1 to 2 months after 4th dose. The reporter's call was escalated to Medical Information System. This case was identified as duplicate of US2016012046. Case US2016012046 was deleted and all the future correspondence will be added in the present case which stands as case of record for this patient.
Sex: U
Vaccine: MENB
Symptoms: Abdominal pain upper, Dizziness, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from two contactable nurses via a Pfizer sales representative. The nurses reported similar events for 3 patients. This is the third of 3 reports. A patient of unspecified age, gender and ethnicity received the first dose of TRUMENBA (lot number M13066) via an unspecified route of administration, on unknown date, at single dose. Relevant medical history included streptococcal infection before the vaccine. Concomitant medications were not reported. On unknown date the patient experienced faint redness and swollen at sight, fever at 101 F, stomach pain, vomiting, dizzy, severe headache, severe soreness of arm and she was nauseous. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from two contactable nurses via a Pfizer sales representative. The nurses reported similar events for 3 patients. This is the third of 3 reports. A patient of unspecified age, gender and ethnicity received the first dose of TRUMENBA (lot number M13066) via an unspecified route of administration, on unknown date, at single dose. Relevant medical history included streptococcal infection before the vaccine. Concomitant medications were not reported. On unknown date the patient experienced faint redness and swollen at sight, fever at 101 F, stomach pain, vomiting, dizzy, severe headache, severe soreness of arm and she was nauseous. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Myalgia, Pain
Clinical narrative: This is a spontaneous report from a non-contactable nurse. A 17-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose. Relevant medical history and concomitant medications were not reported. About 6-7 hours later the patient experienced severe headache, muscle aches and pain on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 16-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II recombinant human albumin (rHA) status (lot# L009213, expiration date, dose, anatomical location and route of administration were not reported). On 16-NOV-2015, the patient was vaccinated with another improperly stored dose of M-M-R II recombinant human albumin (rHA) status (lot# L009213, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because of the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected, as no further information was available.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (lot # K020215 and expiry: 15-MAY-2016), route, dose and strength were not reported, which was improperly stored at 23.5 degrees Fahrenheit for 11 hours. The patients experienced no adverse events. There was no prior temperature excursions and the nurse called due to data logger. This is one of the several cases from same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Chest discomfort, Decreased appetite, Dizziness, Nausea
Clinical narrative: This is a spontaneous report from a contactable pharmacist through a company representative. A 17-year-old female patient received first dose of TRUMENBA (batch/lot number: J28923, expiry date 30Jun2016) on 11Nov2015, at 0.5 ml single, probably intramuscularly in the left arm. Medical history and concomitant medications were not provided. The patient experienced nausea, back pain, tight chest, light headed, no appetite on unknown date in Nov2015. Events outcome was unknown. Follow-up (08Jan2016): New information from the same contactable pharmacist included: reporter's occupation, vaccination site. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for two brothers. This is the second of two reports. A male patient of unspecified age received the first single dose of TRUMENBA on an unknown date. Medical history and concomitant medications were not provided. After vaccination, on an unknown date, the patient experienced red, warm, swollen arms, vomiting and a high fever. Events outcome was unknown. Follow-up (22JAN2016): Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Lethargy, Nausea, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse via a sales representative. A male patient of unknown age (may be 17 or 18-year-old) and ethnicity received first single dose of TRUMENBA at 0.5 ml in the arm on an unknown date. Concomitant medications and medical history were unknown. The patient was lethargic and experienced nausea, vomiting, fever and fatigue. This happened on an unknown date, several weeks before this report. The patient only received one dose and decided to not get the subsequent doses. Outcome was not provided. Follow-up (12FEB2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 07-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII recombinant human albumin (rHA) status (lot# L003859, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information is not expected, as no further information is available.
Sex: U
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer representative. A patient of unknown age, gender and ethnicity received TRUMENBA on an unknown date (sometime between Jul and now, year not specified), at 0.5 ml single, intramuscular, in the arm. Medical history and concomitant medications were not reported. On an unknown date, immediately after receiving the vaccine, the patient experienced feeling faint. Outcome was recovered on an unspecified date. Follow-up (08JAN2016): Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Injection site bruising, Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable consumer (mother). A 20-year-old male patient received first single dose of TRUMENBA around 1600 on 19Oct2015. Concomitant medication included an unspecified blend allergy shot, one injection administered every three weeks (last dose before the event was on 16Oct2015). Concurrent condition included allergy. On 19Oct2015 the patient experienced chills and muscle weakness from 16.00 to around 23.00. Later he went to sleep and was okay the next morning. These events recovered completely on an unspecified date in Oct2015 (uncertain whether the end date was 19Oct2015 or 20Oct2015). Outcome of the event bruise at the injection site was unknown. Follow-up (06-FEB-2016): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (billing manager) via Pfizer sales representative. A 18 year-old female patient of unspecified ethnicity received TRUMENBA via an unspecified route of administration, on unknown date, at a single dose. Relevant medical history and concomitant medications were not reported. The patient experienced localized redness and pain at the injection site on unknown date, two days after receiving the injection. The outcome of the events was unknown.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Chills
Clinical narrative: This is a spontaneous report obtained from a contactable consumer that reported on behalf of her 20-year-old daughter. A 20-year-old female patient received, on 12Jan2016, at 12:00, the first dose of TRUMENBA at 0.5 ml, single dose. The patient received the product at the doctor's office (did not have the lot, expiration and NDC). Relevant medical history and concomitant medications were unknown. On 12Jan2016, at 13:30, the patient experienced severe chills. Patient's doctor has been notified. The patient was treated with ADVIL. Chills worsened and the patient did not recover from the event at time of this report. Follow-up (18FEB2016): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable other hcp (front desk staff) who was reporting on behalf of the physician via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date. Medical history was not reported. There were no concomitant medications. The patient was taken to the emergency room with a severe headache on an unspecified date. The outcome of the event was unknown. Follow-up (16JAN2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer Sales Representative. A female patient of unspecified age and ethnicity received a single dose of TRUMENBA on an unknown date. Medical history and concomitant medications were not provided. After vaccination, on an unknown date, the patient experienced sore arm. Event outcome was unknown. Follow-up (02Dec2015): New information reported from a contactable nurse includes: confirmation of reporter's occupation (nurse). Follow-up (06-JAN-2016): Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Immediate post-injection reaction
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer representative. A 16 years old female patient received TRUMENBA on an unknown date, at 0.5 ml single, intramuscular, in arm. Medical history and concomitant medications were not reported. The patient experienced headache on an unknown date immediately after receiving the vaccine. The event resolved on an unknown date. Follow-up (17DEC2015): Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: FLUX, MENB, MNQ
Symptoms: Headache
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received a single dose of TRUMENBA, a single dose of MCV4 (manufacturer unknown) and a single dose of quadrivalent flu vaccine, all on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a bad headache. Clinical outcome of the event was unknown at time of this report. Follow-up (19DEC2015): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 18-years-old male patient of an unspecified ethnicity received TRUMENBA, intramuscular on an unspecified date at 0.5 ml, single dose. The patient medical history was none, the patient was healthy and the patient's did not receive any concomitant medications. The patient previously took human papilloma vaccine and experienced syncope. The patient experienced fainted on an unspecified date with outcome of unknown. Follow-up (15JAN2016): Follow-up attempts completed. No further information expected.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable physician reported through a Pfizer sales representative. A 20-years-old female patient received TRUMENBA (Lot number J28923, exp. date Jun2016, NDC number of TRUMENBA: 0005-0100-05), via an unspecified route of administration on 12Oct2015 at 0.5ml single dose. Medical history included asthma diagnosed when the patient was little. The patient's concomitant medications were not reported. On the same date the patient experienced rash near where injection site would have been. The patient was treated with BENADRYL. The outcome was unknown. Follow-up (09DEC2015): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Injection site erythema, Injection site swelling, Rash generalised, Skin discolouration
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old female patient. The patient had unspecified reaction to fluoxetine. On 10-JAN-2016 the patient was vaccinated with a regular dose of ZOSTAVAX (lot # L015414, expiration date 01-AUG-2016, subcutaneous, vaccination site unknown). There was no concomitant medication. On an unknown date in 2016 (reported as a few days later) the patient experienced that the injection site was swollen and red. The pharmacist reported that patient saw an unspecified healthcare provider, who prescribed out of the counter (OTC) calamine lotion and other unspecified products, which the patient did not use. The pharmacist reported that "a week or so later" (on an unknown date in 2016) the patient experienced a purplish rash over her total body. Both injection site swelling and redness and the rash resolved with no treatment, on unspecified dates in 2016. The pharmacist reported that the patient was prescribed steroid eye drops, for an unspecified reason, on 08-FEB-2016, and received fluorometholone (adverse event). The outcome of the adverse event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 07-FEB-2016, the patient was vaccinated with the dose of improperly exposed (to 20 F for 72 hours) ZOSTAVAX injection, subcutaneously, lot # L000448, expiration date 08-MAR-2016 (dose was not reported). No known adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer and subsequently from a contactable nurse on behalf of physician. A 18-year-old female patient received TRUMENBA (Lot # M13066, Expiration Date 30Sep2016) intramuscular 0.5 ml single dose in the left arm on 06Jan2016 15:30. Medical history and concomitant medications were not reported. The patient complained of weak on 07Jan2016 with outcome of recovered, terrible headache on Jan2016 with outcome of recovering, fatigue on 07Jan2016 with outcome of recovered, joint pain in knees on 07Jan2016 with outcome of recovered, really sore in vaccine area on 07Jan2016 with outcome of recovered, a little nausea on 06Jan2016 with outcome of recovered, pain on 06Jan2016 with outcome of recovered. Clinical course was reported as follows: The patient received TRUMENBA on 06Jan2016 and during the night she woke up with a little nausea and some pain. By the time she woke up on 07Jan2016 morning and the nausea was gone, but the pain had worsened, she had a terrible headache, was weak, had fatigue, joint pain in her knees and was really sore where the vaccine had been administered. The adverse events did not require an emergency room or doctor visit. She took ADVIL on 07Jan2016 night and her mom was a pediatrician who monitored her. The nurse was provided with the information regarding the adverse events by the patient. The nurse considered there was a reasonable possibility that the event is related to suspect product. The nurse was willing to be contacted again by Pfizer on the reported adverse events. Follow up (17Feb2016): New information reported from a contactable nurse on behalf of physician included: suspect dosage; indication detail; reported informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer and subsequently from a contactable nurse on behalf of physician. A 18-year-old female patient received TRUMENBA (Lot # M13066, Expiration Date 30Sep2016) intramuscular 0.5 ml single dose in the left arm on 06Jan2016 15:30. Medical history and concomitant medications were not reported. The patient complained of weak on 07Jan2016 with outcome of recovered, terrible headache on Jan2016 with outcome of recovering, fatigue on 07Jan2016 with outcome of recovered, joint pain in knees on 07Jan2016 with outcome of recovered, really sore in vaccine area on 07Jan2016 with outcome of recovered, a little nausea on 06Jan2016 with outcome of recovered, pain on 06Jan2016 with outcome of recovered. Clinical course was reported as follows: The patient received TRUMENBA on 06Jan2016 and during the night she woke up with a little nausea and some pain. By the time she woke up on 07Jan2016 morning and the nausea was gone, but the pain had worsened, she had a terrible headache, was weak, had fatigue, joint pain in her knees and was really sore where the vaccine had been administered. The adverse events did not require an emergency room or doctor visit. She took ADVIL on 07Jan2016 night and her mom was a pediatrician who monitored her. The nurse was provided with the information regarding the adverse events by the patient. The nurse considered there was a reasonable possibility that the event is related to suspect product. The nurse was willing to be contacted again by Pfizer on the reported adverse events. Follow up (17Feb2016): New information reported from a contactable nurse on behalf of physician included: suspect dosage; indication detail; reported informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received first dose of TRUMENBA, intramuscular on unknown date in Dec2015 single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced flu like symptoms on Dec2015. The event lasted a couple of days then resolved. The event was assessed as non-serious.