chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Dizziness, Influenza like illness, Injection site discolouration, Malaise, Mobility decreased
Clinical narrative: PATIENT RECEIVED 3 VACCINES ON APRIL 28, 2018. NEXT DAY HE FELT DIZZY, SLEEPY, LIGHTHEADED, GENERAL MALAISE, LIKE A FLU. HIS ARMS WERE BULGED AND SWOLLEN, HE COULD BARELY MOVE THEM UP. HE DENIES FEVER. HE VISITED HIS PRIMARY PHYSICIAN ON 4/30/2018 AND BROUGHT THE PRESCRIPTION OF LEVAQUIN 750MG 1 TAB EVERY DAY FOR 7 DAYS AND ALLEGRA 180MG FOR 1 TAB DAILY FOR 15 DAYS TO THE PHARMACY. DR. DIAGNOSED A GENERAL REACTION TO THE VACCINES, DERMATITIS AND CELLULITIS HE WAS OPPOSED TO GIVE MULTIPLE SHOTS ON SAME DAY AS YOU COULD NOT STATE WHICH VACCINE WAS THE CAUSATIVE ALTHOUGH BOTH ARMS HAVE THE SAME REACTIONS. I HAVE THE CHANCE TO SEE PATIENT AGAIN ON MAY 2 AND HIS ARMS WERE STILL BULGED AND SWELL. HE HAD A BLACK SPOT ON ONE OF THE INJECTION SITE AT THE LEFT ARM. HE STATES, WHEN HE TOOK THE MEDICINES THE DAY BEFORE, HE FELT DIZZY, LIKE LOW SUGAR, ALTHOUGH HE IS NOT DIABETIC. I TOLD HIM TO TAKE HIS PRESCRIPTIONS AS USUAL AND TAKE THE NEW ONES WITH FOOD.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Peripheral swelling, Somnolence
Clinical narrative: PATIENT RECEIVED 3 VACCINES ON APRIL 28, 2018. NEXT DAY HE FELT DIZZY, SLEEPY, LIGHTHEADED, GENERAL MALAISE, LIKE A FLU. HIS ARMS WERE BULGED AND SWOLLEN, HE COULD BARELY MOVE THEM UP. HE DENIES FEVER. HE VISITED HIS PRIMARY PHYSICIAN ON 4/30/2018 AND BROUGHT THE PRESCRIPTION OF LEVAQUIN 750MG 1 TAB EVERY DAY FOR 7 DAYS AND ALLEGRA 180MG FOR 1 TAB DAILY FOR 15 DAYS TO THE PHARMACY. DR. DIAGNOSED A GENERAL REACTION TO THE VACCINES, DERMATITIS AND CELLULITIS HE WAS OPPOSED TO GIVE MULTIPLE SHOTS ON SAME DAY AS YOU COULD NOT STATE WHICH VACCINE WAS THE CAUSATIVE ALTHOUGH BOTH ARMS HAVE THE SAME REACTIONS. I HAVE THE CHANCE TO SEE PATIENT AGAIN ON MAY 2 AND HIS ARMS WERE STILL BULGED AND SWELL. HE HAD A BLACK SPOT ON ONE OF THE INJECTION SITE AT THE LEFT ARM. HE STATES, WHEN HE TOOK THE MEDICINES THE DAY BEFORE, HE FELT DIZZY, LIKE LOW SUGAR, ALTHOUGH HE IS NOT DIABETIC. I TOLD HIM TO TAKE HIS PRESCRIPTIONS AS USUAL AND TAKE THE NEW ONES WITH FOOD.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 13-APR-2018, the patient was vaccinated with an expired dose of VAQTA injection, lot # N005605 with expiration date on 08-APR-2018 (dose and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent(MERCK STERILE DILUENT). On 28-OCT-2016 the patient was vaccinated with unspecified doses of expired VARIVAX (lot # K018960, expiry date: 15-OCT-2016) and/or M-M-R II injection (lot # K020188, expiry date: 22-OCT-2016) (dose, frequency and route were not reported) for prophylaxis (expired product administered). It was not reported that, sterile diluent(MERCK STERILE DILUENT) used to reconstitute vaccines was expired. The reporter also stated that, it was unknown whether the patient received MMR II or VARIVAX separately or MMR II concomitant with VARIVAX. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Albumin status for M-M-R II is recombinant human albumin (rHA).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (MERCK STERILE DILUENT). On 04-NOV-2016 the patient was vaccinated with unspecified doses of expired VARIVAX (lot # K018960, expiry date: 15-OCT-2016) and/or M-M-R II injection (lot # K020188, expiry date: 22-OCT-2016) (dose, frequency and route were not reported) for prophylaxis (expired product administered). It was not reported that, sterile diluent (MERCK STERILE DILUENT) used to reconstitute vaccines was expired. The reporter stated that, it was unknown whether the patient received MMR II or VARIVAX separately or MMR II concomitant with VARIVAX. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Albumin status for M-M-R II is recombinant human albumin (rHA).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (MERCK STERILE DILUENT). On 07-NOV-2016 the patient was vaccinated with unspecified doses of expired VARIVAX (lot # K018960, expiry date: 15-OCT-2016) and/or M-M-R II injection (lot # K020188, expiry date: 22-OCT-2016) (dose, frequency and route were not reported) for prophylaxis (expired product administered). It was not reported that, sterile diluent (MERCK STERILE DILUENT) used to reconstitute vaccines was expired. The reporter stated that, it was unknown whether the patient received MMR II or VARIVAX separately or MMR II concomitant with VARIVAX. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Albumin status for M-M-R II is recombinant human albumin (rHA).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (MERCK STERILE DILUENT). On 14-NOV-2016 the patient was vaccinated with unspecified doses of expired VARIVAX (lot # K018960, expiry date: 15-OCT-2016) and M-M-R II injection (lot # K020188, expiry date: 22-OCT-2016) (dose, frequency and route were not reported) for prophylaxis (expired product administered). It was not reported that, the sterile diluent (MERCK STERILE DILUENT) used to reconstitute vaccine was expired. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Albumin status for M-M-R II is recombinant human albumin (rHA).
Age: 1.08
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a radiology technician concerning a 13 month old child patient of unknown gender. Pertinent medical history, concurrent conditions, allergies or concomitant medications were reported. On 25-APR-2018, the patient was vaccinated with a dose of PROQUAD lot # N016113, expiry date 21-NOV-2018 for prophylaxis (strength, dose, dosage schedule and route were not provided) and a dose of VARIVAX for prophylaxis (strength, dose, dosage schedule, route, indication of use, lot # and expiry date were not provided). (overdose). No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 66 year old female patient. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. In 2007(reported as about "11 years ago"), the patient was vaccinated with first dose of PNEUMOVAX 23 injection for "Prevention for pneumococcal disease" (route of administration, lot #, expiration date were not reported). In 2011 (reported as "about 7 years ago"), the patient experienced a rash that looked like a mosquito bite at the injection site. The physician assistant reported that, the patient was getting the rash once a year for about 7 years. No treatment was given for the adverse event. The patient did not seek medical attention. The outcome of the event was unknown. Casual relatedness between the event and the PNEUMOVAX 23 was not reported.
Age: 56.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a nurse referring to a 56 year old male patient.  No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-OCT-2011, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route of administration, lot number and expiration date were not reported). On an unspecified day in November 2016, the patient received a dose of PREVNAR 13. On 24-APR-2018, the patient was vaccinated with PNEUMOVAX 23, lot # R000692 expiring on 09-SEP-2019, 0.5 ml, intramuscularly for prophylaxis. On an unspecified day in April 2018 the patient experienced injection site cellulitis type reaction.  The patient was seen in the urgent care on 27-APR-2018 where he was given an antibiotic.    The outcome of injection site cellulitis was unknown. The event did not required hospitalization and was not considered a disabling or life threatening condition. This is one of two reports from the same source.; Sender's Comments: US-009507513-1805USA001324:
Age: 56.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Erythema, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a nurse referring to a 56 year old male patient.  No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-OCT-2011, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route of administration, lot number and expiration date were not reported). On an unspecified day in November 2016, the patient received a dose of PREVNAR 13. On 24-APR-2018, the patient was vaccinated with PNEUMOVAX 23, lot # R000692 expiring on 09-SEP-2019, 0.5 ml, intramuscularly for prophylaxis. On an unspecified day in April 2018 the patient experienced injection site cellulitis type reaction.  The patient was seen in the urgent care on 27-APR-2018 where he was given an antibiotic.    The outcome of injection site cellulitis was unknown. The event did not required hospitalization and was not considered a disabling or life threatening condition. This is one of two reports from the same source.; Sender's Comments: US-009507513-1805USA001324:
Age: 56.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: This spontaneous report was received from a nurse referring to a 56 year old male patient.  No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-OCT-2011, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route of administration, lot number and expiration date were not reported). On an unspecified day in November 2016, the patient received a dose of PREVNAR 13. On 24-APR-2018, the patient was vaccinated with PNEUMOVAX 23, lot # R000692 expiring on 09-SEP-2019, 0.5 ml, intramuscularly for prophylaxis. On an unspecified day in April 2018 the patient experienced injection site cellulitis type reaction.  The patient was seen in the urgent care on 27-APR-2018 where he was given an antibiotic.    The outcome of injection site cellulitis was unknown. The event did not required hospitalization and was not considered a disabling or life threatening condition. This is one of two reports from the same source.; Sender's Comments: US-009507513-1805USA001324:
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Injection site bruising, Injection site induration, Injection site mass, Injection site rash
Clinical narrative: This spontaneous report was received from a nurse prescriber concerning a 18 year old female patient. The patient had no relevant medical history. The patient's drug reactions/allergies included aloe vera. The patient's concomitant medications included ZOLOFT, ORTHO EVRA and albuterol. On 18-APR-2018, the patient was vaccinated with GARDASIL 9 (lot # N021732 and expiration date of 01-FEB-2020), for vaccination (dose, route of administration and anatomical location were not reported). On 28-APR-2018, the patient developed a rash, a hard lump (injection site mass) and bruising 1 centimeter in diameter at the injection site. On the same date (reported as around the same time), she developed diarrhoea. The patient called the nurse prescriber and she advised her to take BENADRYL (unknown dose and frequency) and topical heat to alleviate the symptoms. No laboratory diagnostics or studies were performed. On 02-MAY-2018, the patient recovered from diarrhoea and injection site rash, but did not recover from injection site mass. The outcome of injection site bruising was unknown. The causal relationship between the aforementioned events and therapy with GARDASIL 9 was not reported.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Rash, Swelling
Clinical narrative: This spontaneous report has been received from a 63 year old male patient via a company representative (reported as relative). The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. On an unknown date in 2018 (reported as after administration), the patient experienced swelling neck and rash on both arms and neck. The patient was currently taking cephalexin 500 mg twice daily, however the company representative assumed may be the treatment, but could not 100% confirm. The outcome of swelling neck and rash on both arms and neck was unknown. The causal relationship between the adverse events and the therapy was not assessed.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Cellulitis, Full blood count, Neck pain, Swelling
Clinical narrative: This spontaneous report has been received from a 63 year old male patient via a company representative (reported as relative). The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. On an unknown date in 2018 (reported as after administration), the patient experienced swelling neck and rash on both arms and neck. The patient was currently taking cephalexin 500 mg twice daily, however the company representative assumed may be the treatment, but could not 100% confirm. The outcome of swelling neck and rash on both arms and neck was unknown. The causal relationship between the adverse events and the therapy was not assessed.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Antinuclear antibody, Borrelia test, C-reactive protein, Differential white blood cell count, Erythema
Clinical narrative: This spontaneous report has been received from a 63 year old male patient via a company representative (reported as relative). The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. On an unknown date in 2018 (reported as after administration), the patient experienced swelling neck and rash on both arms and neck. The patient was currently taking cephalexin 500 mg twice daily, however the company representative assumed may be the treatment, but could not 100% confirm. The outcome of swelling neck and rash on both arms and neck was unknown. The causal relationship between the adverse events and the therapy was not assessed.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Full blood count, Metabolic function test, Musculoskeletal pain, Neck pain, Red blood cell sedimentation rate
Clinical narrative: This spontaneous report has been received from a 63 year old male patient via a company representative (reported as relative). The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. On an unknown date in 2018 (reported as after administration), the patient experienced swelling neck and rash on both arms and neck. The patient was currently taking cephalexin 500 mg twice daily, however the company representative assumed may be the treatment, but could not 100% confirm. The outcome of swelling neck and rash on both arms and neck was unknown. The causal relationship between the adverse events and the therapy was not assessed.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Spinal pain, Swelling
Clinical narrative: This spontaneous report has been received from a 63 year old male patient via a company representative (reported as relative). The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. On an unknown date in 2018 (reported as after administration), the patient experienced swelling neck and rash on both arms and neck. The patient was currently taking cephalexin 500 mg twice daily, however the company representative assumed may be the treatment, but could not 100% confirm. The outcome of swelling neck and rash on both arms and neck was unknown. The causal relationship between the adverse events and the therapy was not assessed.
Sex: M
Vaccine: VARCEL
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from an unspecified healthcare worker, who was also the patient's mother, via company representative and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, reported as "several years ago", the patient was vaccinated with VARIVAX injection for vaccination (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown dates, reported as "since then", the patient had experienced seizures. It was stated that the patient was seen by an unspecified neurologist, however, it was unknown if any treatment was provided for the event, as well as, if the neurologist's visits started prior or after vaccination with VARIVAX. At the reporting time, the patient had not recovered from the seizures and the reporter did not assess the causal relationship between therapy with VARIVAX and the event. Upon internal review, seizure was determined to be a medically significant event.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history concurrent conditions, drug reactions and allergies were not reported. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT) Lot # N013297 and expiration date 25-SEP-2019. On 01-MAY-2018, the patient was vaccinated with an expired dose of VARIVAX for prophylaxis, lot #M005972 and expiration date  02-FEB-2018 (strength, dose, frequency and route of administratin were not reported). No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA002675: US-009507513-1805USA002676:
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from an office manager referring to a 18 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 12-APR-2018, the patient was vaccinated with the first dose of GARDASIL 9 by intramuscular route (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 26-APR-2018, the patient was received the second dose of with GARDASIL 9 (lot # N022584 with expiration date of 15-JUN-2020), by intramuscular route (strength, dose and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from an approximately 50 year old female with acquired immunodeficiency syndrome (AIDS) and codeine allergy. In 2017 (reported as "sometime last year"), the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration not provided) for the prevention of shingles. ZOSTAVAX had been reconstituted with sterile diluent (lot number not provided). The patient reported she was administered the ZOSTAVAX at a pharmacy when she had "full blown AIDs." On an unknown date in 2017 (reported as "sometime last year"), the patient broke out in lesions which covered her entire body. The patient sought medical attention and was admitted to a hospital (length of stay unspecified) and was given unspecified treatment. She was reported to have been "at death's door." A biopsy of the lesions determined the lesions to be chickenpox. The outcome of the chickenpox was reported as recovered. The patient was requesting compensation for her pain and suffering. Chickenpox was considered to be life-threatening. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history concurrent conditions, drug reactions and allergies were not reported. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT) Lot # N013297 and expiration date 25-SEP-2019. On 01-MAY-2018, the patient was vaccinated with an expired dose of VARIVAX for prophylaxis, lot #M005972 and expiration date  02-FEB-2018 (strength, dose, frequency and route of administration were not reported). No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA002676: US-009507513-1805USA001997:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history concurrent conditions, drug reactions and allergies were not reported. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT) Lot # N013297 and expiration date 25-SEP-2019. On 02-MAY-2018, the patient was vaccinated with an expired dose of VARIVAX for prophylaxis, lot #M005972 and expiration date  02-FEB-2018 (strength, dose, frequency and route of administratin were not reported). No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA001997: US-009507513-1805USA002675:
Sex: M
Vaccine: PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. It was reported that a a male patient (the reporter's father) of unknown age and ethnicity, received the second dose of PREVNAR 13 on an unknown date at single dose in the arm for immunization. Patient medical history and concomitant medications were not reported. Past drug history included the first dose of PREVNAR 13 for immunization. The reporter stated that patient's arm was extremely sore, and the patient developed body aches all over. At the time of this report, the patient was feeling better but the arm was still extremely sore. The information on the batch number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Chills, Pain
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for four patients. This is the 1st of four reports. A patient of an unspecified age, gender, race and ethnicity received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced body ache and chills. Clinical outcome of the events was unknown at time of this report. The information on the lot number has been requested. Sender's Comments: Linked Report(s) : US-PFIZERINC-2018186944 same reporter/drug/event, different patient; US-PFIZERINC-2018186945 same reporter/drug/event, different patient; US-PFIZERINC-2018186901 same reporter/drug/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Chills, Pain
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for four patients. This is for the second of the four reports. A patient of an unspecified age, gender, race and ethnicity received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced body ache and chills. Clinical outcome of the events was unknown at time of this report. The information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018186943 same reporter/drug/event, different patient. US-PFIZER INC-2018186901 same reporter/drug/event, different patient.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Initial unsolicited report received from physician on 01-May-2018. This case involves female patient (age not reported) who was vaccinated with dose FLUZONE HIGH DOSE (batch number- UI869AB; expiration date, dose, dose series were not reported) on an unknown date. Medical history and concomitant medications were not reported. On an unknown date following vaccination patient had pain, swelling on left arm and itching on left arm. Lab data and corrective treatment were not reported. Outcome of the events not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: Severe nausea, malaise, myalgias and fever to 102'.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: RED RASH AROUND INJECTION SITE, 3 INCHES IN DIAMETER.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Nodule, Pain, Skin warm
Clinical narrative: Pain, redness, hard knot, painful to touch, warm to touch.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood glucose normal, Blood test normal, Cardiac monitoring normal, Cardiac pacemaker evaluation
Clinical narrative: On the morning of May 4 (less than 24 hours after vaccine) I passed out while eating breakfast. I was out for about 15-20 seconds according to my husband. When I woke up, I was alert and weak feeling. Had been incontinent and wet the chair that I was sitting in. I did not fall out of the chair.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Loss of consciousness, Syncope, Urinary incontinence
Clinical narrative: On the morning of May 4 (less than 24 hours after vaccine) I passed out while eating breakfast. I was out for about 15-20 seconds according to my husband. When I woke up, I was alert and weak feeling. Had been incontinent and wet the chair that I was sitting in. I did not fall out of the chair.
Age: 1.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Vaccine was given in error. Physician notified. Office manager notified. Mother of patient notified and states patient is not displaying any ill effects.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Mass, Skin warm, Urticaria
Clinical narrative: 2" x 1" lump, warm to touch, hives.
Age: 1.33
Sex: M
Vaccine: MMRV
Symptoms: Vaccination error
Clinical narrative: MMRV vaccine was given in error. Physician notified. Office manager notified. Mother notified and states patient is not having any signs or symptoms of any ill effects. Will continue to monitor.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen from elbow to shoulder and severe pain (36 h). Pt using ice and ADVIL, slowly starting to improve.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Varicose vein
Clinical narrative: Pt. stated redness, swelling and red varicose and warm to touch from/at injection site. Pt. explained to take TYLENOL and Ice. Pt. came into clinic and they prescribed clindamycin and prednisone.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient complains of dizziness the evening of receiving vaccine that is ongoing.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Seizure, Syncope, Urinary incontinence
Clinical narrative: 11 yr old Female received Tdap on Right arm and MENVEO to Left arm at 3:55 pm. Pt was laying on exam table with back semi elevated. I stayed with Pt for 2-3 min after vaccines administered without reaction. I left the exam room #4 when Mom opened door and asked for help. RN went to assist, I followed into exam room. Pt had a vasovagal syncopal seizure and urine incontinence lasting for a few seconds. Dr. assisted and assessed patient right away after incident. 4:00 pm B/P 102/68 P- 77 4:10 pm B/P 99/62 P- 87 4:15 pm B/P 96/64 P- 64 4:15 pm patient felt dizzy, eyes rolling to side as if going to pass out while laying on exam table with back semi sitting then vomited after dizzy spell. Another RN assisted with Pt at all time during incident making sure patient was safe. 4:20 pm B/P 100/65 P- 66 4:30 pm B/P 95/63 P- 75 4:30 pm Orange juice given. 5:00pm B/P 96/62 P-73 5:10 pm Pt assessed by Dr., sitting upright 95/64 P- 77 Dr. discharged patient. 5:20 pm patient taken to exit via wheelchair with Mom due to wet clothes but was feeling well and able to ambulate.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: 11 yr old Female received Tdap on Right arm and MENVEO to Left arm at 3:55 pm. Pt was laying on exam table with back semi elevated. I stayed with Pt for 2-3 min after vaccines administered without reaction. I left the exam room #4 when Mom opened door and asked for help. RN went to assist, I followed into exam room. Pt had a vasovagal syncopal seizure and urine incontinence lasting for a few seconds. Dr. assisted and assessed patient right away after incident. 4:00 pm B/P 102/68 P- 77 4:10 pm B/P 99/62 P- 87 4:15 pm B/P 96/64 P- 64 4:15 pm patient felt dizzy, eyes rolling to side as if going to pass out while laying on exam table with back semi sitting then vomited after dizzy spell. Another RN assisted with Pt at all time during incident making sure patient was safe. 4:20 pm B/P 100/65 P- 66 4:30 pm B/P 95/63 P- 75 4:30 pm Orange juice given. 5:00pm B/P 96/62 P-73 5:10 pm Pt assessed by Dr., sitting upright 95/64 P- 77 Dr. discharged patient. 5:20 pm patient taken to exit via wheelchair with Mom due to wet clothes but was feeling well and able to ambulate.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Two hrs plus - shivering shaking.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given Hep A 20 days too soon. Shot was given on 5-7-18, but shot was not due until 5-27-18.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth at injection site. Started 12 - 36 hours post administration. No home care tx.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: FEVER, ACHES, CHILLS. VERY SORE ARM.
Age: 0.17
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event reported. Pt was given Tdap on 05/02/2018 - wrong dose due to age.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills developed about 8 pm that night. Chills subsided over night and fever continued until Saturday evening.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Areflexia, Asthenia, Balance disorder, CSF protein increased
Clinical narrative: I woke up on 11/06/17 and went to get out of bed to let my dog out. My legs felt like spaghetti, and I had to hang on to the bannister to get down the stairs. I contacted my primary physician, who told me to go to the ER. I drove there and was subjected to a full battery of tests, including an MRI on my head, neck, spinal column and lower back. Nothing was found, and I was discharged. I had trouble getting to my car but managed to drive home. I went to bed and when I woke the morning of 11/07/17, my legs seemed even weaker. When I let the dog out, I fell. My husband took me back to the ER, where they told me to drive without delay to another hospital for a lumbar puncture. Was noted that I appeared to have absent reflexes in my knees and ankles. Weakness continued to spread bilaterally upwards from my feet to my torso. Nothing further done that day, despite my complaints that if this was GBS, it was a progressive disease and needed immediate treatment. Finally, on 11/08/17, a nerve conduction study/EMG was conducted but not completed, as the hospital neurologist felt that the first part alone supported a clinical diagnosis of GBS. I was sent for an LP, in which they found increased proteins. Treated with a 5-day course of IVIg, after which I was discharged to home. At this time (05/08/18), both legs still tingle from hip area to feet. The neuropathy extends up to my waist on the left side and about 6 inches higher on my right side. It feels as if I am wearing a thick sanitary pad between my legs, and I also feel as if I am not able to exert the pressure needed for complete bowel evacuation. I have difficulty sitting and lying down; it feels as if there is an obstruction between any surface and my rear end, making me feel that I am tilted and unable find a comfortable balance on chair or bed. Although I am managing to walk independently, it often feels as if my feet are curved under on the sides and do not set flat on the floor. Balance problems continue; I fell out of the shower, over the side of the bathtub, a few weeks ago but was not hurt. Have been prescribed gabapentin (300 mg 3x/day and 100 mg PRN) for the constant pins-and-needles feeling and incredible tightness that spasms through my buttocks, legs and feet. I also have the feeling of a constant "wedgie" at my rectum.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Electromyogram abnormal, Fall, Full blood count normal, Guillain-Barre syndrome
Clinical narrative: I woke up on 11/06/17 and went to get out of bed to let my dog out. My legs felt like spaghetti, and I had to hang on to the bannister to get down the stairs. I contacted my primary physician, who told me to go to the ER. I drove there and was subjected to a full battery of tests, including an MRI on my head, neck, spinal column and lower back. Nothing was found, and I was discharged. I had trouble getting to my car but managed to drive home. I went to bed and when I woke the morning of 11/07/17, my legs seemed even weaker. When I let the dog out, I fell. My husband took me back to the ER, where they told me to drive without delay to another hospital for a lumbar puncture. Was noted that I appeared to have absent reflexes in my knees and ankles. Weakness continued to spread bilaterally upwards from my feet to my torso. Nothing further done that day, despite my complaints that if this was GBS, it was a progressive disease and needed immediate treatment. Finally, on 11/08/17, a nerve conduction study/EMG was conducted but not completed, as the hospital neurologist felt that the first part alone supported a clinical diagnosis of GBS. I was sent for an LP, in which they found increased proteins. Treated with a 5-day course of IVIg, after which I was discharged to home. At this time (05/08/18), both legs still tingle from hip area to feet. The neuropathy extends up to my waist on the left side and about 6 inches higher on my right side. It feels as if I am wearing a thick sanitary pad between my legs, and I also feel as if I am not able to exert the pressure needed for complete bowel evacuation. I have difficulty sitting and lying down; it feels as if there is an obstruction between any surface and my rear end, making me feel that I am tilted and unable find a comfortable balance on chair or bed. Although I am managing to walk independently, it often feels as if my feet are curved under on the sides and do not set flat on the floor. Balance problems continue; I fell out of the shower, over the side of the bathtub, a few weeks ago but was not hurt. Have been prescribed gabapentin (300 mg 3x/day and 100 mg PRN) for the constant pins-and-needles feeling and incredible tightness that spasms through my buttocks, legs and feet. I also have the feeling of a constant "wedgie" at my rectum.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Immunoglobulin therapy, Intervertebral disc degeneration, Intervertebral disc protrusion, Muscle spasms, Muscular weakness
Clinical narrative: I woke up on 11/06/17 and went to get out of bed to let my dog out. My legs felt like spaghetti, and I had to hang on to the bannister to get down the stairs. I contacted my primary physician, who told me to go to the ER. I drove there and was subjected to a full battery of tests, including an MRI on my head, neck, spinal column and lower back. Nothing was found, and I was discharged. I had trouble getting to my car but managed to drive home. I went to bed and when I woke the morning of 11/07/17, my legs seemed even weaker. When I let the dog out, I fell. My husband took me back to the ER, where they told me to drive without delay to another hospital for a lumbar puncture. Was noted that I appeared to have absent reflexes in my knees and ankles. Weakness continued to spread bilaterally upwards from my feet to my torso. Nothing further done that day, despite my complaints that if this was GBS, it was a progressive disease and needed immediate treatment. Finally, on 11/08/17, a nerve conduction study/EMG was conducted but not completed, as the hospital neurologist felt that the first part alone supported a clinical diagnosis of GBS. I was sent for an LP, in which they found increased proteins. Treated with a 5-day course of IVIg, after which I was discharged to home. At this time (05/08/18), both legs still tingle from hip area to feet. The neuropathy extends up to my waist on the left side and about 6 inches higher on my right side. It feels as if I am wearing a thick sanitary pad between my legs, and I also feel as if I am not able to exert the pressure needed for complete bowel evacuation. I have difficulty sitting and lying down; it feels as if there is an obstruction between any surface and my rear end, making me feel that I am tilted and unable find a comfortable balance on chair or bed. Although I am managing to walk independently, it often feels as if my feet are curved under on the sides and do not set flat on the floor. Balance problems continue; I fell out of the shower, over the side of the bathtub, a few weeks ago but was not hurt. Have been prescribed gabapentin (300 mg 3x/day and 100 mg PRN) for the constant pins-and-needles feeling and incredible tightness that spasms through my buttocks, legs and feet. I also have the feeling of a constant "wedgie" at my rectum.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve conduction studies abnormal, Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia
Clinical narrative: I woke up on 11/06/17 and went to get out of bed to let my dog out. My legs felt like spaghetti, and I had to hang on to the bannister to get down the stairs. I contacted my primary physician, who told me to go to the ER. I drove there and was subjected to a full battery of tests, including an MRI on my head, neck, spinal column and lower back. Nothing was found, and I was discharged. I had trouble getting to my car but managed to drive home. I went to bed and when I woke the morning of 11/07/17, my legs seemed even weaker. When I let the dog out, I fell. My husband took me back to the ER, where they told me to drive without delay to another hospital for a lumbar puncture. Was noted that I appeared to have absent reflexes in my knees and ankles. Weakness continued to spread bilaterally upwards from my feet to my torso. Nothing further done that day, despite my complaints that if this was GBS, it was a progressive disease and needed immediate treatment. Finally, on 11/08/17, a nerve conduction study/EMG was conducted but not completed, as the hospital neurologist felt that the first part alone supported a clinical diagnosis of GBS. I was sent for an LP, in which they found increased proteins. Treated with a 5-day course of IVIg, after which I was discharged to home. At this time (05/08/18), both legs still tingle from hip area to feet. The neuropathy extends up to my waist on the left side and about 6 inches higher on my right side. It feels as if I am wearing a thick sanitary pad between my legs, and I also feel as if I am not able to exert the pressure needed for complete bowel evacuation. I have difficulty sitting and lying down; it feels as if there is an obstruction between any surface and my rear end, making me feel that I am tilted and unable find a comfortable balance on chair or bed. Although I am managing to walk independently, it often feels as if my feet are curved under on the sides and do not set flat on the floor. Balance problems continue; I fell out of the shower, over the side of the bathtub, a few weeks ago but was not hurt. Have been prescribed gabapentin (300 mg 3x/day and 100 mg PRN) for the constant pins-and-needles feeling and incredible tightness that spasms through my buttocks, legs and feet. I also have the feeling of a constant "wedgie" at my rectum.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 27-APR-2018, the patient was vaccinated one dose of with M-M-R II, intramuscularly to an unspecified arm, lot# N027781 and expiration date: 08-AUG-2019. There were no adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age referring to herself. There was no information about the patient's concurrent conditions, medical history or concomitant medication provided. On 01-MAY-2018, the patient was intramuscularly vaccinated with a dose of GARDASIL 9 (exact dose, lot# and expiry date were not reported) for prophylaxis. Later on that day she found out she was pregnant. No adverse effect were reported.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pain in extremity, Rash erythematous, Swelling
Clinical narrative: pPtient had swelling and red rash and feeling hot and sore in arm that received vaccine for over 1 week after vaccine
Age: 33.0
Sex: F
Vaccine: DT
Symptoms: Bursitis, Muscle swelling, Musculoskeletal pain
Clinical narrative: Severe bursitis-like pain in shoulder even after eight days. May just be ongoing muscle inflammation or actual bursitis. Recommended treatment NSAIDs and waiting to heal; still ongoing at this time.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Nausea, malaise, vomiting.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness
Clinical narrative: About 9pm I got up off the couch and was dizzy. Thought I was dehydrated so I drank bottle of water. More dizzy at 11pm. Slowly laid down and slept til 6am. Woke up still dizzy - dissipated thru the day and was no longer dizzy by 5-6pm.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Occurrence of a red patch on her right arm after her SHINGRIX shot Friday 05/04/2018. The area was red, tender, warm to touch and patient feels her arm was swollen. The reaction was noticed 10-12 hours after the vaccine was administered. No fever. Taking BENADRYL PRN and using cold compress on affected area.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Vaccination complication
Clinical narrative: SHE STARTED HAVING RED PATCHES ALL OVER THE PLACE WHERE SHE GOT VACCINE AND IT IS PAINFUL SHE WENT TO HER DR, DR TOLD THAT IS IS REACTION TO VACCINE AND REPORT IT TO PHARMACY WHERE SHE GOT IT. SHE CALLED THE PHARMACY.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: After giving injection patient started to complain of dizziness, she felt better after 10 minutes and then home. 30 minutes after Mom called stated patient felt dizzy and nausea. Informed to put patient's legs up while laying down and kept patient hydrated. If symptoms persist and getting worse to take patient to ER. I called Mom the next day, she stated she took patient to ER. Per Mom would bring patient back if symptoms did not improved. Mom made an appointment for 4-25-18 and missed appointment.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) and (batch number 5NY3B, expiry date 13th July 2020). On 27th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 29th April 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved. The reporter considered the injection site rash to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported that they had a SHINGRIX clinic on Friday (27th April 2018). Three of her patients returned to her pharmacy on reporting date with the same symptoms. All three patients were female. The reporter did not have additional details to differentiate one patient from the other. They used two different lot number of SHINGRIX. This case has been linked with case US2018GSK080994 and US2018GSK080995, reported by the same reporter.