chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram abnormal, Epilepsy
Clinical narrative: Per parent, the night of immunization patient had a fever. The next day patient complained of headache, child was sent to school. About an hour later seen at nurses office with complaint of fatigue. Child laid down about 1 hr - nurse noted patient was gurgling, stiffening body for about 5 min. Pt treated at hospital. Pt has since had another seizure in Dec. Dx's epilepsy by neuro. on KEPPRA.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Full blood count normal, Headache, Iron binding capacity total normal, Musculoskeletal stiffness
Clinical narrative: Per parent, the night of immunization patient had a fever. The next day patient complained of headache, child was sent to school. About an hour later seen at nurses office with complaint of fatigue. Child laid down about 1 hr - nurse noted patient was gurgling, stiffening body for about 5 min. Pt treated at hospital. Pt has since had another seizure in Dec. Dx's epilepsy by neuro. on KEPPRA.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Per parent, the night of immunization patient had a fever. The next day patient complained of headache, child was sent to school. About an hour later seen at nurses office with complaint of fatigue. Child laid down about 1 hr - nurse noted patient was gurgling, stiffening body for about 5 min. Pt treated at hospital. Pt has since had another seizure in Dec. Dx's epilepsy by neuro. on KEPPRA.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Injection site pain
Clinical narrative: Prolonged soreness at (L) delt vax site, with perceived numbness and weakness, no objective weakness.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Movement disorder, Musculoskeletal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Left arm - pain from finger tips - shoulder - fever chills - aches everywhere. Fri 23rd 2015 shot was given Monday 26 had to be seen in medical clinic. Arm wont move still very painful. Recheck 28th. Friday January 23, 2015 at 8:00 am I met with Dr, I was given a pneumococcal 23 shot. By 11:00 am I was starting to get sick to my stomach and my arm felt like it was on fire and radiating to my finger tips and up my neck. After the 1 1/2 drive home I was beginning to get feverish and was extremely chilled. The pain in my arm was unbearable. Saturday I call ask a nurse who told me to watch it and if my fever went over 101 to go and get it checked out. Sunday I called back to dr office they told me to go the local hospital and get it looked at. Monday morning, January 26, 2015 I made an appointment to see my local dt. I am unable to abduct my left arm. I was prescribed hydrocodone apar 5-325. Because of the severe pain and inability to move my arm. I returned to the dr for a follow up at January 29. 2015. There was little to NO improvement since the first visit. This visit they prescribed: cyclobenzaprine 10 mg, nabumetone 750 mg and methylprednisolone 4 mg. I have a follow up appointment on Feb 2, 2015 to be revaluated. As of today January 29, 2015 my arm is still immoveable.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 11x12 cm area on left deltoid that is erythematous and indurated and tender to touch. Temp up to 102.3 degree. Treated with BENADRYL and MOTRIN po.
Age: 34.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Pruritus
Clinical narrative: Pruritis on upper arms, upper legs starting 12 hours after vaccine and lasting up to 48 hours after vaccine. No hive, visible rash, or other symptoms. Pruritis controlled by cetrizine.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye pruritus, Gingival swelling, Lacrimation increased, Lip swelling, Nasal congestion
Clinical narrative: Itchy, watery eyes. Sneezing. Severe sinus pressure, runny nose, swelling of nose, lips, gums. Treated with BENADRYL for 24 hours.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paranasal sinus discomfort, Rhinorrhoea, Sneezing
Clinical narrative: Itchy, watery eyes. Sneezing. Severe sinus pressure, runny nose, swelling of nose, lips, gums. Treated with BENADRYL for 24 hours.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye pruritus, Gingival swelling, Lacrimation increased, Lip swelling, Paranasal sinus discomfort
Clinical narrative: Itchy, watery eyes. Sneezing. Severe sinus pressure, runny nose, swelling of nose, lips, gums. Treated with BENADRYL for 24 hours.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rhinorrhoea, Sneezing, Swelling
Clinical narrative: Itchy, watery eyes. Sneezing. Severe sinus pressure, runny nose, swelling of nose, lips, gums. Treated with BENADRYL for 24 hours.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown demographics. On an unknown date these patients were vaccinated with doses of ROTATEQ (dose, frequency, therapy route, lot # and expiry date unspecified) which were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event was unknown. Reporting pharmacist considered the event to be not related to ROTATEQ. This is one of several reports received from the same source (MARRS # 1502USA002297 and MARRS # 1502USA002298). Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Influenza virus test negative, Pyrexia
Clinical narrative: Patient complained of breathing difficulties 4 hrs. after receiving Flu vaccine. Pt said she also had a fever and received breathing treatment in emergency room. Patient filled two scripts (FLONASE and PROAIR). Dr unsure if breathing problems due to flu vaccine.
Sex: F
Vaccine: TTOX
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a healthcare professional on 19 September 2013. A female patient who had history of nickel allergy and concomitant medication were not reported, had received a dose of Tetanus toxoid (Manufacturer: unknown, lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient had reaction due to nickel allergy. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 23 Aug 2013. It was reported that the patient was administered a dose of Tetanus Toxoid vaccine on an unspecified date, which was expired vaccine. No adverse event was reported. List of documents held by sender: None.
Age: 80.0
Sex: F
Vaccine: TTOX
Symptoms: Rash
Clinical narrative: Initial report received from a non-healthcare professional via other company (Merck) on 11 March 2014. Other company number: 1-554678524. An 80-years-old female patient had received a dose of Tetanus Toxoid (Manufacturer Unknown) (batch number, dose number, route and anatomical side of administratoin and not reported) vaccine on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date patient had experienced "rash-spreading". Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the patient was unknown. List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: Initial information was received from a consumer on 04 Mar 2014. The case is link to 2014SA029568 case (same patient). A patient whose demographic details, medical history and concomitant medication were not reported received, a dose of Tetanus Toxoid vaccine on an unspecified date (Route, site, dose and Batch number were not reported). It was reported that on an unspecified date after vaccination patient was very sick with a low grade fever, headache and aches. Laboratory investigations and corrective treatment were not reported. At the time of report outcome of event was recovered. List of documents held by sender: None.
Age: 57.0
Sex: M
Vaccine: TTOX
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Initial report received from a consumer (the patient) on 24 February 2014. A 57-year-old male patient had received a dose of Tetanus Toxoid (manufacturer unknown, batch number, dose number, route and site of vaccination were not reported) on an unspecified date. The patient received concomitant medications with aspirin 81 mg 1x daily at night, SYNTHROID 75 mcg 1x daily in the morning, LANTUS solostar 50 units, NOVOLOG flexpen, 16 units before lunch, before dinner and later night, VICTOZA 0.6 mg in the morning, Metformin XR 500 mg 1 tablet 2x per day, vitamin D3-1000 IU 1x daily in the morning, LOVAZA 1 gm 2 capsules 2x per day, LIPITOR 10 mg 1x daily at night, KEPPRA 1000 mg 1 tablet 2x per day, VIMPAT 100 mg 1.50 tablets 2x per day, COZAAR 25 mg, FLOWMAX 0.4 mg 1 tablet 2x per day and AVODART 0.5 mg 1 capsule daily at night. On an unspecified date, the patient experienced rash, hives and itchy. Corrective treatment and laboratory details were not reported. On an unspecified date, the patient had recovered. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: TTOX
Symptoms: Skin swelling
Clinical narrative: Initial information received from a consumer (the patient) on 23 January 2014. An 62-year-old female patient had received a dose of TETANUS TOXOID, (lot number, route, site of administration were not reported) on an unspecified date. The patient's medical history includes high blood pressure and arthritis. On an unspecified date, the patient's skin swelled to size of dime. Treatment details were not reported. The patient outcome is unknown. Documents held by sender: None. Follow up information was received on 07 April 2014: It was updated that the patient had received TETANUS TOXOID little under the skin at the age of 21 years and had an event of skin swelled to size of dime.
Sex: U
Vaccine: TTOX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 14 Mar 2014. A patient whose demographic details, medical history and concomitant medications were not reported received a dose of Tetanus Toxoid on an unspecified date. (Route, dose, site and batch number not reported). It was reported that on an unspecified date patient received expired vaccine. No adverse event was reported. Documents held by sender: none.
Sex: M
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Initial report received from a non-healthcare professional via other company (Merck national service center) on 14 March 2014. A male patient, whose age, medical history and concomitant medications were not reported, had received a dose of Tetanus vaccine (lot number, dose number and site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced an unspecified allergic reaction. laboratory data and corrective treatments were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 07 January 2014. Some patients (no information was provided regarding patients) had received a dose of tetanus toxoid (tetanus Toxoid Adsorbed) on an unspecified date. it was reported that an expired dose of vaccine was administered. No adverse event was reported. List of documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: TTOX
Symptoms: Musculoskeletal pain
Clinical narrative: Initial report received from healthcare professional on 2 April 2014. A '52-year-old female patient', had medical history of headache from 23 March 2014 to 31 March 2014, and concomitant medication of AUBAGIO 14 mg daily from 21March 2014 due to the possibility of Lyme disease, and ibuprofen as needed were reported, had received dose of Tetanus Toxoid (Lot number, expiration date, route and site of vaccination was not reported) on an unspecified date due to two ticks bites on 25 March 2014 and 27 March 2014 and had experienced right shoulder hurting. The laboratory details and corrective treatment were not reported. The outcome of the event was unknown at the time of report. List of documents held by sender: none. Follow-up received on 29 April 2014. No new information was provided.
Sex: U
Vaccine: TTOX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse case was received from a healthcare professional on 30 OCT 2013. The cases were received at GPV on 21 March 2014. A patient whose demographic details, , medical history and concomitant medication were not reported received, a dose of TETANUS TOXOID vaccine on an unspecified date (ROUTE, site dose and Batch number not reported). It was reported that on an unspecified date patient received expired dose of vaccine. Laboratory investigations were not reported. No adverse event was reported. List of documents held by sender were none.
Sex: U
Vaccine: TD
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 01 April 2014. A patient (no other information was provided regarding patient) had received the dose of Tet Tox instead of Td vaccine an unspecified date. i.e. wrong vaccine administered. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 25 June 2013. A patient (No information was provided regarding the patient) had received an intradermal 0.1 ml dose of Tetanus toxoid vaccine (Manufacture unknown) instead of Tubersol. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 27 January 2014. The cases were received on 21 March 2014. A patient had received a dose of Tetanus Toxoid, manufacturer unknown on an unspecified date. It was reported that the patient receivd vaccine which had expired on January 3. No adverse events were reported. List of documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine, Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from other company (Merck) on 15 April 2014. This case was initially reported by a non-healthcare professional. A 77-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of Tetanus Toxoid, (lot number, dose number, route and site of vaccination were not reported) on an unspecified date. It was reported that the patient developed swelling and redness at injection site. The patient also had allergy to Tetanus. Complementary investigations and corrective treatments were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Initial report received from healthcare professional on 22 April 2014. The '64-year-old' female patient's initials was not provided, whose medical history and concomitant medication were not reported, had received dose of TETANUS (TETANUS TOXOID) on an unspecified date. (Lot number and expiration date, dose number was not reported) and on an unspecified date patient had experienced numbness, and dizziness. The laboratory details and corrective treatment were not reported. The outcome of the event was unknown at the time of report. List of documents held by sender: none.
Age: 89.0
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine, Pain
Clinical narrative: Initial report received from a consumer (the patient) on 12 March 2014. An 89-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of TETANUS TOXOID (TETANUS) (Manufacturer unknown, batch number, dose number, route and site of vaccination unknown) on an unspecified date. On an unspecified date, the patient experienced an allergy to tetanus with the reaction of "pain". Lab data and corrective treatment was not provided. At the time of this report, the outcome was unknown. Document Held by Sender: None.
Sex: U
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Initial report received from a healthcare professional via other company (Merck national service center) on 02 August 2013. Other company reference number: 1-7937382277. A patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of Tetanus vaccine (manufacturer: Sanofi-Pasteur, lot number, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient had experienced an unspecified allergic reaction. Laboratory data and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial report received from a healthcare professional on 26 July 2013. A patient, whose gender, age, medical history and concomitant medications were not reported, had received a dose of Tetanus Toxoid Adsorbed vaccine derived from horses (manufacturer: unknown, batch number, route and anatomical a site of administration were not reported) on an unspecified date. It was reported that, the patient experienced allergy to tetanus derived from horses. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Initial report received on 31 October 2013 from a consumer. A 76 year old female patient, medical history and concomitant medications were not reported, received a dose of Tetanus (tetanus toxoid) (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient had allergy with the tetanus toxoid. Event was not resolved at the time of report. Corrective treatment included fexofenadine hydrochloride (Allegra allergy, 12 hr). List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a Healthcare professional on 22 January 2014. the case was received on 21 March 2014. A patient inadvertently received expired TETANUS TOXOID, ADSORBED vaccine. No adverse event was reported. List of documents held by sender: none.
Sex: M
Vaccine: TD
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 05 June 2013. A male patient was administered Tetanus Toxoid Ads vaccine (Lot number: U3989BA), while administering some leaked out at the injection site. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 10 October 2013. The patient had received expired tetanus toxoid vaccine. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 13-month-old female patient who received KINRIX (batch number KJ924, expiry date 22nd October 2014). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX.
Age: 0.6
Sex: U
Vaccine: HIBV, MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 23 May 2013. a 7-month-old patient had received ACTHIB and it was reconstituted with menactra. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Initial information received from other company (Pfizer) on 13 August 2013. The information was initially received from a consumer. Manufacturer report number: US-PFIZER INC-2012272135. A female patient whose at the time of event, medical history and concomitant medications were not reported, had received a dose of Tetanus Toxoid vaccine from unknown manufacturer (batch number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date after receiving Tetanus Toxoid vaccine, the patient developed allergy (not specified). Corrective treatments and laboratory investigations were not reported. The outcome of event was not reported. Documents held by sender: none. Follow-up information received on 27 November 2013: As the current reporter has no further information. End of follow-up.
Age: 0.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 3-month-old male patient who received KINRIX (batch number A75D7, expiry date 30th September 2016). On 5th December 2014, the patient received KINRIX .5 ml. On 5th December 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: KINRIX given as primary series instead of individual components.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site pruritus, Local reaction, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Swelling of (L) upper arm at vaccine site. Hard and itchy. Erythema.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 33 patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored VARIVAX (Merck), 0.5 ml, subcutaneous. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 04 September 2013. This case is invalid as no information regarding patient was provided. Some (No information was provided regarding the patient) had received ACTHIB: mixed with saline. No adverse event was spread. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 September 2013. The patient had received Expired dose of ACTHIB. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 08 January 2014. A patient (gender and age at the time of event was not reported) had received a dose of Tetanus Toxoid instead of ADACEL vaccine on an unspecified date. No adverse event was reported. Documents held by sender: none.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a female consumer of unknown age regarding herself. Concurrent conditions and medical history was not reported. On 20-JAN-2015, patient was vaccinated with ZOSTAVAX vial, through injection  (dose was not reported). Concomitant medications were not reported. On an unknown date approximately in January 2015 the patient did not feel like she actually received the vaccine when she was given the ZOSTAVAX from her physician's office. The outcome of the event was unknown. The causality of the reported event was not reported. No adverse experience were reported. No further adverse event (AE) information was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 03 January 2014. A patient had received a third dose of ACTHIB and DAPTACEL on 19 October 2013 and forth dose on 2 January 2014. It's an inappropriate schedule of vaccine administered. No adverse event was reported. List of documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 years old female patient. Patient had no pertinent medical history  but was allergic to penicillin, unspecified sulfas and KEFLEX. On 02-FEB-2015 the patient was vaccinated with ZOSTAVAX lot # K014834 and expiry: 14-DEC-2015, 0.65 ml, subcutaneous. She was taking "a lot" of unspecified concomitant medications. On an unknown date in February 2015 the patient experienced redness and swelling at the injection site after receiving the suspect vaccine. The patient sought medical attention and called the pharmacist. There was no treatment given for the events and no lab diagnostics studies were performed. The reporter was unaware of the patient's physician name. The patient did not recovered from redness and swelling at the injection site. Relatedness between the events and ZOSTAVAX was not specified. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Wrong technique in drug usage process
Clinical narrative: Initial case was received from a healthcare professional on 13 January 2013. The patient of unknown demographics (age and gender not reported) whose medical history and concomitant medication was not reported had received ACTHIB (dose, route, batch number and anatomical site of administration not reported) on an unspecified date. On an unknown date, the patient received ACTHIB Reconstituted with sterile water and administered which was considered as "Does not count as valid and should be repeated".
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a male patient of unknown age with no pertinent medical history and drug reactions/ allergies. On 07-DEC-2014 the patient was vaccinated with a dose of ZOSTAVAX (route, dose and frequency unknown), lot # K010648, expiration date: 30-OCT-2015. There was no concomitant medication. The patient was still experiencing swelling at the injection site (onset date unknown). The patient sought medical attention via going to see a doctor. No treatment was given for the adverse event and no lab diagnostics studies were performed. The outcome of swelling at the injection site was reported as not recovered/not resolved. The relationship of the adverse event and ZOSTAVAX has been requested.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 02 August 2013. A 4-month-old patient was administered PENTACEL and ACT-HIB on the same day. No adverse event was reported. List of documents held by sender: none.
Age: 0.2
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional in 04 September 2013. It was reported that 8-week-old patient received both ACTHIB and PENTACEL (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none. Addendum 29 October 2013: Upon internal review of this case the event coding was changed to overdose and no adverse event was added in the event screen.
Age: 65.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Activities of daily living impaired, Facial pain, Herpes zoster, Hypersomnia, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a female patient of unknown age, regarding herself. Patient's concurrent conditions included drug reactions/allergies to LODINE and morphine. Other relevant medical history was reported as none. Approximately on an unknown date in 2011 (reported as 4 years ago) the patient was vaccinated with ZOSTAVAX, (1 single shot) (lot number and route unspecified). Concomitant therapies included tetanus toxoid vaccine, hepatitis b vaccine (manufacturer unknown) and multiple unspecified medications. On 08-NOV-2014 the patient developed pain that radiated from her tooth area to her eye. The patient went to emergency room where she was diagnosed with shingles after receiving ZOSTAVAX. The patient sought medical attention by speaking with physician. X-ray and other unspecified tests were conducted of which results were unknown. The patient was treated with VALTREX. The patient stated that shingles were around her eye,forehead, nose, cheek and temple. The patient stated that she could not take care of herself  for 2 months and during that time she slept for 20 hours a day. The outcome of the events was reported as not recovered/not resolved. The causality of the events with ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: X-ray
Clinical narrative: This spontaneous report was received from a female patient of unknown age, regarding herself. Patient's concurrent conditions included drug reactions/allergies to LODINE and morphine. Other relevant medical history was reported as none. Approximately on an unknown date in 2011 (reported as 4 years ago) the patient was vaccinated with ZOSTAVAX, (1 single shot) (lot number and route unspecified). Concomitant therapies included tetanus toxoid vaccine, hepatitis b vaccine (manufacturer unknown) and multiple unspecified medications. On 08-NOV-2014 the patient developed pain that radiated from her tooth area to her eye. The patient went to emergency room where she was diagnosed with shingles after receiving ZOSTAVAX. The patient sought medical attention by speaking with physician. X-ray and other unspecified tests were conducted of which results were unknown. The patient was treated with VALTREX. The patient stated that shingles were around her eye,forehead, nose, cheek and temple. The patient stated that she could not take care of herself  for 2 months and during that time she slept for 20 hours a day. The outcome of the events was reported as not recovered/not resolved. The causality of the events with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist, via Sanofi, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength, indication not reported). The reporter stated that his colleague witnessed, on an unknown date, the patient experienced adverse reaction (swelling) int he arm. The patient ended up in the emergency for treatment. The outcome of adverse reaction (swelling) int he arm was reported as recovered/resolved. The relatedness between event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions and medical history were not provided. The reporter reported that he had seen many injection site reactions in unspecified patients who received ZOSTAVAX (dose, lot#, dose# and route not reported) on unspecified dates. He reported that the injection site reactions were "mostly quarter-sized rashes that got red and raised, but some progress to a '2x4 area' around the injection site. Sometimes the injection site areas turned 'red and ugly-looking', but the injection site reactions usually went away in approximately a week." He was not certain if he had seen any vesicular rashes, but he stated that many people told him that they develop a rash after receiving ZOSTAVAX. He was not able to recall any specific persons, nor did he think that he would be able to recall any specific instances in the future. The outcome of rash was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a nurse and described the occurrence of drug dose administration interval too long in a patient who received TWINRIX. On an unknown date, the patient received the 2nd dose of TWINRIX. On an unknown date, an unknown time after receiving TWINRIX, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information: A second dose in a TWINRIX 0, 1, 6 month schedule was delayed.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Dry skin, Eyelid oedema, Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to her husband, 61 year old male patient. The patient's concurrent condition includes gout. The patient's medical history included skin dryness or itching on legs and dandruff problem on scalp. The patient did not have any past drug reactions or allergies. On 02-OCT-2014, the patient was vaccinated with ZOSTAVAX lot # K008884, expiration date 20-SEP-2015, 0.65 ml, subcutaneously. Concomitant therapies included colchicine, indomethacin (manufacturer unknown), probiotics (unspecified) and niacinamide. On 03-OCT-2014, the patient developed a red, warm blister at the ZOSTAVAX injection site which resolved approximately on 10-OCT-2014 (reported as after about one week). In October 2014 (reported as one to three weeks after the administration of ZOSTAVAX), the patient developed tiny, little blister things on his face, near his eyes, on his forehead and on his scalp which were all painful at times. On an unknown date, the patient also experienced dry, flaky skin on his face and itching on his face and scalp. On an unknown date, the patient's eyes were red and puffy. All these events would appear, go away and then reappear at unspecified intervals. On an unknown date, the patient sought medical attention at the office of unspecified physician. No treatment was reported. No lab diagnostic studies were performed. The outcome of the events of "red, warm blister at the ZOSTAVAX injection site" was reported as recovered/resolved. The outcome of the other events was unknown. The relatedness between the event and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Ocular hyperaemia, Pain, Pruritus, Skin exfoliation
Clinical narrative: This spontaneous report as received from a pharmacist refers to her husband, 61 year old male patient. The patient's concurrent condition includes gout. The patient's medical history included skin dryness or itching on legs and dandruff problem on scalp. The patient did not have any past drug reactions or allergies. On 02-OCT-2014, the patient was vaccinated with ZOSTAVAX lot # K008884, expiration date 20-SEP-2015, 0.65 ml, subcutaneously. Concomitant therapies included colchicine, indomethacin (manufacturer unknown), probiotics (unspecified) and niacinamide. On 03-OCT-2014, the patient developed a red, warm blister at the ZOSTAVAX injection site which resolved approximately on 10-OCT-2014 (reported as after about one week). In October 2014 (reported as one to three weeks after the administration of ZOSTAVAX), the patient developed tiny, little blister things on his face, near his eyes, on his forehead and on his scalp which were all painful at times. On an unknown date, the patient also experienced dry, flaky skin on his face and itching on his face and scalp. On an unknown date, the patient's eyes were red and puffy. All these events would appear, go away and then reappear at unspecified intervals. On an unknown date, the patient sought medical attention at the office of unspecified physician. No treatment was reported. No lab diagnostic studies were performed. The outcome of the events of "red, warm blister at the ZOSTAVAX injection site" was reported as recovered/resolved. The outcome of the other events was unknown. The relatedness between the event and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 February 2013. A patient had received ACT-HIB and PENTACEL on same visit in September 2012. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Scar
Clinical narrative: This spontaneous report as received from a 60 year old female pharmacist who was also the patient, concerning herself. Information about patient's medical history was not provided. She had no drug reactions or allergies. On 02-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose: 0.65 ml, frequency was unspecified, subcutaneously) (lot # K008884, expiration date: 20-SEP-2015), as her doctor recommend it since her age was appropriate. Concomitant therapies included: niacinamide, fish oil and calcium. On an unknown date in January 2015, the patient developed "three, tiny, little "rashy things" on her back in the shoulder area under bra strap which were painful to touch" (painful rash). No treatment was given for adverse event and no diagnostic tests were performed. The patient did not seek medical attention. No product quality complaint (PQC) was involved. The outcome of the event was recovered (on an unknown date in 2015) also reported as "resolved on an unspecified date leaving little scars". The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This sontaneous report as recived from nurse practitioner refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical hisotry was not reportd. On an unknon date unspecified number of patients were vaccinated with improperly stored (incorrect product storage) PEDVAXHIB (0.5 ml, once) (lotn umber unspecified), intramuscular. Concmoitant medicatinos were not reported. The reporter stated that the unspecified patients received doses of PEDVAXHIB between 10-AUG-2014 and 24-JAN-2015. No adverse efefcts (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with PEDVAXHIB was not reported. This case is linked to #1502USA000900 via same reporter link. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong drug administered, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 08 August 2013. A 15-month-old patient receiveed Act-HIB vaccine reconstitute4d with DTaP/IPV component of PENTACEL. DTaP/IPV was not to be administered to the child. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date unspecified number of patients were vaccinated with improperly stored (incorrect product storage) GARDASIL (0.5 ml, once) (lot number unspecified), intramuscular. Concomitant medications were not reported. The reporter state that the unspecified patients received doses of GARDASIL between 10-AUG-2014 and 24-JAN-2015. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. This case is linked to #1502USA001952 via same reporter ling. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes are big and swollen.
Sex: U
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Swollen tongue
Clinical narrative: This spontaneous report as received from a pharmacist, via Sanofi, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength, route of administration not reported). On an unknown date the patient experienced anaphylactic response and tongue swelled. The patient was ok. The emergency care (reported as 911) came and patent resolved. The patient did not need anything. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (healthcare worker) refers to unspecified patients of unknown demographics. Since an unknown date these patients were administered with improperly stored VARIVAX (Merck) (dose, frequency, therapy route, lot #, expiry date not specified). No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event was unknown. Reporting healthcare worker considered the event to be not related to VARIVAX (Merck). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Urticaria
Clinical narrative: Information has been received from a patient's husband referring to his 62 year old wife without drug reactions/allergies. On 23-JAN-2015 the patient was seen at her physician's office, because of pain and a rash on her back. During that visit the patient was diagnosed with hives and was given ZOSTAVAX (lot#, expiration date and dose unspecified, route was reported as "injection") and an unspecified corticosteroid. On 26-JAN-2015, the patient's pain had worsened and the patient was seen at an urgent care center where she was diagnosed with shingles. The reporter stated that the patient was prescribed morphine, lidocaine an unspecified topical formula, oxycodone, and an unspecified antiviral medicine. The reporter also stated that the patient had other unspecified pertinent medical issues. No lab diagnostics studies performed. The event outcome was not resolved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, concerning a 57 year old female patient. The patient's medical history included hepatitis. On 24-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date and route were not reported), dose and frequency reported as one shot for vaccine. Co-suspect and concomitant therapies were not reported. The pharmacist reported that on 25-JAN-2015, the patient experienced an injection site warmth, injection site swelling and injection site nodule after receiving ZOSTAVAX. At the time of the report the outcome for site warmth, injection site swelling and injection site nodule was unknown. The patient seeks medical attention on the pharmacy. The pharmacist told the patient to "put on it ice" and to take BENADRYL. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Loss of consciousness
Clinical narrative: Vaccine administered and RN left room. Mom opened door and patient in arms passed out. Patient placed supine on exam table, vitals stable as patient begins to arouse, at 1120. Snack offered as patient rests. Vitals repeated and stable at 1130. Ambulates out of office with mom at 1135.
Age: 8.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 8 year old male patient. Information regarding medical history and concurrent condition was not provided. On 12-NOV-2014, 4 days before his 9th birthday, the patient was vaccinated with a dose of GARDASIL (dose, dose number, lot #, application site and route were not reported) (inappropriate schedule of vaccine administered). Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: (L) arm pain x 24 hours. TX: TORADOL, NORCO, Methylprednisolone.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 12-JAN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (INJ 120Y) at 46.6F for 64 hours (lot#, expiration date, dose and route were unknown). No adverse events were reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: TTOX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 06 June 2013. A dose of Tetanus vaccine (manufacturer: unknown) that had expired on 8 February (year not provided) was administered to a patient on 08 May (year not provided). No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Urticaria
Clinical narrative: Initial report received from healthcare professional on 18 June 2013. A "63-year-old female patient now", age at the time of event occurred was not reported and pre-existing physician diagnosed allergies, birth defects and medical conditions and concomitant medication not reported, had received a dose of tetanus vaccine (lot number, route and site of vaccination was not reported) on an unspecified date in 70's of the patient. It was reported that the patient experienced hives after vaccination. It was reported that the allergy was due to horse serum that she had experienced after receiving "tetanus vaccine". The reporter does not have any other information to report. Corrective treatment and laboratory details were not reported. The patient was recovered from adverse event on an unspecified date. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 04 September 2013. A patient (No information was provided regarding the patient) had received an expired (expiry: 16 August 2013) ACTHIB vaccine on 03 September 2013. No adverse event was reported. List of documents held by sender: none.