chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: Initial unsolicited report received from a physician's assistant on 11 August 2016. This case involves a 39-year-old male patient who was vaccinated with a dose of ADACEL (batch number: U5406AA, expiration date: 05 June 2018, dose was not reported) intramuscularly in the left deltoid on 03 August 2016. Patient's Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications included were not reported. On 09 August 2016, six days following the vaccination, the patient experienced painful and swollen left arm, had periodic hot sweats, had enlarged and tender lymph nodes, rash around left armpit, nausea, headache, "tight" feeling in chest and short of breath. On an unspecified date, following the vaccination the patient had elevated blood pressure. It was reported that the patient required emergency room or doctor visit. Lab data and corrective treatment were not reported. Patient had not recovered from the events. List of documents held by sender: none. Sender's Comments: Tight feeling in chest and short of breath is unlisted for DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Six days post vaccination, patient experienced, tight feeling in chest, short of breath and had an elevated blood pressure along with periodic hot sweats. Additional information regarding the investigation results to rule out the underlying cause of the reported events, relevant medical history, concurrent conditions and concomitant medications, if any are needed for complete assessment of the case. Based on the available information, no conclusion can be drawn.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a physician's assistant on 11 August 2016. This case involves a 39-year-old male patient who was vaccinated with a dose of ADACEL (batch number: U5406AA, expiration date: 05 June 2018, dose was not reported) intramuscularly in the left deltoid on 03 August 2016. Patient's Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications included were not reported. On 09 August 2016, six days following the vaccination, the patient experienced painful and swollen left arm, had periodic hot sweats, had enlarged and tender lymph nodes, rash around left armpit, nausea, headache, "tight" feeling in chest and short of breath. On an unspecified date, following the vaccination the patient had elevated blood pressure. It was reported that the patient required emergency room or doctor visit. Lab data and corrective treatment were not reported. Patient had not recovered from the events. List of documents held by sender: none. Sender's Comments: Tight feeling in chest and short of breath is unlisted for DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Six days post vaccination, patient experienced, tight feeling in chest, short of breath and had an elevated blood pressure along with periodic hot sweats. Additional information regarding the investigation results to rule out the underlying cause of the reported events, relevant medical history, concurrent conditions and concomitant medications, if any are needed for complete assessment of the case. Based on the available information, no conclusion can be drawn.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Initial unsolicited report received from a physician's assistant on 11 August 2016. This case involves a 39-year-old male patient who was vaccinated with a dose of ADACEL (batch number: U5406AA, expiration date: 05 June 2018, dose was not reported) intramuscularly in the left deltoid on 03 August 2016. Patient's Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications included were not reported. On 09 August 2016, six days following the vaccination, the patient experienced painful and swollen left arm, had periodic hot sweats, had enlarged and tender lymph nodes, rash around left armpit, nausea, headache, "tight" feeling in chest and short of breath. On an unspecified date, following the vaccination the patient had elevated blood pressure. It was reported that the patient required emergency room or doctor visit. Lab data and corrective treatment were not reported. Patient had not recovered from the events. List of documents held by sender: none. Sender's Comments: Tight feeling in chest and short of breath is unlisted for DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Six days post vaccination, patient experienced, tight feeling in chest, short of breath and had an elevated blood pressure along with periodic hot sweats. Additional information regarding the investigation results to rule out the underlying cause of the reported events, relevant medical history, concurrent conditions and concomitant medications, if any are needed for complete assessment of the case. Based on the available information, no conclusion can be drawn.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. The nurse practitioner reported, that on an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot #, expiration date 23-SEP-2017 and lot # L037561, expiration date 23-NOV-2017 (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist and pharmacist technician refers to a female patient of unknown age. The patient's medical history included herpes zoster (date not reported). On 16-JAN-2014 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included simvastatin, enalapril maleate/ hydrochlorothiazide, levothyroxine sodium and gabapentin. On an unknown date, it was reported that the patient after being vaccinated with ZOSTAVAX experienced a "mild case of shingles." The outcome of herpes zoster is unknown. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a adult female patient who received Influenza vaccine Quadrivalent. In September 2015, the patient received Influenza vaccine Quadrivalent .5 ml. In September 2015, less than a month after receiving Influenza vaccine Quadrivalent, the patient experienced injection site pain, injection site swelling, injection site warmth and injection site redness. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site warmth and injection site redness were recovered/resolved. The reporter considered the injection site pain, injection site swelling, injection site warmth and injection site redness to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The hospital employee who received an unknown Quadrivalent flu vaccine for 2015-2016 season in right arm and experienced injection site pain, injection site swelling, injection site warmth and injection site redness. She noted the side effects were lasted a couple of days but then resolved. The patient did not see her physician or seek medical treatment for the stated injection site reactions. She received the vaccine through the occupation health facility of the hospital. She was not aware of the manufacture of the vaccine she received. On 8th August 2016, the representative stated that, he called at 7 pm last Friday (5th August 2016) to report the incident but GlaxoSmithKline was closed at that time, when he was reminded about the 24 hour reporting policy.
Age: 17.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Face injury, Fall, Lip injury, Neurological examination normal, Syncope
Clinical narrative: Fainted after injection and fell hitting face against floor, cutting lip. Had not eaten since 11:00 AM. Neuro exam normal.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site noted.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Presyncope
Clinical narrative: About 10 min after vaccination (tdap, MENVEO and HPV9) felt light headed and was presyncopal. Patient was placed on a bed, given some water and graham crackers, felt better after about an hour. Discharged home.
Age: 69.0
Sex: M
Vaccine: PNC
Symptoms: Myalgia
Clinical narrative: Muscle pain in front right chest and back right below shoulder.  Lasted about 2 weeks. Treated with ibuprofen.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Hypotonic-hyporesponsive episode, Vomiting
Clinical narrative: After receiving last vaccine patient experienced a hypotonic hypo responsive reaction. After which she vomited several times. Patient was given juice and monitored for 15 minutes before being walked to the car by the nurse.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Foster mother was still in WIC office when nurse noticed a red swollen area developing above the Band-Aid and above the injection site.  At it's largest area was quarter sized, red and warm to touch.  Foster mother called pediatrician from WIC office. Received instructions to have pt remain at WIC office for 30min.  If S/S worsen seek emergency medical tx.  Foster mother was given instruction by the pediatrician office to give the pt 1.25ml of Benadryl po once she gets home and to apply a cool cloth.  Foster mother remained at WIC office 1hr and 15min from time hive like area originally appeared. Hive like area had disappeared before she left and red area was disappearing.  Mother was back in Health Department office 8/15/2016.  Discussed follow up with her.  States she gave the Benadryl as instructed although the hive area was gone.  Child received DtaP 8/15/2016 without any problems.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Dizziness, Hypotonic-hyporesponsive episode
Clinical narrative: Pt stated he was starting to feel dizzy and light-headed. While waiting on arrival on cot, pt had hypotonic-hyporesponsive reaction lasting approx. 1 min. Lowered to the cot, became alert immediately after. Pt drank juice and laid down for approx. 10 min until he felt better. Sat on side of cot and stood up with no further signs or symptoms. Advised to eat after leaving and rest.
Age: 3.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Pruritus, Rash
Clinical narrative: Broke out on rash on back, trunk then face. +itching. No fever. Good appetite.  Counseled mom on removing from daycare and calling PMD.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions, drug reactions or allergies was not reported. On 20-JUL-2016, the patient was inadvertently vaccinated with an expired dose of PROQUAD, (dose, route of administration, and frequency were not provided) with lot # K021548, expiration date 06-MAY-2016. There were not concomitant therapies reported. No adverse event was produced. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N), concerning an unspecified patient (unknown age and gender). The patient's pertinent medical history and concurrent conditions were not provided. On 15-AUG-2016 the patient was vaccinated with an improperly stored dose of VARIVAX lot # M002063, expiration date 12-JAN-2018, (concentration, dosage and therapy route were not provided). There was no concomitant therapies reported. No adverse effects were reported. The vaccine was exposed to 11.7 F for 2 hours and 48 minutes and the call was made because of digital data logger. There were no previous exposures. No product quality complaint (PQC) was involved. This is one of two reports from the same source (MARRS#1608USA008365). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. In 2006, reported as "about 10 years ago", the patient was vaccinated with a dose of ZOSTAVAX 19400 Y (lot #, expiration date, dose number and therapy route were unknown). Concomitant therapies were not provided. The physician reported that on an unknown date, the patient developed swelling for two weeks at injection site that hurt tremendously. The outcome of swelling at the injection site that hurt tremendously was reported as recovered at the time of the report. No product quality complaint (PQC) was involved. This is one of two reports from the same source (MARRS # 1608USA008887). Additional information is not expected as no consent to follow up was given.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Injection site erythema, Injection site swelling
Clinical narrative: Narrative: LUE swelling after PPSV 23 injection yesterday. Erythema of proximal LUE. Symptoms: Erythema Multiform.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Pyrexia
Clinical narrative: Feels fever/chills, rigorous appearance, 99.8 degrees symptoms started 20 minutes earlier, vaccines administered 1 hour earlier treated with rest and TYLENOL.
Age: 20.0
Sex: M
Vaccine: HPV9, MENB, HPV4, MENB
Symptoms: Dyspnoea, Movement disorder, Pain, Swelling, Throat tightness
Clinical narrative: Seen in ER in PM - left side pain - unable to move arm/left side, swollen, painful - throat closed up , heavy breathing - to ER/EMS - got BENADRYL, Epi, BENADRYL. Seen again in ER 8/10/16 - chest pain, heavy breathing.
Age: 20.0
Sex: M
Vaccine: HPV9, MENB, HPV4, MENB
Symptoms: Anaphylactic reaction, Extensive swelling of vaccinated limb, Injection site swelling
Clinical narrative: Seen in ER in PM - left side pain - unable to move arm/left side, swollen, painful - throat closed up , heavy breathing - to ER/EMS - got BENADRYL, Epi, BENADRYL. Seen again in ER 8/10/16 - chest pain, heavy breathing.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received TDAP and MCV4 in left deltoid and HPV 9 in right deltoid. On 8-9-16. Morning of 8-10-16 noted redness and swelling small (left deltoid). Increased in size. Office visit 8-12-16. Left deltoid had an area of redness, swelling and tenderness 6 inches x 4 inches. Tx with KEFLEX and cool compresses.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: On Aug 14th, pt reported that she started to develop erythema, itchiness and warmth around the injection site 3 days after the injection. The redness has spread in the next 3 days, it was about 2" x 4" in size by Aug 14th. Pt is afebrile. No other s/sx of systematic toxicity. Instructed pt to take antihistamine, use cold compress then contact her MD the next day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness/swelling/induration of right upper arm extending to lower arm onset 8/12/16. Circumferences: RUA 23.7cm RLA 20cm LUA 20cm LLA 17.5cm. tx BENADRYL, Ibuprofen every 6 hours starting 8/12.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram normal, Pyrexia
Clinical narrative: Had vaccine 8/11/16 at 2:30 pm. Developed fever 101.3-101.6 at 5 am 8/12/16 chest pain and shortness of breath at 7 am. Took to emergency room , chest x-ray, EKG and urine-done-all normal. Told allergic to immunization.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Urine analysis normal
Clinical narrative: Had vaccine 8/11/16 at 2:30 pm. Developed fever 101.3-101.6 at 5 am 8/12/16 chest pain and shortness of breath at 7 am. Took to emergency room , chest x-ray, EKG and urine-done-all normal. Told allergic to immunization.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Papule, Rash
Clinical narrative: Rash began day after immunization. Not itchy, no pain. Erythematous papule with central firm papule, scattered on extremities. No vesicles. No pustules. No treatment given.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site macule, Injection site pain, Injection site swelling
Clinical narrative: Notified Clinic on 8/18/19 and apt scheduled for 8/19/16. 8/19/19-Large 10cm erythematous, slightly swollen tender macular lesion to (L) deltoid, no localized nodes. Rx given for BACTROBAN ointment on 8/19/16.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Pain
Clinical narrative: Arm where injection given is still very painful 3 1/2 weeks later. Painful to lift arm, to move arm when first waking up in morning.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site rash
Clinical narrative: Developed rash on arm near injection site 24 hrs after receiving it. BENADRYL and hydrocortisone cream.
Age: 10.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Muscle twitching, Posturing, Tremor
Clinical narrative: An hour after administration of HPV and ADACEL, child developed focal twitching, shaking, dystonic posturing of the (R) leg, (R) hand, without loss of consciousness.
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA, HIBV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Mother reported patient could no bend her left leg; Pain in left leg.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Right arm painful and swollen at injection site. Area size of baseball. No fever.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Joint range of motion decreased, Muscle tightness, Pain, Skin reaction
Clinical narrative: Left shoulder redness, pain, muscle tightness, limited range of motion. Reported by pt.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: C/o left upper arm pain with redness and warmth. Pt received PNEUMOVAX 23 vaccine 8/17/16. Pt states symptoms started shortly afterwards. He states symptoms have improved over last 24 hours. He denies respiratory distress, chest pain, and all other constitutional symptoms.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: I received the PNEUMOVAX vaccine 08/18/16 and had extreme pain in my arm. It has swollen up and bubbled up. I have been up all night vomiting.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Tenderness
Clinical narrative: Patient woke up during the night with tenderness to his left arm and did not feel like he could move it. Had roommate help him move it around and took some ibuprofen. Presented today with some mild swelling and tenderness to left shoulder. No redness noted or fever reported. Able to move shoulder in all directions. Is feeling better. This is his 3rd shot in the series.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient had a little nausea this morning. Presented today with left shoulder tender and mildly swelling.  No redness noted or fever reported.  Able to move shoulder in all directions.  Took some Tylenol this morning and is feeling better. This is her 3rd shot in the series.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Redness, swelling, and heat in arm vaccine was administered.
Age: 75.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient said he was itching on his arms, lower back, and legs.  Patient had mild redness on his lower back. Patient went to the emergency room.  They did not diagnose him with anything, no labs were done, no medications prescribed, no recommendations were made, and patient was release.  Patient came to the pharmacy after his ER visit and said he feels good now.
Age: 5.0
Sex: M
Vaccine: IPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Right thigh w/ erythema under injection site.  Approx area of induration 3cm x 3c,
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to his wife, a 64 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. Concomitant therapies included INDERAL, SINGULAIR, PREVACID and CENTRUM Performance (ginseng (+) ginkgo (+) minerals (unspecified)). On 11-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 (unspecified strength and dose) lot # L026033 and expiration date 27-MAR-2017, via intramuscular, in the right arm. On 12-AUG-2016, the patient experienced pain under right breast; no treatment was received and pain began to subside on 14-AUG-2016, but was not entirely gone (recovering). The causality between the PNEUMOVAX 23 and the event was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Feeling hot, Headache, Oropharyngeal pain
Clinical narrative: Zoe's symptoms started 5pm on 8/16/16 same day as vaccine was given. First she felt dizzy and was light sensitive-she felt a headache coming on. Then feeling of chills and fever, but was afebrile. When she woke up the next morning she started with headache 7/10, light sensitivity and sore throat. Zoe took MOTRIN and TYLENOL, pushed fluids but no relief from headache. Symptoms continued into 08/18/16-same symptoms as stated above. Headache did not resolve till 8/19/16.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Photophobia
Clinical narrative: Zoe's symptoms started 5pm on 8/16/16 same day as vaccine was given. First she felt dizzy and was light sensitive-she felt a headache coming on. Then feeling of chills and fever, but was afebrile. When she woke up the next morning she started with headache 7/10, light sensitivity and sore throat. Zoe took MOTRIN and TYLENOL, pushed fluids but no relief from headache. Symptoms continued into 08/18/16-same symptoms as stated above. Headache did not resolve till 8/19/16.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: Day of inj-headache slight, soreness at site. Day 2 - erythema, hive at location. Itching.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt. received BEXSERO-dose 2 within an hour arm became painful and slightly swollen and red-significant pain persisted for more than a week-sx resolved. (No reaction after 1st BEXSERO).
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's mother reports patient developed an area of approx. 4"x3" on right arm an injection site that was red, raised and warm. Use of BENADRYL and compresses 8/17/16. 8/19/16-area improving, no longer raised or warm, red fading.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report was received from a medical assistant refers to patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 17-AUG-2016, the patient was inadvertently vaccinated with a dose of VARIVAX lot # M009765, expiry date 23-FEB-2018 and a dose of PROQUAD lot # M012985, expiry date 12-SEP-2017 on different unspecified arms (dose, strength, dose number, vaccination site, route not provided). Product quality complaint (PQC) was not involved. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) referring to a 60 year old male patient. The patient's concurrent conditions included obesity, hypertension and diabetes. He did not have known drug allergies. Concomitant medications were not reported. On 28-JUL-2016, the patient was vaccinated with ZOSTAVAX (19400 PFU: plaque-forming units), subcutaneous. Lot # and anatomical location were not reported. On 01-AUG-2016 (reported as "4 days later"), the patient experienced a red, itchy, blistering rash on his mid back and anterior chest, and he complained of burning pain. The reporter stated that the patient was seen in the office on 08-AUG-2016 and the physician prescribed Acyclovir and Ibuprofen. The reporter also stated that the patient would be seen on 22-AUG-2016. It was not product quality complaint involved. At the time of reporting the outcome of the events was unknown. The causality assessment between the events and the suspect therapy was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Eye swelling, Swelling face
Clinical narrative: After the immunizations were received had to go to ER w/eye, face swelling. Received DECADRON and BENADRYL.
Age: 19.0
Sex: U
Vaccine: MENB
Symptoms: Blister, Rash
Clinical narrative: Patient seen in office for well care on 8/4/2016. Reported to have developed rash between 8/11-8/12. Did not return to office for care. Developed blisters. Seen by dermatology.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: A spontaneous report was received on 19-JUL-2016 from a healthcare worker/certified medical assistant (CMA). The CMA reported that multiple unspecified patients received PROQUAD (Lot No L046508, expiration date 17-MAY-2017), and VARIVAX (Lot No. L041205, expiration date 20-OCT-2017) that were improperly stored on multiple unspecified dates. Temperature: Min 2.3F and Max 6.6F. Time frame: 40 hours. No adverse effects were reported. No further information provided. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Paraesthesia, Urticaria
Clinical narrative: Redness at injection site, 2 whelp-like areas tingling-called Dr.-he said BENADRYL 25mg-We gave her an ice pack-She went home and took 25mg BENADRYL-her husband is home too. She will take more BENADRYL it needed and will seek EMS if SOB-increased reaction.
Age: 9.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Inappropriate schedule of drug administration, Limb discomfort
Clinical narrative: Vaccines inadvertently administered second set of catch up vaccines early. First set administered 7-28-2016. Telephone call to child's father - through interpreter - revealed no adverse effects - denied fever. Some mild arm discomfort.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chest X-ray, Electrocardiogram, Fatigue, Laboratory test
Clinical narrative: C/o nausea and tired, weakness then syncope episode, went to ER given IV fluids.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Syncope
Clinical narrative: C/o nausea and tired, weakness then syncope episode, went to ER given IV fluids.
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea
Clinical narrative: Information has been received from Pfizer Inc. (manufacturer control # 2016348841) on 20-JUL-2016. Information has been received from a consumer referring to her mother of unknown age on 15-JUL-2016. The patient's medical history and concurrent conditions were not reported. On an unknown date in 2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported). On 12-JUL-2016 (reported as three days ago), the patient experienced diarrhoea. The outcome of diarrhoea and the causality were not reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Chills, Full blood count, Headache, Metabolic function test normal
Clinical narrative: Approx 12hrs after receiving MENACTRA pt developed severe/intense HA, fever 100.3, chills, nausea abd pain. Seen in office 8/18/16 1045 by Dr. BW done-will recheck Pt 8/22/16.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Nausea, Pyrexia
Clinical narrative: Approx 12hrs after receiving MENACTRA pt developed severe/intense HA, fever 100.3, chills, nausea abd pain. Seen in office 8/18/16 1045 by Dr. BW done-will recheck Pt 8/22/16.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unknown number of unspecified patients of unknown gender and age. Information regarding patients' medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L039638, expiry date: 23-AUG-2017). No adverse effect was reported. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid area swollen-started a little nite of injection. Next day the same, worse the night after injection given. Area is warm, red, tense and painful.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Skin tightness
Clinical narrative: (L) deltoid area swollen-started a little nite of injection. Next day the same, worse the night after injection given. Area is warm, red, tense and painful.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient had no pertinent medical history, concomitant medications and did not have known allergies. On 29-JUL-2016, the patient was vaccinated with ZOSTAVAX, 19400 Plaque Forming Unit (PFU), subcutaneous. Dose, lot # and expiration date were not provided. On an unknown date in 2016, after vaccination, the patient experienced redness and swelling at injection site. The reporter stated that the patient was sought on 17-AUG-2016 and that the redness and swelling were gone (recovered), but "there was a round patch of darkened skin at the injection site". No treatment was given for the events and laboratory test were not performed. It was not a product quality complaint involved. The outcome of darkened skin at the injection site was reported as recovering. The causality assessment between the events and the suspect therapy was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Abdominal pain, Chills, Headache, Injection site pain, Nausea
Clinical narrative: Syncope and collapse less then one minute after receiving immunizations. Patient was pale, nauseous, blood pressure 100/62. Patient laid supine for 1.5 hours in the office after onset of symptoms until she felt well enough to leave the office. 1 hour after immunization patient started complaining of severe right shoulder pain. On 6/23/16 patient called to report abdominal pain 4/10, chills, body aches and severe headache. Symptoms did not resolved till 06/24/16.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pain, Pallor, Syncope
Clinical narrative: Syncope and collapse less then one minute after receiving immunizations. Patient was pale, nauseous, blood pressure 100/62. Patient laid supine for 1.5 hours in the office after onset of symptoms until she felt well enough to leave the office. 1 hour after immunization patient started complaining of severe right shoulder pain. On 6/23/16 patient called to report abdominal pain 4/10, chills, body aches and severe headache. Symptoms did not resolved till 06/24/16.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unknown number of unspecified patients of unknown gender and age. Information regarding patients' medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L039660, expiry date: 04-FEB-2018). No adverse effect was reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hypotonic-hyporesponsive episode, Loss of consciousness
Clinical narrative: PATIENT ADVISED THAT SHE USUALLY PASSES OUT AFTER GETTING VACCINES. VACCINES ADMINISTERED AND ABOUT 3 MINS LATER PATIENT EXPERENCED A HYPOTONIC HYPORESPONSIVE EVENT. PATIENT WAS HELPED TO THE COT AND GIVEN JUICE AND AFTER ABOUT 15 MINS PATIENT STATED SHE WAS WELL ENOUGH TO LEAVE.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ, VARCEL
Symptoms: Dizziness, Hypotonic-hyporesponsive episode
Clinical narrative: Pt stated feeling lightheaded after administration of immunizations. While another nurse was bringing cot and juice, patient had hypotonic-hyporesponsive reaction that lasted about 30 sec-1 minute. He became alert, drank juice, and sat in chair for about 15 minutes with no other signs and symptoms. Pt stated he felt better and advised to eat after leaving appointment.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Pain in extremity, Rash macular
Clinical narrative: Boyfriend grabbed her arm it hurt. Looked and saw a few blotches around site and redness at injection site. Resolved next day or two.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Meningitis
Clinical narrative: Admitted to hospital with diagnosis of meningitis.
Age: 25.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Abdominal discomfort, Decreased appetite, Urticaria, Vomiting, Weight decreased
Clinical narrative: NEXT DAY HAD HIVES ON ARM THAT SPREAD TO BACK AND SIDE OF BODY, UPSET STOMACH, LOSS OF APPETITE, VOMITING. SHE CONTACTED AN ADVISE NURSE ON THE PHONE NOT SURE ON WHAT DAY. 08/19 STILL HAS STOMACH UPSET AND LOSS OF APPETITE WITH POTENTIAL WEIGHT LOSS THE HIVES ARE GOING AWAY.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV, VARCEL
Symptoms: Abdominal pain upper, Cough, Extra dose administered, Eye irritation, Influenza like illness
Clinical narrative: On Friday the 19th of August we was driving to church and my son complained that his eyes was burning and when my daughter looked back she said his eyes was watering and I pulled over and seen the same. He has had fevers and had a cough and flu like symptoms. That same day in the evening we came home and he showed me that the site where the shot was administered had 3 bumps on it and it was gone the next day. The following week he was complaining of stomach aches and leg and feet pain. We went to office that Wednesday the 17th and they said he was fine. In the evening of the 17th around 7pm he complained his arm hurt and the site area was red and many welts was present, we went to the ER and it was gone within 30 minutes.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Lacrimation increased, Pain in extremity
Clinical narrative: On Friday the 19th of August we was driving to church and my son complained that his eyes was burning and when my daughter looked back she said his eyes was watering and I pulled over and seen the same. He has had fevers and had a cough and flu like symptoms. That same day in the evening we came home and he showed me that the site where the shot was administered had 3 bumps on it and it was gone the next day. The following week he was complaining of stomach aches and leg and feet pain. We went to office that Wednesday the 17th and they said he was fine. In the evening of the 17th around 7pm he complained his arm hurt and the site area was red and many welts was present, we went to the ER and it was gone within 30 minutes.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV, VARCEL
Symptoms: Pyrexia
Clinical narrative: On Friday the 19th of August we was driving to church and my son complained that his eyes was burning and when my daughter looked back she said his eyes was watering and I pulled over and seen the same. He has had fevers and had a cough and flu like symptoms. That same day in the evening we came home and he showed me that the site where the shot was administered had 3 bumps on it and it was gone the next day. The following week he was complaining of stomach aches and leg and feet pain. We went to office that Wednesday the 17th and they said he was fine. In the evening of the 17th around 7pm he complained his arm hurt and the site area was red and many welts was present, we went to the ER and it was gone within 30 minutes.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: PATIENT STATES ARM IS HOT AND WARM TO TOUCH. REDNESS OBSERVED THROUGHOUT THE UPPER ARM AND HAS SPREAD.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWELLING, WARMTH AT SITE, PAIN.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Guardian reports vomiting, diarrhea and high fever (101-102 F).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2cm area of redness and swelling at injection site.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever to 103, approx. 10 pm, taken to ER had seizure at ER.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Local swelling, Musculoskeletal pain, Myalgia, Nausea, Neck pain
Clinical narrative: Raised red mark on arm, extreme shoulder pain, muscle soreness, arm soreness, neck soreness, nausea.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity
Clinical narrative: Raised red mark on arm, extreme shoulder pain, muscle soreness, arm soreness, neck soreness, nausea.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Insomnia, Nervousness, Pain
Clinical narrative: ANXIETY/NERVOUSNESS; DIFFICULTY SLEEPING; BODY ACHING. IT IS IMPROVING TODAY WHICH IS ABOUT 48 HOURS AFTER VACCINE WAS GIVEN.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, a little swollen at site of injection.
Age: 32.0
Sex: F
Vaccine: FLU3, HEP, HEPA, PPV, TDAP
Symptoms: Dizziness, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Around 4:00 PM on 8/18/2016 patient reported getting a very high temperature and her arm was extremely sore. On 8/19/16, patient reported that she was dizzy, had nausea with vomiting, continued high temperature, and a sore arm to the point she considered not reporting to work.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Within minutes of receiving an AFLURIA trivalent flu shot, patient describes a metallic taste in her mouth after receiving AFLURIA flu shot.
Age: 21.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood thyroid stimulating hormone normal, Dizziness, Electrocardiogram normal, Fatigue, Full blood count normal
Clinical narrative: Nausea followed by syncope and 2 minutes of unconsciousness before leaving the office; followed by persistent nausea, dizziness and fatigue, which resulted in her staying in the exam room for 1 hr. She had recurrent symptoms 8/16 PM, and 8/17 AM, resulting in eval at the ER.  In ER, she was noted to be hypotensive during the episode, with BP in the 70s/40s.
Age: 21.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hypotension, Loss of consciousness, Metabolic function test normal, Nausea, Syncope
Clinical narrative: Nausea followed by syncope and 2 minutes of unconsciousness before leaving the office; followed by persistent nausea, dizziness and fatigue, which resulted in her staying in the exam room for 1 hr. She had recurrent symptoms 8/16 PM, and 8/17 AM, resulting in eval at the ER.  In ER, she was noted to be hypotensive during the episode, with BP in the 70s/40s.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Decreased appetite, Dizziness, Headache, Hypoaesthesia, Pyrexia
Clinical narrative: Dizziness, Headache and decreased appetite, low grade fever-99.0 and a "little" bit of numbness in her fingers. Denies swelling or redness at site of injection or changes in behavior and no other s/s of serious reaction. I advised to take pt to ER for evaluation d/t to mom is concerned.
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Angioedema, Erythema, Local reaction
Clinical narrative: Giant hive red circular about 1-1 1/2 inch in diameter on the arm. Dr said it was a severe localized reaction but swears he is not allergic.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Lip swelling, Urticaria
Clinical narrative: Hives, swelling of the lips.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Headache, nausea, low grade fever.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood test normal, Dizziness, Loss of consciousness
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of passed out in a female patient who received MENVEO. Co-suspect products included TRUMENBA. In June 2016, the patient received the 1st dose of MENVEO (intramuscular) and the 1st dose of TRUMENBA (intramuscular). In June 2016, several hours after receiving MENVEO, the patient experienced passed out (serious criteria GSK medically significant) and dizziness. In June 2016, the outcome of the passed out and dizziness were recovered/resolved. It was unknown if the reporter considered the passed out and dizziness to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a Pfizer Territory Manager and was not provided product information by the reporter. The patient's medical history was unknown. Concomitant medication were unknown by the reporter. On 17th June 2016, the non-GlaxoSmithKline sales representative stated that he was on luncheon at a pediatric office and a nurse and a physician shared adverse events for 4 separate patients who received MENVEO and standard 1st dose of TRUMENBA (non-GSK vaccine). They stated that at least 3 patients also received MENVEO on the same day. The reporting sales representative had limited information regarding patient's details (initials, date of birth, age, height, weight and ethnicity was unknown) and adverse events. In June 2016, few hours after vaccination with MENVEO and TRUMENBA on the same day, the patient experienced dizziness, lightheadedness and passed out. The patient went to the emergency department. The date of visit to emergency department and the duration of the visit was unknown. In June 2016, the patient underwent blood test and the blood work was fine. Other investigation was unknown. The reporting sales representative did not have reporting nurse's last name. The reporter email and prescribing email was unknown. The National Drug Code (NDC), lot number and expiration date was unknown for both TRUMENBA and MENVEO. The nurse did not have time to provide that product information at the time of reporting. The patient had not received another vaccine due to the 2nd dose was not due at the time of reporting. This case was not associated with product complaint and there was no medical information request. This case has been linked to cases US2016GSK116036, US2016GSK116035 and US2016GSK116038, reported by the same reporter.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood test normal, Dizziness, Loss of consciousness
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of passed out in a female patient who received MENVEO. Co-suspect products included TRUMENBA. In June 2016, the patient received the 1st dose of MENVEO (intramuscular) and the 1st dose of TRUMENBA (intramuscular). In June 2016, several hours after receiving MENVEO, the patient experienced passed out (serious criteria GSK medically significant) and dizziness. In June 2016, the outcome of the passed out and dizziness were recovered/resolved. It was unknown if the reporter considered the passed out and dizziness to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a Pfizer Territory Manager and was not provided product information by the reporter. The patient's medical history was unknown. Concomitant medication were unknown by the reporter. On 17th June 2016, the non-GlaxoSmithKline sales representative stated that he was on luncheon at a pediatric office and a nurse and a physician shared adverse events for 4 separate patients who received MENVEO and standard 1st dose of TRUMENBA (non-GSK vaccine). They stated that at least 3 patients also received MENVEO on the same day. The reporting sales representative had limited information regarding patient's details (initials, date of birth, age, height, weight, and ethnicity was unknown) and adverse events. In June 2016, few hours after vaccination with MENVEO and TRUMENBA on the same day, the patient experienced dizziness, lightheadedness and passed out. The patient went to the emergency department. The date of visit to emergency department and the duration of the visit was unknown. In June 2016, the patient underwent blood test and the blood work was fine. Other investigation was unknown. The reporting sales representative did not have reporting nurse's last name. The reporter email and prescribing email was unknown. The National Drug Code (NDC), lot number and expiration date was unknown for both TRUMENBA and MENVEO. The nurse did not have time to provide that product information at the time of reporting. The patient had not received another vaccine due to the 2nd dose was not due at the time of reporting. This case was not associated with product complaint and there was no medical information request. This case has been linked to cases US2016GSK116036, US2016GSK116037 and US2016GSK116038, reported by the same reporter.