chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a healthcare professional via Pfizer (under the Mnufacturer report number: 2016295524) on 16 Jun 2016. This case involves a patient (age and gender not reported) who was vaccinated with Tetanus (lot number, expiry date, dose, dose series detail, route and site of administration were not reported) on an unknown date. The medical history and concomitant medications were not reported. It was reported that on an unknown date (unspecified timeframe after vaccination), the patient experienced allergy to the vaccine. The lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine, Anaphylactic reaction, Similar reaction on previous exposure to drug
Clinical narrative: This case is linked with 2016SA111915 (same patient). Initial unsolicited report received from a consumer (extracted from the medical records) on 30-JUN-2016. This case involves a 35-year-old female patient who was vaccinated with a dose of FLU SHOT (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient had a medical history of allergy to flu vaccine, tuberculin/ppd vaccine, bactrim vaccine, Buspar vaccine, Reglan vaccine and pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccination with in four weeks prior to date of vaccination were reported as unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had similar reaction after flu shot and allergy to flu vaccine. It was reported that the patient required ER visit. Lab data and corrective treatment were not reported. The outcome of the event was not reported. Upon medical review, the case was considered as serious due to important medical event: Anaphylactic reaction (similar reaction after flu shot). List of documents held by sender: none. Sender's Comments: The case is very poorly documented. The patient had a significant allergic history to Bactrim (critical), Buspar (Moderate), Reglan (Moderate) and Tuberculin/PPD (critical). Further information on the symptoms the patient experienced after the flu shot, vaccination details, time to onset, data confirming the diagnosis, allergy testing to identify the culprit allergen, etc. will be needed for complete assessment of this case. Based on the information available, a role of the vaccine cannot be ruled out.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: Pain in left arm even now after 8 months muscle pain trouble turning head left to right - pain behind left ear goes up it muscle between shoulder and neck.  I have about 3 months of daily papers. As of 5-29-16 got worse. I have 3 months of records daily and weekly if needed.
Age: 14.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, TD, VARCEL
Symptoms: Fall, Head injury, Nausea
Clinical narrative: On 5 July 2016, at approximately 2:10 pm, and several minutes after the patient received her last vaccination (a HPV9 vaccination) she leaned forward in her chair, fell out of the chair, and bumped her head on the floor. Patient was laid flat on the floor. Patient felt nauseous and sat up to try and vomit, but was unsuccessful. Patient was laid back down on mat with her legs elevated. A call was placed to 911 at approximately 2:20. Patient recovered and was evaluated by the paramedics. As a precautionary follow-up the patient was transported to hospital.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dizziness, Dysgeusia
Clinical narrative: Pt felt dizzy like she might faint had chest pain and funny taste in mouth. Pt rested in waiting area checked BP -140/80. Pt felt a little better after 15 min. Checked back with pt at 7:30 she was feeling better.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of injection site.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: 7-12 Received vaccine. 7-13 - 7-15 c/o nausea vomiting once a day, stomach pain with h/a's no dizziness or fever present.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Peripheral swelling
Clinical narrative: Left arm swelling, pain at injection site. Difficulty lifting up arm. Redness over upper arm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left arm hot, firm, swollen, itchy from shoulder to elbow.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Tdap injection 7/8/16. Pt noted redness on left arm at bedtime on 7/14/16. Temp. 97.9 today in office. Redness is 14 cm down arm and 12 cm across. Pt does not c/o pain at site. Arm is warm to touch.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Muscle spasms, Sleep disorder, Tremor
Clinical narrative: Mother states that patient had uncontrollable muscle spasms, constant tremoring and that when the patient is trying to sleep she is woken up by the muscle spasms.  Mother reports that patient was taken to her primary care doctor and was given an IM dose of steroids to help alleviate symptoms.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Muscle twitching
Clinical narrative: Mother states that patient had uncontrollable muscle spasms, constant tremoring and that when the patient is trying to sleep she is woken up by the muscle spasms.  Mother reports that patient was taken to her primary care doctor and was given an IM dose of steroids to help alleviate symptoms.
Age: 16.0
Sex: M
Vaccine: HEP, HPV4, MNQ
Symptoms: Product reconstitution issue
Clinical narrative: Meningococcal vaccine was reconstituted incorrectly. It will be repeated.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Nodule, Rash
Clinical narrative: Patient developed w/I 24 hours a rash accompanied w/ a large localized nodule. The patient describes the nodule as softball size and bruised.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Varicella
Clinical narrative: Pt report "bumps" she believes are chicken pox that itch developing.  A few on each arm, a few on back and stomach.
Age: 25.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Injection site rash, Lethargy, Nausea, Pyrexia
Clinical narrative: PT presented on 7/15/16 with fever, lethargy, nausea, and rash at injections site.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Mom noticed rash on right lower extremity red pimple like then traveled up to arm and chest and then became faint and almost resolved.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Supraclavicular lymphadenopathy.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Blood glucose decreased, Dyskinesia, Fatigue, Seizure, Similar reaction on previous exposure to drug
Clinical narrative: Seemed tired on the morning of 7/8.  Parents check blood sugar and was 38.  Started having whole body jerks, questionable seizure activity.  Had similar reaction 2 weeks after receiving previous MMR vaccine.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Eye movement disorder, Feeling abnormal, Headache, Lethargy, Muscle contractions involuntary
Clinical narrative: AFTER HPV SHOT WAS ADMINISTERED TO HIS RIGHT ARM, MY SON'S EYES SHIFTED TO THE RIGHT AND FROZE, THEN HIS ARMS WENT STIFF, BENT INTO HIS CHEST, WITH HIS FISTS CLOSED. HIS HEAD TILTED TO THE RIGHT. HE GOT HIGHLY VISIBLE GOOSE BUMPS ALL OVER HIS ARMS AND LEGS.  HE WAS UNRESPONSIVE TO VOICE PROMPTS.  HIS EYES REMAINED OPEN.  HE SHOOK A LITTLE. THE NURSE LAID HIM BACK ON THE BED. WE TRIED TO TALK TO HIM, BUT HE WAS STILL UNRESPONSIVE.  WITHIN A FEW MINUTES, HE IMMEDIATELY CAME TO AND STARTED TO SIT UP FRANTICALLY, NOT KNOWING WHAT JUST HAPPENED.  THE NURSE ASKED HIM SOME QUESTIONS, TO WHICH HE ANSWERED ONE INCORRECTLY, SHE HAD HIM LAY BACK DOWN AND WE EXPLAINED WHAT HAPPENED TO HIM.  THEN HE SAID HE DIDN'T FEEL VERY GOOD AND SHE PUT AN ALCOHOL PAD NEAR HIS NOSE TO HELP WITH HIS NAUSEOUSNESS.  THEN BEFORE HE COULD SIT UP QUICK ENOUGH, HE VOMITED ALL OVER HIMSELF.  WHEN HE GOT COMPLETELY UPRIGHT, THE NURSE GAVE HIM A TRASH CAN AND HE VOMITED SOME MORE IN IT.  AFTER SITTING AND LAYING AND DRINKING SIPS OF WATER, ALONG WITH COLD WET TOWELS ON HIS FOREHEAD AND NECK... SHE ASKED HIM TO STAND AND SIT IN THE CHAIR DIRECTLY ACROSS FROM BED.  HE DID SO VERY SLOWLY.  AFTER SITTING FOR A FEW MINUTES, HE VOMITED AGAIN IN THE TRASH CAN ABOUT 3 OR 4 TIMES.  PRIOR TO THIS VISIT, HE HAD NOT BEEN SICK... AND HASN'T BEEN SICK WITH ANYTHING SINCE THE WINTER TIME AND THAT WAS JUST A MILD COLD.  HE DID HAVE A SMALL BOWL OF FROOT LOOPS ABOUT AN HOUR AND A HALF PRIOR TO THIS VISIT. ONCE HOME, WALKING VERY SLOWLY TO GET INSIDE... WE CLEANED HIM UP AND HE IMMEDIATELY LAID ON THE COUCH AND FELL ASLEEP.  HE HAS NO TEMPERATURE, BUT IS EXTREMELY LETHARGIC.  HE COMPLAINED OF SLIGHT HEADACHE AND NAUSEA. IT IS NOW ALMOST 4:00 PM ON 7/15/2016.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Musculoskeletal stiffness, Nausea, Piloerection, Posture abnormal, Somnolence
Clinical narrative: AFTER HPV SHOT WAS ADMINISTERED TO HIS RIGHT ARM, MY SON'S EYES SHIFTED TO THE RIGHT AND FROZE, THEN HIS ARMS WENT STIFF, BENT INTO HIS CHEST, WITH HIS FISTS CLOSED. HIS HEAD TILTED TO THE RIGHT. HE GOT HIGHLY VISIBLE GOOSE BUMPS ALL OVER HIS ARMS AND LEGS.  HE WAS UNRESPONSIVE TO VOICE PROMPTS.  HIS EYES REMAINED OPEN.  HE SHOOK A LITTLE. THE NURSE LAID HIM BACK ON THE BED. WE TRIED TO TALK TO HIM, BUT HE WAS STILL UNRESPONSIVE.  WITHIN A FEW MINUTES, HE IMMEDIATELY CAME TO AND STARTED TO SIT UP FRANTICALLY, NOT KNOWING WHAT JUST HAPPENED.  THE NURSE ASKED HIM SOME QUESTIONS, TO WHICH HE ANSWERED ONE INCORRECTLY, SHE HAD HIM LAY BACK DOWN AND WE EXPLAINED WHAT HAPPENED TO HIM.  THEN HE SAID HE DIDN'T FEEL VERY GOOD AND SHE PUT AN ALCOHOL PAD NEAR HIS NOSE TO HELP WITH HIS NAUSEOUSNESS.  THEN BEFORE HE COULD SIT UP QUICK ENOUGH, HE VOMITED ALL OVER HIMSELF.  WHEN HE GOT COMPLETELY UPRIGHT, THE NURSE GAVE HIM A TRASH CAN AND HE VOMITED SOME MORE IN IT.  AFTER SITTING AND LAYING AND DRINKING SIPS OF WATER, ALONG WITH COLD WET TOWELS ON HIS FOREHEAD AND NECK... SHE ASKED HIM TO STAND AND SIT IN THE CHAIR DIRECTLY ACROSS FROM BED.  HE DID SO VERY SLOWLY.  AFTER SITTING FOR A FEW MINUTES, HE VOMITED AGAIN IN THE TRASH CAN ABOUT 3 OR 4 TIMES.  PRIOR TO THIS VISIT, HE HAD NOT BEEN SICK... AND HASN'T BEEN SICK WITH ANYTHING SINCE THE WINTER TIME AND THAT WAS JUST A MILD COLD.  HE DID HAVE A SMALL BOWL OF FROOT LOOPS ABOUT AN HOUR AND A HALF PRIOR TO THIS VISIT. ONCE HOME, WALKING VERY SLOWLY TO GET INSIDE... WE CLEANED HIM UP AND HE IMMEDIATELY LAID ON THE COUCH AND FELL ASLEEP.  HE HAS NO TEMPERATURE, BUT IS EXTREMELY LETHARGIC.  HE COMPLAINED OF SLIGHT HEADACHE AND NAUSEA. IT IS NOW ALMOST 4:00 PM ON 7/15/2016.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Staring, Tremor, Unresponsive to stimuli, Vomiting
Clinical narrative: AFTER HPV SHOT WAS ADMINISTERED TO HIS RIGHT ARM, MY SON'S EYES SHIFTED TO THE RIGHT AND FROZE, THEN HIS ARMS WENT STIFF, BENT INTO HIS CHEST, WITH HIS FISTS CLOSED. HIS HEAD TILTED TO THE RIGHT. HE GOT HIGHLY VISIBLE GOOSE BUMPS ALL OVER HIS ARMS AND LEGS.  HE WAS UNRESPONSIVE TO VOICE PROMPTS.  HIS EYES REMAINED OPEN.  HE SHOOK A LITTLE. THE NURSE LAID HIM BACK ON THE BED. WE TRIED TO TALK TO HIM, BUT HE WAS STILL UNRESPONSIVE.  WITHIN A FEW MINUTES, HE IMMEDIATELY CAME TO AND STARTED TO SIT UP FRANTICALLY, NOT KNOWING WHAT JUST HAPPENED.  THE NURSE ASKED HIM SOME QUESTIONS, TO WHICH HE ANSWERED ONE INCORRECTLY, SHE HAD HIM LAY BACK DOWN AND WE EXPLAINED WHAT HAPPENED TO HIM.  THEN HE SAID HE DIDN'T FEEL VERY GOOD AND SHE PUT AN ALCOHOL PAD NEAR HIS NOSE TO HELP WITH HIS NAUSEOUSNESS.  THEN BEFORE HE COULD SIT UP QUICK ENOUGH, HE VOMITED ALL OVER HIMSELF.  WHEN HE GOT COMPLETELY UPRIGHT, THE NURSE GAVE HIM A TRASH CAN AND HE VOMITED SOME MORE IN IT.  AFTER SITTING AND LAYING AND DRINKING SIPS OF WATER, ALONG WITH COLD WET TOWELS ON HIS FOREHEAD AND NECK... SHE ASKED HIM TO STAND AND SIT IN THE CHAIR DIRECTLY ACROSS FROM BED.  HE DID SO VERY SLOWLY.  AFTER SITTING FOR A FEW MINUTES, HE VOMITED AGAIN IN THE TRASH CAN ABOUT 3 OR 4 TIMES.  PRIOR TO THIS VISIT, HE HAD NOT BEEN SICK... AND HASN'T BEEN SICK WITH ANYTHING SINCE THE WINTER TIME AND THAT WAS JUST A MILD COLD.  HE DID HAVE A SMALL BOWL OF FROOT LOOPS ABOUT AN HOUR AND A HALF PRIOR TO THIS VISIT. ONCE HOME, WALKING VERY SLOWLY TO GET INSIDE... WE CLEANED HIM UP AND HE IMMEDIATELY LAID ON THE COUCH AND FELL ASLEEP.  HE HAS NO TEMPERATURE, BUT IS EXTREMELY LETHARGIC.  HE COMPLAINED OF SLIGHT HEADACHE AND NAUSEA. IT IS NOW ALMOST 4:00 PM ON 7/15/2016.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Swelling
Clinical narrative: Patient had severe muscle pain in her arm. Mentioned that she had swelling too. Went to the emergency room.Ddr prescribed pain medication.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Local reaction of redness and itching on left arm around vaccine site.
Age: 30.0
Sex: M
Vaccine: MEN
Symptoms: Erythema, Injection site erythema, Injection site swelling, Rash, Urticaria
Clinical narrative: The injection site on left arm was swollen and red; all of left arm became red, bumpy and itchy (hives); patient had to take 75 mg of Benadryl three times in order to get relief.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Blood test, Computerised tomogram head, Fall, Generalised tonic-clonic seizure, Head injury
Clinical narrative: Patient had grand mal seizure while sitting on a toilet. He fell from toilet and hit his head on floor.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling and fever at injection site/arm after second shot of series. No reaction after first part of series.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Local redness, bruising on Right upper arm, swelling on legs/feet. No fever reported, no rash, no breathing issues, painful arm, unable to lift arm since days after vaccination.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Discomfort, Pain in extremity
Clinical narrative: Patient received BOOSTRIX and ZOSTAVAX injections in her left arm  on 6/30/16. On 7/9/16 patient came into the pharmacy complaining of left arm pain. She stated that her arm felt very sore. She states she went to the doctor on Wednesday 7/6 who told her to use Ibuprofen to help with the pain. On 7/9 stated that she was still having discomfort but that the ibuprofen and heat were helping with the pain. She stated that she would call on Monday 7/11 if pain continued to persist. We have not since heard from her and have tried calling her several times a day since then with no response. So under the assumption that all is okay now.
Age: 9.0
Sex: F
Vaccine: IPV
Symptoms: Pain in extremity, Rash
Clinical narrative: Since she got the shot, got pain in the arm, and after 3 days is getting painful rash under arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site vesicles, Pyrexia
Clinical narrative: Patient called on 7/13/16 with itching and redness/tenderness at injection site.  On 7/14/16 she was at pharmacy with round, red, blistered rash at injection site area approximately 3 inches in diameter.  She stated area was sore and itchy.  She also had a low grade fever.  She had been to her doctor who had prescribed Cephalexin 500mg and Mupirocin ointment.  On 7/15/16 her doctor prescribed a Methylprednisolone 4mg dose pack.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient called on 7/13/16 with itching and redness/tenderness at injection site.  On 7/14/16 she was at pharmacy with round, red, blistered rash at injection site area approximately 3 inches in diameter.  She stated area was sore and itchy.  She also had a low grade fever.  She had been to her doctor who had prescribed Cephalexin 500mg and Mupirocin ointment.  On 7/15/16 her doctor prescribed a Methylprednisolone 4mg dose pack.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Erythema, Induration, Limb discomfort, Malaise
Clinical narrative: Received pneumococcal vaccine left deltoid AND routine allergy shot in left and right arms on 12 Jul.  Felt well until next day when developed left arm discomfort, 4th/5th left hand parasthesias, lower lip tingling, malaise, tactile temps, 6cmx4cm area of induration/pink skin color change on bicep and chest discomfort which she attributed to left arm discomfort.  No urticarial/angioedema/GI/CNS sx.  Went to work on day of sx development and completed pushups and pullups.  Took Tylenol but became concerned b/c induration appeared to be moving distally and paresthesias above and lower lip tingling were persisting.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Paraesthesia oral, Skin warm
Clinical narrative: Received pneumococcal vaccine left deltoid AND routine allergy shot in left and right arms on 12 Jul.  Felt well until next day when developed left arm discomfort, 4th/5th left hand parasthesias, lower lip tingling, malaise, tactile temps, 6cmx4cm area of induration/pink skin color change on bicep and chest discomfort which she attributed to left arm discomfort.  No urticarial/angioedema/GI/CNS sx.  Went to work on day of sx development and completed pushups and pullups.  Took Tylenol but became concerned b/c induration appeared to be moving distally and paresthesias above and lower lip tingling were persisting.
Age: 53.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red, swollen and very itchy. The swelling was about 5 inches in diameter.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Blistery rash forming on the buttocks.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Blistery rash forming on the buttocks.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dyskinesia, Fall, Injury, Loss of consciousness
Clinical narrative: Patient passed out while sitting on medical bed and fell off causing injuries. Patient's head was jerking while she was unconscious. Nurse walked away turning her back from her not monitoring her after vaccination.
Age: 67.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Injection site erythema, Pyrexia
Clinical narrative: Resolved by 11/5/10. Headache, fever and 3cm red circle at injection site.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Dizziness, Electrocardiogram normal, Immediate post-injection reaction, Pregnancy test negative, Presyncope
Clinical narrative: Pt received the 3 vaccines listed below. She immediately became dizzy. She laid in supine position for 30 minutes and drank fluids. She felt better so left office in stable condition. As she was leaving the building she became syncopal and was seen in ER.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Urine analysis normal
Clinical narrative: Pt received the 3 vaccines listed below. She immediately became dizzy. She laid in supine position for 30 minutes and drank fluids. She felt better so left office in stable condition. As she was leaving the building she became syncopal and was seen in ER.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Nasal congestion
Clinical narrative: Shortness of breath/nasal congestion. Albuterol 90MCG puff(s) QID, Prednisone 40 MG every day.
Age: 68.0
Sex: M
Vaccine: VARCEL
Symptoms: Dizziness, Tachycardia
Clinical narrative: Patient monitored for 30 minutes until complaints subsided. Patient left facility in stable condition and stated his heart was not pounding and was not dizzy and I feel fine. Dizziness and Tachycardia
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Tenderness
Clinical narrative: Tdap vaccine was administered on 7/13/16. Provider reports localized swelling and tenderness. No abscess, fluctuance or redness. TYLENOL/ibuprofen. Cold compress to area.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: Right after vaccine pt. failed. O2 99% BP: 94/52, light headed for 20 min. Pt given popsicle and water. Rest in room until feeling better with mother.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess limb
Clinical narrative: Abscess of left arm c/o systemic involvement.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: After administration of vaccine patient experienced syncopy BP 98/50 waited 15 minutes rechecked BP 92/60.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, VARCEL
Symptoms: Dizziness, Hypoaesthesia oral, Lip swelling, Swollen tongue
Clinical narrative: Patient became dizzy 10-15 min after vaccine. He started to complain that his lips and tongue and felt numb and swollen. His vitals were normal. He had no swelling that was noted on exam. He received 50mg of BENADRYL. After 20 min he felt fine and was d/c' d home. He had no hives, cough or wheezing.
Age: 9.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Gait disturbance, Joint swelling, Movement disorder, Pain in extremity, Tenderness
Clinical narrative: Mom called to report reactions to vaccine which includes left leg pain, left lower thigh and knee swelling, tenderness, limping, difficulty bending and straightening knee.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Rash along upper arm around the area of the vaccine administered. No problems, just large area of raised redness.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction, Tenderness
Clinical narrative: Local reaction to vaccine BOOSTRIX. Mild erythema and tenderness.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site pruritus, Sluggishness
Clinical narrative: (R) arm near inj site is reddish (Began evening of 7/11/16). Redness is less than 1/2 the width of her upperarm. Initially it was painful but as of 7/14 is not painful. It is itchy. Felt sluggish after vaccine. Felt numbness in hand but it resolved. No tongue/throat swelling or shortness of breath. No fever or chills. Plan: ZYRTEC/ice. Follow up if sx's do not get better.
Age: 51.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site erythema, Injection site pain, Product preparation error
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received BOOSTRIX (batch number 7RJ9B, expiry date 18th November 2018). Co-suspect products included VAQTA (batch number L009445, expiry date 1st June 2017). Concomitant products included VIVOTIF. On 24th June 2016, the patient received BOOSTRIX (intramuscular) .5 ml and VAQTA (intramuscular) at an unknown dose and frequency. On an unknown date, less than a month after receiving BOOSTRIX, the patient experienced injection site pain (serious criteria other: As per reporter), injection site erythema (serious criteria other: As per reporter) and inappropriate reconstitution technique. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved and the outcome and the outcome of the inappropriate reconstitution technique was unknown. It was unknown if the reporter considered the injection site pain and injection site pain and injection site erythema to be related to BOOSTRIX. Additional information was provided as follows: On 24th June 2016, at 11:45, the patient received BOOSTRIX and 2 doses of pediatric VAQTA, in the same arm (right deltoid). The patient was at the healthcare professional's office for the pain, at the time of reporting. Inappropriate reconstitution technique was reported as an event, however, no details were reported if it was related to BOOSTRIX or VAQTA. The batch number reported for BOOSTRIX (7RJ98) did not exist and was updated to 7RJ9B as per the sales database.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injections site pain in an unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patients experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. The reporter considered the injection site pain to be related to BEXSERO. Additional details were provide as follows: The sales representative stated that the nurse indicated that she had already reported this to the VAERS. The patient's age at vaccination was not reported. The reporter stated that, they had several incidences where the patients have experienced severe pain to touch at the site of injection after receiving BEXSERO. No swelling or redness was reported. The sales representative was not sure of the spelling for the last name of the reporter. She did provide the email but did note that she had trouble reading it from her laptop.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 08-DEC-2015, the patient was vaccinated with a dose of GARDASIL, intramuscular injection, (Lot # K010215 with an expiration date of 05-MAY-2017), (strength and dose were not provided). On 08-FEB-2016, the patient was vaccinated with a dose of GARDASIL, intramuscular injection, (Lot #, expiration date, strength and dose were not provided). The reporter stated that the patient received GARDASIL 9 (Lot # L001312 with an expiration date of 24-FEB-2017) inadvertently on 15-MAR-2016. No side effect were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: This spontaneous report was received from a consumer referring to a female patient of unknown age, who was her mother in law. The patient's pertinent medical history, allergies and concurrent conditions were not reported. Approximately, in September 2014 (also reported as "in fall 2014"), the patient was vaccinated with ZOSTAVAX (anatomical route of vaccination, dose number, lot number and expiration date were not provided). The patient's concomitant medications were not reported. On an unknown date, the patient presented with pain followed by a rash days later. Subsequently, on 11-JUN-2016, the patient was diagnosed with shingles. The patient started treatment with antiviral on an unspecified date. Moreover, she was prescribed with CAPZASIN (also reported as capsasin) cream and lidocaine patches for the pain. The reported stated, that the patient's pain persisted and due to it on 11-JUL-2016, she was placed on therapy with NEURONTIN. At the time of this report, the outcome of herpes zoster was reported as not recovered and the outcome of vaccination failure was unknown. Additionally, the reporter did not provide for a causality between the adverse events and vaccination with ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This solicited report as received from the patient's mother, as part of a marketing research program conducted by C Space, refers to a male patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL. Dose, route, lot number and expiration date were not provided. No other suspect or concomitant therapies were reported. On an unknown date at the Doctor's office, the patient's mother stated "My son said the shot was painful" (injection site pain). The outcome of the event was unknown. The causality between the event and the therapy with GARDASIL was unknown. Additional information is not expected because there is no consent to contact the Physician.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a consumer, refers to the daughter of her sister's friend who was a currently grown adult female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (strength, dose, route of administration, lot number and expiration date were unknown). There were no concomitant therapies reported. The patient had an outbreak of varicella after receiving the vaccine years ago, on an unknown date. The patient also reported that, on unspecified dates, she had had "shingles" numerous times in the years after receiving it. The outcome of varicella and shingles was unknown. The causality between VARIVAX and varicella and shingles was not provided. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This spontaneous report was received from a nurse referring to a 18 year old male patient. There was none drug reactions/allergies or medical history. On 12-JUL-2016, the patient was vaccinated with a dose of GARDASIL 9, intramuscularly (dose, lot Number and expiration date were not provided). Concomitant therapy included TRUMENBA. The nurse reported that on 12-JUL-2016, after received GARDASIL 9, the patient experienced a syncope reported as the patient "started to pass out" but he did not lose consciousness. The patient rested and "revived".  Approximately in July 2016, the patient recovered from syncope. There was none lab diagnostic studies performed and the patient did not seek medical attention due to the event. The nurse did not assess the causality between the syncope and GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 24-JUN-2016, the patient was vaccinated with an unspecified dose of GARDASIL 9 (lot # expiration date and dose were not reported) which had been improperly stored during 24 hours at 9.50 degrees C and 144 hours stored at temperatures between 8.01 degrees C to 8.11 degrees C. Concomitant medications were not reported. There was not previous temperature excursion and the call was made because of a data logger. No adverse effects were reported and there was no PQC involved. This is one of several cases from the same source (MARRS # 1607USA004298 and 1607USA006955). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX lot# L025205 with expiration date: 07-JUL-2017 (dose and route of administration were not reported) or lot# M002062 with expiration date: 12-JAN-2018 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date (also reported as some doses were administered on 30-JUN-2016 and some doses were administered on unspecified dates), the unspecified patients were vaccinated with unspecified doses of MMR II (lot number L049314, expiration date: 03-DEc-2017; lot number L041455, expiration date: 22-OCT-2017; lot number L026551, expiration date: 16-JUL-2017; lot number L032044, expiration date: 24-AUG-2017) (dose, route and anatomical location of administration were not reported), which were improperly stored. Temperature excursions reported maximum temperature 51.3 F for 84 hours and minimum temperature 27.7 F for 314 hours. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies  were not provided. On 08-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553, expiration date: 16-JUL-2017, (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot#L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This solicited report has been received from an unspecified reporter. This report refers to a 11 year old female patient, enrolled in a market research. No information on patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (strength, dose, indication, lot# and expiration date were not reported). On an unknown day in May 2016, the patient experienced injection site pain. It was reported that the patient received multiple unspecified vaccines that day. The outcome of the event was reported as recovered 3 days after injection. The action taken with GARDASIL was reported as none. The reporter considered injection site pain to be related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an adult patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown dates, the patient was inadvertently vaccinated with two pediatric doses of RECOMBIVAX HB injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. 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 nurse concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, also reported as on 21-SEP-2016, the patient was vaccinated with an unspecified dose of VARIVAX (Lot # K016132, expiration date 21-SEP-2016) (dose was not provided) which had been improperly stored. Concomitant medications were not reported. No adverse effects were reported and there was no PQC involved. This is one of several cases from the same source (MARRS # 1607USA006955 and 1607USA006956). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-JUL-2016, the patient received the second dose of GARDASIL (lot# reported as M005714, expiration date: 03-OCT-2017, dose, route of administration and injection site were not provided) one week earlier. No adverse reactions were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 14-JUN-2016, the patient was vaccinated with an unspecified dose of GARDASIL 9 (Lot # expiration date and dose were not reported) which had been improperly stored during 24 hours at 9.50 C and 144 hours stored at temperatures between 8.01 C to 8.11 C. Concomitant medications were not reported. There was no previous temperature excursion and the call was made because of a data logger. No adverse effects were reported and there was no PQC involved. This is one of several cases from the same source (MARRS # 1607USA004298 and 1607USA006956). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to 9 adult patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were inadvertently vaccinated with pediatric doses of RECOMBIVAX HB injection (dose, route of administration, lot# and expiry date were not reported). The medical assistant stated that the patients completed RECOMBIVAX HV series with three does of pediatric formulation (dates unspecified). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint involved. This is one of two reports received from the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site reaction, Pain in extremity, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. The patient's medical history was not reported. There were not known drug reactions or allergies. On 11-JUL-2016, the patient was vaccinated with ZOSTAVAX, subcutaneous, (strength, dosage, frequency, lot# and expiration date were not reported). There were not concomitant therapies. On 11-JUL-2016, the patient experienced headache, dizziness, large welts around the arm injection site, and stated that her arm felt hot, itchy and achy. The pharmacist also stated that the patient used topical hydrocortisone cream and BENADRYL to treat the symptoms, which did not resolve the symptoms. Therefore, she sought medical attention from her primary care physician, who prescribed prednisone oral tablets. There were not laboratories diagnostics performed. The outcome of dizziness, pruritus, pain in extremity, feeling hot, injection site urticaria and headache was unknown at the time of this report. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. The patient's medical history was not reported. There were not known drug reactions or allergies. On 11-JUL-2016, the patient was vaccinated with ZOSTAVAX, subcutaneous, (strength, dosage, frequency, lot# and expiration date were not reported). There were not concomitant therapies. On 11-JUL-2016, the patient experienced headache, dizziness, large welts around the arm injection site, and stated that her arm felt hot, itchy and achy. The pharmacist also stated that the patient used topical hydrocortisone cream and BENADRYL to treat the symptoms, which did not resolve the symptoms. Therefore, she sought medical attention from her primary care physician, who prescribed prednisone oral tablets. There were not laboratories diagnostics performed. The outcome of dizziness, pruritus, pain in extremity, feeling hot, injection site urticaria and headache was unknown at the time of this report. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 18-MAY-2016, the patient was vaccinated with improperly stored dose of MMR II 0.5 ml injection, lot# L027432, expiration date 22-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 13-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L027432, expiration date: 22-JUL-2017, (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 1.0 ml injection, lot#L027432, expiration date 22-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 07-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553, expiration date: 16-JUL-2017, (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 31-MAR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553, expiration date: 16-JUL-2017, (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD which had lot  L045678 and expiration date of 09-MAY-2017 (dose, dosage number and route of administration were not provided). Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursion on an unspecified date: 5.4 F for 16 hours. Reportedly, there had been previous temperature excursion and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 10-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L027432, expiration date: 22-JUL-2017, (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.