chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Gastrointestinal disorder, Nausea
Clinical narrative: Initial unsolicited case received from a physician on 11 Oct 2017. This case involves a male patient (age not reported) who was vaccinated with 0.5 ml single dose of FLUZONE QUADRIVALENT (Batch number, expiry date, dose in series and site of administration was not reported) via intramuscularly on an unspecified date (reported as several years ago) for immunization. Patient's medical history and concomitant medications were not reported. On an unknown date, post vaccination, patient had gastrointestinal symptoms such as nausea and diarrhea. Lab tests and corrective treatment was not reported. On an unknown date, Patient was recovered from all events. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from consumer on 07-NOV-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number: J97D2, expiration date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, post vaccination, patient had an allergic reaction. Lab data and corrective treatment was not reported. Outcome of the event was not reported. Upon internal reveiw, the company decided to consider the case as serious due to IMPORTANT MEDICAL EVENT : Allergic reaction. List of documents held by sender: none.; Sender's Comments: This is a poorly documented case in which patient experienced allergic reaction after vaccination. Time to onset is not known. More details regarding patient's medical history, allergic history, previous vaccination history, history of similar episode, vaccination details, confirmed diagnosis, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Dysgeusia, Erythema, Paraesthesia
Clinical narrative: Employee states that 20 mins after receiving vaccine he noticed a metallic taste. As well his face turned red. He stated he had a tingling sensation that started on his face and descended down his body to his knees, then ascended back to his face. Employee states he took BENADRYL.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) arm erythema, swelling-mid shoulder to elbow. Non tender, no LAD. No fever.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Chest discomfort, Hypotension, Pain in extremity, Skin test positive
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of anaphylaxis in a adult female patient who received FLULAVAL QUADRIVALENT (batch number 222FX, expiry date 30th April 2018). On 4th October 2017, the patient received FLULAVAL QUADRIVALENT. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT, the patient experienced anaphylaxis (serious criteria GSK medically significant), chest tightness, pain in arm and hypotension. The patient was treated with EPIPEN, BENADRYL and oxygen. On an unknown date, the outcome of the anaphylaxis, chest tightness, pain in arm and hypotension were unknown. It was unknown if the reporter considered the anaphylaxis, chest tightness, pain in arm and hypotension to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The reporter stated that patient received the FLULAVAL QUADRIVALENT in left arm and experienced pain same arm. The patient went to the emergency room and was given EPIPEN, oxygen and BENADRYL. Then the patient recovered 2 to 3 hours after the treatment given. On 14th November 2017, the patient underwent a skin test and experienced anaphylaxis again. The reporter would like to know if we have literature on this topic. No additional information was provided.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had severe pain, swelling and redness at the injection site. Patient sought care from physician and was diagnosed with infection.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination complication
Clinical narrative: Received flu vaccine on 11/20/2017. On 11/21/17 developed area of redness at injection site. Redness significantly spread on 11/22/17. Seen in office on 11/22/17. Diagnosed with vaccine reacton. No evidence of fever or cellulitis.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Paraesthesia
Clinical narrative: Following injection, patient started feeling a "shock" down her arm she continued to have pain at the injection site and applied ice. Upon waking the next morning, the patient reports continued pain and a "red area" around her left upper arm. Denies urticaria. Presented to office today noting improvement.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient came in to show the injection site which was circular, large in diameter beyond site and hot to the touch. Very little swelling. Asked her to use ice, Ibuprofen, BENADRYL and hydrocortisone cream. Asked her to return if symptoms persist. Contacted pt but no response.
Age: 31.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Dizziness, Nausea, Seizure, Syncope
Clinical narrative: Patient received - BOOSTRIX and TYPHIM in left arm then HAVRIX in right arm. Pt. fainted, then convulsed. 911 was called, by the time 911 was on line patient had stopped convulsing and woken up. He was dizzy and nauseated. After 30 mins. patient felt fine. Refused paramedic help and walked out of pharmacy.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoglycaemia, Syncope
Clinical narrative: Patient fainted after FLUVIRIN (R) was administered, most likely due to low sugars (hypoglycemia) since patient only one egg to eat all day (and shot was administered at 2:30 PM). Observed pt, gave fluids and took BP reading 3 separate times w/n a hour period.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hot flush, Paraesthesia oral, Tremor
Clinical narrative: Has never had reaction to flu-injection 5 min. after mouth tingling -10 min. later shaky hot flash faint and flushing -BP 138/82 P88 O2 100%. Repts carry her own BENADRYL 25 mg as she often gets like this with different medications. Took 25mg ate lunch wanted 25mg more of BENADRYL -2 hrs later drove herself home. Called nursing supervisor feeling good.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Vaccination complication
Clinical narrative: Patient came into Pharmacy the day after receiving the Flu and pneumovax vaccine with her left arm extremely red, puffy and hot to the touch. I told her to take some ADVIL and ice it. I wasn't sure if it was cellulitis so I told her to follow up with her primary. She did. MD stated no cellulitis just a reaction to vaccine.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local Rxn began within 2 hrs of vaccination has occurred in prior years. 6 cm swelling (L) deltoid, pain. Tx PEPCID, BENADRYL, CLARITIN, MEDROL, ice.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever of 101, pain, redness and swelling of left shoulder and arm.
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Gait inability, Nausea, Presyncope
Clinical narrative: Approximately 20-25 minutes after injection, very delayed vasovagal response. Awoke immediately after response. Approximately 15 minutes after response, very nauseated. Unable to ambulate - very weak.
Age: 20.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt. came in for a TB skin test read and was complaining of itching and redness to the area. Pt. had itching, redness with a measurement of 50 x 35 and warmth to Varicella injection site. Pt. also received Hep A and Meningo on the same day. WHNP-BC looked at site and recommended BENADRYL and Hydrocortisone.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Cough, Eye oedema, Face oedema, Oedema mouth, Pharyngeal oedema
Clinical narrative: Child's reaction included fever of 100F and approximately 15 hours after receiving his vaccines he suddenly began to have edema of the face, throat, eyes, mouth and dry cough. He was taken to urgent care and treated with oral steroids and Benadryl.  They think it is related to the vaccines. He responded well to the treatment and is doing ok as of today.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Child's reaction included fever of 100F and approximately 15 hours after receiving his vaccines he suddenly began to have edema of the face, throat, eyes, mouth and dry cough. He was taken to urgent care and treated with oral steroids and Benadryl.  They think it is related to the vaccines. He responded well to the treatment and is doing ok as of today.
Age: 25.0
Sex: M
Vaccine: HEPAB
Symptoms: Swollen tongue
Clinical narrative: PATIENT CALLED ABOUT 1 HOUR AND 15 MINUTES AFTER RECEIVING TWINRIX AND SAID HE THINKS THE ROOF OF HIS TONGUE IS SWOLLEN. ADVISED HIM TO TAKE 50MG BENADRYL AND HAVE SOMEONE DRIVE HIM TO THE ER. PATIENT CAME IN THE NEXT DAY TO SAY THAT HE FEELS BETTER AND DOES NOT NEED THE PREDNISONE THAT AN ER DR CALLED IN LAST NIGHT. HE STATED THAT HE RECEIVED BENADRYL, PREDINSONE AND PEPCID AT THE ER AND WAS KEPT FOR A COUPLE OF HOURS AND GOT DISCHARGED.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: Patient was given an extra Hep. B.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash, Swelling, Vaccination site pain
Clinical narrative: Large raised rash developed on arm. Area of redness and swelling (accompanied by itching) developed same day of vaccination and increased to approximately 4 inches in diameter by next day. Vaccination area continues to be painful with raised rash for approximately a week, when the rash/raised area began to subside. Itching symptom subsided in approximately 1 1/2 weeks and temporarily relieved when BENADRYL was taken.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site rash
Clinical narrative: Large raised rash developed on arm. Area of redness and swelling (accompanied by itching) developed same day of vaccination and increased to approximately 4 inches in diameter by next day. Vaccination area continues to be painful with raised rash for approximately a week, when the rash/raised area began to subside. Itching symptom subsided in approximately 1 1/2 weeks and temporarily relieved when BENADRYL was taken.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Patient complains of feeling pain on site of injection and on shoulder since being vaccinated on 10/23/2017. States she has difficulty raising her hand up and trouble dressing her self due to pain. NO rash or itchiness or weakness in the arms just painful. Has been referred to Orthopedic for further evaluation as patient not willing to come in to the clinic for evaluation.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and soreness to biceps muscle of right arm below the injection site. Pain began almost immediately after injection. Redness appeared 24 hours after injection.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, Mumps antibody test negative
Clinical narrative: Vaccine administered today 11/22/2017 had expiration date of 10/22/2017. County Health Department was contacted for further instructions. Per Health Department and as previously planned, patient is to have blood work/titer done in one month to check for immunity of mumps. Patient had blood work on 11/17/2017 to check for immunity. Titers indicated had immunity to rubella, rubeola, and varicella but not mumps. Telephone call to patient and made aware the vaccine administered had expired on 10/22/2017, advised that blood work would be ordered for one month to check her status of immunity to mumps. Patient agreed would have blood work done in one month.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Patient complains of site soreness which at times radiates down elbow to hand.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt. received PROQUAD and VARIVAX vaccines same day. This was realized after documentation of vaccine administration by PHN. Client was observed for 30 minutes for any adverse reactions per protocol. None noted. PHN called Merck & Co (manufacturer) to discuss potential side effects and things to look for. Injection site soreness, fever, and rash were communicated to mother as side effects to look for. Mother was notified of the incident and of side effects to look for. If any are observed, PHN let mother know to call client's primary health care provider or emergency services as warranted. PHN provided name and phone number to client's mother for follow-up.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Orthostatic hypotension, Syncope
Clinical narrative: Patient had two syncopal events the morning after vaccinations. Vaccines given 11/21/2017 around 3:00 PM and patient had syncopal events 11/22/2017 around 11:00 AM. Patient seen in office around 11:40 AM on 11/22/2017 and orthostatic blood pressures obtained. Orthostatic hypotension identified (sitting BP 106/73 to standing 83/53). Encouraged patient to increase intravascular volume by increasing fluid intake of water and GATORADE, eating salty snacks, and decreasing caffeine intake. No sudden changes in position. Will follow-up in 3-5 days.
Age: 67.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: At time presented (11/15/17) approx. 3 1/2" red, raised rash; hard and hot to the touch; very sore. Still increasing in size but slowing down. Rash covers both injection sites.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt. received FLUZONE QUAD vaccine IM 10/30/17. Mother reported pt. to be experiencing a couple of hives, which was normal for pt. Mother called back to office 11/2/17 to report increase hives, face, arms, chest, legs. Which she was treating with oral BENADRYL. Denied any other symptoms. Resolved after 5 days. F/U with mother 11/15/17, no further symptoms to report.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient states he was vomiting since getting the influenza immunization.
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable Health Care Professional reported similar events for three patients. This 1st of three reports. This Health Care Professional reported for a male patient (son). A male patient of an unspecified age, race and ethnicity received  TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient became ill and experienced pretty bad fatigue, fever and feeling crummy. Clinical outcome of the adverse events was unknown at time of this report. No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017503287 Same Reporter, Different Patient.
Sex: U
Vaccine: MENB
Symptoms: Fatigue, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable Health Care Professional (HCP). This HCP reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of an unspecified age, race/ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unknown date, at single dose, for immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient became ill and experienced pretty bad fatigue, fever and was feeling crummy. Clinical outcome of the adverse events was unknown at time of this report. No follow-up attempts possible. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017503288 Same reporter, different patient;US-PFIZER INC-2017503280 Same reporter, different patient
Sex: U
Vaccine: MENB
Symptoms: Fatigue, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable Health Care Professional reported similar events for 3 patients. This is the 3rd of 3 reports. A patient of unspecified age, gender, race and ethnicity received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient became ill and experienced pretty bad fatigue, fever and was feeling crummy. Clinical outcome of the adverse events was unknown at time of this report. No follow-up attempts possible. No further information expected. Sender's Comments: Linked Report(s): PFIZER INC-2017503287 Same reporter/product/events, different patient; PFIZER INC-2017503280 Same reporter/product/events, different patient.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abscess, Erythema, Full blood count normal, Injection site pain, Malaise
Clinical narrative: After vaccines on 11/16 pt noticed redness and swelling that evening and the following day started to have malaise and severe pain at the site of injections, went to UC and was started on doxycycline and KEFLEX, followed at the clinic the following day since appeared to start forming an abscess but redness area was slightly improved since on antibiotic. Continued with Tx and a couple of days later it has been 40% improved. Pt gets allergy injections weekly on both arms, last dose the previous Monday.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Neutrophil count increased, Swelling
Clinical narrative: After vaccines on 11/16 pt noticed redness and swelling that evening and the following day started to have malaise and severe pain at the site of injections, went to UC and was started on doxycycline and KEFLEX, followed at the clinic the following day since appeared to start forming an abscess but redness area was slightly improved since on antibiotic. Continued with Tx and a couple of days later it has been 40% improved. Pt gets allergy injections weekly on both arms, last dose the previous Monday.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Patient received a flu shot in left arm on 10/15/2017. Beginning the next day, the arm near injection site became very sore with a little numbness. The pain and lack of range of motion did not get any better. On 10/25/2017, saw doctor and was put on an 8 days course of oral prednisone. Patient felt better, but pain came back after steroid course was done.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Redness and swelling around injection site measuring 8in diameter per patient and pain.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: REDNESS, SWELLING THROUGHOUT CIRCUMFERENCE OF UPPER ARM, PT TOOK BENADRYL AND SYMPTOMS ARE STARTING TO RESOLVE, COULD STILL SEE REDNESS TODAY (2 DAYS POST-INJECTION).
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: FEVER 104.3, REDNESS, HEAT AND SWELLING 1-2 INCHES AROUND INJECTION SITE.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Blindness, Pallor, Syncope
Clinical narrative: Patient turned pale and began to faint after shot. She stated she felt weak and couldn't see. Ambulance was called and patient was feeling better once they arrived. They took BP which was 78/56 then repeated in 5 minutes 86/64. Patient refused fingerstick and refused to go to hospital.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient reported having red bumps around both arms. She applied hydrocortisone to rash. She described the rash as non-itching. I advised the patient to see physician if rash doesn't resolve within couple days and take BENADRYL. If she has trouble breathing or swallowing of lip, throat or tongue, she needs to go to ER.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Mobility decreased, Pain, Pruritus
Clinical narrative: Erythema, warmth, itching covering 80 percent of upper arm, pain, unable to lift arm fully due to discomfort.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Erythema, warmth, itching covering 80 percent of upper arm, pain, unable to lift arm fully due to discomfort.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Administration site swelling, Administration site warmth, Fatigue, Injection site erythema
Clinical narrative: Extreme fatigue for 2 days. Swelling, redness and heat in local area to administration from 11/17 and continuing through today 11/22.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Chest pain, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Immediate swelling around injection site. Soreness at site and radiating around upper arm. Overnight, rash and soreness in upper arm, armpit and onto chest. Day two, soreness migrating to shoulder (less in arm and chest). Day three soreness and stiffness to base of head, soreness in arm and chest is gone.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity, Rash
Clinical narrative: Immediate swelling around injection site. Soreness at site and radiating around upper arm. Overnight, rash and soreness in upper arm, armpit and onto chest. Day two, soreness migrating to shoulder (less in arm and chest). Day three soreness and stiffness to base of head, soreness in arm and chest is gone.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chest pain, Injection site pain
Clinical narrative: 3 days from administration of vaccination patient experienced pain from injection site that traveled through her right axilla across her chest and into her left axilla. She reports no rash or itching.
Age: 22.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: On 11/15, 5 days after patient received the vaccines she experienced excruciating pain in her left arm. She was unable to lift or turn (the motion to put on a seatbelt was very painful). She also experienced numbness in her pinky and ring finger of her left arm. Pain had not resolved on through 11/21. 11/22 patient's arm is able to lift and able to motion to put a seatbelt on.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Debilitating dizziness, some queasiness, has persisted for several hours.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Malaise, Peripheral swelling
Clinical narrative: Red swollen arm and malaise. Patient wanted both shots in one are because she had a mastectomy on the other side.
Age: 81.0
Sex: M
Vaccine: FLUA3
Symptoms: Fall
Clinical narrative: Patient left the pharmacy after immunization, shopped in the store for a little while and then fell down during a checkout process at the front register. He told cashier that he tripped over something, but cashier thinks he looked a little dizzy before it happened. Patient refused the offer to call 911.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Skin infection
Clinical narrative: Skin infection. given keflex. Too soon for outcome, rx fill ed today ( 11/22/17 ).
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling of arm with heat radiating from the site of injection, patient called doctor and  is putting ice on arm  and taking benadryl per doctor's orders.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever one day after vaccine, rash 3 days after vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Hypoaesthesia, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Patient had a knot, redness, and hot feeling at injection site. Her arm was so sore that she could not turn over in bed. She states that her fingertips are numb and the entire arm is painful.  The had a Medrol dospak prescribed on 10/27/2017 and on 11/07/2017. On 11/22/2017, she still expresses discomfort.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient had a knot, redness, and hot feeling at injection site. Her arm was so sore that she could not turn over in bed. She states that her fingertips are numb and the entire arm is painful.  The had a Medrol dospak prescribed on 10/27/2017 and on 11/07/2017. On 11/22/2017, she still expresses discomfort.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: PATIENT CAME TO THE PHARMACY ON 11/22/17 COMPLAINING THAT SHE HAS NOT BEEN ABLE TO LIFT HER LEFT ARM ABOVE SHOULDER LEVEL SINCE SHE RECEIVED HER FLU SHOT ON 10/25/17.  I ASKED IF SHE HAD SEEN ANYONE OR HER DOCTOR TO EVALUATE IT AND SHE SAID NO.  I RECOMMENDED SHE BE EVALUATED TO DETERMINE WHAT THE ISSUE IS.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Hypoaesthesia, Pain in extremity
Clinical narrative: Received flu shot without any issues at the time, experienced some expected soreness, however, it lasted more than 2 days. Upon that time, the pain was radiating down to her thumb and back and it was painful and numb for the patient. One week later, she went to the hospital.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain, Sputum discoloured
Clinical narrative: Patient called Nov 21, 2017 has had a sore throat since Nov 1, 2017, patient told to go to doctor. Nov 22 phlegm brown now clear may have bronchitis coughing. Patient went to Dr. Nov 22, 2017 given VENTOLIN inhaler and ZITHROMAX. Patient did not call back to this pharmacy patient went to another pharmacy. No other contact with patient, yet phone not answered.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: The injection was given on 11-20 at Pharmacy. I called my doctor that night because of pain, hardness and swelling larger than the palm of my hand over deltoid muscle in left arm. She instructed take aspirin and keep record of temperature. Swelling somewhat subsided in that area BUT traveled down arm until by the 3 day the arm beneath the elbow 3 inches was swollen. I called doctor again and was told to go to nearest emergency room and I did at Hospital where the doctor told me to take Prednisone for 5 days due to an allergic reaction to the injection. The arm was warm, red and swollen all the way down past the elbow.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: The injection was given on 11-20 at Pharmacy. I called my doctor that night because of pain, hardness and swelling larger than the palm of my hand over deltoid muscle in left arm. She instructed take aspirin and keep record of temperature. Swelling somewhat subsided in that area BUT traveled down arm until by the 3 day the arm beneath the elbow 3 inches was swollen. I called doctor again and was told to go to nearest emergency room and I did at Hospital where the doctor told me to take Prednisone for 5 days due to an allergic reaction to the injection. The arm was warm, red and swollen all the way down past the elbow.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Anaplastic astrocytoma, Biopsy brain abnormal, Second primary malignancy
Clinical narrative: Subject is enrolled on a clinical trial that is evaluating the monovalent HPV vaccine in cancer survivors. Subject received 3 doses  of HPV-9 vaccine (given on 8/22/16, 11/2/16 and 3/8/17). On 11/10/17, subject was diagnosed with a secondary malignancy (anaplastic astrocytoma) which has been deemed by the site responsible physician as unrelated to the HPV vaccine and likely related to the radiation that the subject received for treatment of his primary cancer. Treatment in progress.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: Blister with water beneath surface in area where bandaid adhesive touched skin near immunization site accompanied by itching. Mom is taking to MD today.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site reaction, Injection site swelling, Pain
Clinical narrative: Reaction to injecton site; swollen; redness body aches/headache. Patient took BENADRYL at onset.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Pt received Senior Flu Vaccination on 11-21-17. Pt returned to pharmacy on 11-22-17 complaining of red welt at injection site. Pt was still concerned so went to ER to have it checked out. Was prescribed 7 day course of doxycycline.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site rash, Injection site swelling, Urticaria
Clinical narrative: Rash and swelling to right upper arm; hives. Patient instructed to take BENADRYL and TYLENOL/Ibu for the pain.
Age: 33.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Syncope twice (fainted) with urinary incontinence on first pass out, called 911, treated by EMT and transported to hospital.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Immune thrombocytopenic purpura, Lymphocyte count increased, Petechiae, Platelet count decreased
Clinical narrative: Acute Idiopathic Thrombocytopenic Purpura -food sensitivities. Petechiae on legs and face, supportive measures and observe for Sx of high fevers and pt being ill. Sx comes and goes. Ongoing.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Erythema, Skin warm
Clinical narrative: Redness, warm to touch.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving vaccine. Patient was out for 15-20 seconds.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Papule, Pyrexia
Clinical narrative: 1 week after admin of vaccine, Pt. developed fever, at highest of 101 F with slightly raised papules covering belly, back, arms, legs and face.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of upper left arm with redness and warmth.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient said he developed a bump at injection site a couple of days after the shot. It is still there and hasn't gone away yet. No regular MD so has not been looked at.
Age: 4.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Patient has swelling on right deltoid at 12 cm w/a bruise at 2cm in diameter in the middle. Recommended warm compresses, ibuprofen and BENADRYL as needed. Child in no distress.
Age: 23.0
Sex: U
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states that even 3 weeks after administration her arm is sore, has limited mobility, and has difficulty raising arm.
Age: 72.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Skin tightness
Clinical narrative: Entire upper arm appeared swollen and pink. Patient complained of a tight itchy feeling.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Erythema
Clinical narrative: Erythema beginning approximately 48 hours after vaccine given in (R) quadricep. Seemed to improve then increased in redness 7cm x 8cm zone of erythema at peak 11/13/17. Was seen 11/14/17 and was fading. Mom iced and did Epsom salt bathes.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm began swelling within 4 - 5 hours of administration - pain, heat, swelling, expanded; visited Urgent Care who prescribed cephalexin and ibuprofen 1 day later; 2nd day after, swelling increased so patient visited ER. BENADRYL was added, swelling started subsiding.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema
Clinical narrative: After 24 hrs of MMRV and DTaP-IPV patient with 8 cm diameter of erythema around injection sites.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site warmth, Local reaction
Clinical narrative: Large local reactive manifestation, no erythema, increased warmth of 14 x 19 cm (R) ant thigh.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV
Symptoms: Eye movement disorder, Pyrexia, Tremor, Vomiting
Clinical narrative: Mom called had vomiting 3 hours after vaccine 4:00pm - Fever 101.4 ax, questionable febrile seizure, shaking, eyes deviated to one side. Patient sent to Emergency Department.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Patient became faint as walking through waiting room after flu immunization. Patient laid down on floor. Hydrated with water, then assisted to sitting position. Doctor notified and examined patient.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Eye movement disorder
Clinical narrative: Patient walking through waiting room after receiving flu immunization. Patient felt faint - eyes rolled back in head per mother. Placed in lying position then hydrated with water after faintness resolved. Assisted to sitting position. Doctor notified and examined patient.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives of upper chest and upper back 24 hours after immunization. Started w/pruritus 12 hours after vaccine. No dysphagia or SOB.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Periorbital oedema
Clinical narrative: Periocular edema. Medication: Hydroxyzine 10 mg/5ml 5mL q 6 hours.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Patient said he had pain in the arm and trouble moving his arm later in the day after the flu shot. Can't sleep on his side.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Soarness of the left arm. Patient cannot lift arm over his head or place a gallon of  milk on the top shelf.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Injection site pain
Clinical narrative: Patient reported a small amount of injection site pain the day of the vaccine. This pain eventually went away, but returned worse around a week after the shot. Then about 20 days after the shot the patient had a severe sharp burning pain on her left forearm that only occurs when she reaches her arm downward.
Age: 19.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Syncope, Vomiting
Clinical narrative: Patient seemed like having syncope, while sitting in chair in waiting room with his parents (few mts after). Heard mom scream to call 911. Had the intern call 911. Patient had fainted while in the chair. Tried to wake patient up. Patient regained consciousness in a few mts. gave some water to drink. Patient was sweaty on forehead. He told, he did not eat anything in morning, may be he got dizzy that's why. Gave him a cereal bar to eat. He drank more water but threw up. EMT arrived. Checked vitals. Told him not to drink more water yet. He was ok after that. Patient signed the release form to not go to ER. EMT left. Had patient wait for another 20 mts to make sure he was ok. Called after an hr at home to check on him, Dad told he was doing fine. Called MD next day to inform of the incidence. Patient did tell EMT that he felt dizzy about a month ago at the gym while working out.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: I am not sure about the exact flu vaccine I was given, but I felt dizziness as I was leaving the medical facility immediately after the shot was administered. The next day woke up with severe dizziness and nausea and could not keep any food or drink down, threw up everything I ate or drank. Day 2, I am still feeling very dizzy. This is a very severe side effect and if I don't improve by tomorrow I will seek medical attention. I have never had such dizziness and there is no other reason for this, my blood pressure is normal and heart rate as usual. My husband has to hold me when I get up to go anywhere.
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema
Clinical narrative: Patient was given PNEUMOVAX 23 in the right shoulder. The next day the patient came back in and there was redness along the right biceps. Patient was asked if it could possibly be a  result of something else. He said he does some lifting at work, but he did not think that was a result from the lifting. There was no redness, swelling, or any other reaction at or near the injection site. The patient's physician was notified that day and she said she would follow up with the patient. The patient was notified of this, and said he had just got off of the phone with his physician.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Dysphonia, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Sore throat, cough, hoarse voice, achy, light fever.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Tinnitus, Vomiting
Clinical narrative: Dizziness immediately after injection, pt passed out for maybe 2-3 secs and regained consciousness, she stated she had ringing in ears for maybe a minute and pt. vomited soon after; paramedics came and assessed pt. after.
Age: 7.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report was received from a physician referring to a 7 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions and conocmitant medications was reported.  On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # N014945, expiry date 31-AUG-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis.  The administered dose of hepatitis a vaccine, inactivated (VAQTA) underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fhrenheit degrees for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a pharmacy student and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 26-OCT-2017, the patient was vaccinated with a dose of ZOSTAVAX, 19 400 plaque-forming units (PFU), lot # N025386, expiration date: 08-DEC-2018, intramuscularly instead subcutaneously, for prophylaxis. Concomitant therapies included sterile diluent. No adverse events were reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 26-OCT-2017, the patient was vaccinated with a dose of ZOSTAVAX, 19 400 plaque-forming units (PFU), lot # N025386, expiration date: 08-DEC-2018, intramuscularly instead subcutaneously, for prophylaxis. Concomitant therapies included sterile diluent. No adverse events were reported.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 64 year old female patient. Her pertinent medical history, drug reactions or allergies and concomitant medications were none. On 22-OCT-2017, the patient was vaccinated with ZOSTAVAX subcutaneously, lot # N020852 with expiration date on 31-JUL-2018 for prophylaxis (also reported as: "shingles vaccination") (dose was not reported). Other suspect therapy included sterile diluent (Merck) subcutaneously, lot # N013283 with expiration date on 03-OCT-2019 (dose was not reported). On 23-OCT-2017, the patient sought for medical attention and called the pharmacy to report that the injection site "was red, raised, and warm to touch". The pharmacist reported, the patient's symptoms persisted on 26-OCT-2017. None lab tests were done and no treatment was given for adverse events. The outcome of adverse events was reported as not recovered. The relatedness between adverse events and ZOSTAVAX was not reported. No product quality complaint was involved.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 64 year old female patient. Her pertinent medical history, drug reactions or allergies and concomitant medications were none. On 22-OCT-2017, the patient was vaccinated with ZOSTAVAX subcutaneously, lot # N020852 with expiration date on 31-JUL-2018 for prophylaxis (also reported as: "shingles vaccination") (dose was not reported). Other suspect therapy included sterile diluent (Merck) subcutaneously, lot # N013283 with expiration date on 03-OCT-2019 (dose was not reported). On 23-OCT-2017, the patient sought for medical attention and called the pharmacy to report that the injection site "was red, raised, and warm to touch". The pharmacist reported, the patient's symptoms persisted on 26-OCT-2017. None lab tests were done and no treatment was given for adverse events. The outcome of adverse events was reported as not recovered. The relatedness between adverse events and ZOSTAVAX was not reported. No product quality complaint was involved.
Age: 1.25
Sex: U
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 15-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 06-JUN-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # reported as N00236, expiration date 24-OCT-2019 (dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 19-MAY-2017 till 06-JUN-2017, the vaccine was exposed to various temperature excursions ranging from 34 degrees Fahrenheit to 49 degrees Fahrenheit for the period of up to 46 hours at a time. Data logger was not involved. No adverse effects were reported.  There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 65.0
Sex: F
Vaccine: FLUA3, PPV, FLUX, PPV
Symptoms: Chills, Nausea, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a 65-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On 24-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscular, lot # N014946, expiration date 01-FEB-2019 (dose was not reported) for prophylaxis. On the same day, 24-OCT-2017, the patient was vaccinated with influenza virus vaccine (unspecified) (dose, route of administration, lot number and expiration date were not provided). On 24-OCT-2017, 8 hrs after vaccination, the patient had fever, chills, nausea, sleeplessness, and sore arm at injection site. Treatment was not given for adverse events. The outcome of fever, chills, nausea, sleeplessness was reported as recovered on 25-OCT-2017 (reported as "by the next morning"). The outcome of sore arm at injection site was reported as resolved on 29-OCT-2017 (reported as "arm soreness persisted for 3 to 4 days, and resolved without treatment"). The relatedness between PNEUMOVAX 23 and the events was not provided.
Age: 65.0
Sex: F
Vaccine: FLUA3, PPV, FLUX, PPV
Symptoms: Chills, Injection site pain, Insomnia, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a 65-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On 24-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscular, lot # N014946, expiration date 01-FEB-2019 (dose was not reported) for prophylaxis. On the same day, 24-OCT-2017, the patient was vaccinated with influenza virus vaccine (unspecified) (dose, route of administration, lot number and expiration date were not provided). On 24-OCT-2017, 8 hrs after vaccination, the patient had fever, chills, nausea, sleeplessness, and sore arm at injection site. Treatment was not given for adverse events. The outcome of fever, chills, nausea, sleeplessness was reported as recovered on 25-OCT-2017 (reported as "by the next morning"). The outcome of sore arm at injection site was reported as resolved on 29-OCT-2017 (reported as "arm soreness persisted for 3 to 4 days, and resolved without treatment"). The relatedness between PNEUMOVAX 23 and the events was not provided.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cold sweat, Erythema, Injection site urticaria, Pain in extremity, Pruritus
Clinical narrative: This spontaneous report as received from a nurse, refers to a 65 year old female patient. No information on the patient's pertinent medical history and drug reactions or allergies was provided. On 24-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N014946, expiry date: 01-FEB-2019, intramuscularly for prophylaxis (strength and dose number were not reported). Concomitant therapies included influenza virus vaccine (unspecified). On 24-OCT-2017 (reported as: "8 hours later"), the patient experienced: fever, chills, sleeplessness, hives, rash and sore arm at injection site. Nurse reported that all symptoms resolved on approximately 25-OCT-2017, by the next morning without any treatment. Arm soreness persisted for 3 to 4 days and resolved without treatment on approximately 28-OCT-2017. The patient did not seek medical attention. No lab diagnostics were performed. The causality assessment between the events and PNEUMOVAX 23 was not reported.