chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: nurse used MMR Chicken Pox Diluent and did not use the HIB Diluent to reconstitute the ActHIB; Initial information received on 08-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who was vaccinated with the HIB (PRP/T) VACCINE [ACT-HIB] (formulation: unknown, lot: UI988AA and expiry date 03-Oct-2020 via intramuscular route in the left thigh) that was mixed with the vial of the diluent for MMR chicken pox vaccines on 07-Jul-2019.  The patient's medical history were not reported.  Concomitant medications included Prevnar 13 and  Dtap  It was an actual medication error due to wrong solution used in drug reconstitution as nurse used MMR Chicken Pox Diluent and did not use the HIB Diluent to reconstitute the ActHIB. Sterile water was used to reconstitute ActHib  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient is late for her second dose of Imovax vaccine by 11 days; Initial information received on 08-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 19 years old female patient who was vaccinated with a first dose of a 0.5 ml RABIES (HDC) VACCINE [IMOVAX RABIES] (lot NIK303N and Exp. Date 08-Dec-2019) via intramuscular route in the left deltoid on 26-Jun-2019 and was late for her second dose of Imovax vaccine by 11 days.  The patient's medical history not reported and no other vaccines or medications were given that day.  It was an actual medication error case due to inappropriate schedule of vaccine administered as patient was late for her second dose of Imovax vaccine by 11 days.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: L arm pain starting after nap following vaccines. Patient unable to lift arm because of pain. No swelling or warmth. Low grade temp 99. No additional signs/symptoms.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Full blood count, Headache, Laboratory test normal, Metabolic function test, Nausea
Clinical narrative: 24 hrs later - severe neck pain, "my body is disintegrating"; severe nausea + headache - jaw pain - body aches - seen at urgent care, lab normal, dx probable vaccine event had also just started birth control 3 days prior.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Neck pain, Pain, Pain in jaw, Urine analysis, Vaccination complication
Clinical narrative: 24 hrs later - severe neck pain, "my body is disintegrating"; severe nausea + headache - jaw pain - body aches - seen at urgent care, lab normal, dx probable vaccine event had also just started birth control 3 days prior.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: The morning of 7/6/19 (L) upper arm was noted to be  erythematous, with moderate edema. Upper arm was warm  to touch & indurated. Child was taken to an  Urgent Care where the diagnosis of vaccine reaction  and cellulitis were made. Child was started on  Clindamycin & told to use warm compresses 3x/day.  To f/u with our office in 2-3 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: The morning of 7/6/19 (L) upper arm was noted to be  erythematous, with moderate edema. Upper arm was warm  to touch & indurated. Child was taken to an  Urgent Care where the diagnosis of vaccine reaction  and cellulitis were made. Child was started on  Clindamycin & told to use warm compresses 3x/day.  To f/u with our office in 2-3 days.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Urticaria
Clinical narrative: Sore arm, flu-like symptoms, and hives starting several hours after the injection.  Flu-like symptoms have persisted through the second day.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Cellulitis, Erythema, Induration, Skin warm
Clinical narrative: Vaccines given 7/9/19, redness, warmth and induration noted 7/10/19 in the evening, redness spreading on 7/11/19, no pain, itching, or fevers. No known insect bites, no tick bites.  Treating for cellulitis with augmentin.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: red rash approx. 1-1/2 below injection site, and 2 1/4 inch diameter red spots on inner upper arm
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: Weakness in lower extremities, more weakness in left side than right side
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Aprx 3 hours after injection, I experienced extreme tiredness.  Later that evening  I felt like I had been hit by a truck - severe muscle aches and fever of 100.3 F.  The full following day the tiredness, muscle aches and fever continued.  I stayed in bed.  Around midnight of the 2nd day after vaccination I felt some relief.  48 hours later I am much better but not fully recovered.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Patient complains of an internal burning sensation running through both arms and chest area.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Feeling abnormal, Headache, Hyperacusis, Pain
Clinical narrative: I began feeling poorly on Saturday.  I was achy and not sleeping well.  Sunday I had a terrible headache in the right side of my head and began to break out in a rash on the right side of my face.  By Monday, I was nauseous, had a terrible headache and the rash was getting worse.  I had at least 5 spots on my face where I was breaking out.  The sores were large and hurt.  They didn't really itch, it was more painful than itchy.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, Poor quality sleep, Rash
Clinical narrative: I began feeling poorly on Saturday.  I was achy and not sleeping well.  Sunday I had a terrible headache in the right side of my head and began to break out in a rash on the right side of my face.  By Monday, I was nauseous, had a terrible headache and the rash was getting worse.  I had at least 5 spots on my face where I was breaking out.  The sores were large and hurt.  They didn't really itch, it was more painful than itchy.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pyrexia
Clinical narrative: CHRONIC FATIGUE, FEVER, FLU-LIKE SYMPTOMS ONGOING FOR 6+ WEEKS PER PATIENT
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness over entire rt upper deltoid area and swelling, very tender to touch.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: injection site reaction.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site haemorrhage, Injection site pain, Injection site pruritus
Clinical narrative: Patient  came into the pharmacy on 7/9/19 for her 2nd dose of the Shingrix vaccine.  She reported she bled and experienced pain right away after the injection. She used an ice pack to help alleviate the pain the first day.   She said her injection site is  painful, itchy, burning, and numb,  and the experience is very different from her 1st dose (pain was minimal).   She said she experienced a lot of discomfort on 7/10/19. Upon observing the injection site on 7/11/19, it was red and swollen around the site.   Patient said she will take ibuprofen for the pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right arm swelling from shoulder to elbow  with mild erythema and warmth. No fever. Onset within 12 hours of vaccine administration. Swelling decreasing after 48 hours but remains at 72 hours after admin
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Donor stated she began to feel dizzy approximately 10 minutes after she received vaccine. She then threw up and has a headache. Donor states she still feels nauseous. No treatment was initiated at this time. Employee was sent out to an emergency clinic for medical care by RN.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: "I need to get the MMRII vaccine because my doctor said I don't have the rubella component"; This spontaneous report was received from a female patient, concerning herself. Information about her pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), injection for prophylaxis (strength, route, lot number and expiration date were not provided).   On an unspecified date, the patient reported that she did not have the rubella component (rubella antibody negative), therefore she said she needed to get a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Additionally, it could not be determined if the consumer had negative titers to rubella or if she had ever received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) previously, but this could not be ruled out. The patient sought medical attention and she was seen by the physician. It was not reported if other diagnostic laboratories, or studies were performed or if she received treatment for the event. At the moment of this report, the event of rubella antibody negative was not resolved.  The reporter did not provide causality assessment between the aforementioned event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: On 7/6/19 (Saturday), patient received a Shingrix shot in the left deltoid muscle. On 7/9/19 (Tuesday)  pt came to pharmcay asking for advise. He reported his arm was swollen, red and hot to the touch. Rph asked to see the arm. There was a band-aid on the arm> Rph asked if that band-aid was the band-aid he received on Saturday? Pt said yes. Rph asked pt to remove bandaid, to see if the site of injection looked infected. The skin looked fine. There was indeed a red swollen lump below the injection site and was hot to touch. On questioning, pt said he did not have any reaction,except a sore muscle on Saturday. Then suddenly on Tuesday morning, he awoke with a red swollen lump on his left upper arm, was concerned and came to pharmacy. Rph reffered pt to be checked by his PCP.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: On 7/6/19 (Saturday), patient received a Shingrix shot in the left deltoid muscle. On 7/9/19 (Tuesday)  pt came to pharmcay asking for advise. He reported his arm was swollen, red and hot to the touch. Rph asked to see the arm. There was a band-aid on the arm> Rph asked if that band-aid was the band-aid he received on Saturday? Pt said yes. Rph asked pt to remove bandaid, to see if the site of injection looked infected. The skin looked fine. There was indeed a red swollen lump below the injection site and was hot to touch. On questioning, pt said he did not have any reaction,except a sore muscle on Saturday. Then suddenly on Tuesday morning, he awoke with a red swollen lump on his left upper arm, was concerned and came to pharmacy. Rph reffered pt to be checked by his PCP.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injection site pain, Pyrexia, Rash, Rash morbilliform
Clinical narrative: low grade fever 99 range; measles type rash on upper back and leg pain
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Lethargy, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: PT RECEIVED PNEUMOVAX 23 VACCINE ON 5/29, AND WALKED IN ON 5/31 C/O LEFT ARM PAIN, SWELLING, REDNESS, LETHARGY, WARM AND TENDER FOR TOUCH IN HIS LEFT ARM.  PATIENT WAS TREATED WITH CLINDAMYCIN 300 MG TID FOR 7 DAYS. SYMPTOMS RESOLVED.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: PT RECEIVED PNEUMOVAX 23 VACCINE ON 5/29, AND WALKED IN ON 5/31 C/O LEFT ARM PAIN, SWELLING, REDNESS, LETHARGY, WARM AND TENDER FOR TOUCH IN HIS LEFT ARM.  PATIENT WAS TREATED WITH CLINDAMYCIN 300 MG TID FOR 7 DAYS. SYMPTOMS RESOLVED.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster in T11 dermatome
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood pressure decreased, Dizziness, Headache, Pain, Pallor
Clinical narrative: Patient received vaccine (HPV9) and within seconds he start feeling dizzy and complaining of headache and blurry vision - as minutes passed his face color change and became pale and headache was worsening - patient was alert and responding to questions but in pain. Blood pressure drop from ~126/69 to 87/38 - decision was made to use EpiPen due to concerns for anaphylaxis - patient started to recovering from symptoms slowly within minutes after EpiPen - blood pressure back to 100/57
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Vision blurred
Clinical narrative: Patient received vaccine (HPV9) and within seconds he start feeling dizzy and complaining of headache and blurry vision - as minutes passed his face color change and became pale and headache was worsening - patient was alert and responding to questions but in pain. Blood pressure drop from ~126/69 to 87/38 - decision was made to use EpiPen due to concerns for anaphylaxis - patient started to recovering from symptoms slowly within minutes after EpiPen - blood pressure back to 100/57
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Significant pain at injection site, elevated temperature, aching muscles throughout body, fatigue, headache
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Chest discomfort, Dizziness, Headache, Oropharyngeal pain
Clinical narrative: Headache, fever, sore throat, tightness of chest, dizziness, rash, blisters,
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Headache, fever, sore throat, tightness of chest, dizziness, rash, blisters,
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Within 16 hours of getting the vaccination, I developed uncontrollable shivers, had a headache, reached a fever of 104.2
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Blindness, Deafness, Syncope
Clinical narrative: Patient told her mom that she thought she was losing her hearing and vision. Mom reports that the patient started to faint. Mom caught her and eased her down to the ground and held her. Patient regained consciousness immediately.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Injection site erythema, Muscle spasms, Pain
Clinical narrative: PT SAID WOKE UP AT 130 AM WITH FEVERS, CHILLS, BODY ACHES, BACK ACHE, CRAMPING, REDNESS AROUND INJECTION SITE. IMPROVED DURING THE NIGHT BUT STILL HAS LOWER BACKACHE. HAS TAKEN APAP THROUGHOUT DAY TO HELP BUT CRAMPING AND SHIVERS HAVE IMPROVED.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: PT SAID WOKE UP AT 130 AM WITH FEVERS, CHILLS, BODY ACHES, BACK ACHE, CRAMPING, REDNESS AROUND INJECTION SITE. IMPROVED DURING THE NIGHT BUT STILL HAS LOWER BACKACHE. HAS TAKEN APAP THROUGHOUT DAY TO HELP BUT CRAMPING AND SHIVERS HAVE IMPROVED.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia, Sensory loss
Clinical narrative: c/o numbness along right arm down to wrists
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient came in and complained of redness around the elbow that developed after the injection.
Age: 1.83
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, VARCEL
Symptoms: Fall, Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: MOTHER BROUGHT IN PATIENT. PATIENT HAS TWO RAISED, RED, RASHES ON HER LEFT THIGH. THEY ARE WARM TO TOUCH. PATIENT DID NOT SHOW SIGNS OF PAIN SUCH AS GRIMACING OR PULLING LEG AWAY WHEN THEY WERE TOUGHED, BUT MOTHER STATES THEY ARE PAINFUL BECAUSE THA PATIENT HAS FALLEN. PATIENT MOTHER DENIES FEVER. MOTHER WAS GIVEN VIS SHEETS FOR HEPATITIS A AND MMR. THOSE WERE THE VACCINES THAT WERE DOCUMENTED AS GIVEN ON THE LEFT THIGH. MOTHER WAS GIVEN ER PRECAUTIONS AND ASKED TO RETURN TO THE CLINIC OR GO TO ER IF RAISED AREAS BEGAN TO SPREAD, PATIENT HAD A CHENGE IN BEHAVIOR OR IF PATIENT DEVELOPED A FEVER.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event. Patient was in need of Hepatitis A dose number 2 and was inadvertently given Hepatitis B
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Flushing, Hypoaesthesia oral, Swollen tongue, Throat tightness
Clinical narrative: flushing of neck, tightness of throat and swelling and numbness of tongue, shortness of breath
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: URGENT SAME DAY APPT FOR EYE ISSUE, PARENT DID NOT HAVE IMMUNIZATION RECORDS ADVISED BEHIND ON VACCINE AND PARENT BROUGHT BACK RECORD AND FOUND OUT CHILD WAS VACCINATED BY FATHERS PROVIDER.  PARENT/MOTHER WORRIED FAMILY CLINIC OVERDOSED HER CHILD.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Per patient, after she received the vaccine she has a sore arm to the point where she could not move it for weeks. Had to go to her provider to get it checked out.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Aches, pain, fever
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Brain oedema, Computerised tomogram head, Condition aggravated, Multiple sclerosis relapse, Nuclear magnetic resonance imaging brain
Clinical narrative: MS Exacerbation, severe cereal edema, requiring steroid therapy and hospitalization, followed by weeks of physical therapy.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Nuclear magnetic resonance imaging spinal, Physiotherapy, Steroid therapy
Clinical narrative: MS Exacerbation, severe cereal edema, requiring steroid therapy and hospitalization, followed by weeks of physical therapy.
Age: 44.0
Sex: F
Vaccine: HEP, HEPA, MMR, PPV, TDAP
Symptoms: Fatigue, Pain, Peripheral swelling, Pyrexia
Clinical narrative: patient experienced high fever, body aches, swelling on left arm, fatingued
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Condition aggravated, Fatigue, Herpes simplex
Clinical narrative: within hours patient developed shivering chills, feverish, rash, stomach pain, nausea, myalgia and fatigue along with HSV2 outbreak NDI #1 58160-829-03 with Lot # 445J4 NDI#2 8160-828-03 with Lot # CA 374
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, Rash
Clinical narrative: within hours patient developed shivering chills, feverish, rash, stomach pain, nausea, myalgia and fatigue along with HSV2 outbreak NDI #1 58160-829-03 with Lot # 445J4 NDI#2 8160-828-03 with Lot # CA 374
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria
Age: 57.0
Sex: M
Vaccine: HEP, HEPA, MMR, PPV, TDAP
Symptoms: Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: swelling on left arm, high fever, fatigue
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Presyncope
Clinical narrative: Flu-like symptoms, especially dizziness ;  feeling very lightheaded, close to passing out.  Had to lay down on the  floor to avoid passing out.  Resolved with oral fluids over about 12 hours
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fall, Headache, Laboratory test normal
Clinical narrative: Patient states he went to bed with shivers.  He awoke in the middle of the night with mild headache, low grade fever.  In the morning he started to have muscle weakness and joint soreness, which led to a fall.  He went to the hospital and they admitted him on Tuesday, July 9th, 2019.  They ran several tests but everything came back normal.  He was released on Wednesday, July 10th  and made a full recovery.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Middle insomnia, Muscular weakness, Pyrexia
Clinical narrative: Patient states he went to bed with shivers.  He awoke in the middle of the night with mild headache, low grade fever.  In the morning he started to have muscle weakness and joint soreness, which led to a fall.  He went to the hospital and they admitted him on Tuesday, July 9th, 2019.  They ran several tests but everything came back normal.  He was released on Wednesday, July 10th  and made a full recovery.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Cellulitis, Chills, Delirium, Inflammatory marker increased
Clinical narrative: RECIEVED 6/27 SYMPTOMS STARTED 2 DAYS LATER STARTING WITH CHILLS EARLY IN THE MORNING AND BECAME DELIRIOUS AND WAS PICKED UP BY AN AMBULANCE AND TAKEN TO THE HOSPITAL. EMERGENCY ROOM BROUGHT FEVER DOWN AFTER A COUPLE HOURS. INFECTIOUS DISEASE DR SAID THAT THE PATIENTS SYMPTOMS WERE CAUSED BY SHINGRIX SHOT. PATIENT WAS TREATED WITH ANTIBIOTICS IN THE HOSPITAL AND STATES THAT HIS ARMS/LEGS BECAME SWOLLEN. PATIENT STATES THAT HE GAINED 20 POUNDS OF WATER AND AS OF 7/11 PATIENT IS BACK TO NORMAL WEIGHT BUT WHILE BEING TREATED GOT ANOTHER FEVER. PATIENT RECIEVED BACTRIM UPON RELEASE FROM HOSPITAL. PATIENT GOT ANOTHER TEMPERATURE AFTER LEAVING HOSPITAL. CELLULITIS WAS IN THE PATIENTS LEFT ARM BUT THE SHINGRIX SHOT WAS GIVEN RIGHT ARM. CELLULITIS IS NOW ALMOST GONE AND BEING TREATED WITH THE PRESCRIBE BACTRIM FROM BEING RELEASED. PRIMARY CARE DR WAS THE PRESCRIBING DR FOR THE BACTRIM THE PATIENT IS TAKING. PATIENT STATES THAT HIS SISTER SAYS HE HAS CELLULITIS NOT THE HOSPITAL. HE THEN CALLED HIS PRIMARY CARE PHYSICIAN  PRESCRIBED BACTRIM. HOSPITAL DID NOT RELEASE PATIENT WITH MEDICATION
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Oedema, Peripheral swelling, Pyrexia, Vaccination complication
Clinical narrative: RECIEVED 6/27 SYMPTOMS STARTED 2 DAYS LATER STARTING WITH CHILLS EARLY IN THE MORNING AND BECAME DELIRIOUS AND WAS PICKED UP BY AN AMBULANCE AND TAKEN TO THE HOSPITAL. EMERGENCY ROOM BROUGHT FEVER DOWN AFTER A COUPLE HOURS. INFECTIOUS DISEASE DR SAID THAT THE PATIENTS SYMPTOMS WERE CAUSED BY SHINGRIX SHOT. PATIENT WAS TREATED WITH ANTIBIOTICS IN THE HOSPITAL AND STATES THAT HIS ARMS/LEGS BECAME SWOLLEN. PATIENT STATES THAT HE GAINED 20 POUNDS OF WATER AND AS OF 7/11 PATIENT IS BACK TO NORMAL WEIGHT BUT WHILE BEING TREATED GOT ANOTHER FEVER. PATIENT RECIEVED BACTRIM UPON RELEASE FROM HOSPITAL. PATIENT GOT ANOTHER TEMPERATURE AFTER LEAVING HOSPITAL. CELLULITIS WAS IN THE PATIENTS LEFT ARM BUT THE SHINGRIX SHOT WAS GIVEN RIGHT ARM. CELLULITIS IS NOW ALMOST GONE AND BEING TREATED WITH THE PRESCRIBE BACTRIM FROM BEING RELEASED. PRIMARY CARE DR WAS THE PRESCRIBING DR FOR THE BACTRIM THE PATIENT IS TAKING. PATIENT STATES THAT HIS SISTER SAYS HE HAS CELLULITIS NOT THE HOSPITAL. HE THEN CALLED HIS PRIMARY CARE PHYSICIAN  PRESCRIBED BACTRIM. HOSPITAL DID NOT RELEASE PATIENT WITH MEDICATION
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PATIENT PRESENTED WITH REDNESS AND SWELLING THAT EXTENDED FROM SHOULDER TO UNDER ARM PIT. SWELLING WAS MINIMAL. PATIENT WAS INSTRUCTED TO TAKE BENADRYL AND TO KEEP A COLD COMPRESS (ICE PACK) ON AREA AND TO CALL PHARMACY IF SWELLING OR REDNESS WORSENED OR DID NOT BEGIN TO RESOLVE
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Chiropractic, Neuralgia, Pain in extremity
Clinical narrative: arm pain that feels neuropathic. has been hurting for over 1 week. patient is seeing a chiropractor for it. she says the pain  sometimes runs to her upper back behind her armpit
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Histamine intolerance, Injection site reaction, Mastocytoma
Clinical narrative: Mastocytoma on right thigh at site of injection
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Band neutrophil count, Blood chloride normal, Blood creatinine normal, Blood culture negative, Blood glucose increased
Clinical narrative: Patient with fever around vaccine site on R thigh same day as vaccine was given 5/14/19.  Fever resolved after 2 days but R thigh redness persisted and began expanding.  Fever returned 5/19/19 with continued expansion of erythema now from thigh to ankle and more fussiness.  Pt was admitted for possible thigh cellulitis/vaccine allergic reaction.  IV  Cefazolin x 2 days with decreased erythema then developed purple macular lesions on R thigh thought to be due to some bruising at site where there had been significant swelling.  Seen by ID in hospital and dermatology post discharge.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased, Carbon dioxide decreased
Clinical narrative: Patient with fever around vaccine site on R thigh same day as vaccine was given 5/14/19.  Fever resolved after 2 days but R thigh redness persisted and began expanding.  Fever returned 5/19/19 with continued expansion of erythema now from thigh to ankle and more fussiness.  Pt was admitted for possible thigh cellulitis/vaccine allergic reaction.  IV  Cefazolin x 2 days with decreased erythema then developed purple macular lesions on R thigh thought to be due to some bruising at site where there had been significant swelling.  Seen by ID in hospital and dermatology post discharge.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Culture urine negative, Full blood count abnormal, Haemoglobin decreased, Injection site bruising, Injection site discolouration
Clinical narrative: Patient with fever around vaccine site on R thigh same day as vaccine was given 5/14/19.  Fever resolved after 2 days but R thigh redness persisted and began expanding.  Fever returned 5/19/19 with continued expansion of erythema now from thigh to ankle and more fussiness.  Pt was admitted for possible thigh cellulitis/vaccine allergic reaction.  IV  Cefazolin x 2 days with decreased erythema then developed purple macular lesions on R thigh thought to be due to some bruising at site where there had been significant swelling.  Seen by ID in hospital and dermatology post discharge.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability, Lymphocyte percentage
Clinical narrative: Patient with fever around vaccine site on R thigh same day as vaccine was given 5/14/19.  Fever resolved after 2 days but R thigh redness persisted and began expanding.  Fever returned 5/19/19 with continued expansion of erythema now from thigh to ankle and more fussiness.  Pt was admitted for possible thigh cellulitis/vaccine allergic reaction.  IV  Cefazolin x 2 days with decreased erythema then developed purple macular lesions on R thigh thought to be due to some bruising at site where there had been significant swelling.  Seen by ID in hospital and dermatology post discharge.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Monocyte percentage, Neutrophil percentage, Platelet count increased, Pyrexia, Rash macular
Clinical narrative: Patient with fever around vaccine site on R thigh same day as vaccine was given 5/14/19.  Fever resolved after 2 days but R thigh redness persisted and began expanding.  Fever returned 5/19/19 with continued expansion of erythema now from thigh to ankle and more fussiness.  Pt was admitted for possible thigh cellulitis/vaccine allergic reaction.  IV  Cefazolin x 2 days with decreased erythema then developed purple macular lesions on R thigh thought to be due to some bruising at site where there had been significant swelling.  Seen by ID in hospital and dermatology post discharge.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: White blood cell count normal
Clinical narrative: Patient with fever around vaccine site on R thigh same day as vaccine was given 5/14/19.  Fever resolved after 2 days but R thigh redness persisted and began expanding.  Fever returned 5/19/19 with continued expansion of erythema now from thigh to ankle and more fussiness.  Pt was admitted for possible thigh cellulitis/vaccine allergic reaction.  IV  Cefazolin x 2 days with decreased erythema then developed purple macular lesions on R thigh thought to be due to some bruising at site where there had been significant swelling.  Seen by ID in hospital and dermatology post discharge.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site hypoaesthesia, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: (L) deltoid with area of induration ~3.5cm diameter somewhat tender and visible compared to contralateral shoulder. Patient also describes numbness over lateral aspect of left arm but neurovascular exam intact. Area of inflammation not fluctuant MCV4/MenB in (L) deltoid.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Oedema
Clinical narrative: PATIENT CALLED 7/11@8:45AM AND REPORTED ABOUT A QUARTER SIZE EDEMA (NOT SO MUCH REDNESS). SHE WAS CONSULTED TO APPLY HC AND MAY USE NSAID TX. SHE WAS ALSO ADVISED TO CALL BACK NEXT DAY IF NOT IMPROVING OR GETS WORSE. PATIENT ALSO REPORTS DIARRHEA.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site urticaria, Skin irritation
Clinical narrative: Developed large wheal of the right lateral upper arm, 8 cm x 7 cm in size. No respiratory involvement, just localized skin irritation. Sx's started day after injection administration w/ slow progressive worsening. Provided Benadryl & Motrin for resolution
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Erythema, Pain, Pruritus, Swelling
Clinical narrative: redness (approximately 3-4" in diameter 7/11/19). Swelling - has decreased since date of injection pt has used ice  pain intermittent itching  Patient reported ADRS and RPh contacted PCP who scheduled apt 7/12/19 @ 10 AM MD office will follow up with pharmacy if patient allows. Per practice assistant in fear of privacy violation
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Nausea; swelling, heat + reddness at injection site. 4x4 size. Hardness developed under site. Then ran low grade fever 99 degrees 7/2/19 but on 7/3/19 ran 100.8 degrees Appetite loss; fatigued; light headed. Itching at site 7/6 - present
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pyrexia, Swelling
Clinical narrative: Nausea; swelling, heat + reddness at injection site. 4x4 size. Hardness developed under site. Then ran low grade fever 99 degrees 7/2/19 but on 7/3/19 ran 100.8 degrees Appetite loss; fatigued; light headed. Itching at site 7/6 - present
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram head normal, Headache
Clinical narrative: Woke in the night with excruciating pain left side of head above ear. Took hydrocodone was able to sleep for a bit. Woke up still bad pain went to urgent care. All checks normal given Tramadol if no better. Advised to go to ER for CT scan. Pain subsided a bit but went to ER eve 7/3 - CT scan, blood work neg - given Fentanyl + Toradol. Advised if not better see a neurologist - no better saw neurologist who put her on prednisone for 1 week. Feeling better. Still on prednisone if no better will f/u with neuro.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Asthenopia, C-reactive protein normal, Fatigue, Feeling abnormal, Full blood count
Clinical narrative: Pt called the office & then was subsequently advised to come in & be seen after 1 week of headaches (worse than her usual migraine headaches & not responsive to ibuprofen); fatigue, eyes feeling "heavy" and she "doesn't feel right in her body". Denies dizziness, photo/phonophobia, visual changes, syncope, near-syncope, appetite changes, (+) nausea, no vomiting or diarrhea. No fevers/sweats/chills. I spoke with CDC & based on their protocols it was determined that this reaction, lasting 1 week in duration meets criteria for allergic reaction to vaccine and/or one of its components. Given that this was pts 1st time being vaccinated for both Hepatitis A and HPV; we can not isolate cause and will last as allergic to both; avoiding future vaccination to both in the future. Current treatment plan will include labs (done) prednisone x 7 days, Zantac 150mg BID for nausea + antihistamine; Benadryl or Atarax 25mg every 6hrs prn allergy & re-assess in 10-14 days. Pt and mother instructed to return for worsening of symptoms other concerns. Advised to increase fluid intake. Advised of drowsiness related to antihistamines. Questions/concerns addressed.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Headache, Hypersensitivity, Liver function test, Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Pt called the office & then was subsequently advised to come in & be seen after 1 week of headaches (worse than her usual migraine headaches & not responsive to ibuprofen); fatigue, eyes feeling "heavy" and she "doesn't feel right in her body". Denies dizziness, photo/phonophobia, visual changes, syncope, near-syncope, appetite changes, (+) nausea, no vomiting or diarrhea. No fevers/sweats/chills. I spoke with CDC & based on their protocols it was determined that this reaction, lasting 1 week in duration meets criteria for allergic reaction to vaccine and/or one of its components. Given that this was pts 1st time being vaccinated for both Hepatitis A and HPV; we can not isolate cause and will last as allergic to both; avoiding future vaccination to both in the future. Current treatment plan will include labs (done) prednisone x 7 days, Zantac 150mg BID for nausea + antihistamine; Benadryl or Atarax 25mg every 6hrs prn allergy & re-assess in 10-14 days. Pt and mother instructed to return for worsening of symptoms other concerns. Advised to increase fluid intake. Advised of drowsiness related to antihistamines. Questions/concerns addressed.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Culture negative, Joint fluid drainage, Mobility decreased, Swelling
Clinical narrative: Shoulder Pain; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a 84-year-old male patient who received Herpes zoster (Shingrix) (batch number BF4J5, expiry date 5th July 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that the patient experienced left shoulder pain on the side of administration. No additional details were provided.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Shoulder Pain; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a 84-year-old male patient who received Herpes zoster (Shingrix) (batch number BF4J5, expiry date 5th July 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that the patient experienced left shoulder pain on the side of administration. No additional details were provided.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blister, Chills, Swelling of eyelid, Vision blurred
Clinical narrative: Hives down middle of forehead, down nose, corner of eye inflamed, chills, weakness headache on  rt. side of face, Eye pain, blurry vision rt. eye.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Eye inflammation, Eye pain, Headache
Clinical narrative: Hives down middle of forehead, down nose, corner of eye inflamed, chills, weakness headache on  rt. side of face, Eye pain, blurry vision rt. eye.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria, Vision blurred
Clinical narrative: Hives down middle of forehead, down nose, corner of eye inflamed, chills, weakness headache on  rt. side of face, Eye pain, blurry vision rt. eye.
Age: 21.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Headache, Nausea, Neck pain
Clinical narrative: Severe headache, nausea and  neck pain
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Redness/swelling - dx with Cellulitis
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: a second dose of MMR II was inadvertently administered instead of VARIVAX; fatigue; Information has been received from a medical assistant referring to a 13 months old female patient. The patient's concomitant medication was not provided, and the patient had no pertinent medical history or drug/allergies reactions.   On 01-MAY-2019, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number and expiration date, frequency and route were not provided) for prophylaxis. On 11-JUN-2019 (also reported as 05-JUN-2019), a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot R020923, expiration date 22-JUL-2020, route was subcutaneous) was inadvertently administered instead of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number and expiration date, frequency, indication and route were not provided) (wrong product administered). The patient was now experiencing fatigue. It was confirmed that this was human error and not product confusion.   No product quality complaint (PQC) was involved. There was no treatment given for the adverse events, lab diagnostics/studies performed, or medical attention. The outcome of fatigue was reported as not recovered. The causality assessment was not provided.   Lot Number R020923 with therapy type of rHA is valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live.
Sex: M
Vaccine: MMR, UNK
Symptoms: Joint swelling, Joint warmth, Pyrexia, Rash, Urticaria
Clinical narrative: joints became swollen and hot to touch; hot to touch; Developed ras and hives on his chest, behind both ears and on his legs; Developed ras and hives on his chest, behind both ears and on his legs; Low grade fever; This spontaneous report was received from a nurse referred to a 12 month old male patient with immunisation. The patient's medical history and concomitant medications were not reported. On 28-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R036581 and an unknown expiry date for immunisation. Other suspect therapy included sterile diluent (lot# S011944 and expiry date 18-DEC-2021). On 28-JUN-2019, reporter stated that the patient developed a low grade fever(pyrexia) later that night and on 29-JUN-2019, the patient developed a rash and hives on his chest, behind both ears and on his legs(rash generalised and urticarial). On 01-JUL-2019, the patient's joint became swollen and hot to touch (swelling and skin warm). The outcome of pyrexia, joint swelling, urticarial, rash generalised and skin warm were reported as recovering. Causality assessment was not provided. No PQC found.
Age: 25.0
Sex: F
Vaccine: HEP, HPV9, MMR
Symptoms: Inappropriate schedule of product administration, Injection site induration, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: the pain went down her arm, intermittently; she experienced pain at the injection site; the injection site for the M-M-R II was raised, firm  and inflamed; the injection site for the M-M-R II was raised, firm  and inflamed; she received her first dose of M-M-R II on an unspcified date, approximately one year ago; This spontaneous report was received from a medical student, via company representative,referring to a 26 year old non-pregnant female patient. The patient was allergic to nonsteroidal anti-inflammatory drug (unspecified) (NSAIDs). The patient did not have any medical history or concurrent conditions. The sterile diluent was used for vaccine reconstitution.  In approximately April 2018 (also reported as "approximately one year ago"), the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  for prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported) (product administered to patient of inappropriate age).  On 18-APR-2019, the patient received a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported), along with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and an unspecified hepatitis b vaccine (manufacturer unknown) all of them for prophylaxis (dose, dose number, route of administration anatomical injection site, lot number and expiration date were not reported).  On the same date, the patient experienced pain at the injection site (vaccination site pain) and the pain went down her arm, intermittently (pain in extremity) for two weeks.  Besides, the patient stated that the injection site where she received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was raised, firm and inflamed (injection site induration and injection site inflammation) for two months. It was reported that all the adverse effects had resolved after the two months. It was unknown if the patient sought for medical attention, but she did not received any treatment for the events and no diagnostic laboratories or studies were performed to the patient.  The causality assessment between Hepatitis B Vaccine (manufacturer unknown), measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) with the aforementioned events was not reported.
Age: 25.0
Sex: F
Vaccine: HEP, HPV9, MMR
Symptoms: Pain in extremity
Clinical narrative: the pain went down her arm, intermittently; she experienced pain at the injection site; the injection site for the M-M-R II was raised, firm  and inflamed; the injection site for the M-M-R II was raised, firm  and inflamed; she received her first dose of M-M-R II on an unspcified date, approximately one year ago; This spontaneous report was received from a medical student, via company representative,referring to a 26 year old non-pregnant female patient. The patient was allergic to nonsteroidal anti-inflammatory drug (unspecified) (NSAIDs). The patient did not have any medical history or concurrent conditions. The sterile diluent was used for vaccine reconstitution.  In approximately April 2018 (also reported as "approximately one year ago"), the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  for prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported) (product administered to patient of inappropriate age).  On 18-APR-2019, the patient received a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported), along with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and an unspecified hepatitis b vaccine (manufacturer unknown) all of them for prophylaxis (dose, dose number, route of administration anatomical injection site, lot number and expiration date were not reported).  On the same date, the patient experienced pain at the injection site (vaccination site pain) and the pain went down her arm, intermittently (pain in extremity) for two weeks.  Besides, the patient stated that the injection site where she received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was raised, firm and inflamed (injection site induration and injection site inflammation) for two months. It was reported that all the adverse effects had resolved after the two months. It was unknown if the patient sought for medical attention, but she did not received any treatment for the events and no diagnostic laboratories or studies were performed to the patient.  The causality assessment between Hepatitis B Vaccine (manufacturer unknown), measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) with the aforementioned events was not reported.