chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer on 08-JUN-2020, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical condition, medical history or concurrent conditions were not reported. On or about 19-JUL-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of vaccination, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms o additional adverse effects reported; patient inadvertently received expired first dose in VAQTA immunization series; Information has been received from office manager regarding a 61-years-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 08-JUN-2020, the patient was vaccinated with a expired first dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot number: S001832 with expiration date 12-MAY-2020) (strength, frequency and anatomical location were not reported) (expired vaccine used).   No symptoms or additional adverse effects reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Nausea
Clinical narrative: FATIGUE; trembling; Skin pain; CHILLS/teeth chattering; SKIN SENSITIVITY; NAUSEA; HEADACHE; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (6 months back 1st dose received. Please refer the case US2020092731).   On 1st June 2020, the patient received the 2nd dose of Shingrix. On 1st June 2020, 9 hrs after receiving Shingrix, the patient experienced chills, sensitive skin, nausea, headache, fatigue, tremor and skin pain. In June 2020, the outcome of the sensitive skin was recovered/resolved. On an unknown date, the outcome of the chills, nausea, headache, tremor and skin pain were recovered/resolved and the outcome of the fatigue was recovering/resolving.   It was unknown if the reporter considered the chills, sensitive skin, nausea, headache, fatigue, tremor and skin pain to be related to Shingrix.  Additional details were provided as follows: On 1st June 2020, the patient received 2nd dose of Shingrix. 9 hour after receiving the vaccine the patient experienced the patient described the skin sensitivity as pain on her skin all over the skin was sensitive to the touch, the chills were described as trembling and teeth chattering. The fatigue was better but still present at the time of this report.  The events were lasted approximately 8 hours.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020092731:dose #1
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Sensitive skin, Tremor
Clinical narrative: FATIGUE; trembling; Skin pain; CHILLS/teeth chattering; SKIN SENSITIVITY; NAUSEA; HEADACHE; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (6 months back 1st dose received. Please refer the case US2020092731).   On 1st June 2020, the patient received the 2nd dose of Shingrix. On 1st June 2020, 9 hrs after receiving Shingrix, the patient experienced chills, sensitive skin, nausea, headache, fatigue, tremor and skin pain. In June 2020, the outcome of the sensitive skin was recovered/resolved. On an unknown date, the outcome of the chills, nausea, headache, tremor and skin pain were recovered/resolved and the outcome of the fatigue was recovering/resolving.   It was unknown if the reporter considered the chills, sensitive skin, nausea, headache, fatigue, tremor and skin pain to be related to Shingrix.  Additional details were provided as follows: On 1st June 2020, the patient received 2nd dose of Shingrix. 9 hour after receiving the vaccine the patient experienced the patient described the skin sensitivity as pain on her skin all over the skin was sensitive to the touch, the chills were described as trembling and teeth chattering. The fatigue was better but still present at the time of this report.  The events were lasted approximately 8 hours.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020092731:dose #1
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Eyelid rash, Inappropriate schedule of product administration, Rash
Clinical narrative: Rash on neck/Rash on neck, eyelids and around mouth; Rash on neck, eyelids; second dose in May of 2020 (>6months); This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (On 2nd August 2019, 1st dose received. Please refer the case US2020092761).   On 2nd May 2020, the patient received the 2nd dose of Shingrix (intramuscular) and Hepatitis A vaccine. On 2nd May 2020, unknown after receiving Shingrix and not applicable after receiving Hepatitis A vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced rash and eyelid rash. On an unknown date, the outcome of the rash, eyelid rash and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the rash and eyelid rash to be related to Shingrix and Hepatitis A vaccine.  Additional details were provided as follows: The patient received 1st dose on 2nd August 2019, and 2nd dose received on 2nd May 2020, which led to lengthening of the vaccination schedule. Less than a month after receiving the 2nd dose of Shingrix the patient experienced rash on her neck, eyelids and around her mouth. The patient was unsure which arm she received the Shingrix and which arm she received the Hepatitis A vaccine.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020092761:
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: started to have chills; low grade fever / higher this morning (100 F); This case was reported by a consumer and described the occurrence of chills in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th May 2020, the patient received Shingles vaccine. On 4th June 2020, 5 days after receiving Shingles vaccine, the patient experienced chills and fever. On an unknown date, the outcome of the chills was unknown and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingles vaccine, the patient started to have chills and a low-grade fever. His temperature was slightly higher on the day of reporting which was recorded 100 degree F. The reporter reported onset of side effect was about 5 days, and asked was that normal. The patient asked if this could be related to the vaccine.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: diagnosed with shingles; This case was reported by a medical representative via call center representative and described the occurrence of shingles in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number 5TH3L, expiry date 19th November 2021) for prophylaxis.   On 12th May 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th May 2020, 16 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix vaccine in left deltoid and diagnosed with shingles. No additional information provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain of skin
Clinical narrative: FATIGUE; Skin pain; trembling; CHILLS/Teeth chattering; SKIN SENSITIVITY; NAUSEA; HEADACHE; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 9 hrs after receiving Shingrix, the patient experienced chills, sensitive skin, nausea, headache, fatigue, tremor and skin pain. On an unknown date, the outcome of the chills, sensitive skin, nausea, headache, tremor and skin pain were recovered/resolved and the outcome of the fatigue was recovering/resolving.   It was unknown if the reporter considered the chills, sensitive skin, nausea, headache, fatigue, tremor and skin pain to be related to Shingrix.   Additional details were provided as follows: Before 6 months from the date of reporting the patient received 1st dose of Shingrix. 9 hour after receiving the vaccine the patient experienced the patient described the skin sensitivity as pain on her skin all over the skin was sensitive to the touch, the chills were described as trembling and teeth chattering. The fatigue was better but still present at the time of this report.  The events were lasted approximately 8 hours.  For tolerance to 2nd dose refer linked case US2020AMR093114, reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR093114:dose #1
Sex: F
Vaccine: VARZOS
Symptoms: Sensitive skin, Tremor
Clinical narrative: FATIGUE; Skin pain; trembling; CHILLS/Teeth chattering; SKIN SENSITIVITY; NAUSEA; HEADACHE; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 9 hrs after receiving Shingrix, the patient experienced chills, sensitive skin, nausea, headache, fatigue, tremor and skin pain. On an unknown date, the outcome of the chills, sensitive skin, nausea, headache, tremor and skin pain were recovered/resolved and the outcome of the fatigue was recovering/resolving.   It was unknown if the reporter considered the chills, sensitive skin, nausea, headache, fatigue, tremor and skin pain to be related to Shingrix.   Additional details were provided as follows: Before 6 months from the date of reporting the patient received 1st dose of Shingrix. 9 hour after receiving the vaccine the patient experienced the patient described the skin sensitivity as pain on her skin all over the skin was sensitive to the touch, the chills were described as trembling and teeth chattering. The fatigue was better but still present at the time of this report.  The events were lasted approximately 8 hours.  For tolerance to 2nd dose refer linked case US2020AMR093114, reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR093114:dose #1
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid rash, Rash
Clinical narrative: Rash on neck/Rash on neck, eyelids and around mouth; Rash on neck, eyelids; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd August 2019, 1 days after receiving Shingrix, the patient experienced rash and eyelid rash. On an unknown date, the outcome of the rash and eyelid rash were unknown.   It was unknown if the reporter considered the rash and eyelid rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  Less than a year, a year after receiving the 1st dose of Shingrix the patient experienced rash on her neck, eyelids and around her mouth. For tolerance to 2nd dose refer linked case US2020AMR093219, reported by the same reporter. The reporter did consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR093219:Same patient; 2nd dose
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was inadvertently administered an expired dose of Daptacel/No AE; Initial information was received on 03-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 5 year old female patient who received expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT (IPV) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for Immunisation.  On 03-Jun-2020, the patient received a fifth 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5366AA, expiry date- 07-Feb-2020) via unknown route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  Patient was inadvertently administered an expired dose of Daptacel in the left thigh.  At the time of report, no adverse event reported.  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.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Seven year old patient received  Quadracel/No AE; Initial information was received on 03-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a seven-year-old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  The patient received MMR and VARICELLA VACCINE as concomitant medications.  On 01-Jun-2020, the patient received a 0.5 mL fifth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5688AA, expiry date: 26-Nov-2021] via an intramuscular route at the left leg for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration.   At the time of report, no adverse event was reported.  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.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: The patient was getting an injection but she pulled away and received about half the medication, no adverse event; Initial information was received on 05-Jun-2020 regarding an unsolicited valid non-serious case from a nurse  This case involves an 11 year old female patient who was getting a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]  injection but she pulled away and received about half the medication (Underdose)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL)  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6638AA, expiry 12-Apr-2022) via intramuscular route in the left arm for prophylactic vaccination  It was a case of an actual medication error due to vaccine underdose  It was reported that a female nonpregnant child was getting the injection and pulled away so she only received about half the medication.  At the time of report, no adverse event was reported.  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.
Sex: U
Vaccine: IPV, MNQ
Symptoms: Product storage error
Clinical narrative: door being left open for too long during inventory-human error with no adverse event; Initial information regarding this unsolicited valid non-serious case from a other health professional was received via call center and transmitted to Sanofi on 08-Jun-2020.  This case involved an unknown age patient of unknown demographics for whom door being left open for too long during inventory-human error (Product storage error), while the patient store the vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and IPV (VERO) [IPOL].  Medical history and concomitant drug were not reported.  On an unknown date, it was reported that the vaccines were stored in refrigerator. And reported that Menactra and Ipol (opened) were exposed to 9.4C for 2 hours and 15 minutes due to the refrigerator door being left open for too long during inventory-human error (Product storage error).  Also it is a case of actual medication error due to Product storage error.  No relevant laboratory data was reported.  Final diagnosis was Product storage error.  Action taken with the suspect was not applicable. Corrective treatment was not reported. Outcome of the event was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  No further relevant information were received.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given an expired dose of Adacel with no adverse event; Initial information received on 08-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient (age and gender not reported) who was given an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) (lot U5898AA expiry date-30-Mar-2020) for prophylactic vaccination.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U5898AA exp date-30-Mar-2020) for prophylactic vaccination.  It was an actual medication error due to expired vaccine used. (expired product administered).   At the time of reporting, the patient had no 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 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.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Fatigue, Hyperhidrosis, Hypersomnia
Clinical narrative: I had continuous chills, unsteady legs , and general fatigue. I felt feverish on and off throughout the day, with much sweating  I spent the entire day and night of June 9th in bed, sleeping most of those hours.  I had no adverse effects with the first shot in this series
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I had continuous chills, unsteady legs , and general fatigue. I felt feverish on and off throughout the day, with much sweating  I spent the entire day and night of June 9th in bed, sleeping most of those hours.  I had no adverse effects with the first shot in this series
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: low  grade fever (100.0 F) chills, severe overall weakness treatment was Tylenol and rest outcome was complete recovery after two days
Age: 1.33
Sex: M
Vaccine: HIBV, MMR
Symptoms: Eye swelling, Swelling face
Clinical narrative: Patient received MMR and Hib vaccines at 4:05pm on 6/10/2020, patient left clinic.  Mother returned to clinic after physical requesting to speak with PCP at 4:15pm. Mother then stated "this is an emergency", patient started with sudden onset eye and facial swelling. , Mother left clinic, went to lab and states swelling began while at lab. No provider available in pod - patient immediately brought to clinic, roomed in room 5 and evaluated by Dr. Patient given Benadryl, Epipen Jr, and Prednisone in clinic, 911 called and patient transferred to Hospital ER.
Sex: U
Vaccine: VARZOS
Symptoms: Eczema, Skin reaction
Clinical narrative: eczema-skin reaction; Eczema; This case was reported by a consumer via call center representative and described the occurrence of skin reaction in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin reaction and eczema. On an unknown date, the outcome of the skin reaction and eczema were unknown.   The reporter considered the skin reaction and eczema to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked if Shingrix vaccine could cause eczema. The patient thought the skin reaction might be from the vaccine.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: ITCHING AND RED CIRCLE AROUND INJECTION SITE
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: The patient said his arm started to hurt 2 weeks after his vaccine. He said it feels like it is in the area that the vaccine was given. He said it only hurts every 2 to 3 days not every day. I recommended that he follow up with his PCP to have his arm checked.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Onset of tonic-clonic seizure and fever of 105 about 1900h. Rescue was called. Seizure lasted 3-4 minutes. -spontaneous resolution, no abnormalities by EMT - transported to ER awake alert and acting normal -observation in ER discharged 2056. Fever resolved no further seizures.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site urticaria, Pruritus
Clinical narrative: Red, intchy hives on front and back of both legs
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Red, intchy hives on front and back of both legs
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: On 06/11/2020 at 0841-Medical Assistant gave a 2 year old Pneumovax 23 instead of Prevnar 13.  At 0852 Practice Manager and Provider was made aware of the incident. At 0857 the CDC was called,spoke with staff who transferred me to staff who then stated " there is no reason to believe the the vaccine will be harmful to the patient even though Pneumovax 23 is contraindicated for this patient". During this time patient and mom remained in the office for observation. At 0913 the Doctor spoke with the parent and informed them of what occurred and the steps that the office will be taken and the next step of the child. The mother voiced understanding and scheduled an appointment for eight weeks to get the Prevnar13 administered.  Patient and mother was given instructions on what to do in the event of any allergic reaction to the incorrect vaccine that was given today. Patient and mother  left the office at 0941 with no negative reaction to the vaccination given.
Age: 16.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased, Pain in extremity
Clinical narrative: Large 5-6 inch by 5-6 inch injection site redness, warmth and swelling. Pain is limiting arm movements.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Pain
Clinical narrative: Mother states after vaccines given seemed fine except for c/o soreness and nothing noticed when going to bed that night.   Woke up on 06/03/2020 with redness and swelling which progressed to about 2/3 of upper arm.   Seen in office 06/04/4020 and described by physician "5-6 cm round erythema with mild induration with internal band of clearing and central pinpoint erythema"   The surrounding redness was greater area (not measured) .   Mother has pictures available   Spoke with mother on phone on 06/09/2020 and much improved.   Redness has mostly resolved as of today and left with "hard knot"   I realize with 4th and 5th doses of DTaP you can rarely have exaggerated responses involving entire extremity - this may be the case.   I explained this to mother.   Physician assessed as possible reaction to vaccine or local reaction.   No systemic effects noted.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: Patient stated that within a couple of days of administration, he noticed tingling/numbness in his toes which have persisted and spread slowly throughout his foot over the course of months.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Woke up in the middle of the night with fever and chills.  Took Advil the next morning and later that afternoon.  I also experienced a sore throat all day.  Two days later, arm is still sore and there is redness around the injection site.  Fever and sore throat are gone.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. The patient's medical history, historical drugs and concomitant therapies were not reported.   In 2008, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.   On an unknown date, subsequent to the vaccination, the patient was treated for shingles. The patient would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the event was not recovered, and the causal relationship between the event and Zoster Vaccine Live (ZOSTAVAX) was related.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: sore muscles; feeling tired; Arm hurts; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2020, the patient received Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced myalgia, tiredness and pain in arm. On an unknown date, the outcome of the myalgia, tiredness and pain in arm were unknown.   It was unknown if the reporter considered the myalgia, tiredness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was selected as per the vaccine indication. On 1sy June 2020, the patient received shingles vaccine and experienced feeling tired, sore muscles, arm hurts. The patient asked was this normal.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Injection site pain, Pain
Clinical narrative: upset stomach; aching; soreness at injection site; headache; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced upset stomach, pain, injection site pain and headache. On an unknown date, the outcome of the upset stomach, pain, injection site pain and headache were unknown.   It was unknown if the reporter considered the upset stomach, pain, injection site pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. After receiving the Shringrix the patient experienced upset stomach, aching, soreness at injection site and headache. The patient asked how long do side effects from shingle vaccine usually last.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Burning Pain; This case was reported by a other health professional via interactive digital media and described the occurrence of pain burning in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain burning. On an unknown date, the outcome of the pain burning was unknown.   It was unknown if the reporter considered the pain burning to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had burning pain.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: injection site sore; injection site red; injection site warm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site warmth. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient said the patient would apply ice to injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: I have second effect with the vaccine; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had second effect with the vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Redness at and around the injection site covering the entire forearm/Redness at and around the injection site; Injection site is also hot to touch; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 week after receiving Shingrix, the patient experienced erythema of extremities and injection site warmth. On an unknown date, the outcome of the erythema of extremities was not recovered/not resolved and the outcome of the injection site warmth was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. About a week after vacciantion, the patient experienced redness at and around the injection site covering the entire forearm.  The redness at injection site was also hot to touch.  Hot to touch lasted for 2 days, but the redness was present at the time of reporting. No other details were provided. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: chills, headache, fever (99.5-100.5), joint pain
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever up to 103.4 lasted one day (day 9 following shot) Full body rash began 9 days following the shot  (still has but is lessening)
Age: 13.0
Sex: M
Vaccine: VARCEL, UNK, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Vaccine was given IM instead of SQ. No noted adverse reactions at time of injection. Nurse spoke with patients mother via phone and she advised patient was doing good and voiced no problems.
Age: 13.0
Sex: M
Vaccine: VARCEL, UNK, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given IM instead of SQ. No noted adverse reactions at time of injection. Nurse spoke with patients mother via phone and she advised patient was doing good and voiced no problems.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Basophil count normal, Basophil percentage, C-reactive protein increased, Differential white blood cell count, Eosinophil count normal
Clinical narrative: She was seen in clinic about 6 days ago.  She received her meningitis type B bexsero vaccine.  This was her booster vaccination and she did not react to last injection. Received vaccine in right leg.  The vaccine felt fine going in.  That night she had significant pain at the injection site.  And woke up with pain.  Patient states three days later she noticed redness and bruising.  Over the last 3 days redness has increased in size.  Pain is getting better.  Area has been warm to touch .  One headache on Monday none since.   Nothing else has changed.  No other symptoms other than her baseline aches/systemic complaint which are unchanged and follows with her doctors for these things.  SKIN:  She has large erythematous 20 cm x 18 cm area on her anterior right thigh.  It extends about 2 cm or so by the most medial aspect from the margins that she drew but the rest looks okay.  There is a resolving 2 inch or so area of yellow bruising around where the shot was given she says its a little sore there to touch but nothing significant.  There is no nodule or abscess or fluctuant indurated area felt.  The rest of the area is nontender.  Maybe slightly more warm than the rest of the surrounding skin but not significantly.  The area around the bruised area at the most superior lateral aspect the erythema seems like it is starting to fade in scattered areas.  I drew new margins.  Discussed whether this is an injection site reaction and/or cellulitis.  I really think a large local reaction.  Seems larger than typical and even with reading vaccine insert.  We discussed these possibilities.  Discussed obtaining blood work or not.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Eosinophil percentage, Granulocyte count, Granulocyte percentage, Haematocrit normal, Haemoglobin normal
Clinical narrative: She was seen in clinic about 6 days ago.  She received her meningitis type B bexsero vaccine.  This was her booster vaccination and she did not react to last injection. Received vaccine in right leg.  The vaccine felt fine going in.  That night she had significant pain at the injection site.  And woke up with pain.  Patient states three days later she noticed redness and bruising.  Over the last 3 days redness has increased in size.  Pain is getting better.  Area has been warm to touch .  One headache on Monday none since.   Nothing else has changed.  No other symptoms other than her baseline aches/systemic complaint which are unchanged and follows with her doctors for these things.  SKIN:  She has large erythematous 20 cm x 18 cm area on her anterior right thigh.  It extends about 2 cm or so by the most medial aspect from the margins that she drew but the rest looks okay.  There is a resolving 2 inch or so area of yellow bruising around where the shot was given she says its a little sore there to touch but nothing significant.  There is no nodule or abscess or fluctuant indurated area felt.  The rest of the area is nontender.  Maybe slightly more warm than the rest of the surrounding skin but not significantly.  The area around the bruised area at the most superior lateral aspect the erythema seems like it is starting to fade in scattered areas.  I drew new margins.  Discussed whether this is an injection site reaction and/or cellulitis.  I really think a large local reaction.  Seems larger than typical and even with reading vaccine insert.  We discussed these possibilities.  Discussed obtaining blood work or not.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: She was seen in clinic about 6 days ago.  She received her meningitis type B bexsero vaccine.  This was her booster vaccination and she did not react to last injection. Received vaccine in right leg.  The vaccine felt fine going in.  That night she had significant pain at the injection site.  And woke up with pain.  Patient states three days later she noticed redness and bruising.  Over the last 3 days redness has increased in size.  Pain is getting better.  Area has been warm to touch .  One headache on Monday none since.   Nothing else has changed.  No other symptoms other than her baseline aches/systemic complaint which are unchanged and follows with her doctors for these things.  SKIN:  She has large erythematous 20 cm x 18 cm area on her anterior right thigh.  It extends about 2 cm or so by the most medial aspect from the margins that she drew but the rest looks okay.  There is a resolving 2 inch or so area of yellow bruising around where the shot was given she says its a little sore there to touch but nothing significant.  There is no nodule or abscess or fluctuant indurated area felt.  The rest of the area is nontender.  Maybe slightly more warm than the rest of the surrounding skin but not significantly.  The area around the bruised area at the most superior lateral aspect the erythema seems like it is starting to fade in scattered areas.  I drew new margins.  Discussed whether this is an injection site reaction and/or cellulitis.  I really think a large local reaction.  Seems larger than typical and even with reading vaccine insert.  We discussed these possibilities.  Discussed obtaining blood work or not.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: She was seen in clinic about 6 days ago.  She received her meningitis type B bexsero vaccine.  This was her booster vaccination and she did not react to last injection. Received vaccine in right leg.  The vaccine felt fine going in.  That night she had significant pain at the injection site.  And woke up with pain.  Patient states three days later she noticed redness and bruising.  Over the last 3 days redness has increased in size.  Pain is getting better.  Area has been warm to touch .  One headache on Monday none since.   Nothing else has changed.  No other symptoms other than her baseline aches/systemic complaint which are unchanged and follows with her doctors for these things.  SKIN:  She has large erythematous 20 cm x 18 cm area on her anterior right thigh.  It extends about 2 cm or so by the most medial aspect from the margins that she drew but the rest looks okay.  There is a resolving 2 inch or so area of yellow bruising around where the shot was given she says its a little sore there to touch but nothing significant.  There is no nodule or abscess or fluctuant indurated area felt.  The rest of the area is nontender.  Maybe slightly more warm than the rest of the surrounding skin but not significantly.  The area around the bruised area at the most superior lateral aspect the erythema seems like it is starting to fade in scattered areas.  I drew new margins.  Discussed whether this is an injection site reaction and/or cellulitis.  I really think a large local reaction.  Seems larger than typical and even with reading vaccine insert.  We discussed these possibilities.  Discussed obtaining blood work or not.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Mean platelet volume decreased, Monocyte count normal, Monocyte percentage, Platelet count normal, Red blood cell count normal
Clinical narrative: She was seen in clinic about 6 days ago.  She received her meningitis type B bexsero vaccine.  This was her booster vaccination and she did not react to last injection. Received vaccine in right leg.  The vaccine felt fine going in.  That night she had significant pain at the injection site.  And woke up with pain.  Patient states three days later she noticed redness and bruising.  Over the last 3 days redness has increased in size.  Pain is getting better.  Area has been warm to touch .  One headache on Monday none since.   Nothing else has changed.  No other symptoms other than her baseline aches/systemic complaint which are unchanged and follows with her doctors for these things.  SKIN:  She has large erythematous 20 cm x 18 cm area on her anterior right thigh.  It extends about 2 cm or so by the most medial aspect from the margins that she drew but the rest looks okay.  There is a resolving 2 inch or so area of yellow bruising around where the shot was given she says its a little sore there to touch but nothing significant.  There is no nodule or abscess or fluctuant indurated area felt.  The rest of the area is nontender.  Maybe slightly more warm than the rest of the surrounding skin but not significantly.  The area around the bruised area at the most superior lateral aspect the erythema seems like it is starting to fade in scattered areas.  I drew new margins.  Discussed whether this is an injection site reaction and/or cellulitis.  I really think a large local reaction.  Seems larger than typical and even with reading vaccine insert.  We discussed these possibilities.  Discussed obtaining blood work or not.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Red cell distribution width normal, White blood cell count normal
Clinical narrative: She was seen in clinic about 6 days ago.  She received her meningitis type B bexsero vaccine.  This was her booster vaccination and she did not react to last injection. Received vaccine in right leg.  The vaccine felt fine going in.  That night she had significant pain at the injection site.  And woke up with pain.  Patient states three days later she noticed redness and bruising.  Over the last 3 days redness has increased in size.  Pain is getting better.  Area has been warm to touch .  One headache on Monday none since.   Nothing else has changed.  No other symptoms other than her baseline aches/systemic complaint which are unchanged and follows with her doctors for these things.  SKIN:  She has large erythematous 20 cm x 18 cm area on her anterior right thigh.  It extends about 2 cm or so by the most medial aspect from the margins that she drew but the rest looks okay.  There is a resolving 2 inch or so area of yellow bruising around where the shot was given she says its a little sore there to touch but nothing significant.  There is no nodule or abscess or fluctuant indurated area felt.  The rest of the area is nontender.  Maybe slightly more warm than the rest of the surrounding skin but not significantly.  The area around the bruised area at the most superior lateral aspect the erythema seems like it is starting to fade in scattered areas.  I drew new margins.  Discussed whether this is an injection site reaction and/or cellulitis.  I really think a large local reaction.  Seems larger than typical and even with reading vaccine insert.  We discussed these possibilities.  Discussed obtaining blood work or not.