chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event, Herpes zoster, Pain, Vaccination failure
Clinical narrative: 46 days after receiving the second shot Shingles outbreak/ Suspected vaccination failure; shingles outbreak; pain; symptoms; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and mepolizumab (Nucala) solution for injection in pre-filled pen for asthma.   The patient's past medical history included herpes zoster (it was resolved). Previously administered products included Zostavax. Concurrent medical conditions included asthma.   On an unknown date, the patient received the 1st dose of Shingrix, the 2nd dose of Shingrix and Nucala at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix and Shingrix and not applicable after starting Nucala, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and adverse event. The patient was treated with valaciclovir hydrochloride (Valacyclovir). The action taken with Nucala was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and adverse event were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and adverse event to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles, pain and adverse event to be related to Nucala.  Additional information was provided as follows: The case was reported by patient himself. The age at vaccination was not reported. The patient had the Shingrix vaccine for shingles, both in the series also before starting on Nucala. He started Nucala about 18 months before time of reporting, 46 days after receiving the second shot of Nucala he had a second Shingles outbreak, which was treated with a prescription antiviral, valcyclovir. Pain and symptoms resolved within one week. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dyspnoea, Eosinophil count increased, Weight decreased
Clinical narrative: cough; Short of breath; Losing 30 pounds / weight loss; high eosinophils; This case was reported by a consumer via call center representative and described the occurrence of cough in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingles vaccine. On an unknown date, between 1 and 2 months after receiving Shingles vaccine, the patient experienced cough, shortness of breath, weight loss and eosinophil count high. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the cough, shortness of breath, weight loss and eosinophil count high were not recovered/not resolved.   It was unknown if the reporter considered the cough, shortness of breath, weight loss and eosinophil count high to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and developed a cough and had become short of breath.   The reporter reported losing 30 pounds, but it was unclear if that was prior to the onset of breathing problems or after, or if the weight loss was deliberate.  The patients doctor has told her she has high eosinophils and was recommending treatment with Nucala and had not started taking Nucala. This call was regarding questions about Nucala, a medication the reporter has not started taking it yet.  The potential AE for the shingles vaccine was not recognized until after the call ended, so additional information was not available. The patient received Shingrix 2nd dose in February 2020.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: soreness at injection site; redness at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number 557ZA, expiry date 1st December 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by the nurse for herself. The age at vaccination was not reported. The patient experienced redness and soreness at injection site. The reporter consented to follow up. The case has been linked with the case US2020138148 and US2020AMR138449 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020138148:same reporter US-GLAXOSMITHKLINE-US2020AMR138449:same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Herpes zoster, Rash, Vaccination failure
Clinical narrative: received second dose of Shingrix / shingles but not a fully fledged case; Shingles; Rash; shivering; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and shivering. On an unknown date, the outcome of the vaccination failure and shivering were unknown and the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and developed shivering that night, and had a rash.  The physician said the rash was shingles but not a fully fledged case. It was reported the rash/ shingles was not itchy or painful but it did appear to be spreading. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 21.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Differential white blood cell count, Dizziness, Electrocardiogram, Full blood count, Human chorionic gonadotropin
Clinical narrative: 21 yr old female presents to clinic for immunizations.  Reviewed her imms record and she is due for Meningococcal and TDAP.  Pt is is college student. spoke to dr. and best to give her Meningococcal B.  Pt received these immunization at 1430.  At 1440 while pt was walking to exit she felt faint.  Her knees buckled and she kneeled on the floor in NP office.  Pt never loss conscience  Pt was placed in a chair.  She was responding appropriate to questions and was A/O x 3.  Pt was taken back to the treatment room and placed on a stretcher with HOB 40 degrees.  It was noted in her right hand her fingers were contracting.  Pt reports she did not eat or drink all day and the only water she had was with her Effexor.
Age: 21.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Metabolic function test, Muscle contractions involuntary, Muscular weakness, Urine analysis
Clinical narrative: 21 yr old female presents to clinic for immunizations.  Reviewed her imms record and she is due for Meningococcal and TDAP.  Pt is is college student. spoke to dr. and best to give her Meningococcal B.  Pt received these immunization at 1430.  At 1440 while pt was walking to exit she felt faint.  Her knees buckled and she kneeled on the floor in NP office.  Pt never loss conscience  Pt was placed in a chair.  She was responding appropriate to questions and was A/O x 3.  Pt was taken back to the treatment room and placed on a stretcher with HOB 40 degrees.  It was noted in her right hand her fingers were contracting.  Pt reports she did not eat or drink all day and the only water she had was with her Effexor.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Cheilitis, Pruritus, Rash, Urticaria
Clinical narrative: It was a rash/hives on arms, back and inner thighs. Severe itching. Now is currently present on lips.
Age: 1.25
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Rash, swelling and induration around injection site
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Medical Assistant administered Dtap- IPV for routine vaccine. Medical Assistant noticed expiration date after the administration.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Patient said he felt fine the day of the vaccination. Day after he felt off, no specific symptoms, just not quite right. Day 2 after vaccination, he felt worse. Finally in June, he was feeling back to normal. He reported having no COVID symptoms during this time.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Rash, Rash pruritic, Rash vesicular
Clinical narrative: 1 day after getting vaccine at his local pharmacy he developed a scattered vesicular rash on and erythemic base  to his bilateral forearms, one spot on his chest and 3 days later several to his bilateral ankles.  some erythema to injection site.  rash is puritic  which benadryl and hydrocortisone improve this.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia, Rash, Rash morbilliform, Screaming
Clinical narrative: Fever started 1/7/20 and was 101 degrees.  Was warm to the touch when she woke up on 1/8/20 but after her morning nap she woke up shaking uncontrollably and had a fever of 105 degrees.  I called the nurse at pediatrics and she said to alternate giving her tylenol and ibuprofen.  I did and it brought her fever down to 101-102 degrees.  Had fever until 1/9/20 when it finally went down.  Then she started to get a rash which started in her trunk/torso area.  It looked exactly like Measles.  She had the rash until it slowly started to go away on 1/14/20.  Every night that she had the fever and rash she woke up screaming uncontrollably for at least an hour every night.  Was in severe pain, didn't want to be held because her body hurt but also didn't want to be set down.  When I brought her into the doctor they denied that it could even remotely be from the vaccine, even though the rash looked exactly like the Measles.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Skin warm, Tremor
Clinical narrative: Fever started 1/7/20 and was 101 degrees.  Was warm to the touch when she woke up on 1/8/20 but after her morning nap she woke up shaking uncontrollably and had a fever of 105 degrees.  I called the nurse at pediatrics and she said to alternate giving her tylenol and ibuprofen.  I did and it brought her fever down to 101-102 degrees.  Had fever until 1/9/20 when it finally went down.  Then she started to get a rash which started in her trunk/torso area.  It looked exactly like Measles.  She had the rash until it slowly started to go away on 1/14/20.  Every night that she had the fever and rash she woke up screaming uncontrollably for at least an hour every night.  Was in severe pain, didn't want to be held because her body hurt but also didn't want to be set down.  When I brought her into the doctor they denied that it could even remotely be from the vaccine, even though the rash looked exactly like the Measles.
Age: 0.83
Sex: F
Vaccine: DTAP
Symptoms: Dermatitis acneiform, Injection site nodule, Injection site swelling, Rash, Swollen tongue
Clinical narrative: Same day (day0) : swollen orange sides of tongue. Swollen at injection sight. Day1: labia swollen and orange, tongue no longer swollen but tongue can only go to the right. Swollen at injection sight. Day2: pimple like rash on upper arms, swollen labia resolved, tongue still deviated to the right. Swollen at injection sight. Day 3: pimple like rash on thighs, rash on on upper arms resolved, tongue deviates to the right, Swollen at injection sight. Day 17: tongue still deviates to the right, small nodule remains at injection sight
Age: 0.83
Sex: F
Vaccine: DTAP
Symptoms: Tongue paralysis, Vulvovaginal swelling
Clinical narrative: Same day (day0) : swollen orange sides of tongue. Swollen at injection sight. Day1: labia swollen and orange, tongue no longer swollen but tongue can only go to the right. Swollen at injection sight. Day2: pimple like rash on upper arms, swollen labia resolved, tongue still deviated to the right. Swollen at injection sight. Day 3: pimple like rash on thighs, rash on on upper arms resolved, tongue deviates to the right, Swollen at injection sight. Day 17: tongue still deviates to the right, small nodule remains at injection sight
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: pt got the vaccine and walked away only to return a bit later and sit on the chair. Her husband stated she was feeling dizzy. I asked her to sit down and gave her bottled water to drink. They stated she had not eaten anything either so I gave her a protein bar . Shae ate that and drank the water. I asked her to take deep breaths and relax. During this time I was made aware that she gets this way just from the fear of needles as she goes through these episodes when she has blood drawn. After about 15 minutes I asked pt to stand for a bit and to look around. Then I asked her to walk a little. She looked fine and with the husbands permission let them go but to call us if any issues.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; outbreak of herpes zoster; Information has been received from a lawyer regarding a case in litigation, regarding a female patient of unknown age (the patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not provided). On unknown date, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, on unknown date, the patient suffered an outbreak of herpes zoster and post herpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. The patient's symptoms resulted in physical limitations not present prior to using the Zoster Vaccine Live (ZOSTAVAX) vaccine, also sustained severe and permanent personal injuries, serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the patient's outcome was not recovered, and the event of herpes zoster and post herpetic neuralgia were assessed as related. The lawyer considered both events to be disabling.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; on 22-JUL-2020, a dose of properly stored GARDASIl 9 with expiration date 21-JUL-2020 was inadvertently administered to a male patient; This spontaneous report has been received from a registered nurse, concerning to 20-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was inadvertently vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N025429 with expiration date 21-JUL-2020 (dose, frequency, route and anatomical location were not provided) for prophylaxis. No additional adverse events were reported.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Chills; Headache; Fever; felt so bad; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 17th July 2020, the patient received the 2nd dose of Shingrix. On 18th July 2020, 1 days after receiving Shingrix, the patient experienced chills, headache, fever and feeling bad. On an unknown date, the outcome of the chills, headache and fever were recovering/resolving and the outcome of the feeling bad was unknown.   The reporter considered the chills, headache and fever to be related to Shingrix. It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient began experiencing chills, fever and headache the next day.  At the time of reporting, the patient was still experiencing these side effects.  The patient stated that, he went to the emergency room because he felt so bad but there was nothing they could do for him.  The reporter was consented to follow up. The patient was advised to follow up with his healthcare professional if they continued and were bothersome. This case was linked with case US2020138156, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020138156:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Pain of skin, Pyrexia
Clinical narrative: fever; upset GI; pain in the skin; This case was reported by a other health professional and described the occurrence of fever in a adult female 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 fever, gastrointestinal upset and skin pain. On an unknown date, the outcome of the fever, gastrointestinal upset and skin pain were unknown.   It was unknown if the reporter considered the fever, gastrointestinal upset and skin pain to be related to Shingrix.  Additional details were provided as follows: Th patient was born in 1963. The age at vaccination was not reported. After receiving Shingrix, the patient experienced fever, upset gastrointestinal and skin pain. The reporter checked with the label and it said1 out of 6 people can't work next day. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Ciprofloxacin with an associated reaction of hypoaesthesia. Concurrent medical conditions included numbness, hypersensitivity and arthritis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced injection site pain. The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2020138133, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020138133:same patient, 2nd dose
Age: 0.17
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: two month old patient received Menactra injection, No AE; Initial information received on 21-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a two months old patient (gender not reported) who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) [MENACTRA] (batch, expiry date, dosing details, route and site of administration were not reported) for prophylactic vaccination on an unknown date, which was indicated from nine months and older.  Medical history, past medical treatment, vaccination family history and concomitant medication were not provided.  It was a case of an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, 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.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Underdose
Clinical narrative: During vaccination, patient moved and half of the fluid came out of the needle, no AE; Initial information was received on 21-Jul-2020 regarding an unsolicited valid non-serious case from a Nurse.  This case involves a 4 year old male patient who moved during vaccination with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and half of the fluid came out of the needle (Underdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT (IPV) for prophylactic vaccination.  On an unknown date (yesterday), the patient received a fifth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5523AA, Expiry date 20-Sep-2020) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose.  A nurse reported that they were giving an injection to a 4 year old yesterday and he moved and half of the fluid came out of the needle.  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 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: nurse gave Dtap  without the hib portion from  Pentacel, no AE; Initial information received on 22-Jul-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a patient (unknown demographics) to whom nurse injected 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] while reconstituting only Dtap  without the hib portion was given (lot UJ2598A, Expiry date 14-May-2021, route and site of administration were not reported) for prophylactic vaccination on 22-Jul-2020.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to Inappropriate reconstitution technique.  At the time of reporting, 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: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received an expired dose of Quadracel, no AE; Initial information received on 22-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 4 years old male patient who received an expired 0.5 ml first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot: C5497AA, expiry date: 17-Jul-2020) once via an intramuscular route in the right leg for prophylactic vaccination on 22-Jul-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) which were given on 22-Jul-2020 for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of reporting, 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 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.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Menactra was administered to patient, no AE; Initial information was received on 23-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves an 11 year old female patient who received a 0.5 ml expired first primary dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot: U6219BA, expiry date: 16-Jun-2020) via an unknown route in the right deltoid for prophylactic vaccination on 01-Jul-2020.   The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE (HPV VACCINE) for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of reporting, 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.
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Product storage error
Clinical narrative: vaccines were left in a cooler for 7 days max temp 68F , no AE; Initial information received on 23-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult female patient which was IPV (VERO) [IPOL] (lot R1D973M and expiry date: 17-Jul-2021), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5643CA and expiry date: 17-Jul-2021) and HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ138AAB and expiry date: 03-Aug-2021) temperature excursion vaccines were left in a cooler for 7 days max temp 68 farenheit (product storage error).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.  This was potential medication error case due to incorrect product storage.   At the time of reporting, it was not reported if the vaccine was not administered or not  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.
Age: 0.83
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: open IPOL vaccines were exposed to a temperature excursion/ No AE; Initial information was received on 23-Jul-2020 regarding an unsolicited valid non-serious case received from an other health professional (office staff).  This case involves a 10 months old female patient who on 22-Jul-2020 received third dose of IPV (VERO) [IPOL] vaccine (lot R1B252 and expiry date 13-Mar-2021) via intramuscular route in the left thigh for prophylactic vaccination and that vaccine was open and exposed to a temperature excursion (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No other conacamittent vaccines were given at the same time.  Case details: Reporter stated that he would like to know if he should re-administer IPOL vaccines that were exposed to a temperature excursion and mentioned that they had stability issue for open Ipol but had given the product already by the time they found out they should not have given it and no adverse event has been reported to the office.  It was of actual medication error due to incorrect product storage.  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: F
Vaccine: IPV
Symptoms: No adverse event, Product quality issue
Clinical narrative: stability issue for open Ipol / no AE; Initial information received on 23-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 months old female patient who received vaccines IPV (VERO) [IPOL] (lot number and Expiry date unknown) lot R1B252M via intramuscular route in the left thigh for Prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) ; HIB VACCINE CONJ (OMPC) (PEDVAXHIB) and HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B).   It was an actual medication error case due to incorrect product storage.  At a time of reporting no adverse event reported.  It was reported that they had stability issue for open Ipol but had given the product already by the time they found out they should not have given it. Ordered by Nurse Practitioner.  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: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: a staff member administered an expired dose of Menactra to a patient/No AE; Initial information received on 23-Jul-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographic patient who was vaccinated with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6208AB and Expiry date 08-Jul-2020) via unknown route and administration site on an unknown date for prophylactic vaccination.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At the time of reporting 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: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discomfort, Injection site erythema, Injection site rash
Clinical narrative: Redness at site and raised bumps at injection site. On had discomfort if area touched. Afebrile.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Pain in jaw, Trigeminal nerve disorder, X-ray dental normal
Clinical narrative: Nearly 1 week after injection, I began experiencing pain starting midpoint of both my maxillary and mandibular right jaw extending to my ear and on occasion near by right eye.  The pain started gradually but increased in intensity that on June 8,  I visited both my dentist and primary doctor's office.  A panaramic xray was taken by my dentist - revealing no dental cause.  My doctor determined  I was experiencing Trigeminal nerve resulting from the Zostavax vaccine.  I initially was prescribed 100mg (2xdaily) Gabapentin (Neurotin)   The amount was increased to 400mg (3xdaily) on June 12.  The pain intensified as the days went on .  Carbatrol was prescribed but the pharmacy was unable to fill due to supplies.  But June 23 when it was filled, the intensity of the pain began to decrease so it was decided to continue with the Gabapentin.  The pain finally resolved by the beginning of July.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: PT STATED THAT HIS ARM HAD A PINK MARK AFTER THE INJECTION AND NOW AT THE SITE INJECTION WAS GIVEN ALMOST 5 MONTHS LATER HE HAS A RED MARK ON ARM. PT STATES IT HAS TO BE FROM VACCINE AND COULD NOT BE FROM ANYTHING ELSE
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Condition aggravated, Fibromyalgia, Injected limb mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: continued aching and sharp pain and unable to lift or use left arm -As of 7/20 pt had seen MD. MD believes events due to her Fibromyalgia. Advise pt to use heat & Tylenol
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Injection site reaction, Swelling, Urticaria
Clinical narrative: Patient developed swelling 2- by 4cm in size and 3cm long hive, immediately after shot. Patient was given Benadryl 1/2 tsp and was observed for 30 min
Age: 42.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse event.; the patient was inadvertently administered a dose of PREVNAR 13 and PNEUMOVAX 23 concomitantly; This spontaneous report was received from a medical assistant and refers to a 42-year-old male patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 22-JUL-2020, the patient was inadvertently vaccinated with dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial (lot# S036811 and expiration date: 02-AUG-2021) and dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (lot#CM1131 and expiration date 30-APR-2022) concomitantly, (dose, dose number, route of administration and anatomical location of aforementioned vaccines were not reported) both for prophylaxis. No additional adverse events were reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Injection site pain, Insomnia, Nausea
Clinical narrative: swollen arm; nausea/vomiting; nausea/vomiting; shaking; chills; dizziness; pain; insomnia; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and chronic sinusitis. Previously administered products included Shingrix with an associated reaction of peripheral swelling (1st dose was received in February 2020. please refer the case US2020AMR136096).   On 16th July 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 17th July 2020, 1 days after receiving Shingrix, the patient experienced swelling arm, nausea, vomiting, tremor, chills, dizziness, pain, insomnia and injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the swelling arm and injection site pain were not recovered/not resolved and the outcome of the nausea, vomiting, tremor, chills, dizziness, pain and insomnia were recovered/resolved.   It was unknown if the reporter considered the swelling arm, nausea, vomiting, tremor, chills, dizziness, pain, insomnia and injection site pain to be related to Shingrix.  Additional case details were reported as follows: Lot and expiration date unavailable. The patient experienced vomiting, shaking, chills, dizziness, pain, swollen arm and insomnia, all have resolved except the swollen arm with soreness at injection site.  The patient reported testing her temperature, and stated no fever. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR136096:same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Tremor, Vaccine positive rechallenge, Vomiting
Clinical narrative: swollen arm; nausea/vomiting; nausea/vomiting; shaking; chills; dizziness; pain; insomnia; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and chronic sinusitis. Previously administered products included Shingrix with an associated reaction of peripheral swelling (1st dose was received in February 2020. please refer the case US2020AMR136096).   On 16th July 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 17th July 2020, 1 days after receiving Shingrix, the patient experienced swelling arm, nausea, vomiting, tremor, chills, dizziness, pain, insomnia and injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the swelling arm and injection site pain were not recovered/not resolved and the outcome of the nausea, vomiting, tremor, chills, dizziness, pain and insomnia were recovered/resolved.   It was unknown if the reporter considered the swelling arm, nausea, vomiting, tremor, chills, dizziness, pain, insomnia and injection site pain to be related to Shingrix.  Additional case details were reported as follows: Lot and expiration date unavailable. The patient experienced vomiting, shaking, chills, dizziness, pain, swollen arm and insomnia, all have resolved except the swollen arm with soreness at injection site.  The patient reported testing her temperature, and stated no fever. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR136096:same reporter.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus, Rash
Clinical narrative: Pt received anthrax vaccine on Friday 24Jul20 sometime in the afternoon after 12 pm but before 4pm. Pt then reports later that  evening  about 3-4 hours later being severely itchy and noticing a rash covering her entire torso, both arms, both legs, scalp, neck and forehead. Pt states there was no redness or swelling at the vaccine administration site.  Pt denies fever, chills, nausea, vomiting, diarrhea, headache and this ever happening in the past.  Pt was treated with IM does of 10mg  Dexamethasone in clinic and prescribed Aterax to take today. Pt will f/u tomorrow for reeval to determine if longer course of medication is needed.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Paraesthesia, Plasmapheresis
Clinical narrative: Developed Acute Inflammatory Demylenating Polyneuropathy (AIDP), Guillaine-Barre syndrome.  Numbness and tingling.  Admitted to hospital.  Treated with IVIG, some success, relapse while in hospital.  Started on plasmapheresis - 5 treatments.  Helped, released from hospital, third relapse.  still have numbness and tingling one month after release from hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Dermatitis, Erythema, Injection site erythema, Injection site macule, Papule
Clinical narrative: Mother of patient (MOP) describes  patient received two vaccines without any immediate adverse event, one to each thigh. He was a little uncooperative about receipt but then was fine. She denies urticaria, flushing, restlessness, oral/face/throat/tongue swelling, voice change, wheezing, cough, watery eyes, n/v/d within first 2 hours of vaccine receipt. She states he was fine all day. The next day or day after she noted onset of a dermatitis characterized by small erythematous papules that were transient and new lesions formed. The initially presented on his back then spread to his chest and belly over the next week.  She states he had some pruritis, no vesicles or pustules. She noted an erythematous circular macule about dime sized at the injection site on his right thigh and it resolved at the same time as the urticaria  about 3 weeks later. She did not take any pictures. PCP was contacted day 23 and lesions were noted as resolved at that time.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Mother of patient (MOP) describes  patient received two vaccines without any immediate adverse event, one to each thigh. He was a little uncooperative about receipt but then was fine. She denies urticaria, flushing, restlessness, oral/face/throat/tongue swelling, voice change, wheezing, cough, watery eyes, n/v/d within first 2 hours of vaccine receipt. She states he was fine all day. The next day or day after she noted onset of a dermatitis characterized by small erythematous papules that were transient and new lesions formed. The initially presented on his back then spread to his chest and belly over the next week.  She states he had some pruritis, no vesicles or pustules. She noted an erythematous circular macule about dime sized at the injection site on his right thigh and it resolved at the same time as the urticaria  about 3 weeks later. She did not take any pictures. PCP was contacted day 23 and lesions were noted as resolved at that time.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Red, itchy,  painful spots around injection side.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Fatigue, Malaise, Pain
Clinical narrative: He recently had an injection in his left arm 1 week ago for the shingles vaccine.  He states he has had some fatigue and malaise associated with that in the initial 2-3 days after, but that has resolved.  He is not any fevers he is aware of, and no other medication changes.  He has decreased his exercise secondary to the pain and wonders what else he can do for this.  He is not having any vision or hearing changes, neck pain, chest pain, shortness of breath, lightheadedness, dizziness, or abdominal pain at this time. Appears to be a cellulitis
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dyspnoea, Pain in extremity, Painful respiration, Throat tightness
Clinical narrative: 5:15pm Patient complaint of some throat tightness and SOB, his arm is a little sore. Advised to take Zyrtec 10mg and if worsening in respiratory or throat sx to call 911.  6pm parent called stating he is doing better. No throat symptoms, chest aches a bit with deep breaths but no SOB or wheeze. Arm a bit more sore now. Instructed to monitor at home and if any anaphylactic sx to call 911. Advised to get benedryl and give 25mg at HS. Plan to pre-medicate for next HPV vaccine.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Injection site swelling, Pain, Skin warm
Clinical narrative: Swelling at injection site measuring 4 inches x 4 inches in the right arm starting the following day after immunization; nothing on left arm. Painful and hot to touch. Mother has been giving allegra, zyrtec, ice and applying antihistamine cream to the area. The spread of reaction seems to be slowing as of today (07/27)
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Muscle spasms, Myalgia, Nausea
Clinical narrative: muscle cramping pain, headache, extreme fatique, nausea, fever,
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: muscle cramping pain, headache, extreme fatique, nausea, fever,
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site swelling
Clinical narrative: RIGHT LEG SWOLLEN AT INJECTION SITE, NO TREATMENT
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Magnetic resonance imaging, X-ray limb
Clinical narrative: Persistent L should pain.  Has been give ibuprofen, prednisone, PT and recently started naproxen as is not improving
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired vaccine. The vaccine expired on 7/7/2020. Patient was informed of the problem and knows she needs to come back for another immunization to complete the series.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Periorbital swelling, Pyrexia, Swelling face, Urticaria
Clinical narrative: Widespread hives, facial swelling, fever, red face, periorbital swelling Treated with benadryl and po prednisone and sx resolved over next 3 days
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site oedema
Clinical narrative: Erythema less than 100mm, mild bruising at site, mild edema
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient received both vaccines on 7/23/20, patient came in on 7/27/20 with complaint of redness and hot to touch in the areas of injection site. I confirmed with patient she does not have any other symptoms besides these listed. Due to the time frame and patient still having reaction to injection I advised she seek further medical care and to be examined by her provider.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: patient had rash on torso, neck, and legs