chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Insomnia
Clinical narrative: flu like symptoms; CHILLS; MUSCLE ACHES; HEADACHE; fever of 100F - 101F; arm was sore; arm was sore  / extending down to the elbow; NERVE PAIN; not been able to sleep; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 6th September 2019, refer case US2020AMR058222).   On 20th February 2020, the patient received the 2nd dose of Shingrix. On 20th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, pain in elbow, nerve pain and sleeplessness. On 21st February 2020, the patient experienced influenza-like symptoms, chills, muscle pain, headache and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, chills, muscle pain, headache and fever were recovered/resolved and the outcome of the pain in arm, pain in elbow, nerve pain and sleeplessness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills, muscle pain, headache, fever, pain in arm, pain in elbow, nerve pain and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in right arm. The day after vaccination, the patient experienced influenza-like symptoms, chills, muscle pain, headache and fever. In the night of the vaccination, the patient's arm was sore and became more severe on Saturday night presenting in the upper arm and extending down to the elbow, the patient described it as nerve pain and was not been able to sleep since Saturday night due to pain in arm. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neuralgia, Pain in extremity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: flu like symptoms; CHILLS; MUSCLE ACHES; HEADACHE; fever of 100F - 101F; arm was sore; arm was sore  / extending down to the elbow; NERVE PAIN; not been able to sleep; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 6th September 2019, refer case US2020AMR058222).   On 20th February 2020, the patient received the 2nd dose of Shingrix. On 20th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, pain in elbow, nerve pain and sleeplessness. On 21st February 2020, the patient experienced influenza-like symptoms, chills, muscle pain, headache and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, chills, muscle pain, headache and fever were recovered/resolved and the outcome of the pain in arm, pain in elbow, nerve pain and sleeplessness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills, muscle pain, headache, fever, pain in arm, pain in elbow, nerve pain and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in right arm. The day after vaccination, the patient experienced influenza-like symptoms, chills, muscle pain, headache and fever. In the night of the vaccination, the patient's arm was sore and became more severe on Saturday night presenting in the upper arm and extending down to the elbow, the patient described it as nerve pain and was not been able to sleep since Saturday night due to pain in arm. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Erythema, Feeling hot, Hypersensitivity, Injection site erythema
Clinical narrative: has congestion; spring allergies; COPD; red around at the site; had a rash around her arm at the injection site; 10cm  pinpoint red around at the site,  a band around her arm; still warm to touch; had fever; felt ill,  not feeling good; achy; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included smallpox vaccine (had a small pox vaccine about 40 years ago 2 cm above where Shingrix was administered).   On 21st February 2020, the patient received the 1st dose of Shingrix. On 22nd February 2020, 1 days after receiving Shingrix, the patient experienced feeling unwell and general body pain. On 23rd February 2020, the patient experienced fever. On 24th February 2020, the patient experienced injection site rash, erythema, feeling of warmth and injection site erythema. On an unknown date, the patient experienced nasal congestion, allergy and chronic obstructive pulmonary disease. On an unknown date, the outcome of the feeling unwell, general body pain, fever, injection site rash, erythema, feeling of warmth, nasal congestion, allergy, injection site erythema and chronic obstructive pulmonary disease were unknown.   It was unknown if the reporter considered the feeling unwell, general body pain, fever, injection site rash, erythema, feeling of warmth, nasal congestion, allergy, injection site erythema and chronic obstructive pulmonary disease to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination, next day the patient felt ill not feeling good and achy. The second day after vaccination, had fever and on third day had had a rash around arm at the injection site. The reporter stated that, description of rash was 10 cm pinpoint red around at the site, a band around arm. The reporter stated that, the patient still had warm to touch and a shadow of the rash remains.  The patient had congestion with spring allergies that started after the vaccination, and had chronic obstructive pulmonary disease. The patient was seen last week in the office and again day before reporting. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Malaise, Nasal congestion, Pain, Pyrexia
Clinical narrative: has congestion; spring allergies; COPD; red around at the site; had a rash around her arm at the injection site; 10cm  pinpoint red around at the site,  a band around her arm; still warm to touch; had fever; felt ill,  not feeling good; achy; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included smallpox vaccine (had a small pox vaccine about 40 years ago 2 cm above where Shingrix was administered).   On 21st February 2020, the patient received the 1st dose of Shingrix. On 22nd February 2020, 1 days after receiving Shingrix, the patient experienced feeling unwell and general body pain. On 23rd February 2020, the patient experienced fever. On 24th February 2020, the patient experienced injection site rash, erythema, feeling of warmth and injection site erythema. On an unknown date, the patient experienced nasal congestion, allergy and chronic obstructive pulmonary disease. On an unknown date, the outcome of the feeling unwell, general body pain, fever, injection site rash, erythema, feeling of warmth, nasal congestion, allergy, injection site erythema and chronic obstructive pulmonary disease were unknown.   It was unknown if the reporter considered the feeling unwell, general body pain, fever, injection site rash, erythema, feeling of warmth, nasal congestion, allergy, injection site erythema and chronic obstructive pulmonary disease to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination, next day the patient felt ill not feeling good and achy. The second day after vaccination, had fever and on third day had had a rash around arm at the injection site. The reporter stated that, description of rash was 10 cm pinpoint red around at the site, a band around arm. The reporter stated that, the patient still had warm to touch and a shadow of the rash remains.  The patient had congestion with spring allergies that started after the vaccination, and had chronic obstructive pulmonary disease. The patient was seen last week in the office and again day before reporting. The reporter consented to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Chills, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: dose of Shingrix on December 22, 2019, and the second dose a month later on January 22, 2020; has bad shivering all of the time /  started out as chills and she would use her blanket and "later on would be okay; started feeling "awful"; This case was reported by a consumer via call center representative and described the occurrence of chills in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced chills and feels awful. On 22nd January 2020, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the chills was not recovered/not resolved and the outcome of the feels awful and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the chills and feels awful to be related to Shingrix.   Additional details were provided as follows: On 22nd December 2019, the patient received 1st dose of Shingrix and 1 month later received 2nd dose of Shingrix, which led to shortening of vaccination schedule. The patient stated that sometime in January 2020, she started feeling awful and had bad shivering all of the time. She stated that at first it started out as chills and she would use her blanket and later on would be okay. She stated that at the time of reporting, it was worse and was happening all of the time. She had visited her doctor who took blood work and the lab results were okay. She had no fever or anything else. She was asking if this was going to last forever and if there was anything that she can take. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash, Rash pruritic
Clinical narrative: Patient called the clinic 5 days after the vaccine administration to report a rash on the same arm that the vaccine was administered. Patient reported a white bump at the injection site, and there is a rash travelling down the arm to the fingertips that has some itchiness. Patient was prescribed diphenhydramine, and the reaction cleared.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Influenza virus test negative, Malaise, Pyrexia, Rash
Clinical narrative: received vaccines on 3/30/20-.  Parents reported Fevers, rash and diarrhea starting  4/2/2020.  Rash was on trunk and extremities.  They were seen at an ER on 4/4/2020.  Fever ( up to 103) persisted  until into the night of 4/6 (now resolved)  but rash appeared to be fading and diarrhea continued.  They had a telehealth visit on 4/7 and an office visit on 4/8.  The visit  on 4/8 was due to worsening or change in rash parents had seen and child acting like he did not feel as well and threw up twice in the morning.  In the office on 4/8-- the rash appeared to be c/w  urticaria and responded to oral benadryl in office.  As the rash faded the child's temperament in the office improved as well.  Currently treating w/ combination of kids Zyrtec  daily and benadryl for breakthrough rash. .    Vital signs were stable and lungs were clear.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria, Vomiting
Clinical narrative: received vaccines on 3/30/20-.  Parents reported Fevers, rash and diarrhea starting  4/2/2020.  Rash was on trunk and extremities.  They were seen at an ER on 4/4/2020.  Fever ( up to 103) persisted  until into the night of 4/6 (now resolved)  but rash appeared to be fading and diarrhea continued.  They had a telehealth visit on 4/7 and an office visit on 4/8.  The visit  on 4/8 was due to worsening or change in rash parents had seen and child acting like he did not feel as well and threw up twice in the morning.  In the office on 4/8-- the rash appeared to be c/w  urticaria and responded to oral benadryl in office.  As the rash faded the child's temperament in the office improved as well.  Currently treating w/ combination of kids Zyrtec  daily and benadryl for breakthrough rash. .    Vital signs were stable and lungs were clear.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea haemorrhagic, Gastrostomy, Haematochezia, Influenza, Oesophagogastric fundoplasty
Clinical narrative: flu; the patient was readmitted to the hospital from 3/9/2020 through 3/12/2020 for vomiting and and bloody diarrhea; the patient was readmitted to the hospital from 3/9/2020 through 3/12/2020 for vomiting and and bloody diarrhea; This spontaneous report was received from a physician and refers to a infant female patient who was born with congenital diaphragmatic hernia and lung hypoplasia. The patient's medical history included hospitalization for two months after birth, due to congenital anomalies. There was no information about the patient's allergies, drug reactions or concomitant therapies provided. On unknown date in 2019, while hospitalization after birth, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dose, lot # and expiration date were not reported) for prophylaxis. On unknown date in February 2020, the patient was admitted to the hospital due to the flu. The patient sought medical attention and received unspecified treatment. While hospitalization G-tube was placed as well as Nissen fundoplication procedure due to congenital anomalies. During the admission, the patient was administered all age appropriate unspecified vaccines, except the second dose ofrotavirus vaccine, live, oral, pentavalent (ROTATEQ). Since 9-MAR-2020 to 12-MAR-2020, the patient was readmitted to the hospital because of vomiting and bloody diarrhea. The patient sought medical attention and received unspecified treatment.  The outcome of flu was unknown. The physiaican reported that the event of vomiting had resolved but the patient still had blood in stool.   The causality assessment between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.   Upon internal review the event of bloody diarrhea (haematochezia) was considered to be medically significant.
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: flu; the patient was readmitted to the hospital from 3/9/2020 through 3/12/2020 for vomiting and and bloody diarrhea; the patient was readmitted to the hospital from 3/9/2020 through 3/12/2020 for vomiting and and bloody diarrhea; This spontaneous report was received from a physician and refers to a infant female patient who was born with congenital diaphragmatic hernia and lung hypoplasia. The patient's medical history included hospitalization for two months after birth, due to congenital anomalies. There was no information about the patient's allergies, drug reactions or concomitant therapies provided. On unknown date in 2019, while hospitalization after birth, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dose, lot # and expiration date were not reported) for prophylaxis. On unknown date in February 2020, the patient was admitted to the hospital due to the flu. The patient sought medical attention and received unspecified treatment. While hospitalization G-tube was placed as well as Nissen fundoplication procedure due to congenital anomalies. During the admission, the patient was administered all age appropriate unspecified vaccines, except the second dose ofrotavirus vaccine, live, oral, pentavalent (ROTATEQ). Since 9-MAR-2020 to 12-MAR-2020, the patient was readmitted to the hospital because of vomiting and bloody diarrhea. The patient sought medical attention and received unspecified treatment.  The outcome of flu was unknown. The physiaican reported that the event of vomiting had resolved but the patient still had blood in stool.   The causality assessment between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.   Upon internal review the event of bloody diarrhea (haematochezia) was considered to be medically significant.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-1465) was received from a pharmacist on 06-Jun-2019. It describes a 15-year-old female consumer who "took two doses in a row", while being on Vivotif for an unknown indication.  Case report: The consumer took two doses in a row. The doses were taken on 05-Jun-2019 and 06-Jun-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Muscle pain; Tingling all over body; This case was reported by a pharmacist via call center representative and described the occurrence of tingling in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 39KB3, expiry date 1st April 2022) for prophylaxis.   On 27th February 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th February 2020, immediately after receiving Shingrix, the patient experienced tingling. On an unknown date, the patient experienced muscle pain. On an unknown date, the outcome of the tingling was not recovered/not resolved and the outcome of the muscle pain was recovered/resolved.   It was unknown if the reporter considered the tingling and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient started experiencing tingling all over the body right after getting the vaccine and it had still not resolved. Less than 2 months after vaccination, the patient experienced muscle pain and had recovered.  The pharmacist did not know when exactly the muscle pain started and resolved. No further details were provided.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ageusia, Anosmia, Inappropriate schedule of product administration
Clinical narrative: loss of taste and smell; loss of taste and smell; had first dose of Shingrix on 23SEP2020 and second dose on 02APR2020; This case was reported by a consumer via call center representative and described the occurrence of taste loss in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd April 2020, the patient received the 2nd dose of Shingrix. On 2nd April 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced taste loss and loss of smell. The action taken with Shingrix was unknown. On an unknown date, the outcome of the taste loss, loss of smell and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the taste loss and loss of smell to be related to Shingrix.  Additional details were provided as follows: The patient reported that around the time of the first dose vaccination, she noted that she lost sense of smell and taste, noticed that especially with food. The patient received 2nd dose of Shingrix late, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ageusia, Anosmia
Clinical narrative: loss of taste and smell; loss of taste and smell; had first dose of Shingrix on 23SEP2020 and second dose on 02APR2020; This case was reported by a consumer via call center representative and described the occurrence of taste loss in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd April 2020, the patient received the 2nd dose of Shingrix. On 2nd April 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced taste loss and loss of smell. The action taken with Shingrix was unknown. On an unknown date, the outcome of the taste loss, loss of smell and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the taste loss and loss of smell to be related to Shingrix.  Additional details were provided as follows: The patient reported that around the time of the first dose vaccination, she noted that she lost sense of smell and taste, noticed that especially with food. The patient received 2nd dose of Shingrix late, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 0.08
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: accidentally administered flu shot to one month old patient/ No AE; Based on information previously received on 16-Dec-2019, the following information (case previously considered as non-valid became valid) has been amended.  Initial information was received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.   This case involves a one months old female patient who was accidentally administered with 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (formulation: prefilled syringe) (lot number: UT6645KA and expiry date: not reported) via unknown route in an unknown administration site for prophylactic vaccination on 11-Dec-2019 .  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was 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 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: 6.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a six year seven month old patient received a dose of Adacel instead of the Pediatric Dtap vaccine/No AE; a six year seven month old patient received a dose of Adacel instead of the Pediatric Dtap vaccine/No AE; Initial information received on 18-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a six year seven-month old female patient who received a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6638AA, expiry date: 12-Apr-2022 via unknown route in the right foot on 11-Mar-2020 instead of the pediatric DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTAP].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  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 holders 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: 0.33
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a four months old female patient accidently received a 0.25 ml dose of Fluzone Quadrivalent/No AE; Initial information received on 18-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a four months old female patient who accidently received a first dose of 0.25 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot U6653BD, expiry date: 30-Jun-2020 via intramuscular route in the left thigh on 18-Mar-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error 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 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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received ActHIB with expired diluent, no adverse event; Initial information received on 19-Mar-2020 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a patient (age and gender not reported) who received a dose of expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot number unknown, powder expiry 27-Jun-2020 and diluent expiry 13-Mar-2020) via unknown route and unknown administration site on an unknown date for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was reported that they administered ActHIB on yesterday. ActHIB powder has an expiration date of 27-Jun-2020 and the diluent has an expiration date of 13-Mar-2020.   It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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.  There will be no information available on the batch number for this case.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given expired diluent; Initial information received on 19-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 months old male patient who was administered a 0.5 mL dose with an expired vaccine of HIB (PRP/T) VACCINE [ACT-HIB] (powder lot number- UI964AA and expiry date 28-Jun-2020 and diluent lot number- U6178AA and expiry date 13-Mar-2020) via intramuscular route in left thigh on 19-Mar-2020 for prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Mar-2020, the concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) (not produced by Sanofi Pasteur, lot number unknown) via unknown route in unknown administration site.  It was an actual medication error case due to expired vaccine used.   No adverse event reported at the time of reporting.  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: 1.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product reconstitution quality issue, Underdose
Clinical narrative: DTAP/IPV liquid inserted into the Acthib vial, powder became wet but did not re-suspend, no adverse event; she did administer to patient but an uncertain amount of powder remained in the vial, no adverse event; the liquid was not a short dose, powder just appeared hardened, no adverse event; Initial information received on 24-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 19 months old male patient for whom it was reported that while administering DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] an uncertain amount of powder remained in the vial (underdose), dtap/ipv liquid inserted into the acthib vial, powder became wet but did not re-suspend (product reconstitution quality issue) and the liquid was not a short dose, powder just appeared hardened (product quality issue).   Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); HEPATITIS A VACCINE (HEPATITIS A); and INFLUENZA VACCINE (FLU).   On 24-Mar-2020, the patient received a first dose of 0.5mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Lot number: vial:UJ197AA, diluent: U6615AA) (Expiry date: 02-Mar-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose, product reconstitution quality issue and product quality issue.  Reporter reported product complaint regarding reconstitution of Pentacel. Reporter reported that entire DTAP/IPV liquid was inserted into the Acthib vial, powder became wet but did not re-suspend. Reporter reported that she did administered to patient but an uncertain amount of powder remained in the vial. Reporter reported product was out of refrigeration for a few minutes, taken to patient's room where reconstituted. Reporter reported that the liquid was not a short dose, powder just appeared hardened. As per Q&A section: Appearance : white or gray clumps, flakes, sand like particles and/or difficult to resuspend.  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: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, Injection site erythema
Clinical narrative: Pentacel dose was given sooner than intended to the patient; the injection site quickly turned a little red; Initial information received on 24-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 15 months old male patient who developed the injection site quickly turned a little red (vaccination site erythema), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 07-Jan-2020, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number not reported) via unknown route at an unknown administration site. On 24-Mar-2020 he also received a dose of the same vaccine with an unknown batch number via unknown route at left hip area.  On 24-Mar-2020, the patient's injection site quickly turned a little red (vaccination site erythema) (non-serious), 2 months 17 days following the initial dose and on the same day following the last dose administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  The reporter stated that her physician called her after her son's visit today and informed her that Pentacel was given sooner than intended. He had a dose of Pentacel on 07-Jan-2020 and again today on 24-Mar-2020. Today's dose was given in the left hip area. The reporter reported that her son does not follow the typical schedule of vaccinations. Reporter was unsure which dose this was for her son. Today when it was given, the injection site quickly turned "a little red". The doctor told her this is common with vaccines which contain tetanus. Patient was fine otherwise. Patient had no fever.  It was also a case of actual medication error due to Drug dose administration interval too short.  No laboratory data were reported.  Final diagnosis was vaccination site erythema.   It was not reported if the patient received a corrective treatment.  Event outcome was not reported for vaccination site erythema.  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: 0.58
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: patient was given the Pentacel diluent component alone without it being mixed with the Hib component/No AE; separate ActHIB vaccine was improperly mixed with a Merck sterile water diluent and then administered/NO AE; Initial information was received on 20-Mar-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 7 month old female patient who received diluent component alone without it being mixed with the Hib component of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (0.5 mL dose, lot U6613AA expiry 22Feb2021) and then, when that error was realized, another error was made when a separate HIB (PRP/T) VACCINE [ACT-HIB] (lot UI965AA expiry 29Jun2020) was improperly mixed with a Merck sterile water diluent and then administered, both via unknown route in the left thigh for prophylactic vaccination on 19-Mar-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunization.  It was a case of an actual medication error due to Inappropriate reconstitution technique and Wrong solution used in drug reconstitution.  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: 52.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at the site. + erythema. Temp 103. Advised to take tylenol and apply ice  to the site. Fever subsided and symptoms improved over a couple of hours.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: red left leg and fever
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple unspecified patients were admnistered a dose of improperly stored PEDVAX HIB; No adverse symptoms were reported; This non-valid, spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On unknown dates, the patients were vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S021456, expiration date 25-FEB-2022 (dose, frequency, route of administration were not provided) for prophylaxis.   Administered doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion below 36 Fahrenheit degrees (F) (35.2F) for 15 minutes. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse symptoms were reported.  The case is non-valid due to lack of the patients' identifiers.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; a patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.       On 07-APR-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection administered by subcutaneous route as prophylaxis (dosage regimen, strength, and anatomical location were not reported; lot number and expiration date were unknown by the reporter) (product storage error). The patient experienced no symptoms. It was unknown if the sterile diluent (MERCK STERILE DILUENT) used for administration was stored properly.      The vaccine underwent a temperature excursion of -14.3 degrees Celcius for 12 minutes, with a previous unspecified temperature excursion as captured by a data logger.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient called pharmacy on 4/8/20 to inform the manager that she thinks the flu shot administered on 3/6/20 was placed too high on the shoulder, impacting her shoulder joint. She has been in excruciating pain starting a few days after administration to the point where it is difficult to raise arm above her head to get dressed. Her primary care physician agreed with her assessment and prescribed a round of prednisone but patient did not get much relief.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Antibody test positive, Erythema, Papule, Pruritus, Rash vesicular
Clinical narrative: 03/13/20 at 0900 am :Received Varicella, Dtap +IPV, and MMR vaccines 04/06/20 at 0800 am : Mom noticed fluid filled bumps and redness during bath, mom brought child to clinic, provider applied PPE to self and staff, assessment, lab ordered: varicella IGM and Varicella IGG.  Patient sent home, instructed to keep papules covered, good hand washing and keep sibling away from new baby. 04/08/20 1000am:  mom states scabbing and itching and keeping away from newborn. 04/08/20 01:20 pm:  LAB RESULTS: Varicella zoster IGG 2974.00, varicella zoster IGM 0.91
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Scab
Clinical narrative: 03/13/20 at 0900 am :Received Varicella, Dtap +IPV, and MMR vaccines 04/06/20 at 0800 am : Mom noticed fluid filled bumps and redness during bath, mom brought child to clinic, provider applied PPE to self and staff, assessment, lab ordered: varicella IGM and Varicella IGG.  Patient sent home, instructed to keep papules covered, good hand washing and keep sibling away from new baby. 04/08/20 1000am:  mom states scabbing and itching and keeping away from newborn. 04/08/20 01:20 pm:  LAB RESULTS: Varicella zoster IGG 2974.00, varicella zoster IGM 0.91
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood test normal, Decreased appetite, Hypersomnia, Lethargy, Somnolence
Clinical narrative: EXTREME SLEEPINESS AND DROWSINESS; CANNOT KEEP HIS EYES OPEN; REQUIRING 18+ HOURS OF SLEEP PER DAY; DOESN'T WANT TO EAT OR DRINK OR DO ANYTHING
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Cold sweat, Pain, Paraesthesia
Clinical narrative: the patient complained on the evening after receiving the injection of body aches, shivering, a cold sweat, aching, weakness and body tingling.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Headache, Insomnia, Myalgia
Clinical narrative: Later in the evening, around 10pm, symptoms got worse including: body aches, headache, fever, fatigue--like if someone hit with with bat.   Patient thought initially symptoms were related to food poisoning. Today, patient had soreness on muscles and joints sore, a little fever, and a  headache.  Patient was trying to eat and took naps which were helpful. Patient has not taken any medicine and will follow-up with provider.  Per patient, worse of it was last night since he couldn't even sleep. Vaccine area feels sore but not as much anymore.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Later in the evening, around 10pm, symptoms got worse including: body aches, headache, fever, fatigue--like if someone hit with with bat.   Patient thought initially symptoms were related to food poisoning. Today, patient had soreness on muscles and joints sore, a little fever, and a  headache.  Patient was trying to eat and took naps which were helpful. Patient has not taken any medicine and will follow-up with provider.  Per patient, worse of it was last night since he couldn't even sleep. Vaccine area feels sore but not as much anymore.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Donor reports from 04/05/2020 to 04/08/2020 spreading erythema from injection site, with concomitant warmth and tenderness.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Patient got a localized reaction to shot. There is a aprox.4mm bump on left medial deltoid.  MD notified, gave benadryl at bedside. Transported patient and parent to ER.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMRV, RV5
Symptoms: Albumin CSF, CSF immunoglobulin G index, CSF test, Death, Encephalitis
Clinical narrative: Acute bilateral cerebellitis, respiratory failure, anoxic encephalopathy, death. Presented to Hospital on 1/17/2020, expired 1/25/2020.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMRV, RV5
Symptoms: Hypoxic-ischaemic encephalopathy, Magnetic resonance imaging, Respiratory failure
Clinical narrative: Acute bilateral cerebellitis, respiratory failure, anoxic encephalopathy, death. Presented to Hospital on 1/17/2020, expired 1/25/2020.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Vomited once one hour after vaccine
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: pain at the injection site; received the first dose of Shingrix via subcutaneous route; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 22S3B, expiry date 25th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. Nurse reported that 17 patients received the first dose of Shingrix via subcutaneous route, which led to intramuscular formulation administered by other route. Some of them were female patients. Nurse did not provide initials, date of birth, lot number and expiration dates of the vaccines. She did not said how many patients were male and how many were female. This is 1 of the 17 cases, reported by same reporter.   Follow up information received from nurse on 3rd April 2020 as follows: The patient's demographic details were updated. The batch number updated for the suspect vaccine. The patient's past medical history included hypertension, hyperthyroidism, stress incontinence (small) and osteoarthritis, it was ongoing at the time of reporting.  On 16th January 2020, the patient received the 1st dose of Shingrix  .5 ml. On 16th January 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.  It was unknown if the reporter considered the injection site pain to be related to Shingrix. The VAERS details were updated.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ageusia, Anosmia, Inappropriate schedule of product administration
Clinical narrative: LOSS OF SMELL AND TASTE
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ageusia, Anosmia
Clinical narrative: LOSS OF SMELL AND TASTE
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Swelling face, Swollen tongue, Urticaria
Clinical narrative: Itchy rash, welts, tongue/facial swelling.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site papule, Injection site pruritus, Papule
Clinical narrative: On Wednesday 4/8/20, patient noticed erythematous papules on his right deltoid, his right abdomen, and behind his right ear. They are mildly itchy.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: On Wednesday 4/8/20, patient noticed erythematous papules on his right deltoid, his right abdomen, and behind his right ear. They are mildly itchy.