chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA, PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 1.25
Sex: U
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Immediate post-injection reaction, Injection site pain, Myalgia
Clinical narrative: Immediately following vaccine injection, injection site was sore. The injection site soreness eventually subsided, but the arm has continued to have muscular and shoulder pain since, and the pain has increased over time. It has become somewhat debilitating at this point and I believe I have SIRVA from the injection.
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.17
Sex: U
Vaccine: HIBV, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.58
Sex: M
Vaccine: FLU4, HIBV, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.5
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 19.0
Sex: M
Vaccine: FLU4, HEPAB
Symptoms: Dizziness
Clinical narrative: @ 1:12 pm, patient is sitting on the chair , twinrix and flu vaccine was administered. Right after receiving the vaccine, patient stated "I feel dizzy". LN responded quickly and CODE BLUE was paged overhead. Another staff responded quick and came in the immunization room and helped assessed the patient. Placed patient on a lying position with both legs elevated . VS BP 112/57, HR 52 ,02 sat in RA 98%. Cont. to monitor.  @ 1:15 pm, multiple staff came in to help assessed the patient. Patient still in a lying position with both legs elevated. VS: BP 128/76 ,HR 51, 02 SAT 99% RA.  @ 1:18 PM, patient stated " I feel 100 % okay". Alert and verbally responsive. No c/o dizziness, no pain or discomfort. No difficulty breathing. Staff was still cont.  monitoring the patient.VS: BP 112/57, HR 57, , 02 SAT 98% RA. @1:20 pm, patient stated " I feel okay". No dizziness, no pain or discomfort. Advised patient to stay for another 10 minutes to be monitored. Also advised patient to f/u with his PCM for further eval. regarding what happened today. Patient stated understanding with no further questions at this time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: $ days later , had very severe  stiffness and pain , in muscles , and shoulders , hands were swelled up , unable to make a fist for several , hours in morning , had to use a cane , and unable to move shoulders , and also felt very tired
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Walking aid user
Clinical narrative: $ days later , had very severe  stiffness and pain , in muscles , and shoulders , hands were swelled up , unable to make a fist for several , hours in morning , had to use a cane , and unable to move shoulders , and also felt very tired
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 1.58
Sex: U
Vaccine: FLU4, HEPA, PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Nausea, Pallor, Pyrexia
Clinical narrative: NO REDNESS OR SWELLING @ INJ. SITE  PT BECAME PALE, HEADACHE, NAUSEA, CHILLS, LOW GRADE TEMP.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored VARIVAX was administered to patient on 5/19/2020; No adverse affects reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 19-MAY-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S012036, expiration date 17-APR-2021 (dose and route of administration were not provided) for prophylaxis.  The dose of the product administered to the patient was not stored properly for the time frame of 4 hours in the temperature of 48.2 degrees Fahrenheit on an unknown date. There was no previous temperature excursion. Digital Data Logger was involved. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.   The case was reported by the reporter for the her daughter. The age at the vaccination was not reported. The patient received Shingrix and experienced arm pain.  No details about the patients was available at time of report. The reporter did not consent to follow up. This case linked with US2020084176, US2020AMR084983 and US2020AMR084982, reported by same reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Showed erythema localized to a lesion erythema localized to area of injection in (L) thigh 3in x 1.5in no induration, warm to palpation erythema localized to area of injection (R) thigh 0.8cm x 0.1 cm no induration. Warm to palpation. Discussed reaction to vaccination. Okay to use ice to alleviate pain intermittently. The red may continue to spread. Discussed S&Sx of infection. Will monitor. Fam understands possibility of knot forming or spreading of erythema. Continue w/antipyretics as needed.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, fever, shivering, muscle pain & nausea
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient was given the liquid portion of Pentacel only/ No AE; Initial information was received on 18-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 25 months old female patient who received only liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (fourth dose 0.5 mL, lot number : UJ259AAA, expiry date- 14-May-2021) via intramuscular route in left thigh for prophylactic vaccination on 14-May-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (product preparation issue).  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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ActHib was administered, no AE; Initial information received on 18-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves an unknown demographic patient who was vaccinated with a 0.5 mL expired dose of HIB (PRP/T) VACCINE [ACT-HIB] vaccine (third dose in series, lot UJ121AAE and expiry date was 05-May-2020) via an intramuscular route in the left thigh for prophylactic vaccination on 18-May-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  It is an actual medication error case due to expired vaccine used as it was reported that an expired dose of ActHib was administered to a unknown demographic patient.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Menactra was inadvertently administered to a patient, no adverse event; Initial information was received on 19-May-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves an 18 year old male patient who was administered an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] inadvertently (Expired product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 19-May-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6204AA, expiry date 08-May-2020) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  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.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered with a dose of frozen MENECTRA, no AE; Initial information received on 19-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to cases 2020SA133784, 2020SA133785, 2020SA133787 and 2020SA133786 (same reporter).  This case involves a 18 years old patient who received a dose of frozen MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  It was an actual medication error due to product storage error temperature too low (Product storage error) as the patient was administered with a dose of frozen MENECTRA.  At the time of reporting, the patient did not experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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 batch number for this case.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received pentacel vaccine which was forzen/No AE; Initial information was received on 19-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to cases 2020SA133785, 2020SA133715, 2020SA133786 and 2020SA133787 (same reporter)  This case involves a six-months-old patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]] which was frozen (incorrect product storage).  Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage as patent received a dose of frozen Pentacel.  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.  There will be no information available on the batch number for this case.
Age: 1.58
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: 19 month patient who received pentacel vaccine which was frozen/No AE; Initial information was received on 19-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to cases 2020SA133784, 2020SA133715, 2020SA133786 and 2020SA133787 (same reporter)  This case involves a 19-month-old patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]] which was frozen (incorrect product storage).  Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage as 19 month patient received Pentacel vaccine which was frozen.  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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Product storage error
Clinical narrative: frozen Daptacel was administered to a patient/No AE; Initial information was received on 19-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to cases 2020SA133784, 2020SA133785, 2020SA133715 and 2020SA133787 (same reporter).  This case involves a patient of an unknown demographics who received a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] which was frozen (product storage error).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage as frozen Daptacel was administered to a patient.  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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: ActHiB was frozen and then administered to a patient/No AE; Initial information was received on 19-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to cases 2020SA133784, 2020SA133785, 2020SA133715 and 2020SA133786 (same reporter).  This case involves a patient of an unknown demographics who received HIB (PRP/T) VACCINE [ACT-HIB], which was frozen.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage as ActHIB that had been frozen and then administered.  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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: allergy to tetanus toxoide and vertioxetine; Initial information received on 18-May-2020 regarding an unsolicited valid non-serious courtesy case from a physician via non-licensed partner (pfizer).  This case involves a patient who experienced allergy to tetanus toxoide and vertioxetine (hyeprsensitivity), while he/she received vaccine TETANUS TOXOID and while treated with VORTIOXETINE.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.   On an unknown date, the patient started taking VORTIOXETINE dosage unknown (with an unknown batch number) via unknown route for unknown indication. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergy to tetanus toxoide and vertioxetine (hypersensitivity) (Unknown latency) following the first dose intake and (unknown latency) following the last dose intake of VORTIOXETINE and (Unknown latency) following the administration of TETANUS TOXOID.  Laboratory details were not reported.  Final diagnosis was hypersensitivity.  The action taken for VORTIOXETINE was unknown.  It was not reported if the patient received any corrective treatment.  The event outcome was not reported.  There will be no information available on batch number for this case.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 4 year old child inadvertently received Pentacel instead of Quadracel/no AE; Initial information received on 21-May-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 years old patient who inadvertently received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL](batch number and expiry date not reported) via unknown route in unknown administration site on an unknown date for prophylactic vaccination(wrong product administered). It was also reported that this is the child's 4th dose of DTaP and IPV and an extra dose of HIB.  Past vaccination(s) included tetanus. Medical history, concomitant therapy, medical treatment(s) and family history were not provided.   It was an actual medication error case due to wrong vaccine administered.  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.  There will be no information available on batch number for this case.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient who received a possibly expired vaccine, no adverse event; Initial information was received on 22-May-2020 regarding an unsolicited valid non-serious case from a nurse  This case involves a child patient who possibly received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5202AA, expiry date 16-May-2019) via unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.   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: FLUC4
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Shortness of breath; Dizziness; This is a spontaneous case, reported by other non-health professional to Agency (reference number: SEQW20-00415) on 18-May-2020, concerning a female patient of unknown age.  The patient's medical history and concomitant medications were not provided.  On 29-Dec-2019, the patient was administered Flucelvax Quad [influenza vaccine, subunit influenza virus vaccine polyvalent, anatomical location: left deltoid muscle, batch number: reported as 261922 (Seqirus batch number: 261222), expiry date: Jun-2020, dose and route of administration: not reported] for influenza prophylaxis.  On the same day, after vaccine was administered, the patient started to complain of shortness of breath and dizziness. The patient was transported by ambulance for medical attention and received treatment for the events. No details regarding treatment were provided.  At the time of initial report, the outcome of the events shortness of breath and dizziness was unknown.  Per company, the events of shortness of breath and dizziness were considered serious due to the criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax Quad.  Company comment: The patient developed dyspnoea and dizziness on the same day after vaccination with the suspect product, Flucelvax Quad. Chronology is suggestive. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and both events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed dyspnoea and dizziness on the same day after vaccination with the suspect product, Flucelvax Quad. Chronology is suggestive. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and both events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Erythema, Headache, Pain, Pain in extremity
Clinical narrative: This was the second shingles shot given right before the 6 month period ended. I started that evening with the red swollen warm sore arm like the first time and headache. The next day I started with the fever and body aches fever got to 100.8   I knew these were normal side effects and took Advil.  But then the soreness and swelling went to my underarm and I guess lymph nodes under arm.  It is now Tuesday and the injection site is almost normal but my underarm is still sore and swollen
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Swelling
Clinical narrative: This was the second shingles shot given right before the 6 month period ended. I started that evening with the red swollen warm sore arm like the first time and headache. The next day I started with the fever and body aches fever got to 100.8   I knew these were normal side effects and took Advil.  But then the soreness and swelling went to my underarm and I guess lymph nodes under arm.  It is now Tuesday and the injection site is almost normal but my underarm is still sore and swollen
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Asthenia, Injection site erythema, Injection site warmth, Laboratory test
Clinical narrative: Mother communicated on 05/21/2020 at 12:15 pm and reported that the minor had symptoms to vaccination administered on 05/19/2020. Mother communicates with the office again at 12:29 pm and reports that the minor had symptoms. The symptoms were redness in the area and warmth, fever, sore throat and stomach pain, vomiting and weakness. She also specified that the minor was "very thirsty". The mother was advised about the symptoms that patient may present after vaccination. Mother was called on 05/22/2020 to follow up on the minor and indicated that she had to take the minor to the emergency room because the symptoms continued.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Oropharyngeal pain, Pyrexia, Thirst, Vomiting
Clinical narrative: Mother communicated on 05/21/2020 at 12:15 pm and reported that the minor had symptoms to vaccination administered on 05/19/2020. Mother communicates with the office again at 12:29 pm and reports that the minor had symptoms. The symptoms were redness in the area and warmth, fever, sore throat and stomach pain, vomiting and weakness. She also specified that the minor was "very thirsty". The mother was advised about the symptoms that patient may present after vaccination. Mother was called on 05/22/2020 to follow up on the minor and indicated that she had to take the minor to the emergency room because the symptoms continued.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling 3 inches below injection site
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Patient developed severe diarrhea and had blood in her stool following rotateq vaccination. No constipation, no rashes, no diaper rash or open wounds around diaper area. Did have mucous in stool with streaks of frank red blood. Did not give rotateq at 4 month visit and did not have these symptoms again with pentacel and prevnar. First blood 6 days after rotateq vaccine and diarrhea x 2 days following vaccine.