chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR
Symptoms: Swelling, White blood cell count decreased
Clinical narrative: groin swelling; low white blood cells; This spontaneous report was received from a consumer and refers to a 15-month-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced groin swelling and mild white blood cell count decreased. The outcome of swelling and white blood cell count decreased was unknown. Causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine in use; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-SEP-2020, the patient was vaccinated with improperly stored vaccine, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot#: T013540 has been verified to be a valid lot number, expiration date 17-OCT-2021, albumin status: rHA (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of (6 to 14 Fahrenheit degree (11.7 F)) degrees Fahrenheit for 25 minutes. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reported an improperly stored administered Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 15-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) lot number T013539 was verified to be valid, expiration date reported and  established as 17-OCT-2021 (dose, frequency and route of administration were not provided) for prophylaxis.   The administered dose of vaccine experienced a temperature excursion of 6 to 14 Fahrenheit degrees (11.7 Fahrenheit degrees) for 25 minutes. There was no previous temperature excursion. Digital Data Logger was involved.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician regarding a 34-years-old female patient. The patient's pertinent medical history included depression. Her drug allergies included penicillin and her concomitant medications included bupropion hydrochloride. On an unknown date, a Papanicolaou came out positive for human papilloma virus .  On 13-APR-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose reported as 1, intramuscularly as routine immunization (lot number R028387 with expiration date on 27-JUL-2021) (anatomical location was not reported).  On an unknown date in April 2020, the patient experienced joint pain. The patient did not seek for attention and did not received treatment for the joint pain (arthralgia). On 11-JUN-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose reported as 1, intramuscularly as routine immunization (lot number R028387 with expiration date on 27-JUL-2021) (anatomical location was not reported), and her joint pain got progressively worse after this dose. The physician wondered if the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) should be administered. At the time of this report, the patient had not recovered from joint pain. It was reported that therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not discontinued.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and arthralgia was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Limb discomfort, Pain in extremity, Sleep disorder
Clinical narrative: Pain/Arm was sore; Chills; Fatigue; Arm was uncomfortable; symptoms woke her up at night; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain (1st dose received on an unknown date and experienced pain, refere case US2020187890).   On 17th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). In September 2020, less than a day after receiving Shingrix, the patient experienced pain in extremity, chills, fatigue, limb discomfort and sleep disturbance. The patient was treated with IBUPROFEN. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in extremity, chills, fatigue, limb discomfort and sleep disturbance were unknown.   It was unknown if the reporter considered the pain in extremity, chills, fatigue, limb discomfort and sleep disturbance to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix and experienced pain, chills and continue to feel fatigue. She stated that symptoms were worse also woke her at night. She took two ibuprofen to feel relief. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187890:same reporter, different dose
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: completed the Hep B series as a child, however had low titers; This case was reported by a other health professional and described the occurrence of therapy non-responder in a 20-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The patient was completed the Hepatitis B series and had low titers, which leads to therapy non responder. it was determined the patient would need to be re-vaccinated.  No further details provided. For tolerance of dose to hepatitis B refer case, US2020187913.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187913:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: standard pain; redness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number P7HK7, expiry date unknown) and (batch number 275KY, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain, erythema and swelling were unknown.   It was unknown if the reporter considered the pain, erythema and swelling to be related to FluLaval Quadrivalent.  Additional details were reported as follows: The age at vaccination was not reported. It was reported that the Immunization Consultant from the Immunization Program provided a high-level overview. It was reported that one clinic site got call and patient reported that after the vaccination with FluLaval experienced standard pain, redness, swelling.  It was stated It was possible that these were administration technique errors and not related to vaccine product quality. They are currently evaluating the administration technique and retraining. This case is 1 of the 4 cases reported by same reporter. The reporter did not consent to follow up. The reporter reported 2 different batch number for FluLaval. It was unknown for which case which batch number was provided, hence both batch number were been captured in the case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189448:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189449:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189451:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189450:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Redness from the deltoid injection site that extended to the elbow; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 275KY, expiry date unknown) or (batch number P7HK7, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to FluLaval Quadrivalent.   Additional details were as follows: The age at vaccination was not reported. Patient received FluLaval Quadrivalent with batch number either P7HK7 or 275KY. It was reported that the Immunization Consultant from the Immunization Program provided a high-level overview. It was reported that one clinic site got call and patient reported that after he vaccination with FluLaval experienced redness that extended from the leg injection site to the knee. It was stated It is possible that these were administration technique errors and not related to vaccine product quality. They are currently evaluating the administration technique and retraining. This case is one of the 4 cases reported by same reporter. The reporter did not consent to follow up. It was unknown, which batch number reported for which case, hence both batch number added in subtab.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189451:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189448:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189418:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189450:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: standard pain; redness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number P7HK7, expiry date unknown) or (batch number 275KY, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain, erythema and swelling were unknown.   It was unknown if the reporter considered the pain, erythema and swelling to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received Flulaval and experienced standard pain, redness and swelling. The patient received FluLaval tetra 2020-2021 with batch number either P7HK7 or 275KY. The reporter mentioned that, it was possible that those were administration technique errors and not related to vaccine product quality and were currently evaluating the administration technique and retraining. This case was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189451:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189448:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189418:same reporter US-GLAXOSMITHKLINE-US2020AMR189449:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: uncomfortable side effects.; Adverse event; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced discomfort and adverse event. On an unknown date, the outcome of the discomfort and adverse event were not recovered/not resolved.   It was unknown if the reporter considered the discomfort and adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Shingrix experinced all of the uncomfortable side effects. The reporter did not consent to follow up.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Product complaint
Clinical narrative: noticed blood in the syringe; plunger would not progress / next syringe she tried, she noticed the needle appeared bent; This case was reported by a nurse via sales rep and described the occurrence of injection site hemorrhage in a 55-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number P7HK7, expiry date 30th June 2021) for prophylaxis. This case was associated with a product complaint.   On 17th September 2020, the patient received FluLaval Tetra 2020-2021 season (intramuscular). On an unknown date, immediately after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site hemorrhage and pharmaceutical product complaint. On an unknown date, the outcome of the injection site hemorrhage and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The Health case professional, who was the nurse attempted to give the injection, stated that she followed the procedure for administering an intramuscular injection for Flulaval. However, when she started to push the injection into the patient's arm, the plunger would not progress, she noticed blood in the syringe and pulled out the needle. The caller stated that the patient did not get any of the medication and she threw the needle and syringe away and did not have the LOT No. or the product to return. The next syringe she tried, she noticed the needle appeared bent, so she did not inject the patient.  The reporter did not consent to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2020, the patient received Shingrix (intramuscular). In September 2020, couple of days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in his upper arm intramuscularly around and experienced a sore arm which lasted for a couple days then resolved. The event was got better.  The reporter did not consent to follow up. This case has been linked with case US2020187908, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187908:Wife's case
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia, Rash macular
Clinical narrative: Red blotchy skin just belowthe injection site; a little feverish; achy muscle; tiredness; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced tiredness, fever and muscle pain. On 17th September 2020, the patient experienced red blotches. The patient was treated with ibuprofen. On an unknown date, the outcome of the tiredness, fever and muscle pain were recovered/resolved and the outcome of the red blotches was not recovered/not resolved.   It was unknown if the reporter considered the tiredness, red blotches, fever and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. 2 days later receiving the vaccine developed very red blotchy skin just below the injection site on her left arm.  She also had some tiredness, achy muscle, and was a little feverish. She is taking ibuprofen and the tiredness, achy muscle, and fever have reduced but the red blotchy area was ongoing.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187932:Same Reporter US-GLAXOSMITHKLINE-US2020187935:same reporter US-GLAXOSMITHKLINE-US2020187931:Same Reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Facial shingles; Rash which itches and is red; Rash which itches; Feels hot; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, red rash, itchy rash, skin warm and incomplete course of vaccination. On an unknown date, the outcome of the shingles, red rash, itchy rash, skin warm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, red rash, itchy rash and skin warm to be related to Shingrix and Shingrix.  Additional details were as follows: The age at vaccination was not reported. Female patient herself reported that she received the 1st dose of shingrix vaccine year ago and have not received the 2nd dose yet,which led to incomplete course of vaccination but She stated that about one month back she was diagnosed as having shingles on the right side of her face which has resolved but on the day before reporting she started to experience again. According to her it was shingles with a rash which itches and is red in the middle of her back and she felt hot all over her body without a temperature. It was reported that patient did not receive the 2nd dose which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 44.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received a expired dose of FLUBLOK QUADRIVALENT vaccine/ No AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case is linked to cases 2020SA251862 and 2020SA250807. (Same reporter)  This case involves a 44 year old female patient who received an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided. The patient did not receive any concomitant vaccine.  On 12-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [prefilled syringe, lot number: unknown to reporter (UTR) as the expired vaccines were taken away before reporter could write down, expiry date 30-Jun-2020] via an intramuscular route at the left arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. (latency: On the same day of vaccination)  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.
Age: 50.0
Sex: M
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient recieved an expired FLUBLOK QIV vaccine, no AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case from an other health professional.   This case is linked to cases 2020SA252523 and 2020SA250807. (Same reporter)  This case involves a 50 years old male patient who received an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided. The patient did not receive any concomitant vaccine.  On 12-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [prefilled syringe, lot number: unknown to reporter (UTR) as the expired vaccines were taken away before reporter could write down, expiry date 30-Jun-2020] via an intramuscular route at the left arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. (latency: On the same day of vaccination)  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.
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient recieved an expired flublok quadrivalent vaccine, no AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case is linked to cases 2020SA252523 and 2020SA251862. (Same reporter)  This case involves a 42-year-old female patient who received an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided. The patient did not receive any concomitant vaccine.  On 12-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [prefilled syringe, lot number: unknown to reporter (UTR) as the expired vaccines were taken away before reporter could write down, expiry date 30-Jun-2020] via an intramuscular route at the left arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. (latency: On the same day of vaccination)  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.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site irritation, Joint swelling, Peripheral swelling, Rash
Clinical narrative: swelling on the joints; swelling on the hands and feet; Itchy rash; rash all over; redness and irritation on the left arm  where she received the vaccine; redness and irritation on the left arm  where she received the vaccine; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional (Medical assistant).  This case involves a 4-year-old female patient who experienced itchy rash (rash pruritic), rash all over  (rash), swelling on the joints  (joint swelling), swelling on the hands and feet (peripheral swelling), redness and irritation on the left arm where patient received the vaccine (vaccination site erythema and vaccination site irritation), while she received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 11-Sep-2020, the patient received a fifth dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5635AA and expiry date: not reported:18-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  On 11-Sep-2020, the patient developed a non-serious itchy rash (rash pruritic), rash all over (rash), swelling on the joints  (joint swelling), swelling on the hands and feet (peripheral swelling), redness and irritation on the left arm where patient received the vaccine (vaccination site erythema and vaccination site irritation), on same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event rash pruritic, rash, joint swelling, peripheral swelling, vaccination site erythema and vaccination site irritation was reported as unknown.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Rash pruritic
Clinical narrative: swelling on the joints; swelling on the hands and feet; Itchy rash; rash all over; redness and irritation on the left arm  where she received the vaccine; redness and irritation on the left arm  where she received the vaccine; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional (Medical assistant).  This case involves a 4-year-old female patient who experienced itchy rash (rash pruritic), rash all over  (rash), swelling on the joints  (joint swelling), swelling on the hands and feet (peripheral swelling), redness and irritation on the left arm where patient received the vaccine (vaccination site erythema and vaccination site irritation), while she received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 11-Sep-2020, the patient received a fifth dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5635AA and expiry date: not reported:18-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  On 11-Sep-2020, the patient developed a non-serious itchy rash (rash pruritic), rash all over (rash), swelling on the joints  (joint swelling), swelling on the hands and feet (peripheral swelling), redness and irritation on the left arm where patient received the vaccine (vaccination site erythema and vaccination site irritation), on same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event rash pruritic, rash, joint swelling, peripheral swelling, vaccination site erythema and vaccination site irritation was reported as unknown.
Sex: U
Vaccine: FLUX
Symptoms: Incorrect route of product administration, No adverse event, Product administered at inappropriate site, Wrong product administered
Clinical narrative: The patient was tested with Tubersol accidently instead of receiving influenza vaccine, no AE~; The patient was tested with Tubersol intramuscularly, no AE; The patient was tested with 0.5 ml of Tubersol, no AE; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a patient (demographics unknown) who was tested with 0.5 ml TUBERCULIN TEST [TUBERSOL] intramuscularly instead of receiving a dose of INFLUENZA VACCINE for prophylactic vaccination on an unknown date.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to overdose, product administered at inappropriate site and wrong product 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 lot number.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Joint range of motion decreased, Movement disorder
Clinical narrative: little soreness at the injection site; problems with range of motion and movement; Initial information received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional.  This case involves a 41-year-old female patient who experienced little soreness at the injection site (vaccination site pain) and problems with range of motion and movement (movement disorder), while she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history were not provided. Patient did not receive any other vaccines as concomitant medication.   On 18-Sep-2020 (Friday, afternoon), the patient received a 0.5 mL dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an intramuscular route at the right arm for prophylactic vaccination.  The patient reported that, for the first few days, there was nothing out of the ordinary, just a little soreness at the injection site (vaccination site pain) but as of 21-Sep-2020 or 22-Sep-2020, she had been having problems with range of motion and movement (movement disorder) 3 or 4 days following the administration of INFLUENZA VACCINE.  It was reported that, the patient was not sure which flu vaccine she received, but she knows it was a Sanofi vaccine also not sure if reported events were related to the vaccine or the injection technique of the administering nurse.   Details of laboratory data not reported.  The patient was treated with PARACETAMOL (ACETAMINOPHEN) and hot packs which had helped her little.   The patient was not recovered from movement disorder and event outcome was unknown for vaccination site pain.   There will be no information available on the batch number for this case.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling abnormal, Feeling of despair, Suicidal ideation
Clinical narrative: Thoughts of what would happen if killed himself; Feelings of desperation; General feeling of being off; This spontaneous case was reported on 17-Sep-2020 from pharmacist to agency (reference number: SEQW20-01893) and concerned a 38-year-old, male patient.  The patient's concurrent conditions included type 1 diabetes. The patient's past medication included Afluria Quad last year without a problem. The patient's concomitant medications included Basaglar (insulin glargine) and Novolog (insulin aspart) for type 1 diabetes.  On 15-Sep-2020 in the morning, the patient was vaccinated with Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration, anatomical location: not reported] for influenza prophylaxis. The batch number reported was P100242860 and expiry date 30-Jun-2021.  On the same day in the evening, after receiving Afluria Quadrivalent, the patient started having feeling of desperation and thinking what would happen if he killed himself. It was reported that the patient is usually a very jovial person and normally does not have this thoughts. The patient was not feeling the urge to do it but was thinking what would happen if he killed himself. Additionally, the patient felt general feeling of being off and questioned if the vaccine could cause a systemic reaction or if this could be an interaction since he has recently changed therapy with Basaglar (insulin glargine) and Novolog (insulin aspart) for type 1 diabetes.   At the time of initial reporting on 17-Sep-2020, the patient was recovering from the events. The patient stated he was feeling better but not recovered yet.  The reporter did not provide a causality assessment.  The reporter assessed the case as serious.  Company comment: The patient developed suicidal ideation, feeling of despair and feeling abnormal on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Medical history of diabetes type 1 and use of Novolog (a rapid-acting insulin) confound causality. Fluctuations in blood glucose can result in rapid mood changes, including low mood and irritability. Considering all above mentioned, causal relationship for all events is assessed as not related.; Sender's Comments: The patient developed suicidal ideation, feeling of despair and feeling abnormal on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Medical history of diabetes type 1 and use of Novolog (a rapid-acting insulin) confound causality. Fluctuations in blood glucose can result in rapid mood changes, including low mood and irritability. Considering all above mentioned, causal relationship for all events is assessed as not related.
Sex: F
Vaccine: FLUA3
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This spontaneous case from the Country was received on 20-Sep-2020 from a pharmacist via Agency (reference number: SEQW20-01995) and concerned an elderly, female patient.  The patient's medical history and concomitant medications were not reported.   On an unspecified date in 2017, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On an unspecified date, after receiving Fluad (TIV), the patient developed Bell's Palsy.  On an unspecified date, the patient recovered from the event of Bell's Palsy. The patient was referred by the physician to the pharmacist to see if the patient could take the Fluad this year.   The reporter did not provide a causality assessment.  The event of Bell's Palsy was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A elderly, female patient experienced facial paralysis, an unknown amount of time after administration of Fluad (TIV) vaccine. Temporal relationship needs more clarification. The patient's medical history and concomitant medications were not provided. Due to lack of information, causal role of the suspect product is unassessable.; Sender's Comments: A elderly, female patient experienced facial paralysis, an unknown amount of time after administration of Fluad (TIV) vaccine. Temporal relationship needs more clarification. The patient's medical history and concomitant medications were not provided. Due to lack of information, causal role of the suspect product is unassessable.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Neck pain
Clinical narrative: Patient is complaining of pain in his upper right shoulder and  pain is going up his neck also
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint stiffness, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: Nausea, 100.4° fever, mildly stiff joints, mild sore throat. All symptoms lessened by next morning (within 24 hours of vax). General malaise into the afternoon then full recovery by evening. Note: The original vax brought no reaction other than soreness at injection site for 72 hours. For this 2nd vax, the soreness was gone by 36 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Nausea, 100.4° fever, mildly stiff joints, mild sore throat. All symptoms lessened by next morning (within 24 hours of vax). General malaise into the afternoon then full recovery by evening. Note: The original vax brought no reaction other than soreness at injection site for 72 hours. For this 2nd vax, the soreness was gone by 36 hours.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: large red area formed with bump at site. itchy, warm
Age: 34.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Injection site swelling, Wrong product administered
Clinical narrative: The patient was supposed to have Tdap and flu shots, but instead of giving her the Tdap, she was given HPV vaccine by medical assistant.  pt was 31 6/7 weeks pregnant at time of vaccine, EDC 11/7/20.  no other info available about fetus at this time.  she had swelling of right upper arm, which resolved
Age: 34.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient was supposed to have Tdap and flu shots, but instead of giving her the Tdap, she was given HPV vaccine by medical assistant.  pt was 31 6/7 weeks pregnant at time of vaccine, EDC 11/7/20.  no other info available about fetus at this time.  she had swelling of right upper arm, which resolved
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Chest pain, Dizziness, Dyspnoea, Erythema, Injection site warmth
Clinical narrative: Redness, swelling, rash to right arm.  Pt reported dizziness, chest pains, difficulty breathing & muscle aches.  Tactile warmth at injection site.  Patient noted rash the morning of 9/25/20 and later that day felt like passing out.  Pt took Benadryl.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Myalgia, Peripheral swelling, Presyncope, Rash
Clinical narrative: Redness, swelling, rash to right arm.  Pt reported dizziness, chest pains, difficulty breathing & muscle aches.  Tactile warmth at injection site.  Patient noted rash the morning of 9/25/20 and later that day felt like passing out.  Pt took Benadryl.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Electrocardiogram normal, Heart rate irregular, Hyperhidrosis, Laboratory test normal
Clinical narrative: 28 hours following flu vaccine, she developed irregular heart beat, palpitations, then dizziness, nausea vomiting, sweating episode.  Had to lay down.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Palpitations, Vomiting
Clinical narrative: 28 hours following flu vaccine, she developed irregular heart beat, palpitations, then dizziness, nausea vomiting, sweating episode.  Had to lay down.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Patient reports nerve pain (score 8 out of 10) in the right hand below wrist on the pinky side
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, IPV, PNC13, UNK
Symptoms: Abdominal pain, Acute lymphocytic leukaemia, Crying, Ear infection, Gastroenteritis
Clinical narrative: May 8, 2018: Fever, inconsolable crying, fussy, vomiting,(May 8-May 29th) Diagnosed with fever, abdominal pain, acute gastroenterisis, febrile illness, diagnosed with ear infection then diagnosed with a virus during hospital stay. 3 weeks later diagnosed with Infant Acute Lymphoblastic Leukemia Cancer. ALL tests and records I have. Prior patient was completely healthy. We believe its due to vaccinations, and altering his DNA, because he had all tests done and no genetic reference to this either. We believe the vaccinations overloaded his system and caused the first virus. Then we believe it  lead to the leukemia.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, IPV, PNC13, UNK
Symptoms: Irritability, Pyrexia, Viral infection, Vomiting
Clinical narrative: May 8, 2018: Fever, inconsolable crying, fussy, vomiting,(May 8-May 29th) Diagnosed with fever, abdominal pain, acute gastroenterisis, febrile illness, diagnosed with ear infection then diagnosed with a virus during hospital stay. 3 weeks later diagnosed with Infant Acute Lymphoblastic Leukemia Cancer. ALL tests and records I have. Prior patient was completely healthy. We believe its due to vaccinations, and altering his DNA, because he had all tests done and no genetic reference to this either. We believe the vaccinations overloaded his system and caused the first virus. Then we believe it  lead to the leukemia.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Electrocardiogram normal, Heart rate normal, Injection site erythema, Injection site swelling
Clinical narrative: Patient's blood pressure reached 200/103 after receiving the flu shot. She self administered another blood pressure pill(Losartan 50mg) that evening before going to the hospital. Once she was at the hospital the staff was more concerned about her taking another blood pressure than her blood pressure being up. By this time her blood pressure was coming down. An EKG was performed and it was normal. Her heart rate was normal. They sent her home with no meds. The sight of the flu shot is red, raised and warm to touch.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site warmth
Clinical narrative: Patient's blood pressure reached 200/103 after receiving the flu shot. She self administered another blood pressure pill(Losartan 50mg) that evening before going to the hospital. Once she was at the hospital the staff was more concerned about her taking another blood pressure than her blood pressure being up. By this time her blood pressure was coming down. An EKG was performed and it was normal. Her heart rate was normal. They sent her home with no meds. The sight of the flu shot is red, raised and warm to touch.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Gaze palsy, Syncope, Unresponsive to stimuli
Clinical narrative: Patient noted on vaccine administration record, a previous reaction after vaccine and she stated her mother told her to "to always bring a companion for vaccinations". I asked her to further expand on her reaction and if this was her first shot, she explained she may faint and this was her first flu shot. I requested she sit for the vaccine and stay seated for about 15 mins or more after so I can monitor her. I gave her flu shot and she seemed fine but within 2-3 mins she asked her friend for water because she was feeling odd, in which her friend swiftly went to store for ice water. When i came around the counter to observe her she had fainted in a seated position over the consultation counter, eyes rolled back and unresponsive. I immediately called 911 to explain the situation and while on phone with 911 she regained consciousness and  I asked if she wanted to go to hospital via ambulance. She declined, stating she was coming back and reassuring me she was going to be okay. I hung up with 911, she drank the water and I fanned her with clipboard. She sat for an additional 30 mins until she was okay, I continously asked if she was feeling better and to contact us if she had any concerns.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Pain
Clinical narrative: Around 10:00pm, went to bed about 11:00pm. Couldn't sleep but the pain got worse. Had aches all over. About midnight, too 2 Ibuprofen 800mg, and drank some milk. Next day felt better.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Hypoxia, Loss of consciousness, Seizure, Urinary incontinence
Clinical narrative: Vaccine administered by RN, patient without any symptoms for several minutes, RN left room, then MD was called in by mom and per MD chart note :  "Mother called out from room after patient received HPV and flu vaccine.  Upon entering room, patient noted to have full body convulsions with loss of consciousness.  Patient also lost bladder control.  Episode lasted ~30 seconds from time I walked in room.  Patient became alert without intervention.  AAO x 3 immediately after event.  Color appeared normal.  RN and MA in room and monitored patient as documented below.  I reviewed with mother that syncope is a rather common occurrence after vaccines at this age.  I suspect patient had a hypoxic seizure.  I reassured that this should not lead to any future seizure activity or long term sequelae.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm swelled from shoulder to down around and past elbow.  Area was very warm and was reddened.  Painful, unable to lift arm, not able to sleep on left side the first night. Ice helped; Aleve did not. Symptoms slowly disappeared over the next four days.  Today being the 4th day, it feels OK but still slightly swollen.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Sleep disorder
Clinical narrative: Arm swelled from shoulder to down around and past elbow.  Area was very warm and was reddened.  Painful, unable to lift arm, not able to sleep on left side the first night. Ice helped; Aleve did not. Symptoms slowly disappeared over the next four days.  Today being the 4th day, it feels OK but still slightly swollen.