chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Miliaria, Rash erythematous, Rash pruritic, Skin weeping
Clinical narrative: Red rash on the side of my breast; Red rash on the side of my breast / It is hot; Red rash on the side of my breast / It itches; little rings with a hole in the middle / oozes a clear sticky jell type liquid; oozes a clear sticky jell type liquid; This case was reported by a consumer via media and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced red rash, heat rash, itchy rash, blister and skin weeping. On an unknown date, the outcome of the red rash, heat rash, itchy rash, blister and skin weeping were unknown.   It was unknown if the reporter considered the red rash, heat rash, itchy rash, blister and skin weeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient experienced red rash on the side of breast.  The patient experienced hot and itches. The rash looks like little rings with a hole in the middle and it oozes a clear sticky jell type liquid the patient had the shingles shot.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; This case was reported by a consumer via interactive digital media and described the occurrence of influenza in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 3 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The reporter reported the case for their mother. The age at vaccination was not reported. The reporter's mother received flu shot and 3 days later, they got the flu.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Social problem
Clinical narrative: After dose 2 / diagnosed with Shingles; 1st dose in Nov 2019 / due to Covid-19, 2nd dose on Sep 2020; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   In September 2020, the patient received the 2nd dose of Shingrix. On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced shingles and social problem. On an unknown date, the outcome of the shingles and social problem were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix 1st dose in November 2019 and due to Covid-19, 2nd dose was administered on September 2020 (no exact date was provided). After receiving dose 2, patient was diagnosed with Shingles. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received 2 Flublock vaccinations in one flu season with no adverse event; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious case received from the other healthcare professional from the agency via email at call center (reference number: US-SANOFI-00334210).  This case involved a 66-year old male patient who received 2 INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] vaccinations in one flu season with no adverse event (extra dose administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error due to extra dose administered.  On 21-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE with an unknown batch number via unknown route in unknown administration site for prophylactic vaccination.  On 16-Oct-2020, the patient again received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: UJ455AA) via unknown route in the left arm for prophylactic vaccination.   On 16-Oct-2020, it was reported that the patient received two Flublok vaccinations in one flu season with no adverse event (extra dose administered.).  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 14.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: given Flublok Quadrivalent in error with no adverse event; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist at call center (reference number: US-SANOFI-00334383).  This case involved a 14-year-old female patient who was given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] in error with no adverse event (Wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 27-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: UJ445AA, expiry date: 17-Mar-2021) in error with no adverse event (Wrong product administered) via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered(latency same day).  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 24.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: a patient was administered Flublok vaccine which was held in transition for too long with no adverse event; a patient was administered Flublok vaccine which was held in transition for too long with no adverse event; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional (Medical assistant) via phone at call center as the Agency (reference number: 00336138).  This case involved a 24 years old male patient who was administered with a 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] that was held in transition for too long (lot number: UJ509AA, expiry date: 10-May-2021) via intramuscular route in the left deltoid for prophylactic vaccination on an unknown date (product storage error and product distribution issue).  Medical history, medical treatments, vaccinations, concomitant medication(s) and family history were not provided.  No other vaccines given.  It was a case of an actual medication error due to product storage error (latency: same day).  It was a case of Product shipment delay (latency: same day).  At the time of reporting, the patient had no adverse event.  Caller states that they received an email that states that the Flublok vaccine was held in transition for too long. They did not received the email until the end of the day and two doses had already been administered.   Product used: Used.  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: FLUX
Symptoms: Intensive care, Pneumonia
Clinical narrative: patient was in ICU (Intensive care unit) with pneumonia 3 times; Initial information was received on 18-Nov-2020 regarding an unsolicited valid serious case received from a non-healthcare Professional via social media.  This case involves a female patient of unknown age who experienced pneumonia 3 times and was in ICU (intensive care unit) (pneumonia), while she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [batch number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pneumonia 3 times (pneumonia) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and she was hospitalized for this event (was in ICU- intensive care unit).  It was also reported that she was in good health when she received the shot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for event.  Information on the batch number was requested.; Sender's Comments: This case involves a female patient (unknown age) who experienced pneumonia after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Glands swollen; pain; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media  This case involves a patient (age and gender unspecified) who had glands swollen (lymphadenopathy) and Pain, when received vaccine INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was glands swollen (lymphadenopathy) and pain (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: pneumonia; flu; Initial information received on 22-Nov-2020 regarding an unsolicited valid serious case received from that consumer/non healthcare professional (patient) via social media.  This case involved a 65 years old patient who got the flu (influenza) and pneumonia, while the patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date in 1975, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed pneumonia (serious) and flu (influenza) (non-serious) (unknown latency for both events)following the administration of INFLUENZA VACCINE. The event pneumonia was assessed as medically significant.  It was reported that, patient had not taken flu shot since then and did not take COVID shot.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown for all reported events.  There would be no information available on the batch number for this case.; Sender's Comments: This poorly document case received from media concerns a patient with unknown demography who experienced pneumonia and influenza, after vaccination with INFLUENZA VACCINE (Flu shot), produced by unknown manufacturer. The time to onset is unknown. Moreover, patient's medical condition at time of vaccination, immune status and lab test ruling out predisposing etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Paralysis
Clinical narrative: paralyzed; Initial information received on 22-Nov-2020 regarding an unsolicited valid serious case received from a social media via consumer or non-health care professional.  This case involves a patient of an unknown demographics who got paralyzed (paralysis), while patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [batch number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got paralyzed (paralysis) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown.  Batch number had been requested for suspect product for this case.; Sender's Comments: This poorly document case received from media concerns a patient with unknown demography who experienced paralysis after vaccination with INFLUENZA VACCINE (Flu shot), produced by unknown manufacturer. The time to onset is unknown. Moreover, patient's medical condition at time of vaccination, immune status and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: the reporter thought that she and her husband received FLUZONE HD for this season, In error, the pharmacist gave them the fluzone low dose with no adverse event; Initial information regarding an unsolicited valid non-serious case from a patient was received on 26-Oct-2020.  This case involves an unknown age female patient it was reported that the reporter thought that she and her husband received  INFLUENZA VACCINE TRIVALENT [FLUZONE HD] for this season, in error, the pharmacist gave them the INFLUENZA VACCINE TRIVALENT [FLUZONE] (product dispensing error) (dose, route, anatomical location, expiry date and lot number unknown) for prophylactic vaccination on 20-Oct-2020.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not provided.   This is a true medication error case due to product dispensing error (latency same day).   No laboratory data was provided.  At the time of this report, no adverse event symptoms reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information regarding batch number for the case.
Age: 13.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: it was on the shelf next to the appropriate vaccine and grabbed Flublok by mistake/no AE; a 13 year old was given Flublok inadvertently/no AE; Initial information regarding this unsolicited valid non-serious case from the The Agency (Reference number- 00342329) was received from a pharmacist and transmitted to Sanofi on 02-Nov-2020.  This case involved a 13 year old patient (unknown gender) who inadvertently received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number and expiry date not reported) (Product administered to patient of inappropriate age) via unknown route in unknown administration site for prophylactic vaccination and also reported that it was on the shelf next to the appropriate vaccine and grabbed Flublok by mistake (Wrong product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    It was an actual medication error case due to wrong vaccine administered and Inappropriate age at vaccine administration (latency same day).  Reporter asked for reports for giving Flublok out of recommended age and effects to watch for and told that she would call back with more adverse event details.  Potential PTC(product technical complaint)- no  At the time of reporting, no adverse event was reported.  There will be no information available on the batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 34.0
Sex: F
Vaccine: FLUR4
Symptoms: Paraesthesia, Peripheral swelling, Skin warm
Clinical narrative: fingers in left arm are hot to the touch; tingling in fingers in left arm; swelling in left arm; Initial information regarding an unsolicited valid non-serious case from a pharmacist via The Agency (Reference number- 00349483) was transmitted to Sanofi on 06-Nov-2020.  This case involved a 35 years old female patient who experienced tingling in fingers in left arm (paraesthesia), swelling in left arm (peripheral swelling) and her fingers in left arm are hot to the touch (Skin warm), while she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Relevant medical history, medical treatment, vaccination and family history were not provided.  No concomitant medications given.   On 03-Nov-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE prefilled syringe (lot QFAA2056, expiry date: 30-Jun-2021) via an unknown route in left deltoid for prophylactic vaccination.  On an unknown date, the patient developed non-serious tingling in fingers in left arm (paraesthesia), swelling in left arm (peripheral swelling) and her fingers in left arm are hot to the touch (Skin warm), unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Tenderness
Clinical narrative: Patient noted tenderness from right lower neck extending down to right elbow, erythema to right arm. She went to an urgent care clinic to seek care, and was given information about home care and recommendations for ibuprofen and topical hydrocortisone if needed.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient experienced swelling and rash at injection site. She returned to clinic the same day as the injection and was given benedryl.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Hot flush, Myalgia
Clinical narrative: Woke up at 4:30am with chills, hot flashes, light headedness, muscle aches and joint pain.  Could not return to sleep.  Low grade fever at 9:30am (99.2F)
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Woke up at 4:30am with chills, hot flashes, light headedness, muscle aches and joint pain.  Could not return to sleep.  Low grade fever at 9:30am (99.2F)
Age: 45.0
Sex: F
Vaccine: FLU4, MMR, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right arm swelling, redness, pain at injection site. Treated with cold compress, benadryl, and ibuprophen.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: FATIGUE, MUSCLE ACHES, SHIVERING,HEADACHE
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Product administration error
Clinical narrative: Flu vaccine given twice within 10 minutes. Mom came with patient to my station.  I asked if patient needed a flu shot and if she had flu shot in the past.  Her mom replied yes to both. Vaccine was given. Nurse that gave first shot asked why I had given her another one.  The nurse said she came to me for a certificate of flu shot for school. Mother is not from here and I do not think she understood my question when she said yes. There was not reaction then and I followed up the following day with mother. The patient was fine without any reactions from shot.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy, Drooling, Ear discomfort, Ear pain, Facial paresis
Clinical narrative: The patient received recombinant zoster vaccine (RZV) 0.5 ml IM in Left    deltoid.     Manufacturer: GlaxoSmithKline     Lot#s and Expiration Date: Vial#1-J2N44 Exp-05/17/2022 Vial#2-7TB74     Exp-05/17/2022     Complications: None   at time of the injections. ON NOV22 (plus or minus) patient experienced ear pain and pressure, called nursing triage on November 24 reporting ear pain and ear pressure, numb lips, jaw numbness and drooling and was found to have left lower facial muscle weakness diag w/left sided Bells Palsy
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Jaw disorder, Physical examination
Clinical narrative: The patient received recombinant zoster vaccine (RZV) 0.5 ml IM in Left    deltoid.     Manufacturer: GlaxoSmithKline     Lot#s and Expiration Date: Vial#1-J2N44 Exp-05/17/2022 Vial#2-7TB74     Exp-05/17/2022     Complications: None   at time of the injections. ON NOV22 (plus or minus) patient experienced ear pain and pressure, called nursing triage on November 24 reporting ear pain and ear pressure, numb lips, jaw numbness and drooling and was found to have left lower facial muscle weakness diag w/left sided Bells Palsy
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, X-ray normal
Clinical narrative: pt complains of residual shoulder pain 4 weeks post injection
Age: 13.0
Sex: M
Vaccine: FLUC4, HPV9
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Patient became nauseated and fainted twice within 15 minutes . We gave drink and had him sit. Vomiting occurred.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was due to 12mo/epsdt and was due for routine vaccines of MMR, Varicella, Hep A, Hib, Prevnar 13, and Influenza. When patient received vaccination, vaccine MMRV was given instead of MMR causing patient to get double vaccinated for Varicella. When adverse event was acknowledged the proper steps of reporting began.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: reports late in the evening that day experienced pain to right arm with swelling  from shoulder to forearm. States placed warm compresses to site and took  Bendaryl PO. States called nurse triage line, which advised him to do the same.  Patient states all syptoms have resolved, but wanted facility to be aware. Denies  further needs/concerns.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: the vaccine expired on 10/20/2020 and was administered on 11/2/2020; This spontaneous report has been received from a medical assistant (also reported as consumer) referring to a patient of unknown age and gender. The pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.  On 02-NOV-2020, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (lot#: S030588, which has been verified to be valid for VAQTA formulation vial, expiration date 20-OCT-2020, strength and route of administration were unknown) 1 dose for prophylaxis (expired product administered).
Sex: F
Vaccine: PNC, PPV
Symptoms: Asthma
Clinical narrative: She received PNEUMOV AX 23 in 2004 when she was diagnosed with asthma then Prevnar 13 in 2015 and PNEUMOV AX 23 again in 2017.; This spontaneous report was received from a vaccine account representative and  refers to a 52-years-old female patient. The patient's concurrent conditions included asthma. The patient's  medical history, concomitant therapies, drugs reactions or allergies were not provided.  On unspecified date in 2004,  the patient, who was a pharmacist, was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23)(dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On unspecified date in 2015, the patient was vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR 13)(dose, route of administration, lot # and expiration date were not provided) for prophylaxis and again, on unspecified date in 2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23 )(dose, route of administration, lot # and expiration date were not provided).
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: left arm was painful; left arm was red/ red down past her elbow; left arm was swollen/ swollen past her ebow; This spontaneous report was received from a pharmacist, referring to a 75 -year-old female patient. The patient had no concomitant medication, no pertinent medical history and no drug reactions/ allergies. Information about concurrent conditions was not reported.      On 18-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 mL, lot # T024669 has been verified to be valid, expiration date 21-MAR-2022) intramuscularly in the left arm for prophylaxis.    On 20-NOV-2020, the patient's left arm was red, swollen and painful. The patient's arm was swollen and red down past her elbow. The pharmacist told the patient to put an ice pack on the site. The patient was taking acetaminophen (TYLENOL) for the pain. No lab disgnostics/studies was performed. The patient did not seek medical attention. The outcome of all events was reported as not recovered. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and all events was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T024669; expirationdate: 21-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had herpes zoster; Had herpes zoster; I still continued with the pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and pain. On an unknown date, the outcome of the vaccination failure and herpes zoster were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster and pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. A month and 2 weeks before the date of reporting, the patient had herpes zoster, and still continued with the pain, the medications had not done anything to patient, the patient wanted to know what to do This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.  The reporter consented to follow up.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Near death experience
Clinical narrative: patient felt like death after receiving a dose of Shingrix and Afluria; This case was reported by a pharmacist via call center representative and described the occurrence of near death experience in a adult female patient who received Herpes zoster (Shingrix) (batch number 9DE73, expiry date 31st December 2021) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (AFLURIA) for prophylaxis.   On an unknown date, the patient received Shingrix and AFLURIA. On an unknown date, unknown after receiving Shingrix, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter did not provide complete date of birth. The reporter did not provide lot or expiration date for dose of Afluria. The patient received the vaccines in separate arms. The patient felt like death after receiving a dose of Shingrix and Afluria on the same day. It was unknown if the reporter considered the near death experience to be related to AFLURIA as well. Consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR230407:same reporter
Sex: U
Vaccine: FLU3
Symptoms: Immune system disorder
Clinical narrative: last one attack my immune system and like to kill me; Initial information received on 07-Nov-2020 from Social Media regarding an unsolicited valid non-serious case from a patient.  This case involves a patient of unknown demographics who reported that last one attacked the immune system and like to kill the patient (immune system disorder), while the patient received vaccine influenza quadrival a-b intradermal vaccine [Fluzone].   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect influenza quadrival a-b intradermal vaccine (lot number and expiration date not reported) via unknown route in unknown administration site for prophylaxis vaccination.   On an unknown date, (latency unknown) after administration of suspect vaccine, patient reported the last one attacked the immune system and like to kill the patient (immune system disorder), after one the patient took in 1982 have not had even a sore throat since.   No relevant laboratory test was reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.    There would be no information available on the batch number for this case.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 55 years old patient got Fluzone High Dose with no adverse event; a 55 years old patient got Fluzone High Dose with no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist via The Angency (reference number: 00339992)on 30-Oct-2020.  This case involved a 55 years old male patient for whom it was reported that the patient received a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ536AA, expiration date 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination on 29-Oct-2020 (product administered to patient of inappropriate age and overdose).  Medical history, medical treatments, vaccinations and family history were not provided.  No concomitant medication was reported.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).   It was a case of overdose (latency: same day).  At the time of report no adverse event was reported.  Pharmacist stated FLUZONE HIGH DOSE (HD) was given to a patient per their request, but when they checked the patients chart after administering the vaccine, they realized he was only 55 years old, she wants to know if there are any adverse effects to worry about and requested urgent call back. Caller asked if there is any data on what to expect if a 55 years old patient got Fluzone HD has this happened before. Are there any studies using it in under 65 years old. Caller said yesterday a patient came in and asked for the Fluzone HD vaccine and said he was 65.5 years old. She said he confirmed his age for her too and the technician and asked for the HD vaccine by name too. After she had given it to him, she entered his information in the system and that is when she realized he was 55 and not 65 years old. She called the patient and he said he is doing fine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: patient received a dose of Tenivac on 2nd of November 2020 that had expired on the 23rd of October2020, No AE; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves patient (demographics unknown) who was administered an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number not reported and expiration date: 23-OCT-2020) via unknown route in an unknown administration site for prophylactic vaccination on 2nd November 2020 (Expired product administered).  Medical history, past medical treatment(s), medical treatment(s), concomitant medication (s), vaccination(s) and family history were not reported.  This was an actual medication error due to expired vaccine used [latency was same day].  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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 on the batch number to be requested for this case.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: shot was broken up in a 10% and 90% dose.  he had mild stomach pain after the first dose.  After the second shot, he had increasing stomach pain and vomited.  As his allergist, I treated him for an allergic reaction with epinephrine auto-injector and he did well.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Visual impairment
Clinical narrative: Eyes have clouding and left eye vision diminishing
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Pt said he experience pain in his shoulder a month later. He called his doctor about it. No reaction until a month after shot. Said hurts and sometimes has trouble lifting his shoulder up. He had no pain or trouble the day he reported
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Head discomfort, Nausea
Clinical narrative: I received the flu shot last year around October at my PCP office. Within hours after receiving the shot. I was sitting down waiting TV and I started feeling nauseous and dizzy. i went to lay down and I started getting thirsty I asked my friend to get my water and she brought it in and I could not lift my head to drink the water because I was so weak. The symptoms lasted about 24 hours. I went into the PCP office the following month and reported the symptoms to the PCP and told them I would not like another flu shot like that. The nurse told me it might have been a reaction or germ in my body. No one told me to report the reaction until I came for my shot this year. This year when I went to get the flu shot I was on a Budesonide recently and the PCP stated that they were not comfortable giving me the shot because of the reaction to the flu shot last year.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: HEADACHE EYE PAIN--PHOTOSENSITIVITY PAIN/SWELLING/REDDNESS AT INJECTION SITE GRADE 3 FATIGUE,GRADE 3
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Photosensitivity reaction
Clinical narrative: HEADACHE EYE PAIN--PHOTOSENSITIVITY PAIN/SWELLING/REDDNESS AT INJECTION SITE GRADE 3 FATIGUE,GRADE 3
Age: 1.5
Sex: F
Vaccine: DTAP, DTAPHEPBIP, FLU4, HEPA, HEPA, HIBV, MMR, PNC13, PNC13, VARCEL
Symptoms: Allergy test positive, Constipation, Eye swelling, Pruritus, Rash
Clinical narrative: she was a newborn and was breaking out in hives and rash all over her body and was screaming, not wanting to sleep. i thought she was a colicky baby but looking back on it she was getting allergic reaction to the vaccinations. but the doctors constantly told me that it was baby acne or eczema and it was until she was 9 months old and i got allergy test for her and shes allergic to eggs and peanuts because of these vaccinations. shes constipated, swelling in the eyes, always itching, hive and rash
Age: 1.5
Sex: F
Vaccine: DTAP, DTAPHEPBIP, FLU4, HEPA, HEPA, HIBV, MMR, PNC13, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: she was a newborn and was breaking out in hives and rash all over her body and was screaming, not wanting to sleep. i thought she was a colicky baby but looking back on it she was getting allergic reaction to the vaccinations. but the doctors constantly told me that it was baby acne or eczema and it was until she was 9 months old and i got allergy test for her and shes allergic to eggs and peanuts because of these vaccinations. shes constipated, swelling in the eyes, always itching, hive and rash
Age: 20.0
Sex: F
Vaccine: PPV, RAB
Symptoms: Hypoaesthesia, Injection site bruising, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Day 1 (11/25) - noticed a golf ball sized welt in my left SQ space with redness surrounding the injection site, swelling in my dorsal left arm near my armpit, heat in the injection area, and notable pain upon palpation  Day 2 (11/26) - noticed the welt slowly getting larger but opted to wait and ice/use ibuprofen to manage the symptoms after researching common reactions from Pneumovax 23  Day 3 (11/27) - woke up in the morning with tennis ball sized swelling and the same symptoms as before except the redness had spread and become deeper, chose to call a triage line and was told to mark the redness with a sharpie, continue supportive care, and be seen in the ER if the redness spreads at all or if the swelling does not go down by tomorrow; ended up going to the ER later that night (10 PM) due to increased heat and swelling and severe pain upon just touching the area but the ER doctor said it was a normal reaction at this point and sent me home with supportive care and instructions to return if it did not spontaneously resolve in 1 week or 3-4 days after the vaccination (the discharge instructions stated both, so not sure which was correct)  Day 6 (11/30) - swelling had continued to progress along with redness and never resolved, ice/ibuprofen/heat/Tylenol were not effective in managing swelling or pain, at this point the swelling was as hard as a rock and the size of a softball, redness had spread about halfway to the elbow, heat was still present, pain was unbearable and increased drastically upon palpation to the point that if the site was pushed or bumped hard enough the entire arm would go numb and I would collapse; chose to go to a different ER at this point in which I was immediately rushed to ultrasound for imaging which revealed severe edema ribboned throughout the swelling continuing all the way down the arm, I was sent home on oral antibiotics for now and given strict instructions to monitor for any symptoms of systemic infection or spreading as well as to return if anything should change, also told to follow up with a primary care provider tomorrow for further diagnostics and follow up treatments, began first dose of antibiotics around 7 PM this night   Day 7 (12/1) - woke up and took 2nd dose of antibiotics, would has still progressed and is a similar size, the skin around the wound is painful to the touch and tight feeling like it is pinched, there is significant bruising all the way down to my elbow and the redness is beginning to ribbon down to my elbow as well, I am going into the doctor this afternoon again for follow up
Age: 20.0
Sex: F
Vaccine: PPV, RAB
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Oedema peripheral, Skin tightness
Clinical narrative: Day 1 (11/25) - noticed a golf ball sized welt in my left SQ space with redness surrounding the injection site, swelling in my dorsal left arm near my armpit, heat in the injection area, and notable pain upon palpation  Day 2 (11/26) - noticed the welt slowly getting larger but opted to wait and ice/use ibuprofen to manage the symptoms after researching common reactions from Pneumovax 23  Day 3 (11/27) - woke up in the morning with tennis ball sized swelling and the same symptoms as before except the redness had spread and become deeper, chose to call a triage line and was told to mark the redness with a sharpie, continue supportive care, and be seen in the ER if the redness spreads at all or if the swelling does not go down by tomorrow; ended up going to the ER later that night (10 PM) due to increased heat and swelling and severe pain upon just touching the area but the ER doctor said it was a normal reaction at this point and sent me home with supportive care and instructions to return if it did not spontaneously resolve in 1 week or 3-4 days after the vaccination (the discharge instructions stated both, so not sure which was correct)  Day 6 (11/30) - swelling had continued to progress along with redness and never resolved, ice/ibuprofen/heat/Tylenol were not effective in managing swelling or pain, at this point the swelling was as hard as a rock and the size of a softball, redness had spread about halfway to the elbow, heat was still present, pain was unbearable and increased drastically upon palpation to the point that if the site was pushed or bumped hard enough the entire arm would go numb and I would collapse; chose to go to a different ER at this point in which I was immediately rushed to ultrasound for imaging which revealed severe edema ribboned throughout the swelling continuing all the way down the arm, I was sent home on oral antibiotics for now and given strict instructions to monitor for any symptoms of systemic infection or spreading as well as to return if anything should change, also told to follow up with a primary care provider tomorrow for further diagnostics and follow up treatments, began first dose of antibiotics around 7 PM this night   Day 7 (12/1) - woke up and took 2nd dose of antibiotics, would has still progressed and is a similar size, the skin around the wound is painful to the touch and tight feeling like it is pinched, there is significant bruising all the way down to my elbow and the redness is beginning to ribbon down to my elbow as well, I am going into the doctor this afternoon again for follow up