chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: patient was given RECOMBIVAX HB that was recalled; Administration of improperly stored vaccine; This spontaneous report has been received from a nurse referring to a 9 weeks old patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 23-OCT-2020, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot #: T007984, expiration date not reported, but upon internal validation established as 01-NOV-2022; 0.5 ml) via unknown route for prophylaxis. The vaccine was incorrectly stored and administered to the patient before being recalled (recalled product administered and product storage error).
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Pneumonia, Respiratory symptom
Clinical narrative: pneumonia; Information has been received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On or around 26-OCT-2017, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), suffered upper respiratory symptoms and shortness of breath requiring hospitalization. Plaintiff was diagnosed with pneumonia. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX) and caused by the Zoster Vaccine Live (ZOSTAVAX). The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event pneumonia was not recovered and the reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered the event pneumonia to be disability. Upon internal review, the event pneumonia was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: MMR-11 was administered to 3 patients on 10/26/2020 after a temperature excursion and prior to having vaccines evaluated.; This spontaneous report was received from a health care professional, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 26-OCT-2020, the patient was vaccinated with improperly stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot number S031482 which has been verified to be valid, expiration date reported and validated as 07-OCT-2021) (dose and frequency were unknown by the reporter; vaccination scheme, route of administration, and anatomical site of injection were not reported) as prophylaxis. The administered vaccine was stored at a temperature of below 36 degrees Fahrenheit (F)/2 degrees Celsius (C) (0.9 C to 1.9 C), during a time frame of 10 hours; above 47 F/9 C (9.1 C), during a time frame of 30 minutes. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010939: US-009507513-2010USA011380:
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: 1 dose of Gardasil 9 given to a patient during a vaccine excursion; Information has been received from a vaccine coordinator referring to a 16 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 28-OCT-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R029117, expiration date 10-JUL-2021, 0.5 milliliter; route was not reported) for prophylaxis. The vaccine was during a temperature excursion and was found supported after (incorrect product storage). The storage temperature of the vaccine was 0.7 degree Celsius for a time frame of 2 hours and 47 minutes. There was no previous temperature excursion. The call was not because of a data logger. 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. ; devicelotnumber: R029117; expirationdate: 10-JUL-2021; 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 meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: RN reported a improperly stored PROQUAD administration; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 06-OCT-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (dose and frequency were unknown by the reporter; strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number S027463, expiration date reported as 02-JUN-2021, but upon internal validation, it was established as 02-MAR-2021) as prophylaxis (product storage error).  The vaccine underwent a temperature excursion between 6 degrees Fahrenheit (F) to 14F (11.8F) for 31 hours, as recorded by a data logger. There was no previous temperature excursion.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Developed rash; Clinically confirmed that it was shingles by urgent care; This case was reported by a other health professional via sales rep and described the occurrence of rash in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number AG7M9, expiry date unknown) for prophylaxis.   On 16th October 2020, the patient received the 1st dose of Shingrix. In October 2020, 4 days after receiving Shingrix, the patient experienced shingles. On 20th October 2020, the patient experienced rash. On an unknown date, the outcome of the rash and shingles were unknown.   It was unknown if the reporter considered the rash and shingles to be related to Shingrix.  Additional details were provided as follows: After receiving 1st dose of Shingrix, the patient experienced rash and shingles. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Hepatitis acute
Clinical narrative: ACUTE HEPATITIS; This case was reported by a consumer and described the occurrence of hepatitis acute in an unspecified number of patients 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 hepatitis acute (serious criteria GSK medically significant). On an unknown date, the outcome of the hepatitis acute was unknown.   It was unknown if the reporter considered the hepatitis acute to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter informed by the physician that he had seen at least two more patients with similar diagnoses of acute hepatitis following a Shingrix administration. The reporter consented to follow up. This case has been link with US2020153365, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020153365:same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: painful at the site of injection; stiffness; weakness motion; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   On 15th August 2020, the patient received the 1st dose of Shingrix. On 16th August 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, stiffness and mobility decreased. The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site pain, stiffness and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain, stiffness and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported the patient experienced painful at the site of injection, stiffness and weakness motion after receiving the first dose of Shingrix. The symptoms started the following day. The reporter was not sure if the patient recovered. The patient had not received the second dose yet. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy; Initial information was received on 09-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient) via social media.  This case is linked to cases 2020SA296404, 2020SA296528, 2020SA296430, 2020SA296471, 2020SA296492, 2020SA296544, 2020SA296581, 2020SA296589, 2020SA296655, 2020SA296676, 2020SA296689, 2020SA296710, 2020SA296764, 2020SA296765, 2020SA296803, 2020SA296865, 2020SA296885, 2020SA296898, 2020SA296916, 2020SA296968, 2020SA296983, 2020SA297003, 2020SA297018, 2020SA297073, 2020SA296764, 2020SA296492, 2020SA296528, 2020SA297058 and 2020SA297065 (same reporter).  This case involves a female patient (age unspecified) who had bells palsy (facial paralysis) while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date (four years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious bells palsy (facial paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Her neurologist told her not to get another (BBQ) (expanded term requested) one unless her immune system was compromised. She never had flu.  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.  The information on batch number was requested for this case.; Sender's Comments: This case concerns a female patient who had facial paralysis after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is not clearly defined, but assumedly is about 4 years. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU3
Symptoms: Angioedema, Urticaria
Clinical narrative: angioedema; hives; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a physician in the United States.  This case involves patient of unknown demography who experienced angioedema and hives (urticaria), while the patient received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past vaccination(s) included INFLUENZA with no reactions and has no egg allergies. Medical history, concomitant therapy, medical treatment(s) and family history were not provided.  On 01-Oct-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 01-Oct-2020, the patient developed non-serious angioedema and hives (urticaria) 6 hours following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  Patient was not recovered from both the events at the time of reporting.  There will be no information available on the batch number for this case.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site pain, Pruritus, Rash
Clinical narrative: red, itchy area of little red bumps around 3 inches in size; red bumps around 3 inches in size near injection site; local injection site reaction that is slightly sore; red, itchy red bumps around 3 inches in size at injection site near injection site; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 54 years old female patient who experienced red, itchy area of little red bumps around 3 inches in size (pruritus), (rash erythematous), (vaccination site reaction) and local injection site reaction that is slightly sore (vaccination site pain), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Patient once had an Ear infection and treated with an oral steroid. The patient's vaccination(s) included influenza vaccine for prophylactic vaccination. The patient's medical treatment(s) and family history were not provided.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N).  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious red, itchy area of little red bumps around 3 inches in size (pruritus), (rash erythematous), (vaccination site reaction) and local injection site reaction that is slightly sore (vaccination site pain) around two hours following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Details of laboratory data were not reported.  Patient used topical steroid.  At the time of reporting, outcome of the events were unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Act-hib was mixed with sterile water instead of diluent and was administered to 2 patients/ NO AE; Initial information received on 30-Sep-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves two patients of an unknown demographics who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] (batch number: UJ138AAA, expiry date: 01-Mar-2021, route and site of administration, dosing detains not reported) which was mixed with sterile water instead of diluent and administered (product preparation error) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Extra dose administered, No adverse event
Clinical narrative: The patient received two doses of fluzone in the same season, no AE; Initial information was received on 06-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves female patient who received two doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in the same season (extra dose administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 03-Sep-2020, the patient received a 0.5 ml first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination  On 02-Oct-2020, the patient received a 0.5 ml second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7041LA, expiry: 30-Jun-2021, form: prefilled syringe) via unknown route in the left arm for prophylactic vaccination. The patient had no other vaccine on same day  It was a case of an actual medication error due to extra dose administered on 02-Oct-2020 (latency same day).  The patient was given a second dose of fluzone in error and was concerned about having received two doses in the same season. She was not having any ill effects other than the worry of having received an extra dose. The vaccine was administered both times in the pharmacy  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: local reaction of redness and swelling at site; local reaction of redness at site; local reaction of swelling at site; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00303757) and transmitted to Sanofi on 06-Oct-2020. This case involves a 10 year old female patient who had local reaction of redness and swelling at site (vaccination site inflammation) with symptoms (vaccination site erythema and vaccination site swelling) while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), past vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported, prefilled syringe) once via intramuscular route in the deltoid not specified (NOS) for prophylactic vaccination with 5/8 inch needle.  On an unknown date, the patient developed a non-serious local reaction of redness and swelling at site (vaccination site inflammation) with symptoms (vaccination site erythema and vaccination site swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  However, the patient's parent who is a nurse thought that vaccine was given subcutaneously due to adverse event of local reaction.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome were unknown for both events.  There will be no information available on the batch number for this case
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: 11 year old female patient received expired dose of ADACEL, no adverse event; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 year old female patient who was vaccinated with expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 15-Sep-2020, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5519BA and expiry date: 12-sep-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. (latency on same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Fluzone HD and Fluzone Quadrivalent vaccines were administered subcutaneously, no AE; Based on additional information received on 14-Oct-2020, this case became medically confirmed.  Initial and follow up information regarding an unsolicited non-valid non-serious case received from a non-healthcare professional via Agency (Reference number- 00313623 and 00315619) and transmitted to Sanofi on 13-Oct-2020 and 28-Oct-2020.  This case involves patients who received 0.7 mL INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (batch number LUJ453AB and expiry date 30-JUN-2020) INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via subcutaneous route at the back of the arm instead of deltoid muscle for prophylactic vaccination (Incorrect route of product administration).  Medical history, past medical treatment(s), vaccination(s), and family history were not provided. No concomitant medication was given.  This was an actual medication error case due to inappropriate route of vaccination (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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 for Fluzone Quadrivalent.  Follow up information regarding an unsolicited valid non-serious case received from a healthcare professional via The Agency (Reference number- 00316089) and transmitted to Sanofi on 14-OCT-2020.  Case validity updated and case become medically confirmed.  Batch number, dosing details and expiry date for Fluzone HD Quadrivalent added.  Narrative updated.
Age: 72.0
Sex: U
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Adacel vaccine was given to a 72 year old patient in error with no adverse event; Initial information was received on 21-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist via agency (reference number: 00326385).  This case involved a 72 years old patient (gender unknown) who received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site, in error, for prophylactic vaccination on an unknown date (product administered to patient of inappropriate age).   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration. (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 batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: patient had an reaction to FLUZONE QUADRIVALENT; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves unknown demographics patient who experienced reaction (adverse reaction) to INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number not reported and expiration date unknown] via unknown route for prophylactic vaccination.  On an unknown date, (unknown latency) the patient experienced a non-serious reaction (adverse reaction) to INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests included no lab data.  Final diagnosis was adverse reaction.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: After getting the Flucelvax vaccine patient reported worsening pain starting at the site but moving down her entire arm.  She is now having trouble using this arm.
Age: 64.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Asthenia, Chills, Dizziness
Clinical narrative: Weak, dizzy and chills
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: The initial symptoms were as though somebody had been punching me in the arm repeatedly. Within two hours the pain was excruciating end I could not move my right arm. The pain went from below my elbow to above my shoulder and into my back. I called the office and they told me to just put ice on it. Seriously the pain was unbearable
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Bursitis, Injection site pain, Pain, Product administered at inappropriate site, Tendonitis
Clinical narrative: Shot was given too high on arm and caused severe shoulder pain when lifting or rotating arm.  Diagnosis was tendonitis/bursitis.  One steroid shot and dose pack was given over a week (10/19 - 10/25).
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Diarrhoea, Urticaria
Clinical narrative: diarrhea, confusion, hives given diphenhydramine 50 mg (given at 20:56), famotidine 40 mg (given at 20:56), and methylprednisolone 125 mg (given at 20:57)(all IV)
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Patient states they are having blurred vision post injection
Sex: F
Vaccine: HPV9, MEN, UNK
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: fainted; This spontaneous report was received from a physician via company representative who was reporting on teenage female patient. Her exact age was unknown. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.   On an unknown date, in late August 2020, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, anatomical location, strength, lot number and expiration date were not provided) as routine vaccination. During the same visit, she was also vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) and unspecified meningococcal vaccine (manufacturer unknown) no details were provided regarding those vaccines. After the vaccination the patient was told to remain seated for 15 minutes, but she stood up immediately after receiving the vaccines. The nurse caught her when she fainted. There was no additional adverse events reported. The patient recovered from the event on the same day.  The casual relationship between the patient's faint and suspected vaccines was not reported. Upon internal review, faint was determined to be medically significant.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blister, Feeling hot, Influenza like illness, Oral herpes
Clinical narrative: Fever blisters presented in her mouth, on her lips and in her nose; vomited; felt pain all over her body; felt warm like a temperature but did not have one; like feeing like she had the flu; blisters in her mouth, on her lips and in her nose; very weak; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   On 8th October 2020, the patient received the 1st dose of Shingrix. On 8th October 2020, less than a day after receiving Shingrix, the patient experienced general body pain, feeling of warmth and influenza-like symptoms. On 9th October 2020, the patient experienced vomiting and weakness. In October 2020, the patient experienced blister. On an unknown date, the patient experienced fever blister. The action taken with Shingrix was unknown. On 9th October 2020, the outcome of the general body pain was recovered/resolved. In October 2020, the outcome of the weakness was recovered/resolved. On an unknown date, the outcome of the feeling of warmth and vomiting were recovered/resolved and the outcome of the fever blister and blister were recovering/resolving and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the general body pain, feeling of warmth, vomiting, weakness, fever blister, influenza-like symptoms and blister to be related to Shingrix.  Additional information was provided as follows: The patient felt warm like a temperature but did not have one, four to five hours after receiving the vaccine. At bedtime, she felt pain all over her body described like feeing like she had the flu. She hardly slept due to the pain everywhere. She was very weak and out of it the next morning and could hardly make it to the bathroom where she vomited.  The body pain lasted about 24 hours.  The weakness lasted a week.  Fever blisters presented in her mouth, on her lips and in her nose a few days after administration.  Those were resolving. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Sleep disorder, Vomiting
Clinical narrative: Fever blisters presented in her mouth, on her lips and in her nose; vomited; felt pain all over her body; felt warm like a temperature but did not have one; like feeing like she had the flu; blisters in her mouth, on her lips and in her nose; very weak; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   On 8th October 2020, the patient received the 1st dose of Shingrix. On 8th October 2020, less than a day after receiving Shingrix, the patient experienced general body pain, feeling of warmth and influenza-like symptoms. On 9th October 2020, the patient experienced vomiting and weakness. In October 2020, the patient experienced blister. On an unknown date, the patient experienced fever blister. The action taken with Shingrix was unknown. On 9th October 2020, the outcome of the general body pain was recovered/resolved. In October 2020, the outcome of the weakness was recovered/resolved. On an unknown date, the outcome of the feeling of warmth and vomiting were recovered/resolved and the outcome of the fever blister and blister were recovering/resolving and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the general body pain, feeling of warmth, vomiting, weakness, fever blister, influenza-like symptoms and blister to be related to Shingrix.  Additional information was provided as follows: The patient felt warm like a temperature but did not have one, four to five hours after receiving the vaccine. At bedtime, she felt pain all over her body described like feeing like she had the flu. She hardly slept due to the pain everywhere. She was very weak and out of it the next morning and could hardly make it to the bathroom where she vomited.  The body pain lasted about 24 hours.  The weakness lasted a week.  Fever blisters presented in her mouth, on her lips and in her nose a few days after administration.  Those were resolving. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Injection site urticaria, Vaccination site erythema
Clinical narrative: mild wheel and flare reaction at the site; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to case 2020SA272588 (same reporter).  This case involves a patient with an unknown demographic who experienced mild wheel and flare reaction at the site (vaccination site reaction), when received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious mild wheel and flare reaction at the site (vaccination site reaction) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on lot number for this case.
Sex: M
Vaccine: FLU3, FLUA3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was administered Fluad instead of Fluzone High Dose, no AE; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a male patient who was administered with INFLUENZA VACCINE INACT SAG 3V [FLUAD] (lot number and expiration date not reported) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered) via unknown route at an unknown administration site for prophylactic vaccination in Sep-2020 (exact date was not clear).  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was an actual medication error case due to wrong vaccine administered (same day).  Patient was wondering if he should get re-vaccinated because he wanted the High Dose vaccine.  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 on the batch number for this case.
Age: 66.0
Sex: U
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 66 years old patient was administered Fluzone Quadrivalent instead of Fluzone High-Dose, no AE; Initial information was received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist via phone.  This case involves a 66 years old patient (gender was not reported) who was vaccinated with a 0.5 ml dose of  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number and other dosing details were not reported) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  This was an actual medication error case due to wrong vaccine administered (latency was same day).  The pharmacist wanted to know if they can administer the Fluzone High-Dose as well due to patient.  At the time of reporting, no adverse event 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 available on the batch number for this case.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: sore arms; A patient received an expired fluzone quadrivalent; Initial information was received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA271521 and 2020SA272379 (same reporter).  This case involves a 7 years old female patient who had sore arms (pain in extremity) and was inadvertently administered an expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient had no concomitant vaccines.  On 29-Sep-2020, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6756NA and expiry date: 30-Jun-2020, strength: standard) once via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sore arms (pain in extremity) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was an actual medication error case due to expired vaccine used (latency: same day).  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment for pain in extremity  At the time of report, the outcome of pain in extremity was unknown.   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: 76.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received Fluzone High-Dose Quadrivalent which was in extended shipping time making the vaccine not suitable for use/ No AE; a patient received Fluzone High-Dose Quadrivalent which was in extended shipping time making the vaccine not suitable for use/ No AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2020SA272284 (sister case).  This case involves a 76 years old female patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ501AB, expiry date: 30-Jun-2021) via intramuscular route and right deltoid site on an 26-Sep-2020 for prophylactic vaccination which experienced an extended shipping time making the vaccine not suitable for use (product storage error and product distribution issue).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  No concomitant medication was given to the patient.  It was an actual medication error due incorrect product storage.  It was a case of product shipment delay.  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.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 59 years old patient was administered Fluzone High Dose Quadrivalent, No AE; A 59 years old patient was administered Fluzone High Dose Quadrivalent, No AE; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.   This case involves a 59 years old male patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other medications or vaccines had been administered to the patient.   On 01-Oct-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ483AA, expiry date: 30-Jun-2021) once via unknown route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration. It was also a case of an overdose (latency same day).  The reporter wanted to know the recommendations for a patient that was younger than 65 receiving Fluzone high dose Quadrivalent.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: an 11 year old was inadvertently given the Flublok immunization with no AE; Initial information received on 03-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2020SA272961.  This case involves a 11 years old female patient who inadvertently received 0.5 ml once dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: UJ463AA, expiry date: 19-Mar-2021) via intramuscular route on left arm on 03-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given only the DTaP-IPV portion and ActHIB separately, No AE; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a four-month-old female patient who was administered with the Dtap-IPV portion and Act-HIB with 0.4% sodium chloride separately of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, past medical treatment(s), medical treatment(s), vaccination(s) and family history were not reported.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On 15-Oct-2020 , the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [lot UJ163AAA, U6395AA and expiration date: 15-Oct-2020 and  24-Apr-2021] via intramuscular route in left leg (Dtap-IPV) and in the right leg (Act-HIB) for prophylactic vaccination.  This was an actual medication error due to inappropriate reconstitution technique (PT: product preparation issue) (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.