chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High Dose which was administered to a 15 year old male/ with no AE; Fluzone High Dose which was administered to a 15 year old male/ with no AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 years old male patient who experienced vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ290AB via intramuscular route in the left deltoid on 08-Nov-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error Inappropriate age at vaccine administration and overdose.    It was reported that the patient had no AE symptoms   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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient received only the DTaP-IPV portion of Pentacel, no advesre event; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown demographic patient who was vaccinated with a dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot number not reported via unknown route in unknown administration site on an unknown date. The patient received only the DTaP-IPV portion of Pentacel.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate reconstitution technique.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a edical 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.  Information on the batch number was requested.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction, Anaemia, Bone loss, Colitis ulcerative, Condition aggravated
Clinical narrative: flare of her ulcerative colitis; got a severe reaction, severe inflammatory response; blood loss; anemia; bone loss; weight loss; 57 years old patient was administered Fluzone High-Dose; 57 years old patient was administered Fluzone High-Dose; Initial information received on 11-Nov-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a 57 years old female patient who got a severe reaction, severe inflammatory response (inflammation), blood loss (haemorrhage), anemia (anaemia), bone loss (bone loss), weight loss (weight decreased) and flare of her ulcerative colitis (colitis ulcerative), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing colitis ulcerative.  On 11-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ030AA via unknown route in unknown administration site.  On an unknown date, the patient developed a severe flare of her ulcerative colitis (colitis ulcerative), got a severe reaction, severe inflammatory response (inflammation), blood loss (haemorrhage), anemia (anaemia), bone loss and weight loss (weight decreased) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant. The patient was hospitalized for these events (hospitalization duration 3 days).  It was also a case of inappropriate age at vaccine administration and overdose.  Other relevant tests not reported.  Final diagnosis was severe flare of her ulcerative colitis.  Corrective treatment not reported.  The outcome was unknown for all the events.  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.; Sender's Comments: This case concerns a 57 years old female patient who experienced colitis ulcerative after vaccination with FLUZONE HIGH DOSE. The time to onset was unknown. However, patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Inflammation, Product administered to patient of inappropriate age, Weight decreased
Clinical narrative: flare of her ulcerative colitis; got a severe reaction, severe inflammatory response; blood loss; anemia; bone loss; weight loss; 57 years old patient was administered Fluzone High-Dose; 57 years old patient was administered Fluzone High-Dose; Initial information received on 11-Nov-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a 57 years old female patient who got a severe reaction, severe inflammatory response (inflammation), blood loss (haemorrhage), anemia (anaemia), bone loss (bone loss), weight loss (weight decreased) and flare of her ulcerative colitis (colitis ulcerative), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing colitis ulcerative.  On 11-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ030AA via unknown route in unknown administration site.  On an unknown date, the patient developed a severe flare of her ulcerative colitis (colitis ulcerative), got a severe reaction, severe inflammatory response (inflammation), blood loss (haemorrhage), anemia (anaemia), bone loss and weight loss (weight decreased) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant. The patient was hospitalized for these events (hospitalization duration 3 days).  It was also a case of inappropriate age at vaccine administration and overdose.  Other relevant tests not reported.  Final diagnosis was severe flare of her ulcerative colitis.  Corrective treatment not reported.  The outcome was unknown for all the events.  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.; Sender's Comments: This case concerns a 57 years old female patient who experienced colitis ulcerative after vaccination with FLUZONE HIGH DOSE. The time to onset was unknown. However, patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: vaccine given to oncology patient under the age of 65, no AE; vaccine given to oncology patient under the age of 65, no AE; Initial information was received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographic patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing neoplasm malignant.  It is an actual medication error case due to overdose and inappropriate age at vaccine administration.  It was reported that the vaccine given to oncology patient under the age of 65.  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.  Information on the batch number was requested.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 15 year old female patient received a dose of Flublok Quadrivalent/No AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 15 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1940, expiry date: 30-JUN-2020 via intramuscular route in the left deltoid on 11-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  The patient has not had any adverse reactions at this time.  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: F
Vaccine: HIBV
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: while administering a dose of ActHIB to a 36 months old female patient, she pulled away and only received a small amount of the vaccine/No AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 36 months old female patient who while administering a 0.5 ml fourth dose of HIB (PRP/T) VACCINE [ACT-HIB], she pulled away and only received a small amount of the vaccine lot UI987AAA, expiry date: 01-APR-2020 via intramuscular route in the left deltoid on 11-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of vaccine underdose.  AE symptoms: None reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient who is over 65 received Fluzone Quadrivalent instead of the Fluzone HD, No AE; Initial information was received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves over 65 years old patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number not reported via unknown route in unknown administration site on an unknown date instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong vaccine administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.  Information on the batch number was requested.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: redness; huge welts on the leg; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA316202 (same reporter).  This case involves a 1 years old patient who experienced redness (erythema) and huge welts on the leg (urticaria), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ212AA and lot UT6657JA, via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious redness (erythema) and huge welts on the leg (urticaria) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was erythema and urticaria.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for erythema and urticaria.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: redness; huge welts on the leg; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA316200 (same reporter).  This case involves a 3 years old patient who experienced redness (erythema) and huge welts on the leg (urticaria), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ212AA and lot UT6657JA, via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious redness (erythema) and huge welts on the leg (urticaria) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was erythema and urticaria.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for erythema and urticaria.
Sex: U
Vaccine: FLUR4
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; Initial information received on 12-Nov-2019 regarding an unsolicited valid serious case received from a Pharmacist.  This case involves patient of unknown demographics who experienced anaphylaxis (anaphylactic reaction), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included alpha-gal allergy and patient cannot tolerate mammalian products.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in an unknown administration site.  On an unknown date, the patient developed serious anaphylaxis (anaphylactic reaction) (Unknown latency), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant.  Lab data was not reported.  Final diagnosis was anaphylactic reaction.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for anaphylaxis.  Information on the batch number was requested.; Sender's Comments: This case concerns a patient of unknown demographics presented with anaphylaxis (anaphylactic reaction) after vaccination with FLUBLOK QIV. The time to onset is unknown. Patient's medical history includes alpha-gal allergy and patient cannot tolerate mammalian products. Moreover, medical condition at time of vaccination, previous immunization history, allergy testing and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: FEVER AS HIGH AS 105
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: The area where i received the injection gradually became sore and overnight slight stiffness down to elbow area - I am sure it will go away with time if it gets worse will call Dr
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had swelling and redness from shoulder to elbow with a lump and itch at injection site. Patient treated with oral Benadryl and Tylenol. Sore at injection site for 2 days.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Tenderness
Clinical narrative: 3 inch area of redness upper arm, tender to touch
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dyspepsia, Fatigue, Headache
Clinical narrative: Tiredness, muscle and joint pain, fever, shivering, headache, heartburn
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Tiredness, muscle and joint pain, fever, shivering, headache, heartburn
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Body aches, fever, cold sweats, headaches, light headedness (all lasted about 36hrs).
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: 8 hours after receiving shot I developed a Fever of 101 Fahrenheit, severe aching, and chills. Lasted about 36 hours. Pharmacy never responded to my firm's inquiry as to the type of influenza I received so I am not sure which one it was on you list of influenza vaccines.
Age: 0.08
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: INCORRECT VACCINE GIVEN. NO TX, NO TX TO GIVE. MD SPOKE TO PEDS ID AND CONFIRMED THAT THERE IS NO SIGNIFICANT CLINICAL RISK TO THE CHILD. AND THAT THE CHILD WOULD HAVE TO BE RE-VACCINATED ACCORDING TO THE CDC STANDARDS.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Erythema, Immediate post-injection reaction
Clinical narrative: Patient became short of breath immediately after administration. Face and chest became very red and she told me her chest was tight and she could not breath. Prior to vaccine administration, patient verbally told me as well as documented on the intake form she had gotten her flu shot most every year and had never had any sort of reaction to it.  When I saw that the patient was having trouble breathing, I immediately administered one dose (0.3 mg) of an epi pen to her thigh and told a nearby person to call 911. After epi pen administration patient's face coloring went back to normal and she was able to breath. Paramedics arrived shortly afterwards and took patient to the hospital to ensure she was alright.
Age: 0.5
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: INCORRECT VACCINE WAS GIVEN, NO TX NEEDED. MD SPOKE WITH PEDS ID AND CONFIRMED THAT THERE ARE NO SIGNIFICANT CLINICAL RISK TO THE CHILD AND THAT THE CHILD WOULD HAVE TO BE RE- VACCINATED ACCORDING TO THE CDC STANDARDS.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blister, Chills, Herpes zoster, Malaise
Clinical narrative: 11/10/19 and 11/11/19 - fever, chills, body aches 11/12/19 to 11/15/19 - muscle aches, particularly across middle of chest and back; general malaise 11/16/19 sever back pain, rash from center of back around left side to center of chest.  Urgent clinic - doctor diagnosed as Shingles and prescribed Valtrex and pain medicine (narcotic) As of the date of this report (11/19/19) the rash has continued to deepen in color (red) with some blisters.  Body aches have begun to subside, but still active.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: 11/10/19 and 11/11/19 - fever, chills, body aches 11/12/19 to 11/15/19 - muscle aches, particularly across middle of chest and back; general malaise 11/16/19 sever back pain, rash from center of back around left side to center of chest.  Urgent clinic - doctor diagnosed as Shingles and prescribed Valtrex and pain medicine (narcotic) As of the date of this report (11/19/19) the rash has continued to deepen in color (red) with some blisters.  Body aches have begun to subside, but still active.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: Dose of VARIVAX was inadvertently given to an unspecified 50 year old patient on an unspecified date due to human error; This spontaneous report was received from an administrator referring to a 50 years old patient of unknown gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.       On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (vaccine dosage detail and route of administration not reported; lot # S000132, expiration date 02-JAN-2021) due to human error for prophylaxis (wrong product administered). The reporter stated that this was not product confusion. No product quality complaint (PQC) was involved in this case.
Age: 17.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported; patient was inadvertently administered one dose of Varivax concomitantly with Proquad; patient was inadvertently administered one dose of Varivax concomitantly with Proquad; This spontaneous report was received from a pharmacist and refers to a 17-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-OCT-2019, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, one dose, lot # S019461 and expiration date 24-JUN-2021 (exact dose, site and route of administration were not reported) concomitantly with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, lot # S017245 and expiration date 01-DEC-2020 (exact dose, site and route of administration were not reported) both for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Premature menopause
Clinical narrative: premature ovarian failure; This spontaneous report was received from a physician via a company representative and refers to a 14-year-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, dose and route of administration were not provided) for prophylaxis. On an unknown date, after finishing regimen of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced premature ovarian failure. The patient sought medical attention. It was unknown if any treatment was given for the event and if any lab diagnostics or studies were performed. The outcome of premature ovarian failure was unknown.  The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1911USA007189:
Sex: F
Vaccine: HPV9
Symptoms: Premature menopause
Clinical narrative: premature ovarian failure; This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, dose and route of administration were not provided) for prophylaxis. On an unknown date, after finishing regimen of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient was evaluated for premature ovarian failure. The outcome of premature ovarian failure was unknown.  The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1910USA015759:
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Malaise, Nausea, Pain
Clinical narrative: General malaise followed by body aches and sharp pains all over. By 8 pm trembling and chills, by 9:30 nausea then vomiting which ended around 1am. The following day brought weakness and some minor body aches plus a low grade fever for several hours. Weakness continued for another 48 hours or more.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: General malaise followed by body aches and sharp pains all over. By 8 pm trembling and chills, by 9:30 nausea then vomiting which ended around 1am. The following day brought weakness and some minor body aches plus a low grade fever for several hours. Weakness continued for another 48 hours or more.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Areflexia, CSF test normal, Electromyogram abnormal, Guillain-Barre syndrome, Hypokalaemia
Clinical narrative: Bilateral lower extremity weakness with areflexia: Suspected Guillain-Barre Syndrome-presented to ED 10/21/19 Seen in ED 10/10/19 with lower extremity swelling bilaterally When came to ED on 10/21/19 reported progressive weakness on her legs. D/C note states had weakness x5 days when presented Completed 5 days of IVIG on 10/26/19 Hypokalemia 2.9 on date of presentation
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Immunoglobulin therapy, Magnetic resonance imaging spinal normal, Muscular weakness, Nerve conduction studies abnormal, Peripheral sensory neuropathy
Clinical narrative: Bilateral lower extremity weakness with areflexia: Suspected Guillain-Barre Syndrome-presented to ED 10/21/19 Seen in ED 10/10/19 with lower extremity swelling bilaterally When came to ED on 10/21/19 reported progressive weakness on her legs. D/C note states had weakness x5 days when presented Completed 5 days of IVIG on 10/26/19 Hypokalemia 2.9 on date of presentation
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Peripheral swelling
Clinical narrative: Bilateral lower extremity weakness with areflexia: Suspected Guillain-Barre Syndrome-presented to ED 10/21/19 Seen in ED 10/10/19 with lower extremity swelling bilaterally When came to ED on 10/21/19 reported progressive weakness on her legs. D/C note states had weakness x5 days when presented Completed 5 days of IVIG on 10/26/19 Hypokalemia 2.9 on date of presentation
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Areflexia, Borrelia test negative, CSF myelin basic protein normal, CSF oligoclonal band absent, CSF test normal
Clinical narrative: Bilateral lower extremity weakness with areflexia: Suspected Guillain-Barre Syndrome-presented to ED 10/21/19 Seen in ED 10/10/19 with lower extremity swelling bilaterally When came to ED on 10/21/19 reported progressive weakness on her legs. D/C note states had weakness x5 days when presented Completed 5 days of IVIG on 10/26/19 Hypokalemia 2.9 on date of presentation
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Cryptococcus test, Guillain-Barre syndrome, Hypokalaemia, Immunoglobulin therapy, Magnetic resonance imaging spinal normal
Clinical narrative: Bilateral lower extremity weakness with areflexia: Suspected Guillain-Barre Syndrome-presented to ED 10/21/19 Seen in ED 10/10/19 with lower extremity swelling bilaterally When came to ED on 10/21/19 reported progressive weakness on her legs. D/C note states had weakness x5 days when presented Completed 5 days of IVIG on 10/26/19 Hypokalemia 2.9 on date of presentation
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Muscular weakness, Peripheral swelling, West Nile virus test negative
Clinical narrative: Bilateral lower extremity weakness with areflexia: Suspected Guillain-Barre Syndrome-presented to ED 10/21/19 Seen in ED 10/10/19 with lower extremity swelling bilaterally When came to ED on 10/21/19 reported progressive weakness on her legs. D/C note states had weakness x5 days when presented Completed 5 days of IVIG on 10/26/19 Hypokalemia 2.9 on date of presentation
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain, Mobility decreased, Myalgia
Clinical narrative: Patient experienced severe burning immediately after vaccine was given.  Sharp pain at site.  Muscle became extremely sore and patient was unable to move arm for a few days after.  Discomfort remains with certain ROM activities.  Patient states pain has decreased but continues to linger. No redness or rash noted upon inspection.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Patient experienced severe burning immediately after vaccine was given.  Sharp pain at site.  Muscle became extremely sore and patient was unable to move arm for a few days after.  Discomfort remains with certain ROM activities.  Patient states pain has decreased but continues to linger. No redness or rash noted upon inspection.
Age: 0.83
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: At 2:45 pm, patient woke up from her nap and vomited all over her crib, more than we have ever seen, and were astonished that she was capable of producing than much vomit. Over the next 5 hours, she vomited 7 more times. After two hours of vomiting, I called Advice line. They advised us to bring her to the emergency room, since she was at risk for becoming dehydrated and we didn?t know what was causing the vomit. Since she had received the flu vaccine that morning, I imagined there could be a correlation.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm is swollen, hot, and red four days later.  Looks like Popeyes muscles.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site pain, Injection site rash
Clinical narrative: Flu like symptons ..  headache, nausea, shivering.  Pain and rash at injection site.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Flu like symptons ..  headache, nausea, shivering.  Pain and rash at injection site.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Nausea, Pain, Pyrexia
Clinical narrative: Mild: Fever 101.2, red painful area on arm.  Severe:  full body aches, chills, nausea for two full days.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site reaction, Skin discolouration
Clinical narrative: Darkening of skin at injection site for over one month.  Darkened area did eventually fade.  Unlike a bruise which turns various purples, greens, or yellows, this spot remained the same color and dark throughout the time period.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Injection placed in improper site - right lateral hip. No pain on injection, hours later started to have chills, pain, redness, swelling, itching, general malaise
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Product administered at inappropriate site, Pruritus, Swelling
Clinical narrative: Injection placed in improper site - right lateral hip. No pain on injection, hours later started to have chills, pain, redness, swelling, itching, general malaise
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram head, Diplopia, Fall, Fatigue, Gait disturbance
Clinical narrative: 10/13 - 10/16 leg pain, double vision, headache, gait disturbance 10/21 progressive LE weakness, gait abnormality disconjugate gase, visual disturbance -  diplopia, tired, falls, numbness/tingling 10/21 transfer hospital MRI - caudal equine peripheral nerve involve 10/28 Rehab.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging abnormal, Muscular weakness
Clinical narrative: 10/13 - 10/16 leg pain, double vision, headache, gait disturbance 10/21 progressive LE weakness, gait abnormality disconjugate gase, visual disturbance -  diplopia, tired, falls, numbness/tingling 10/21 transfer hospital MRI - caudal equine peripheral nerve involve 10/28 Rehab.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia, Visual impairment
Clinical narrative: 10/13 - 10/16 leg pain, double vision, headache, gait disturbance 10/21 progressive LE weakness, gait abnormality disconjugate gase, visual disturbance -  diplopia, tired, falls, numbness/tingling 10/21 transfer hospital MRI - caudal equine peripheral nerve involve 10/28 Rehab.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Headache, Pain, Pyrexia
Clinical narrative: I am a healthy strong female and the reaction to this vaccine really surprised me. I had chills, fever, headache, pain in all my body, even chest pain. I strongly believe there should be a warning to patients before the vaccine is administered, specially for older patients.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Back disorder, Inflammation, Pain, Swelling
Clinical narrative: Pt reports back going out the day following and continuing pain/ swelling until day of reporting on 11-18-19; reports inflamed lower back started which has made it difficult to get out of bed. started in the middle lower back and "roles up from there". pt notices an associating with also experiencing his back going out after last years flu shot.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: dose given was expired
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Chills, Decreased appetite, Feeling abnormal
Clinical narrative: I received the injection about 2 pm and within the next hour, I started to feel "odd" and a little cold. I was out running errands, so I decided to go home. As soon as I arrived home, I went to bed with the chills. By 7 pm my temperature was 102 and by 9 pm it was 104. The fever continued all through Weds Nov 6, running about 102 and I stayed in bed all day, drinking fluids, but no appetite. Sometime during that next night I woke up covered in sweat and the fever was gone. I spent Thursday Nov 7 feeling weak and wobbly and stayed home all day. Friday, Nov 8,  was the first day I felt like myself.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Middle insomnia, Night sweats, Pyrexia
Clinical narrative: I received the injection about 2 pm and within the next hour, I started to feel "odd" and a little cold. I was out running errands, so I decided to go home. As soon as I arrived home, I went to bed with the chills. By 7 pm my temperature was 102 and by 9 pm it was 104. The fever continued all through Weds Nov 6, running about 102 and I stayed in bed all day, drinking fluids, but no appetite. Sometime during that next night I woke up covered in sweat and the fever was gone. I spent Thursday Nov 7 feeling weak and wobbly and stayed home all day. Friday, Nov 8,  was the first day I felt like myself.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Myalgia, Rash
Clinical narrative: 11/18/2019 HEADACHE, MUSCLE ACHES 11/19/2019 RASH TO CHEST, BACK ABDOMEN, NECK
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Antinuclear antibody, Cryoglobulins, Full blood count, Henoch-Schonlein purpura, Red blood cell sedimentation rate
Clinical narrative: Henoch-Schoenlein Purpura
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Rheumatoid factor, Streptococcus test
Clinical narrative: Henoch-Schoenlein Purpura
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: VERY SORE AND SWOLLEN ARM AND FELT UNWELL THE FOLLOWING DAY
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Swelling, Tenderness
Clinical narrative: 1 week of severe swelling, erythema, induration and tenderness about 1inch in diameter, persisting for 1 week
Age: 53.0
Sex: F
Vaccine: HEPA, MMR, MNQ, TYP, YF
Symptoms: Dry skin, Erythema, Erythema of eyelid, Pruritus, Skin exfoliation
Clinical narrative: How could I possibly know which arm took which shot, the dose number of the vaccines and/or the manufacturers of the vacs?  Adverse Events: Within two hours of receiving the final vaccination on Oct. 9th, 2019, my face became red and somewhat rough to the touch. A particularly affected area was the skin around (both under and above) my eyes and between my eyebrows. This redness was noticeable enough for a friend I was visiting with that day who had no idea I received the vaccinations asked if I had been in a tanning bed. As the days progressed, the skin surrounding my eyes began flaking off from extreme dry skin. The redness and rough, dry skin continued down my entire face, beneath my chin and on the front of my neck. About a week later this red/dry skin condition was mostly gone. This said, since the vaccinations I have been experiencing unexplained patches itching on different places on my body. This itching shows up as small hive-like bumps surrounded by redness. As this skin condition comes and goes without warning, it is beyond difficult to schedule any examination to take place while symptomatic. Last night, Nov. 18, 2019 was my most recent experience with this itching.
Age: 53.0
Sex: F
Vaccine: HEPA, MMR, MNQ, TYP, YF
Symptoms: Urticaria
Clinical narrative: How could I possibly know which arm took which shot, the dose number of the vaccines and/or the manufacturers of the vacs?  Adverse Events: Within two hours of receiving the final vaccination on Oct. 9th, 2019, my face became red and somewhat rough to the touch. A particularly affected area was the skin around (both under and above) my eyes and between my eyebrows. This redness was noticeable enough for a friend I was visiting with that day who had no idea I received the vaccinations asked if I had been in a tanning bed. As the days progressed, the skin surrounding my eyes began flaking off from extreme dry skin. The redness and rough, dry skin continued down my entire face, beneath my chin and on the front of my neck. About a week later this red/dry skin condition was mostly gone. This said, since the vaccinations I have been experiencing unexplained patches itching on different places on my body. This itching shows up as small hive-like bumps surrounded by redness. As this skin condition comes and goes without warning, it is beyond difficult to schedule any examination to take place while symptomatic. Last night, Nov. 18, 2019 was my most recent experience with this itching.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: A small lump formed under the skin and he has had intense itching of site for the last several months. Did not start until a couple of weeks after the vaccination.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; was administered a dose of Improperly stored PROQUAD; This spontaneous report was received from medical assistant regarding a a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history and drug reactions/allergies were unknown.  The patient's concomitant medication included sterile diluent. On 10-OCT-2019, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: digital data logger) (dose, anatomical location were unknown) (lot # S006835 and expiration date: 02-SEP-2020) via route intramuscular for prophylaxis (product storage error). It was reported that there were no adverse effects. The administered dose of the vaccine experienced a temperature excursion of 15 degree Fahrenheit (°F) to 46°F (20.7°F) for 2 hours 8 minutes, as recorded by digital data logger. The vaccine had a previous temperature excursion of 6°F to 14°F (13.8°F) for 32 minutes.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/ allergies and concomitant medications were not reported. On 12-NOV-2019, the patient was vaccinated with second dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, formulation, dose/frequency, route were unknown) for prophylaxis (product storage error). Reporter stated that, one of the 2 lots listed were administered but unable to differentiate which one at time of call Lot# R033251 expiry date: 29-JUN-2020, Lot# S001101 expiry date: 21-OCT-2020. The vaccine was stored at a temperature of 1.8 degree Celsius for 3 minutes. There was previous temperature excursion of 14.2 degree Celsius for 2 hours 58 minutes. The call was because of data logger. No adverse effects were reported. The outcome of product storage error and no adverse event was unknown.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 18 year old patient received 1mL adult dose instead of pediatric dose. No adverse symptoms.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Erythema, Induration, swelling 15.5 x 17.5 cm.  Treatment cold compression.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Neck pain
Clinical narrative: myalgia, neck pain with motion, global headache visual disturbance, difficulty with focusing on objects, dark spots in front of eyes, difficulty with thoughts: forming/completing thoughts, extreme fatigue, fever and chills. fever to 100 degree. all treated with rest, hydration, tylenol, resolved by 0900 on 11/19/2019
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Thinking abnormal, Vision blurred, Visual impairment
Clinical narrative: myalgia, neck pain with motion, global headache visual disturbance, difficulty with focusing on objects, dark spots in front of eyes, difficulty with thoughts: forming/completing thoughts, extreme fatigue, fever and chills. fever to 100 degree. all treated with rest, hydration, tylenol, resolved by 0900 on 11/19/2019
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Frequent bowel movements, Haematochezia, Occult blood positive
Clinical narrative: Frequent stools with gross blood  4x on 11/18/2019
Age: 71.0
Sex: M
Vaccine: VARCEL
Symptoms: Peripheral swelling
Clinical narrative: This reaction was not reported by patient until 3/21/19 at follow up visit. Swelling of arm
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Dizziness & NauseaVomiting
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: Symptoms: & vomiting, runny nose
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Brought to flu clinic on 11/11/2019 and got flu shot At office appointment on 11/18/2019 chart review showed flu was also given on 10/28/2019
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Erythema, Insomnia, Nausea, Pain in extremity
Clinical narrative: The patient called to say that his arm was very red and swollen. He also reported dizziness, nausea and extreme arm pain that kept him from sleeping. These symptoms lasted for about a day and a half.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: The patient called to say that his arm was very red and swollen. He also reported dizziness, nausea and extreme arm pain that kept him from sleeping. These symptoms lasted for about a day and a half.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Left arm pain immediately - persisting till now + going down arm
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rassh & UrticariaPruritus
Age: 43.0
Sex: M
Vaccine: DTP
Symptoms: Dyspnoea, Flank pain, Nausea, Nephrolithiasis
Clinical narrative: Patient reports to ED 1 day after receiving Tdap vaccine with dyspnea, nausea, and flank pain. Of note, patient was recently diagnosed with an 8mm kidney stone that will required surgical removal shortly after admission. Possible that symptoms were r/t to kidney stones but unsure as the symptoms appeared shortly after vaccine administration.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Myalgia
Clinical narrative: Myalgia & Erythema Multiform
Age: 83.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Injection site erythema, Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: Had swelling, redness, & itching in area of arm (left) that she received both vaccines. Was dizzy and nauseous Friday & Saturday and had trouble getting to bathroom due to nausea. Slept for several hours. Still symptomatic on Saturday 1 day after vaccine & went to ER.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Mother of patient noticed on Saturday 11/16/19 in the morning when bathing her son that his entire upper arm from the sholder to the elbow was red she says about 6" x 3" just on the top of the arm not under. She said the redness looked like a "sunburn." She said the area was very painful for her son and he would not let her hug him. She said she did not do anything to treat it and did not take him in to the doctor. On 11/18 in the morning she said it was lighter pink and still painful.