chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Cough, Nasal congestion, Productive cough, Pyrexia, Upper-airway cough syndrome
Clinical narrative: TOOK THIRD DOSE ON DAY 6; UPPER RESPIRATORY VIRAL INFECTION; This spontaneous case report was received from a nurse (PVX2019-038) on 04-Jan-2019 and a follow-up was received on 10-Jan-2019. The report describes a 70-year-old elderly male consumer who had upper respiratory viral infection following the intake of Vivotif for an unknown indication.   The consumer's medical history included hypertension, Raynaud's disease, and BPH (Benign prostatic hyperplasia) and he had allergies from different drugs (forgetfulness from Flomax, pedal edema from nifedipine, tinnitus from azithromycin) and had a childhood history of penicillin allergy. The consumer used to take alcohol a couple of times in a week.  It was reported that the consumer took Vivotif doses on 01-Jan-2019, 03-Jan-2019, 06-Jan-2019, and 08-Jan-2019, respectively. On 03-Jan-2019, he experienced upper respiratory viral infection with the symptoms of low-grade fever (100.5-degree Fahrenheit) which was resolved on 04-Jan-2019, stuffy nose, coughing, postnasal drip, and phlegm which was resolved on 08-Jan-2019. He took a dose of ibuprofen and an hour later, he took his second dose of Vivotif.  The action taken with respect to the event upper respiratory viral infection was dosage maintained while with respect to the "took third dose on day 6" was not applicable.  The clinical outcome of the event upper respiratory viral infection was resolved with respect to the event "took third dose on day 6" was not applicable.  The reporter's causality with respect to the event upper respiratory viral infection was not related.  Company Comment: In this case a 70-year-old elderly male consumer developed upper respiratory viral infection following the intake of Vivotif. Respiratory tract infection is an infectious condition with commonly viral or bacterial etiology. Hence the causality of the event respiratory tract infection is assessed unlikely with Vivotif vaccine. The causality of the event "took third dose on day 6" was considered as not applicable.; Sender's Comments: Company Comment : In this case a 70-year-old elderly male consumer developed upper respiratory viral infection following the intake of Vivotif. Respiratory tract infection is an infectious condition with commonly viral or bacterial etiology. Hence the causality of the event respiratory tract infection is assessed unlikely with Vivotif vaccine. The causality of the event "took third dose on day 6" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Viral upper respiratory tract infection
Clinical narrative: TOOK THIRD DOSE ON DAY 6; UPPER RESPIRATORY VIRAL INFECTION; This spontaneous case report was received from a nurse (PVX2019-038) on 04-Jan-2019 and a follow-up was received on 10-Jan-2019. The report describes a 70-year-old elderly male consumer who had upper respiratory viral infection following the intake of Vivotif for an unknown indication.   The consumer's medical history included hypertension, Raynaud's disease, and BPH (Benign prostatic hyperplasia) and he had allergies from different drugs (forgetfulness from Flomax, pedal edema from nifedipine, tinnitus from azithromycin) and had a childhood history of penicillin allergy. The consumer used to take alcohol a couple of times in a week.  It was reported that the consumer took Vivotif doses on 01-Jan-2019, 03-Jan-2019, 06-Jan-2019, and 08-Jan-2019, respectively. On 03-Jan-2019, he experienced upper respiratory viral infection with the symptoms of low-grade fever (100.5-degree Fahrenheit) which was resolved on 04-Jan-2019, stuffy nose, coughing, postnasal drip, and phlegm which was resolved on 08-Jan-2019. He took a dose of ibuprofen and an hour later, he took his second dose of Vivotif.  The action taken with respect to the event upper respiratory viral infection was dosage maintained while with respect to the "took third dose on day 6" was not applicable.  The clinical outcome of the event upper respiratory viral infection was resolved with respect to the event "took third dose on day 6" was not applicable.  The reporter's causality with respect to the event upper respiratory viral infection was not related.  Company Comment: In this case a 70-year-old elderly male consumer developed upper respiratory viral infection following the intake of Vivotif. Respiratory tract infection is an infectious condition with commonly viral or bacterial etiology. Hence the causality of the event respiratory tract infection is assessed unlikely with Vivotif vaccine. The causality of the event "took third dose on day 6" was considered as not applicable.; Sender's Comments: Company Comment : In this case a 70-year-old elderly male consumer developed upper respiratory viral infection following the intake of Vivotif. Respiratory tract infection is an infectious condition with commonly viral or bacterial etiology. Hence the causality of the event respiratory tract infection is assessed unlikely with Vivotif vaccine. The causality of the event "took third dose on day 6" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Took first dose of Vivotif with food; Spontaneous report received on 13DEC2019.  A pharmacist reported that a male consumer who "took first dose of Vivotif with food" (PT: Product administration error), while being on Vivotif for immunization. On an unknown date, the consumer took first dose of Vivotif with food. Action taken with Vivotif with respect to reported event was not applicable. Outcome of the reported event was unknown.  Company Comment: A consumer took first dose of Vivotif with food (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif with food (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case (PVX2019-1040) was received form a consumer on 29-Apr-2019. It describes a male consumer who "did not take Vivotif according to schedule". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer did not take Vivotif according to the recommended schedule. The doses were taken on 23-Apr-2019, 26-Apr-2019, and 29-Apr-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "did not take Vivotif according to schedule" was unknown.  Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Adacel was administered to a patient, no adverse event; Initial information received on 16-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse..  This case involves a 13 years old female patient who received an expired booster dose of 0.5 ml of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] via intramuscular route in left deltoid (lot U5477CA, expiry date: 29-Oct-2018) as prophylactic vaccination on 16-MAR-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were given.   This was actual medication error case due to expired vaccine used.  At the time of report no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Generalized intense itching; Hives all over; Initial information was received on 01-Apr-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 56 years old female patient who experienced generalized intense itching (pruritus) and hives all over (urticaria), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INSULIN GLARGINE, LIXISENATIDE (SOLIQUA), INSULIN ASPART (NOVOLOG) and INSULIN DETEMIR (LEVEMIR) for an unknown indication.  On 26-Mar-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 27-Mar-2020, the patient developed a non-serious generalized intense itching (pruritus) and hives all over (urticaria) one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was reported.  Final diagnosis was pruritus and urticaria.   The patient was treated with PREDNISONE (PREDNISONE) and CETIRIZINE HYDROCHLORIDE (ZYRTEK) for pruritus and urticaria.  The patient not recovered from the events of pruritus and urticaria.  There will be no information available on the batch number for this case.
Age: 21.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Syncope
Clinical narrative: Patient fainted for a matter of seconds after administering his second vaccination and I proceeded to catch him in his chair and carefully lay him down on the floor and elevate his legs.  I was going to get me Epi-pen and call 911 when suddenly the patient came back to his senses saying, "please don't call 911, I always faint when getting vaccinated."  I gave the patient water and he ate a piece of chocolate and I monitored him closely for at least 30 minutes before sending him home.     I don't think the event is related to an adverse event since he "always faints" but Id like to report for the record.  The patient will follow up with his second MMRII vaccination in the doctor's office in order to monitor him closely.  I have since followed up with the patient later the same day and now 1 week after and he states that he is doing just fine.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles, Pyrexia
Clinical narrative: Injection given Friday, 3/27 around 10AM - Saturday, 3/28 around 10AM started having a low grade fever 99.8 to 101.4 most of the day - took tylenol Sunday, 3/29 noticed a few small blisters near the injection site on the back of the right upper arm.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash, Rash macular
Clinical narrative: Rash- generalized raised macular rash, blotchy in some areas, dense in many areas. scratching, head to toe. Prescribed hydroxyzine
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Patient presented with 3cmx3cm soft, mildly reddened swelling around injection site; he was very fussy and area appeared to be tender. Given acetaminophen and applied warm compresses in clinic.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Limb discomfort
Clinical narrative: Pt states that the site of injection was swollen and sore the evening right after vaccine administration. The following morning, pt presented to pharmacy and the area of injection appears swollen and bruised.  Pt states that the right arm feels uncomfortable.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: After vaccine patient felt very tired--more than expected. By midnight, patient started to get warm, developed headache, started shivering, had upset stomach, and had a little bit of itching.  Symptoms continued the next day.  The temperature was about 100.8 and noticed that vision was blurred compared to normal.  Symptoms somewhat improved by Saturday, temperature started to decrease,  still had blurred vision, soreness in arm,  and waves of nausea/upset stomach--did not actually throw up at any point.    On Sunday, symptoms continued to improve, fever and headache decreased. Today, patient has waves of blurred vision and nausea/upset stomach for no real reason.  Recovery is at 95% recovery.   After first dose of vaccine on 1/26/2020, only had soreness in arm; received vaccine at same facility.   Patient did not call doctor or pharmacist at any point.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pruritus, Pyrexia, Vision blurred
Clinical narrative: After vaccine patient felt very tired--more than expected. By midnight, patient started to get warm, developed headache, started shivering, had upset stomach, and had a little bit of itching.  Symptoms continued the next day.  The temperature was about 100.8 and noticed that vision was blurred compared to normal.  Symptoms somewhat improved by Saturday, temperature started to decrease,  still had blurred vision, soreness in arm,  and waves of nausea/upset stomach--did not actually throw up at any point.    On Sunday, symptoms continued to improve, fever and headache decreased. Today, patient has waves of blurred vision and nausea/upset stomach for no real reason.  Recovery is at 95% recovery.   After first dose of vaccine on 1/26/2020, only had soreness in arm; received vaccine at same facility.   Patient did not call doctor or pharmacist at any point.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site nodule
Clinical narrative: Patient called 04/06 stating he had a nodule that has developed at the injection site. Denies any complaints of fever, warmth, or rash at the location.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Anti-aquaporin-4 antibody negative, Antibody test positive, Blindness unilateral, Optic neuritis
Clinical narrative: LOSS VISION IN RIGHT EYE  (Optic  Neuritis) 6 WEEKS AFTER  INFLUENZA INJECTION
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Redness, RASH, Swelling & pain at site of injection
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: swelling at injection site; redness at injection site; received the first dose of Shingrix via subcutaneous route; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number LH7ED, expiry date 25th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. Nurse reported that 17 patients received the first dose of Shingrix via subcutaneous route, which led to intramuscular formulation administered by other route. Some of them were female patients. Nurse did not provide initials, date of birth, lot number and expiration dates of the vaccines. She did not said how many patients were male and how many were female. This is 1 of the 17 cases, reported by same reporter.   Follow up information received from Nurse on 3rd April 2020 as follows: The patient's demographic details were updated. The batch number updated for the suspect vaccine.  The patient's past medical history included mixed hyperlipidemia from  28-AUG-2014.  On 10th January 2020, the patient received the 1st dose of Shingrix .5 ml.  On an unknown date, Less than 3 months, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown.  It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix. The VAERS details were updated.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a male patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a medical office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK 1 CAPSULE EVERY DAY; This spontaneous case (791750-1) was extracted through VAERS database on 29-Mar-2019. The case was reported by another healthcare professional via health authority. It describes a 29-year-old female consumer who "took 1 capsule every day", while being on oral Vivotif capsule (lot number: 3003239) for an unknown indication.   Case report: The consumer took two doses in a row.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took 1 capsule every day" was unknown.  Company's Comment: The causality of the event "took 1 capsule every day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 1 capsule every day" was considered as not applicable.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: wake up with soreness at injection site/still sore at the injection site when touched or layed on at night; patient age: 28 years old; This spontaneous report, as received from a registered nurse via the FDA, refers to a 28 years old female patient. The patient had no pre-existing physician-diagnosed allergies, birth detects or medical conditions. The patient had no illness at time of vaccination. The patient had no other medications.  On 10-APR-2019 at 15:00, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail were unknown; lot # 1586752 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 16-FEB-2021) intramuscularly (IM) in the left deltoid for prophylaxis.  On 17-APR-2019, the patient woke up with soreness at injection site. On 06-MAY-2019, the patient still sored at the injection site when touched or lay on at night. The outcome of the event was not recovered. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was related.  Follow-up information has been received from a public health nurse on 07-APR-2020. It was also reported that the patient was at 29 (unit not provided). The patient's demographics was updated. No temperature excursion occurred as a result of a reading from a digital data logger. On 31-MAY-2019, the injection site pain was recovered.
Age: 41.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Asthenia, Asthma, Blood test, Bursitis, Condition aggravated
Clinical narrative: diagnosed with bursitis; Diagnosed with Impingement Syndrome; administered the vaccine to her in the wrong part of her arm; severe pain in the upper left arm close to her shoulder area near the injection site; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 41-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On 6th November 2019, the patient received FluLaval Quadrivalent (intercostal). On 6th November 2019, 10 hrs after receiving FluLaval Quadrivalent and an unknown time after starting cortisone acetate, the patient experienced shoulder pain and vaccine administered at inappropriate site. On 17th February 2020, the patient experienced bursitis and impingement syndrome. The patient was treated with cortisone acetate. On an unknown date, the outcome of the shoulder pain, bursitis, impingement syndrome and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the shoulder pain, bursitis and impingement syndrome to be related to FluLaval Quadrivalent.  Additional details were reported as follows: The patient received the Flulaval Quadrivalent vaccine in left arm and within 10 hours of the injection she experienced severe pain in the upper left arm close to her shoulder area near the injection site.  She tried physical therapy which did not help and had cortisone injections recently.  The patient was diagnosed with bursitis and Impingement Syndrome on 17th February 2020 and she believed that the conditions were related to the part time student who administered the vaccine to her in the wrong part of her arm. She reported the information about VAERS and was seeking compensation under the vaccine compensation act. No other information was reported. The reporter consented to follow up.
Age: 41.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Loss of personal independence in daily activities, Malaise, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: diagnosed with bursitis; Diagnosed with Impingement Syndrome; administered the vaccine to her in the wrong part of her arm; severe pain in the upper left arm close to her shoulder area near the injection site; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 41-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On 6th November 2019, the patient received FluLaval Quadrivalent (intercostal). On 6th November 2019, 10 hrs after receiving FluLaval Quadrivalent and an unknown time after starting cortisone acetate, the patient experienced shoulder pain and vaccine administered at inappropriate site. On 17th February 2020, the patient experienced bursitis and impingement syndrome. The patient was treated with cortisone acetate. On an unknown date, the outcome of the shoulder pain, bursitis, impingement syndrome and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the shoulder pain, bursitis and impingement syndrome to be related to FluLaval Quadrivalent.  Additional details were reported as follows: The patient received the Flulaval Quadrivalent vaccine in left arm and within 10 hours of the injection she experienced severe pain in the upper left arm close to her shoulder area near the injection site.  She tried physical therapy which did not help and had cortisone injections recently.  The patient was diagnosed with bursitis and Impingement Syndrome on 17th February 2020 and she believed that the conditions were related to the part time student who administered the vaccine to her in the wrong part of her arm. She reported the information about VAERS and was seeking compensation under the vaccine compensation act. No other information was reported. The reporter consented to follow up.
Age: 41.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Rotator cuff syndrome, Tendon injury, X-ray normal
Clinical narrative: diagnosed with bursitis; Diagnosed with Impingement Syndrome; administered the vaccine to her in the wrong part of her arm; severe pain in the upper left arm close to her shoulder area near the injection site; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 41-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On 6th November 2019, the patient received FluLaval Quadrivalent (intercostal). On 6th November 2019, 10 hrs after receiving FluLaval Quadrivalent and an unknown time after starting cortisone acetate, the patient experienced shoulder pain and vaccine administered at inappropriate site. On 17th February 2020, the patient experienced bursitis and impingement syndrome. The patient was treated with cortisone acetate. On an unknown date, the outcome of the shoulder pain, bursitis, impingement syndrome and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the shoulder pain, bursitis and impingement syndrome to be related to FluLaval Quadrivalent.  Additional details were reported as follows: The patient received the Flulaval Quadrivalent vaccine in left arm and within 10 hours of the injection she experienced severe pain in the upper left arm close to her shoulder area near the injection site.  She tried physical therapy which did not help and had cortisone injections recently.  The patient was diagnosed with bursitis and Impingement Syndrome on 17th February 2020 and she believed that the conditions were related to the part time student who administered the vaccine to her in the wrong part of her arm. She reported the information about VAERS and was seeking compensation under the vaccine compensation act. No other information was reported. The reporter consented to follow up.
Age: 41.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Bursitis, Injection site pain, Musculoskeletal pain, Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: diagnosed with bursitis; Diagnosed with Impingement Syndrome; administered the vaccine to her in the wrong part of her arm; severe pain in the upper left arm close to her shoulder area near the injection site; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 41-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On 6th November 2019, the patient received FluLaval Quadrivalent (intercostal). On 6th November 2019, 10 hrs after receiving FluLaval Quadrivalent and an unknown time after starting cortisone acetate, the patient experienced shoulder pain and vaccine administered at inappropriate site. On 17th February 2020, the patient experienced bursitis and impingement syndrome. The patient was treated with cortisone acetate. On an unknown date, the outcome of the shoulder pain, bursitis, impingement syndrome and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the shoulder pain, bursitis and impingement syndrome to be related to FluLaval Quadrivalent.  Additional details were reported as follows: The patient received the Flulaval Quadrivalent vaccine in left arm and within 10 hours of the injection she experienced severe pain in the upper left arm close to her shoulder area near the injection site.  She tried physical therapy which did not help and had cortisone injections recently.  The patient was diagnosed with bursitis and Impingement Syndrome on 17th February 2020 and she believed that the conditions were related to the part time student who administered the vaccine to her in the wrong part of her arm. She reported the information about VAERS and was seeking compensation under the vaccine compensation act. No other information was reported. The reporter consented to follow up.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: a "minimal soreness" in her arm; she has been vaccinated with our PNEUMOV AX 23 three previous times/physician wants to give her a 4th booster shot of PNEUMOVAX 23 again; Information has been received from a 56 years old female patient referring to herself. On an unknown date when the patient was "6 years old", she had her spleen removed because she had a "hereditary genetic" disorder called "hemo-spherocytosis", which she explained was an abnormality with the way her blood was shaped causing her spleen to "sometimes reject" or even "attack" her own blood, hence why she had her spleen taken out when she was a child.     On an unknown date in her 20's, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml for pneumonia prevention (prophylaxis) (strength, route, lot# and expiration date were not provided). On an unknown date in her 30's, the patient received the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). In approximately 2010 (reported as about "10 years ago" when she was in her 40's), the patient was administered the third dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (incorrect dose administered).   In approximately 2010 (reported as "after she got her 3rd re-vaccination shot about 10 years ago"), the patient experienced a "minimal soreness" in her arm but she said she recovered fairly quickly from the soreness (she thought the day after the vaccine was given she was fully recovered). The patient also stated her current physician wanted to give her a 4th booster shot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) again for pneumonia prevention out of an "abundance of caution" because her doctor said she "could have a higher risk of infection" as a result of not having a spleen. No product quality complaint (PQC) was involved. The causality assessment was not reported.
Age: 82.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Biopsy skin abnormal, Injection site erythema, Injection site oedema, Injection site pain, Skin cancer
Clinical narrative: malignant fast-growing skin cancer / site of surgical removal of skin cancer looked like a burn; injection site pain; injection site erythema; injection site edema; This spontaneous report was received from a pharmacist referring to a currently 84 year old male patient with glaucoma, high blood pressure, thyroid disorder, diabetes, cardiac disorder, and drug allergy to sulfa and morphine.   Concomitant therapies included glaucoma medication, blood pressure medication, potassium, thyroid medicine, diabetes medicine, digoxin, product for bowel and pain medicine.  On 01-FEB-2018, the patient was vaccinated in the same arm with  influenza virus vaccine (unspecified) and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), intramuscular route, for "vaccine" (dose, lot number and expiration date were not reported, for any of the suspect vaccines).     On an unspecified date, the patient experienced injection site pain, erythema and edema. The patient was seen by a Specialist, on unspecified date, and had a skin biopsy of the vaccination site.  On an unspecified date, the patient was informed it was cancer and subsequently the patient had surgical removal of the skin cancer.  The patient was diagnosed with malignant fast-growing skin cancer (skin cancer) at the vaccination site.  On 25-FEB-2020, the patient sought medical attention and was seen by a physician during an office visit and the vaccination site which was also the site of surgical removal of skin cancer, looked like a burn so the patient was prescribed silver sulfadiazine (SILVADENE) cream as a treatment.  At the reporting time, the patient had not recovered from the events.  The reporter did not assess the causal relationship between suspect therapies and the events.  Upon internal review, skin cancer was determined medically significant.
Age: 82.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Skin neoplasm excision, Vaccination site reaction
Clinical narrative: malignant fast-growing skin cancer / site of surgical removal of skin cancer looked like a burn; injection site pain; injection site erythema; injection site edema; This spontaneous report was received from a pharmacist referring to a currently 84 year old male patient with glaucoma, high blood pressure, thyroid disorder, diabetes, cardiac disorder, and drug allergy to sulfa and morphine.   Concomitant therapies included glaucoma medication, blood pressure medication, potassium, thyroid medicine, diabetes medicine, digoxin, product for bowel and pain medicine.  On 01-FEB-2018, the patient was vaccinated in the same arm with  influenza virus vaccine (unspecified) and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), intramuscular route, for "vaccine" (dose, lot number and expiration date were not reported, for any of the suspect vaccines).     On an unspecified date, the patient experienced injection site pain, erythema and edema. The patient was seen by a Specialist, on unspecified date, and had a skin biopsy of the vaccination site.  On an unspecified date, the patient was informed it was cancer and subsequently the patient had surgical removal of the skin cancer.  The patient was diagnosed with malignant fast-growing skin cancer (skin cancer) at the vaccination site.  On 25-FEB-2020, the patient sought medical attention and was seen by a physician during an office visit and the vaccination site which was also the site of surgical removal of skin cancer, looked like a burn so the patient was prescribed silver sulfadiazine (SILVADENE) cream as a treatment.  At the reporting time, the patient had not recovered from the events.  The reporter did not assess the causal relationship between suspect therapies and the events.  Upon internal review, skin cancer was determined medically significant.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED THIRD DOSE; This spontaneous case (PVX2019-744, PVX2019-756) was received from a pharmacist and consumer on 27-Mar-2019. It describes a female consumer who "missed third dose", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer took the first dose of Vivotif on 21-Mar-2019 and the second dose on 23-Mar-2019. Then, she missed her third dose, which was due on 25-Mar-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed third dose" was unknown.  Company's Comment: The causality of the event "missed third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed third dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THIRD DOSE ON 19-MAR-2019 AND LAST DOSE ON 02-APR-2019; This spontaneous case (PVX2019-800) was received from consumer on 03-Apr-2019. It describes a 36-year-old male consumer who "took third dose on 19-Mar-2019 and last dose on 02-Apr-2019". The consumer was receiving Vivotif for an unknown indication   Case report: The consumer took three doses of Vivotif according to the schedule. The third dose was taken on 19-Mar-2019 but he took the fourth dose on 02-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took third dose on 19-Mar-2019 and last dose on 02-Apr-2019" was unknown.  Company's Comment: The causality of the event "took third dose on 19-Mar-2019 and last dose on 02-Apr-2019" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on 19-Mar-2019 and last dose on 02-Apr-2019" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE THE FOURTH DOSE; This spontaneous case (PVX2019-801) was received from a caregiver on 03-Apr-2019. It describes a 20-year-old adult female consumer who "did not take the fourth dose", while being on Vivotif for an unknown indication.   Case report: The consumer took 3 doses of Vivotif on 18-Mar-2019, 20-Mar-2019, and 22-Mar-2019 respectively. After that, her roommate had thrown out the fourth dose hence she missed to take it.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "did not take the fourth dose" was unknown.  Company's Comment: The causality of the event "did not take the fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take the fourth dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED THIRD DOSE; This spontaneous case (PVX2019-804) was received from a nurse on 03-Apr-2019. It describes a female consumer who "missed third dose", while being on Vivotif for an unknown indication.   Case report: The consumer forgot to take third dose, which was due on 02-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed third dose" was unknown.  Company's Comment: The causality of the event "missed third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed third dose" was considered as not applicable.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK ONLY ONE DOSE; This spontaneous case (PVX2019-803) was received from a consumer on 03-Apr-2019. It describes a female consumer who "took only one dose", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer took only one dose of Vivotif 1.5 weeks ago from the date of the report, after that she did not take the remaining doses.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took only one dose" was unknown.   Company's Comment: The causality of the event "took only one dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK FOURTH DOSE ON DAY 8; This spontaneous case (PVX2019-805) was received from a nurse on 03-Apr-2019. It describes a 58-year-old female consumer who "took fourth dose on day 8", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer did not take Vivotif doses according to the schedule. She took doses on day 1, 3, 5, and 8.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took fourth dose on day 8" was unknown.  Company's Comment: The causality of the event "took fourth dose on day 8" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took fourth dose on day 8" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT COMPLETE THE COURSE ONE WEEK PRIOR TO TRAVEL; This spontaneous case (PVX2019-817) was received from a consumer on 05-Apr-2019. It describes a male consumer who "did not complete the course one week prior to travel". The consumer was receiving Vivotif (lot number: 3003241) for trave.  Case report: The consumer took the first dose of Vivotif on 04-Apr-2019. He had a planned trip on 07-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "did not complete the course one week prior to travel" was unknown.  Company's Comment: The causality of the event "did not complete the course one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete the course one week prior to travel" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-824) was received from a consumer on 08-Apr-2019. It describes a female consumer who "took two doses in a row". The consumer was receiving Vivotif for typhoid prophylaxis.  Case report: The consumer took two doses in a row. The doses were taken on 07-Apr-2019 and 08-Apr-2019.   Action taken with Vivotif was not applicable.   The clinical outcome of the event "took two doses in a row" was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE THE FOURTH DOSE ON TIME; This spontaneous case (PVX2019-835) was received from a consumer on 08-Apr-2019. It describes a female consumer who "did not take the fourth dose on time", while taking of oral Vivotif (lot number: 3003242; one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the third dose of Vivotif on 05-Apr-2019 and did not take her last dose, which was due on 07-Apr-2019.  Action taken with Vivotif with the event "did not take the fourth dose on time" was not applicable.  The clinical outcome of the event "did not take the fourth dose on time" was unknown.  Company's Comment: The causality of the event "did not take the fourth dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take the fourth dose on time" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO UNREFRIGERATED DOSES; This spontaneous case (PVX2019-861) was received from a pharmacist on 11-Apr-2019. It describes a male consumer who "took two unrefrigerated doses", while being on oral Vivotif (one dose every other day; lot no: 3003253) for typhoid fever prophylaxis.  Case report: The consumer picked up Vivotif a week ago and then left it unrefrigerated. She took two unrefrigerated doses on 09-Apr-2019 and 11-Apr-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took two unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK ONLY ONE DOSE/ DID NOT COMPLETE VIVOTIF COURSE ONE-WEEK PRIOR TRAVEL; This spontaneous case (PVX2019-884) was received from a pharmacist on 15-Apr-2019. It describes a 59-year-old adult male consumer who "took only one dose/ did not complete Vivotif course one-week prior travel". The consumer was receiving Vivotif for international travel.  Case report: The consumer took first dose of Vivotif on 11-Apr-2019 after that did not take any more doses. The consumer had a planned trip on 22-Apr-2019 to travel internationally to another country.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took only one dose/ did not complete Vivotif course one-week prior travel" was unknown.  Company's Comment: The causality of the event "took only one dose/ did not complete Vivotif course one-week prior travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose/ did not complete Vivotif course one-week prior travel" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Labelled drug-drug interaction medication error
Clinical narrative: POSSIBLY TOOK VIVOTIF WITHIN 3 DAYS OF ANTIBIOTIC; This spontaneous case (PVX2019-879) was received from a caregiver on 15-Apr-2019. It describes a 17-year-old adolescent male consumer who "possibly took Vivotif within 3 days of antibiotic". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis and oral minocycline extended release (90 mg) for acne.  Case report: The consumer took last dose of minocycline on either 11-Apr-2019 or 12-Apr-2019 and then he took his first dose of Vivotif on 15-Apr-2019.   Action taken with Vivotif and minocycline was not applicable.  The clinical outcome of the event "possibly took Vivotif within 3 days of antibiotic" was unknown.   Company's Comment: The causality of the event "possibly took Vivotif within 3 days of antibiotic" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "possibly took Vivotif within 3 days of antibiotic" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-900) was received from a consumer on 16-Apr-2019. It describes a 67-year-old elderly female consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for typhoid vaccination.  Case report: The consumer took all unrefrigerated doses of Vivotif. The first dose was taken on 09-Apr-2019 and the last dose on 15-Apr-2019.   Action taken with Vivotif was not applicable.   The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Labelled drug-drug interaction medication error
Clinical narrative: TOOK ONLY ONE DOSE; TOOK DOXYCYCLINE WHILE ON VIVOTIF; This spontaneous case (PVX2019-905) was received from a nurse on 16-Apr-2019. It describes a 71-year-old elderly male consumer who "took only one dose" and "took doxycycline while on Vivotif". The consumer was receiving Vivotif for an unknown indication and doxycycline for Lyme disease exposure.   Case report: The consumer took a dose of Vivotif about 2.5 weeks ago from the date of report and then after few days (not more than two days), he had an exposure to Lyme disease. As a prophylaxis, he took doxycycline for 2 weeks.   Action taken with Vivotif and doxycycline was not applicable.  The clinical outcome of the events "took only one dose" and "took doxycycline while on Vivotif" was unknown.   Company's Comment: The causality of the event "took only one dose" and "took doxycycline while on Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose" and "took doxycycline while on Vivotif" was considered as not applicable.