chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Neck pain, Pain in extremity, Peripheral swelling, Rash, Swelling
Clinical narrative: flu like symptoms; lost 16 lbs due; nash; "fatigue is not as bad"; less pain in r hands/pain in feet; swelling in hands/swelling in feet; pain in wrists/elbows/pain in knees/ankles/pain in hips; pain in shoulders; pain in neck; swelling in wrists/in elbows/in shoulders/in knees/in ankles/in hips; swelling in neck; This case was reported by a pharmacist via other and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz).   On an unknown date, the patient received Shingrix and PNEUMOVAX. On an unknown date, less than a month after receiving Shingrix, the patient experienced influenza-like symptoms, weight loss, rash, fatigue, pain in hand, hand swelling, wrist pain, shoulder pain, neck pain, swelling of wrists and neck swelling. On an unknown date, the outcome of the influenza-like symptoms, weight loss, rash, fatigue, pain in hand, hand swelling, wrist pain, shoulder pain, neck pain, swelling of wrists and neck swelling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, weight loss, rash, fatigue, pain in hand, hand swelling, wrist pain, shoulder pain, neck pain, swelling of wrists and neck swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingrix and pneumonvax vaccinations a couple of weeks ago and had flu like symptoms that lasted 2-3 days.  The patient has recovered. The patient lost 16 lbs due to a recently being diagnosed with rash, patient had cholesterol checked 2 weeks and hepatologist was monitoring blood levels.  The patient mentioned all team of MDs had great communication.  Since starting therapy, the patient had not had any side effects noted fatigue was not as bad and had some minor improvements with less pain and swelling in hands, wrists, elbows, shoulders, knees, ankles, feet, neck, and hips on occasion.  The patient would get discouraged but had a great support from friends.  No further information or side effects provided by the patient.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Weight decreased
Clinical narrative: flu like symptoms; lost 16 lbs due; nash; "fatigue is not as bad"; less pain in r hands/pain in feet; swelling in hands/swelling in feet; pain in wrists/elbows/pain in knees/ankles/pain in hips; pain in shoulders; pain in neck; swelling in wrists/in elbows/in shoulders/in knees/in ankles/in hips; swelling in neck; This case was reported by a pharmacist via other and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz).   On an unknown date, the patient received Shingrix and PNEUMOVAX. On an unknown date, less than a month after receiving Shingrix, the patient experienced influenza-like symptoms, weight loss, rash, fatigue, pain in hand, hand swelling, wrist pain, shoulder pain, neck pain, swelling of wrists and neck swelling. On an unknown date, the outcome of the influenza-like symptoms, weight loss, rash, fatigue, pain in hand, hand swelling, wrist pain, shoulder pain, neck pain, swelling of wrists and neck swelling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, weight loss, rash, fatigue, pain in hand, hand swelling, wrist pain, shoulder pain, neck pain, swelling of wrists and neck swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingrix and pneumonvax vaccinations a couple of weeks ago and had flu like symptoms that lasted 2-3 days.  The patient has recovered. The patient lost 16 lbs due to a recently being diagnosed with rash, patient had cholesterol checked 2 weeks and hepatologist was monitoring blood levels.  The patient mentioned all team of MDs had great communication.  Since starting therapy, the patient had not had any side effects noted fatigue was not as bad and had some minor improvements with less pain and swelling in hands, wrists, elbows, shoulders, knees, ankles, feet, neck, and hips on occasion.  The patient would get discouraged but had a great support from friends.  No further information or side effects provided by the patient.
Age: 23.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis; a 23 years old patient  /  received the 1st dose of Shingrix in another facility; This case was reported by a pharmacist via call center representative and described the occurrence of rheumatoid arthritis in a 23-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included tofacitinib citrate (Xeljanz).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant) and inappropriate age at vaccine administration. On an unknown date, the outcome of the rheumatoid arthritis and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the rheumatoid arthritis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient with rheumatoid arthritis received the 1st dose of Shingrix. The patient was currently taking Xeljaiz. The patient did not consent to follow-up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Vision blurred, Visual impairment
Clinical narrative: problems with vision; trouble finding a focal point and could not drive, read or write; could not drive; impaired the daily life life activities; This case was reported by a pharmacist via call center representative and described the occurrence of abnormal vision in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number NT7YR, expiry date 25th March 2022) for prophylaxis.   On 21st August 2020, the patient received the 1st dose of Shingrix. In August 2020, 24 hrs after receiving Shingrix, the patient experienced abnormal vision (serious criteria other: serious by reporter), difficulty focusing eyes, driving ability disturbed and activities of daily living impaired. On an unknown date, the outcome of the abnormal vision, difficulty focusing eyes, driving ability disturbed and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the abnormal vision, difficulty focusing eyes, driving ability disturbed and activities of daily living impaired to be related to Shingrix.  Additional information was provided as follows: The patient experienced problems with vision 24 hours after receiving the first dose of shingrix.  The reporter mentioned that the patient was having trouble finding a focal point and could not drive, read or write. As per the pharmacist, this significantly impaired the daily life activities of the patient. The event was currently ongoing. The patient consulted two ophtalmologists but as of time of reporting, no medical diagnosis for this visual problem was available. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Shivering; This case was reported by a nurse via sales rep and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were unknown.   It was unknown if the reporter considered the fever and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced fever and shivering.
Age: 19.0
Sex: U
Vaccine: MENB
Symptoms: Headache, Myalgia, Pain
Clinical narrative: severe headache; myalgia; severe pain; This is a spontaneous report from a contactable physician. This physician reported similar events for four patients. This is the second of four cases. A 19-year-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA) ,(lot/batch# CM8296), via an unspecified route of administration, on 12Aug2020, at single dose, for immunisation. Medical history and concomitant medications were none. The patient experienced severe headache, myalgia and severe pain all in Aug2020 with outcome of unknown.    No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020335485 Same reporter/event, different patient
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Type 1 diabetes mellitus
Clinical narrative: Type 1 diabetes (diagnosed in March of 1997, but getting sick in fall of 1996)
Age: 1.08
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was in office for a well check visit.  MD ordered ActHIB and Varicella and MA gave Gardisil HPV instead of the HIB by mistake.  Pt did not have any reaction as on 1:30pm when we called after noticing the mistake.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: patient received a cellulitis diagnosis.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Paraesthesia, Rash
Clinical narrative: Rash & ERYTHEMA; INJECTION SITE PAIN; PARESTHESIA
Sex: F
Vaccine: MMR
Symptoms: Contraindication to vaccination
Clinical narrative: It was unknown if patient received MMR II in the past prior to the initial transplant so AE is filed as a precaution; It was unknown if patient received MMR II in the past prior to initial transplant so AE is field as a precaution; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history included kidney transplant. The patient was currently on dialysis and on the list for another kidney transplant. No information regarding the patient's drug reaction or allergies and concomitant medications was provided.  On an unknown date since 10-AUG-2020 (reported as unknown date earlier this week), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (dose, dose number, route of administration, lot # and expiration date were not reported) for prophylaxis. The patient was not on immunosuppressing medications and the physician considered the patient to be immunocompetent.  It was unknown if the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in the past prior the initial transplant (circumstance or information capable of leading to contraindicated product administered). There was no clarifying details about why the patient was receiving the vaccine now provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On or about 19-MAR-2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, lot number, expiration date and anatomical location were not reported) for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unspecified date, the patient was treated by a provider for the following injuries resulting from patient´s zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the herpes zoster was unknown and the casuality assessment between this event and the vaccination with zoster vaccine live (ZOSTAVAX) was reported as related.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AE's; she states that the prescribing information has lots of gaps and misleading information; she states that the prescribing information has lots of gaps and misleading information; This spontaneous report as received from a 45 year old female consumer referring to herself. No information regarding her concurrent conditions, pertinent medical history or allergies and concomitant therapies was provided.   On 21-JAN-2020 the patient was vaccinated with the 1st dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and administration site, indication lot # and expiration date were not reported). On 23-MAR-2020, she received second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and administration site, indication, lot # and expiration date were not reported). The patient called to inquire if her last dose of the suspect vaccine  was safe for her to get 1 month late. She also wants to know if it is safe to get hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) done earlier than recommended. She wanted to know this because; "These vaccinations  going in my body and I wanted to know what happened if taken too late or too soon." The patient wanted to know if  the third dose need to be done at 6 months, or it need to be 6 months from the 2nd shot. She checked her resources, and advised her from that source. She was not satisfied and was very rude and frustrated that she couldn't give her anymore information other than what is on the PI. Patient stated that she had read the PI and it did not provide the proper information that she needed to know. She stated that the prescribing information has lots of gaps, and misleading information (onset of the event was also reported as month ago). She was scheduled on 28-AUG-2020 (Friday) to have the third dose done (therapy was not discontinued), and wanted direction from someone before then. No other adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; an expired PNEUMOVAX 23 vaccine was administered; This spontaneous report was received from a nurse manager, and refers to a patient of an unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.   On 25-AUG-2020, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 ml, once (indication, route of administration were not provided)  (lot # R033342, expiration date reported as 03-AUG-2020, which was verified to be valid). The vaccine did not have any previous temperature excursions. No additional adverse event was reported.   This report is not-valid due to lack of patient's identifiers. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R033342; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered to patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 26-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number T007396, expiration date: 29-AUG-2021) 0.5 ml (route of administration was not provided). The vaccine was stored in temperature of 16.07 degree Fahrenheit for 25 minutes. There was no previous temperature excursion. Digital data lodger was involved.
Sex: F
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: WE ALL GOT DEATHLY ILL; A spontaneous report has been received from a consumer. The report concerns a female patient  of Unknown ethnic origin.    No medical history and  concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     It was reported that patient family doc convinced her family to get this and stated we all got deathly ill (preferred term: Ill-defined disorder). Patient just do probiotics n vitamins.     The outcome of we all got deathly ill was unknown.    The we all got deathly ill was considered non-serious by comapny physician.
Sex: F
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: I GOT SICK THE DAY AFTER THE MIST ???; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history and concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     It was reported that patient had the same reaction every time. She had the mist the day after. She was told that it was a coincidence she got sick and probably already was it happened twice, the day after the mist (preferred term: Malaise).     The outcome of i got sick the day after the mist  was unknown.    The i got sick the day after the mist  was considered non-serious by comapny physician.
Age: 41.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of product administration, Therapeutic response decreased
Clinical narrative: therapeutic response decreased; last dose was given in a different location, and was given earlier than the recommended 6-month schedule; This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 41-year-old male patient who received HBV (Engerix B) (batch number 5397F, expiry date 6th February 2021) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 5397F, expiry date 6th February 2021) for prophylaxis and HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included human immunodeficiency virus test positive.   On 10th February 2020, the patient received the 1st dose of Engerix B. On 17th March 2020, the patient received the 2nd dose of Engerix B. On 14th June 2020, the patient received the 3rd dose of Engerix B. In June 2020, not applicable after receiving Engerix B and Engerix B and unknown after receiving Engerix B, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased and drug dose administration interval too short were unknown.  Additional details were provided as follows: The reporter stated that, the patient was HIV positive. The patient received all 3 dose of Engerix B and had low titer, which led to therapeutic response decreased. The patient received 3rd dose of Engerix B earlier than the recommended schedule, which led to shortening of vaccination schedule. No other information was provided. The reporter consented to follow up.
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Flu-like symptoms; soreness in the arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Tetanus NVS (Tetanus vaccine) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix (intramuscular) and Tetanus vaccine. In August 2020, less than a week after receiving Shingrix and Tetanus vaccine, the patient experienced influenza-like symptoms and pain in arm. On an unknown date, the outcome of the influenza-like symptoms and pain in arm were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to Shingrix and Tetanus vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms for 1 to 2 days after the 18th August 2020 the injection of the first dose of Shingrix.  The patient also stated he had soreness in the arm but he also had a tetanus shot at the same time. All symptoms resolved in 2 days.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020170267:same reporter
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine, Body temperature increased, Cellulitis, Neurological symptom
Clinical narrative: cellulitis in whole upper arm; neurological symptoms; temperature 103 F; allergic to tetanus shot; Initial information was received on 18-Aug-2020 regarding an unsolicited valid serious courtesy case from a consumer/non-health care professional (patient) via Pfizer.  This case involves a female patient (age unspecified) who had cellulitis in whole upper arm (cellulitis), neurological symptoms, temperature 103 F (body temperature increased) and was allergic to tetanus shot (allergy to vaccine), while she received TETANUS TOXOID.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route and administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious cellulitis in whole upper arm (cellulitis) (unknown latency) following the administration of TETANUS TOXOID. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious neurological symptoms, temperature 103 F (body temperature increased) and was allergic to tetanus shot (allergy to vaccine) (unknown latency) following the administration of TETANUS TOXOID.  The patient did not have an anaphylaxis reaction. It was reported that she was supposed to get the Prevnar 13 vaccine today but did not receive it yet.  Relevant laboratory test results included: On an unknown date, the body temperature was 103 F.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns a female patient (age unspecified) who had cellulitis, neurological symptoms, pyrexia and allergy to vaccine (unknown latency) after vaccination with TETANUS TOXOID. The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 5.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The Adacel was given to a 5 year old instead of diphtheria, tetanus and acellular pertussis vaccine (Dtap), No AE; The Adacel was given to a 5 year old child, No AE; Initial information was received on 17-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a five-years-old female patient who was given DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (Product administered to patient of inappropriate age and wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 13-Aug-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6043BA, expiry date 22-Aug-2020) via unknown route in the right arm for prophylactic vaccination instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP).  It was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Dyskinesia, Eye movement disorder, Loss of consciousness, Syncope
Clinical narrative: PATIENT FAINTED AFTER RECEIVING VACCINATION, THEN MOM SAID "OH SHE ALWAYS FAINTS AFTER GETTING SHOTS". MOM SUPPORTED PATIENT IN CHAIR WHILE THE DAUGHTER BEGAN JERKING AND EYES ROLLED BACK IN HEAD. NURSE GRABBED A WET PAPER TOWEL AND WIPED PATIENT'S FACE, NECK, ARMS AND HANDS. MOM STATED THAT PATIENT ONLY HAD FRUIT FOR BREAKFAST AND NO PROTEIN. (VACCINE ADMINISTERED AT 11:45 AM.)  WITHIN 3-5 MINUTES PATIENT REGAINED CONSCIOUSNESS AND NURSE GAVE HER A LOLLIPOP TO LICK.  AFTER RECOVERING IN CHAIR IN EXAM ROOM, MOM STATED THAT DAUGHTER WAS O.K. AND COULD WALK.  NURSE SUPPORTED PATIENT AND WALKED HER TO THE WAITING ROOM WHERE SHE WAS SEATED; NURSE GAVE A BOTTLE OF COLD WATER TO SIP AND STAFF WERE ADVISED TO MONITOR.  AT NO TIME DID PATIENT FALL OR STRIKE HER BODY ON ANY OBJECT.  PATIENT WALKED UNASSISTED TO CAR FROM CLINIC AT NOON
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site reaction, Rotator cuff syndrome
Clinical narrative: RIGHT SHOULDER PAIN/ROTATOR CUFF TENDONITIS , RECOVERED COMPLETELY
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient had redness and pain at both injection sites. She went to urgent care and was treated with Bactrim ds and her symptoms improved
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pruritus, Pyrexia, Skin warm, Swelling
Clinical narrative: RED,SWOLLEN, HOT TO TOUCH, ITCHY CHILD ALSO HAD FEVER MOM GAVE CHILD BENADRYL BECAUSE THE SPOT WAS ALSO ITCHY
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: THE PATIENT NOTICED HIVES/WELTS  UPON WAKING THE NEXT DAY
Age: 1.0
Sex: M
Vaccine: FLU4, MMR
Symptoms: Feeling abnormal, Irritability, Pyrexia, Rash, Vaccination complication
Clinical narrative: My son woke up about a week after the vaccine with a rash that covered his entire body, he also had a mild fever and was irritated and did not feel good. The rash lasted for 3-4 days and there was nothing we could do according  to the pediatrician.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Syncope
Clinical narrative: syncopal episode 5 minutes after vaccine administration, patient fall, no resulting neck or head injury, denied symptoms of concussion on day of vaccination and at follow up check in
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Mouth injury, Skin laceration, Syncope
Clinical narrative: patient fainted approximately 2 minutes after receiving vaccine. came too after about 10-20 seconds. she had a cut on chin and in mouth. emt's were on seen in 5 minutes. patient's father was taking her for follow-up treatment.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: patient presented 2 days after flu shot was given on deltoin region of left arm with a red rash on upper left arm. rash was inflammed and red and was 2 inches below where the flu shot was given. no fever was reported. pharmacist on duty that day counseled patient and told her to take some tyenol if fever presents and probiotics and to follow up with primary care physician if rash worsens. patient has not followed up with pharmacy with course of symptoms since she presented to the pharmacy with the rash.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Same day of receiving vaccine patient had head ache body ache muscle pain which lasted about 5 days. Treated with tylenol and bed rest he was perfectly fine before receiving the vaccine.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Rash
Clinical narrative: Pt developed fussiness on 8/3 She then developed a rash shortly after to her trunk and extremities
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Erythema, Injection site erythema, Urticaria
Clinical narrative: Redness at injection site, red hives on back, arms, hands burning sensation developed in the evening and got worse.  Patient did take Claritin and Benadryl for symptoms.  Doing well now.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomiting x 4 days after each feed. Watery stool 3 times a day. Fever, max temp at 103F
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Hypotension, Injection site erythema, Injection site swelling
Clinical narrative: Patient states he started with fever symptoms the night after the vaccination, such as feeling very cold, shivering, and feeling low blood pressure. He said he felt like that for five minutes then it stopped without taking any medications. The next day he states he woke up with the area of the shot very red and swollen. He called the pharmacy today to follow up on symptoms, and he was counseled on using cold compresses to help with the swelling. He states he is getting better and was able to go to work normally.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient states he started with fever symptoms the night after the vaccination, such as feeling very cold, shivering, and feeling low blood pressure. He said he felt like that for five minutes then it stopped without taking any medications. The next day he states he woke up with the area of the shot very red and swollen. He called the pharmacy today to follow up on symptoms, and he was counseled on using cold compresses to help with the swelling. He states he is getting better and was able to go to work normally.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Started at 12:30 PM with being tired and falling asleep in a chair, then got chills about 3 hours later, checked for fever which was 99.5F, went to bed and slept for 3 hours, woke up with fever of 100F, had a little bit to eat, gradually felt better, slept through the night and am fine the next day.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Swelling
Clinical narrative: most likely pneumovax....red and swollen
Age: 72.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Right arm red with no pian and some heat in area of redness
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster
Clinical narrative: Began side effects of vaccine on August 24th. Sharp head pain, broke out with shingles on face and red eye. Saw medical Doctor and Optometrist. Valacyclovir HCL 1 Gram tablets
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Erythema, Induration, Injection site erythema, Injection site rash, Peripheral swelling
Clinical narrative: 11 y.o. female with no past medical history who presents to clinic with their mother for left arm redness and swelling which began as two discrete "mosquito-like" spots on her left deltoid after getting, TdAP (R deltoid), and HPV + meningitis (both on L deltoid) vaccinations earlier that day. She denies any shortness of breath, cheat pain, nausea, vomiting, change in bowel habits, muscle aches, or trauma.  Right upper deltoid with large area of erythema  and induration without significant warmth spread past marker lines drawn by mother yesterday, Left deltoid without erythema or induration, skin otherwise warm, dry, intact. Doubt cellulitis as no constitutional sx, rash is non-painful, and located directly at injection site. Given benadryl 25mg  today, unknown outcome.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Malaise, Pyrexia
Clinical narrative: Patient came to the pharmacy stating that his head felt hot and that he felt unwell. It was found that the patient had a fever of 103.1. The patient was advised to reach out to his primary care doctor and take Tylenol for symptoms, the pharmacy also reached out to the patients primary care doctor. Patient also received inactivated influenza vaccine at the same time.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Injection site erythema
Clinical narrative: Site very sore, red and swollen for 8 days.  First 2 days had headache, lethargic, nausea, very dizzy,  weak , shivers
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Lethargy, Nausea
Clinical narrative: Site very sore, red and swollen for 8 days.  First 2 days had headache, lethargic, nausea, very dizzy,  weak , shivers
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: Patient received vaccine on 8/28/2020. Patient came to pharmacy on 8/31/2020 reporting that her arm was sore, itcy and red in the area of the injection site with some pain as well. patient was advised to take Tylenol or ibuprofen, keep the site clean and monitor to see if anything worsened. Patient was also found to have a low grade fever of 99.9F. Patient stated that it did not seem to be any worse to day than yesterday. Patient was advised to contact PCP and we reached out to PCP as well.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Severe fatigue, nausea, and headache beginning within a few hours of vaccination and lasting for several days.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient reported redness of her arm from site of vaccination to her elbow. She stated the redness was itchy, not painful. This redness has been on her arm from the day after vaccination and is still red 10 days later. She has been taking prednisone 20mg tablets for 3 days and has 2 more days to take. No resolution with the Prednisone.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site rash, Lethargy, Pyrexia
Clinical narrative: LETHARGY AND 101/102 FEVER FOR 24 HOURS INJECTION SITE RASH AFTER FEVER SUBSIDED
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pain, Pain, Pain in extremity, Tenderness
Clinical narrative: I am currently 30 weeks pregnant with twins (28 weeks at the time of vaccine). Estimated delivery October 23 (at 38 weeks).   My right arm was initially sore for a couple of days after the vaccine, but the soreness subsided and I felt completely normal. Today, two weeks later, the injection site has become increasingly sore to the point where my arm is extremely tender and it is painful to move. No other symptoms at this time.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient began to experience pain a few hours after the vaccine was given. Called pharmacy 3 to 4 days later complaining about the pain and should it last that long. Pharmacist consulted patient and suggested to use Tylenol or Ibuprofen for pain and discomfort. The patient called a week later still experiencing similar pain. The Pharmacist suggested the patient follow up with a medical doctor to evaluate the arm and pain.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Abdominal discomfort, Pain in extremity
Clinical narrative: sore arm and upset stomach, went to ER they sent her home
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Patient reports pain and tingling down to hand. Redness and swelling around the injection site and above elbow
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Erythema, Injection site rash, Pain, Pyrexia
Clinical narrative: Rash to Upper Arms and Legs, pain to the touch, warm, red, sore, fever, seem to spread, sore under arm pits. Started Friday and is continuing today 08/31/2020, left arm does feel better. Patient had similar for 1st Shingrix shot but this is more severe.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Rash to Upper Arms and Legs, pain to the touch, warm, red, sore, fever, seem to spread, sore under arm pits. Started Friday and is continuing today 08/31/2020, left arm does feel better. Patient had similar for 1st Shingrix shot but this is more severe.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: The patient received her flu shot 8/29/2020 at around 3:36 pm. The patient reports warmth, redness, and swelling around the injection site on her right arm. The patient showed the local reaction to the dermatologist. Her dermatologist did not think that the reaction needed any treatment. I advised the patient to continue to keep an eye on the local reaction, and if it does not get better or if it gets worse, then I advised the patient to follow up with her physician.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pruritus, Rash, Skin warm
Clinical narrative: cellulitis . day of vasccination normal reaction, patient very red and itchy , white bumps on friday morning. diagnosed by pcp w/ cellulitis on 8/31/20, hot upper arm,patient had no fever however.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Patient had mild swelling, itching, redness, warm to the touch on the day after immunization.  She noted that the symptoms resolved on their own in about 48 hours.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Lip swelling
Clinical narrative: Patient called Pharmacy stating he had a swollen lip. I informed patient to take some benadryl and recommended he proceed to the ER due to lip swelling which could be a  sign of a severe allergic reaction.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HIGH DOSE WAS GIVEN TO PATIENT THAT IS UNDER THE AGE (65+) INDICATED FOR VACCINE
Age: 89.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: Patient came in on 8/31/2020 to discuss a rash that he believes may be from the Fluad vaccine he received on 8/29/2020.  The rash is only on the left side of his body, specifically some on the left arm and on the left side of the trunk of his body from the waist to just below the armpit.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: pt received IMZ on 8/28/20, and reported noticing a bit of a knot at the injection site the next day, but was not too concerned.  On 8/31/20, the area was a bit red and hot to the touch in about a quarter sized area near injection site.  Pt was going to doctor already this afternoon for a steroid injection, so was going to have the doctor look at it.  Told pt she could apply a cold compress, take some tylenol if needed, and take a benadryl if the spot got bigger or started itching. Told her to contact us back if things got worse, and consult her doctor as well.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Irritability, Pruritus, Pyrexia
Clinical narrative: Pt developed itchy patches of vesicles with erythematous base on left middle finger and right elbow 1 day after receiving vaccine. Also developed fever and irritability following vaccine that lasted 2 days.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash
Clinical narrative: Patient received Fluad vaccine on Friday 8/28/20. On Saturday 8/29/20, she had a rash on her arm that she received vaccine in. On Sunday 8/30/20, the rash spread all over her body. She went to urgent care and got a steroid shot and a written prescription for oral steroids. Patient called our pharmacy on Monday 8/31/20 to notify pharmacist of reaction. Pharmacist added allergy to patient file and filled out VAERS.
Age: 63.0
Sex: F
Vaccine: FLUA4
Symptoms: Rhinorrhoea, Secretion discharge
Clinical narrative: The patient is 63 and Fluad quadrivalent is indicated for over age 65. The patient did not show any reaction signs at time of administration and today 8/31/2020 she patient states that she had no Adverse reaction whatsoever. She had a runny nose and mucus for a couple of days after the vaccine but it was nothing out of the ordinary.  Patient states she feels her normal self and aside from her chihuahua bumping into her arm she has felt no pain. She says when her chihuahua sits on her feet they hurt but that is true every day of her life
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Death. Patient found unresponsive in pharmacy parking lot 4 hours later
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt reported painful swelling in the injection site radiating toward her armpit and down to her elbow.  She denied any shortness or breath or rash.  Called pt back on 8/31 and most swelling had gone down put one tiny red spot on elbow.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Pain in right anf numbing from shoulder to elbow, elbow to wrist and to fingers. Patient still feels symptoms as of this date.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Visual impairment
Clinical narrative: Right after I gave the shot to the patient. Patient got dizzy and have to help her to sit down. She said she is about to fall, cannot see anything and her head is spinning. I Immediately grab water from our shelf.  5minutes after drinking, pt wasn't getting better. She requested to lie down on the floor.  She  claims that she haven't eat that much so she took a chololate bar.  I stayed and watched the patient for 15 to 20 minites.  Patient tried to stand up and right after she stand up she got dizzy again, have to assist her to sit down. Wait another 15minutes and she said she is felling better. I observed her when she stood up and walked her to her car. I gave her an epipen just in case she would need it. She said she is feeling better and just live 2 blocks away.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Muscular weakness
Clinical narrative: Brachial Neuritis- numbness and tingling in arm around injection site and extending into the right hand, muscle weakness  temperature 99.2 as of 9 PM
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Radiculitis brachial
Clinical narrative: Brachial Neuritis- numbness and tingling in arm around injection site and extending into the right hand, muscle weakness  temperature 99.2 as of 9 PM
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blepharospasm, Dizziness, Fatigue, Immediate post-injection reaction, Pallor
Clinical narrative: Syncope immediately following vaccines. Lasted 5-10 minutes post injection. Fading hearing and ?blackout? experienced. Applied cool rag & juice at clinic. Exhaustion and fatigue lasted additional 8 hours, paired with repeated episodes of dizziness, pale skin and repeated left eye twitching. Will update provider with any further changes.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope immediately following vaccines. Lasted 5-10 minutes post injection. Fading hearing and ?blackout? experienced. Applied cool rag & juice at clinic. Exhaustion and fatigue lasted additional 8 hours, paired with repeated episodes of dizziness, pale skin and repeated left eye twitching. Will update provider with any further changes.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Pt presented to ED and was hospitalized for allergic reaction to vaccines
Age: 60.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, redness, swelling at injection site after shot administered on 6/23/20, seen in ER on 6/27/20, instructed to apply cold compresses, take Tylenol or Motrin, rx medrol dos pak. See PCP if worsens.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Injection site pain
Clinical narrative: Patient initially started with really bad pain at injection site and a ball formed. Shortly after that, patient had extensive bruising on his arm. A week later, he reports no pain. However, he still has prominent bruising that seems to be going away.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccine refrigerator went out which compromised the MMR vaccines at time of administration. No adverse effects were reported. We plan to revaccinate patient.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Malaise, Migraine, Paraesthesia
Clinical narrative: Vaccine given 8/25/20 - pt began feeling ill on 8/26. Migraine headache, tingling in arms/legs. Has progressively gotten worse. Went to ER 8/31/20.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Headache, Injection site rash, Pyrexia
Clinical narrative: Dosed on 8/27/20 - 8/28 fever up to 102.4. Chills, headache & rash around site of vaccine
Age: 1.17
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccine refrigerator went out and compromised the MMR vaccines making it invalid at time of administration. No adverse effects were reported. Patient to be revaccinated.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Paraesthesia, Rash
Clinical narrative: pt tolerated vaccine well. Mild discomfort locally  at site of injection on 8/14/20 at night. woke up on 8/15/20 much better. Developed prickly sensation on skin above umbilicus and across mid back on  8/18/20 lasting 3d. Rash developed 8/21/20
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram P wave abnormal, Electrocardiogram QRS complex abnormal, Sinus bradycardia, Syncope
Clinical narrative: Syncope
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Grip strength decreased, Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: Pt is a 75 yo M followed by medical clinic for HTN. Pt presented 08/17 for follow up and received Shingles Vaccination. About an hour after receiving the vaccine, pt returned to the clinic stating he had intense left shoulder pain, including having trouble lifting his arm above his head and having a weaker grip. Due to level of discomfort, pt was given decadron 4 mg IM x 1 dose.  Myalgia & Arthralgia DEXAMETHASONE 4 MG ONCE
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: & Swelling
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Tremor
Clinical narrative: Chills/Shakes/trembling Fatigue
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Genital rash, Rash
Clinical narrative: Rash - chest, back, neckline, private area
Age: 5.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Vomiting
Clinical narrative: Vomiting 730Am - 4pm on 8/22