chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 years old female patient (pt). There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided.  On an unspecified date in 2013, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a healthcare due to the event. It was reported that the pt would continue suffer ongoing injuries, losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster was not reported.   The reporter considered the event of  herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer concerning a currently 67 year old male patient. His medical history, concurrent conditions and concomitant medications were not reported.     On an unspecified date in 2014, the pt was vaccinated by a healthcare provider with a dose of zoster vaccine live(ZOSTAVAX) for the long term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, lot # and expiration date were not reported).        On an unknown date, Plaintiff was treated by a healthcare provider for the following injuries resulting from Plaintiff's zoster vaccine live(ZOSTAVAX) use: herpes zoster. Plaintiff bring this action on behalf of himself.  The outcome of herpes zoster was unknown.    The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 66.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: the 66 year old patient was administered a dose of PROQUAD; no adverse effect; This spontaneous report was received from a medical assistant and refers to a 66 year old patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.   On 11-DEC-2018, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis (product administered to patient of inappropriate age) (dose, strength, route of administration, lot# and expiration date were not reported).         No adverse events were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis contact, Inappropriate schedule of product administration, Influenza like illness, Pruritus, Rash generalised
Clinical narrative: flulike symptoms; rash all over his body; contact dermatitis; Itching; Inappropriate schedule of vaccine; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced influenza-like symptoms, generalized rash, contact dermatitis, pruritus and drug dose administration interval too long. On an unknown date, the outcome of the influenza-like symptoms, generalized rash, contact dermatitis and drug dose administration interval too long were unknown and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, generalized rash, contact dermatitis and pruritus to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the patient's sister-in-law. The age at vaccination was not reported. Nine months after 1st dose, the patient received 2nd of Shingrix at the pharmacy, which led to lengthening of the vaccination schedule. The next day after vaccination, the patient experienced flulike symptoms and then developed a rash all over his body.  The patient saw a dermatologist who told him he did not have shingles but instead had contact dermatitis.  The patient was still itching weeks after receiving the vaccine although he had tried changing his diet but it had not helped.
Sex: U
Vaccine: MENB
Symptoms: Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Developed a fever between 102-104F; Sore arms; Injection site that was hot to the touch; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for three adolescent patients (ages of 16-18). This is third of three reports.  An adolescent patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the arm on an unspecified date at single dose for immunization. The patient's medical history was not reported. Concomitant vaccine included meningococcal vaccine (MCV-4). The patient developed a fever between 102-104F along with sore arms and an injection site that was hot to the touch on an unspecified date. It was reported that events took place after use of product. Outcome of the events was unknown.  Information on the batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019306417 same drug/event, different patient;US-PFIZER INC-2019306395 same drug/event, different patient
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Pt. states that her left upper arm felt sore the night after the vaccine was administered on 8/5/19 and the next day she noticed bruising and a "lump" which hurt to touch at the injection site. Pt. self treated with massaging area and symptoms improving and resolving slowly but taking longer than expected and came in to clinic to report and get evaluated. Pt. did not report symptoms to provider until 8/14/19 and with a 1cm mildly tender, hard lump in the left deltoid site which pt. states has decreased in size since she first noticed it. Pt. with no other pain or discomfort and overlying skin normal without any bruising or rashes. Pt. with full ROM of her left upper extremity and shoulder and her strength and sensation intact.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Candida infection, Crying, Irritability, Malaise, Pyrexia
Clinical narrative: Child presented with fever 101.2 and full body rash upon waking morning of 08/13/2019. Child also presenting as feeling unwell (crying, whining, comfort nursing) As of evening 08/14/2019 fever has lowered to 100.7. Rash remains unchanged.  Child also has Thrush, which presented 08/11/2019.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash
Clinical narrative: Child presented with fever 101.2 and full body rash upon waking morning of 08/13/2019. Child also presenting as feeling unwell (crying, whining, comfort nursing) As of evening 08/14/2019 fever has lowered to 100.7. Rash remains unchanged.  Child also has Thrush, which presented 08/11/2019.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Crying, Fall, Head injury
Clinical narrative: Patient received immunizations and TB skin test on 8/9/2019 at approximately 12:40pm. Patient stood up and got off the exam table and was standing and talking. Within 4-5 minutes, the nursing staff and parent heard a loud thump. The nurse supervisor turned around and observed the patient laying on the ground. He had fallen and hit the back of his head on the floor. His eyes were open but he did not make any noise. The nurse supervisor picked up the patient and put him on the exam table. An ice pack was put on the back of the patient's head. His pupils were checked as well. Within approximately 1-2 minutes of laying on the table, that patient began to cry. His parent was at his side to provide comfort. The patient was monitored for approximately 15-20 minutes. Cognitively and behaviorally, patient was at his baseline (according to the parent). Nursing staff offered to call EMS, but parent declined. Patient had an appointment following this visit for a physical. Nursing staff strongly encouraged parent follow-up with physician during physical exam regarding incident. Additionally, parent was educated that if patient's behavior changed or he began to exhibit symptoms of a head injury, parent needed to immediately seek medical attention at the hospital. Parent verbalized understanding. A follow up phone call was conducted on 8/14/19 with a gentlemen who identified himself as a friend of the family. He reported patient started school 8/13/19 and was "doing good".
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Patient called the morning after to report arm stiffness and limited mobility. I checked with doctor's office and medical assistant said she called the patient and confirmed it was just muscle soreness from IM injection. When I called patient to check up on him again he said he was feeling a lot better and arm was not as stiff.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Full blood count normal, Urine analysis normal
Clinical narrative: 103.7 rectal temperature night of vaccines.  Mom took pt  to ER had blood work and urine done - negative per Mom.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: No averse reaction was seen 15min after vaccine was administered
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73 years old female patient (pt). There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided.  On or about 12-SEP-2012, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a healthcare due to the event. It was reported that the pt would continue suffer ongoing injuries, losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster was not reported.   The reporter considered the herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: No adverse effect reported; hairline crack on the blue luer lock portion of the syringe; vaccine expelling from the syringe/patient likely did not get a full dose; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported.  On 09-AUG-2019, the patient was vaccinated with an unspecified dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (PFS), lot # S004548 and expiration date: 12-AUG-2020 for prophylaxis (strength, route and anatomical location were not reported) and it was reported that pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (PFS) had a small hairline crack on the junction between the syringe and needle which is on the blue luer lock portion of the syringe (syringe issue), resulting in vaccine expelling from the syringe and the patient likely did not get a full dose (vaccine underdose). The effect was noticed during the process of administration. The syringe was not broken into two or more pieces and it did not have a broken component. The tip of the syringe or leur lock adaptor was not loose or broken off of the syringe tip and there was no difficulty trying to attach the syringe needle to the syringe. The syringe tip cap was attached properly prior to use. The syringe tray and carton was not damaged prior to use. No adverse effect was reported. The outcome of syringe issue and vaccine underdose was unknown. Causality assessment of the event syringe issue was not provided.
Sex: M
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome, Sensory disturbance
Clinical narrative: Guillian Barre; sensory weakness; This case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a adult male patient who received DTPa (Reduced antigen) (Boostrix) (batch number H54EX, expiry date 14th June 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and sensory disturbance. On an unknown date, the outcome of the guillain barre syndrome and sensory disturbance were unknown.   It was unknown if the reporter considered the guillain barre syndrome and sensory disturbance to be related to Boostrix.  Additional details were reported as follows: The patient received Boostrix and had sensory weakness. The patient was sent to emergency room. The patient was diagnosed with Guillain Barre syndrome. The reporter consented for follow up.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: Unable to move arm without severe pain.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's mother called morning after vaccine (8/14/19) stating left upper arm was red/ swollen/ and hot to touch . Nurse advised to give benadryl & motrin and rest and call back if worse. Patient's mother called at 12:45 stating redness had gotten worse. Nurse advised mom to bring patient to office.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Local redness and itching, slight swelling.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Swelling, redness, heat, itching
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Received vaccine on 8/13/2019; arm very sore starting at 4:00pm that day.  On 8/14/2019, at 5:08 am, a severe headache woke me up, so I took three 200 mg ibuprofen tablets. This took the edge off, but headache remained.  1:00 pm same day, developing chills and body aches.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Apnoea, Crying, Muscle rigidity, Unresponsive to stimuli
Clinical narrative: Infant was crying after receiving Pediarix vaccine, Then suddenly became unresponsive during injection. Per MA administering, appeared to stop breathing for a second and was rigid. Resolved without intervention within seconds (less than 5 seconds).  Infant was normal after this, observed in the office for 30 minutes. Vitals were normal.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Patient developed 5x6 cm erythematous flat induration with indistinct border on left lateral deltoid with 2 puncture marks noted inside induration
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Rash
Clinical narrative: Exactly two weeks after vaccine - my son broke out in the most terrible rash with blisters and bumps all over his body.  Also, had a fever for 36 hours.    His skin looks absolutely terrible.  It is so scary.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No reaction on the immunization, pt was given Dtap to soon. Pt next dose is on 12/1/19. I called CDC and they inform me that there is no need for harm to come of this.
Age: 9.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Fever started on 8/12/2019, it went up to 104.4 the night of 8/13/2019.  The next morning, 8/14/2019, patient woke up with a mild rash on the back of her neck, chest-stomach area and back.  Rash is sparse in other areas.  Mild itchiness reported by patient.  No other symptoms reported.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Reddness/swelling
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache chills muscle pain fatigue
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: on 8-13-19 started as red spot, then noticed redness and swelling to L upper arm, got bigger throughout day, redness spread but swelling seems improved - on exam L arm deltoid area w approximately 2"x2" erythematous sl firm and tender area, warm to touch, full rom, no streaking, sl raised - Dx:  Cellulitis of Left Upper extremity - Tx:  Amoxicillin-Pot Clavulanate 400-57mg take 2 chewable tabs Q12 hours for 10 days.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Abscess, Bacteraemia, Blood culture negative, Deep vein thrombosis, Osteomyelitis
Clinical narrative: Route listed for administration is "RQ".    2 y.o. previously healthy female who presented with 5 days of lower extremity swelling and fever. On 7/8/19, the patient received a hepatitis A vaccination in outpatient clinic.  Hepatitis A Vaccination documentation from electronic record from outpatient clinic lists given as intra-dermal injection in right quadriceps.   Following this vaccination, she began to have right lower extremity swelling and fevers.   Patient was admitted to the hospital on 7/12/19 for DVT and found to have MRSA bacteremia, osteomyelitis and abscesses.  Patient  was discharged home on IV antibiotics to complete a minimum of 6 weeks treatment from negative blood cultures.  She will follow-up with outpatient Infectious Diseases.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Peripheral swelling, Pyrexia, Staphylococcal infection
Clinical narrative: Route listed for administration is "RQ".    2 y.o. previously healthy female who presented with 5 days of lower extremity swelling and fever. On 7/8/19, the patient received a hepatitis A vaccination in outpatient clinic.  Hepatitis A Vaccination documentation from electronic record from outpatient clinic lists given as intra-dermal injection in right quadriceps.   Following this vaccination, she began to have right lower extremity swelling and fevers.   Patient was admitted to the hospital on 7/12/19 for DVT and found to have MRSA bacteremia, osteomyelitis and abscesses.  Patient  was discharged home on IV antibiotics to complete a minimum of 6 weeks treatment from negative blood cultures.  She will follow-up with outpatient Infectious Diseases.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hep B administered prior to minimum interval. Vaccine to be repeated.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site hypoaesthesia, Injection site nodule, Injection site pain
Clinical narrative: Patient came in on 8/14/19 after receiving vaccine on 7/28/19. The injection site was red with a small bruise to the left of it. The patient complained of still having a knot from the injection and that her arm was still very sore to touch. She also complained of numbness around the site.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Injection site bruising, Injection site erythema, Pain in extremity, Paraesthesia
Clinical narrative: Patient came in on 8/14/19 after receiving vaccine on 7/28/19. The injection site was red with a small bruise to the left of it. The patient complained of still having a knot from the injection and that her arm was still very sore to touch. She also complained of numbness around the site.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Feeling hot, Hypoacusis, Visual impairment
Clinical narrative: Client complained vision went dark and hearing was like she had cotton in her ears, experienced feeling hot. Initial vital signs during episode 98/66 pulse 62. Denied dizziness, pain or nausea. Cooled patient down by fanning her, symptoms subsided a few minutes later. Vital signs before leaving and feeling better, 100/68 pulse 62.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Polyarthralgia, responds to ibuprofen, symptoms improving with time but still present 6 days after vaccine
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Swelling
Clinical narrative: Localized, Redness, swelling
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: red, raised, itchy, warm rash to upper left arm, more so to dorsal side. Student saw clinician, doxycycline prescribed.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncope after receiving GARDASIL 9 vaccine/ the patient passed out/ black out for a couple of seconds; This spontaneous report was received from a nurse via company representative referring to a 12-year-old male patient. The patient's pertinent medical history, concomitant medication, drug reaction and drug allergies were unknown. On 15-MAY-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number 1602283 and expiry date 16-AUG-2021 (upon internal validation established as 18-AUG-2021), first dose of hepatitis a vaccine, inactivated (VAQTA) lot # s002439 and expiry date 15-MAY-2020, second dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number r030487 and expiry date 22-OCT-2020 (dose, route not reported) for prophylaxis and other vaccines included meningococcal acyw conj vaccine (crm197) (MENVEO) (dose, route, frequency, lot number and expiry date were not reported). Immediately after vaccination (15-MAY-2019), the patient experienced syncope and it lasted for less than a minute. The patient was sought for medical attention. The patient received granola bar and water. The nurse reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was the most painful injection of all injections. Outcome of the event syncope was fully recovered within 20 minutes. It was reported that, the patient was not returned to the office after the event. Causality assessment for the event was not provided by the reporter.  Upon internal review, the event syncope was considered to be medically significant.  This is one of the three reports from the same reporter.; Sender's Comments:  US-009507513-1908USA005384: US-009507513-1907USA011407:
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: Syncope after receiving GARDASIL 9 vaccine/ the patient passed out/ black out for a couple of seconds/ she experienced syncope; This spontaneous report was received from a nurse via company representative referring to a 13 year old female patient. The patient's pertinent medical history, concomitant medication, drug reaction and drug allergies were unknown. On 12-JUN-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route not reported) lot number R032767and expiry date 31-AUG-2021 for prophylaxis. Other suspect therapies included meningococcal acyw conj vaccine (crm197) (MENVEO) (dose, route, lot number and expiry date not reported). On the same day (12-JUN-2019), after vaccination the patient was monitored for 15 minutes without symptoms, upon standing she experienced syncope. The patient was sought for the medical attention. The patient was returned to the room and monitored for 20 additional minutes. The nurse reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was the most painful injection of all injections. It was also reported that patient was due for the second dose. On the same day, the patient went home and fully recovered. Causality assessment for the event was not provided by the reporter.  Upon internal review the event syncope was considered to be medically significant.  This is one of the three reports from the same reporter.; Sender's Comments:  US-009507513-1908USA005383: US-009507513-1907USA011407:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; Inappropriate schedule of vaccine administered; This spontaneous report was received from a pharmacist referring to a 19-year-old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On an unknown date in 2011 (when the patient was 11-year-old), patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose (dose, frequency, route, lot# and expiry date were not reported) for prophylaxis. On 09-AUG-2019, (reported as after 8 years) the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration). No adverse event was reported. No additional information was reported. No product quality complaint (PQC) was reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood alkaline phosphatase increased, Blood bilirubin increased
Clinical narrative: elevated alkaline phosphatase; elevated bilirubin; This case was reported by a consumer via call center representative and described the occurrence of alkaline phosphatase increased in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number BF4J5, expiry date 5th July 2021) for prophylaxis.   Concurrent medical conditions included immunoglobulin g low.   On 31st July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st August 2019, 1 days after receiving Shingrix, the patient experienced alkaline phosphatase increased and bilirubin increased. On an unknown date, the outcome of the alkaline phosphatase increased and bilirubin increased were unknown.   It was unknown if the reporter considered the alkaline phosphatase increased and bilirubin increased to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. 3 months before reporting date, patient's blood levels were normal. After receiving the Shingrix, patient's standard yearly blood test showed alkaline phosphatase and bilirubin were high. For 21st August 2019, the patient had another blood test scheduled. The reporter did not consent to follow-up.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Patient came into office crying in waiting room while waiting for immunizations. Once she got back to room she was very upset and stated she felt like throwing up. I let her sit for a few minutes to calm down. I gave immunization and immediately she felt dizzy. I had her lie down on the exam table. She laid there for about 10 minutes. She drank water and ate some crackers because she had not eaten. She was able to sit up and walk without dizziness. I instructed her to eat something and if she is not feeling well to lie down. Also if it gets any worse go to the emergency room. Walked patient to car. BP lying down 108/49 and sitting up 106/65.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Basophil count decreased, Basophil percentage decreased, Chills, Eosinophil count normal, Eosinophil percentage decreased
Clinical narrative: Red swollen painful arm with fevers, chills, and bodyaches and headache
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Haematocrit normal, Haemoglobin normal, Headache, Lymphocyte count normal
Clinical narrative: Red swollen painful arm with fevers, chills, and bodyaches and headache
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: Red swollen painful arm with fevers, chills, and bodyaches and headache
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Monocyte count increased, Monocyte percentage, Neutrophil count increased, Neutrophil percentage increased, Pain
Clinical narrative: Red swollen painful arm with fevers, chills, and bodyaches and headache
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Platelet count normal, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Red swollen painful arm with fevers, chills, and bodyaches and headache
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Red cell distribution width normal, White blood cell count increased
Clinical narrative: Red swollen painful arm with fevers, chills, and bodyaches and headache
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient called around 10:43 am, described waking up to an itchy red rash that broke out on her neck and hairline on the side that her vaccine was administered. According to description, reaction sounded allergic in nature, inquired if additional symptoms were present such as difficulty breathing, swelling, etc, but no other symptoms were present at that time. Recommended that I could evaluate in person if she came to the store, that she could take benadryl to aid in relieving allergic symptoms but cautioned drowsiness. Recommended seeking medical care if worsening of symptoms or new symptoms appeared such as swelling or difficulty breathing or no relief of symptoms within a reasonable amount of time.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Vaccines were administered at 1015 this am (8/14/19). Pt did well following administration. Mom called at 1525 this afternoon (8/14/19) and stated that pt was having fever (tmax 101 oral), headaches, and generalized aching. Her arms were painful to move. Verified that these are common side effects. Reviewed with mother and advised to please call with worsening or further concerns / questions. Made provider aware as well.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Musculoskeletal stiffness, Nausea
Clinical narrative: severe headache, severe chills, severe body aches from head to toes, severe pain at site of injection, neck pain and stiffness, slight nausea
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain
Clinical narrative: severe headache, severe chills, severe body aches from head to toes, severe pain at site of injection, neck pain and stiffness, slight nausea
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Pain in extremity, Weight bearing difficulty
Clinical narrative: cant lift over 10 lbs are is sore from shot , went to pcp who gave medro dose pak for inflammation
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Develop muscle pain, headaches, chills, bodyaches, and fatigue.  Headaches, fatigue and chills have lasted 5 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: Arm: redness, swelling, very painful for 5 days; muscle pain, headache,  shivering for 2 days (was in bed all day on day after vaccine); tired, weak, dizzy off and on for 6 days.  Took ibuprofen first day.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Arm: redness, swelling, very painful for 5 days; muscle pain, headache,  shivering for 2 days (was in bed all day on day after vaccine); tired, weak, dizzy off and on for 6 days.  Took ibuprofen first day.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Nausea, Pain
Clinical narrative: Body aches, headache, and nausea that lasted two full days.  Unable to work and Tylenol, Ibuprofen did not lessen the symptoms.  Almost two weeks later I am still having body aches, some nausea and an occasional headache off and on during the day.  I can work but any exercise beyond  normal daily activities causes these symptoms to come up by the end of the day.  I've talked to the pharmacist where I received my vaccination and she had no idea why this was hanging on so long.  I only had a sore arm with the first shot which I had the first of May, 2019.  I will be contacting my physician today to see if I need to see him.  I've never had a fraction to any immunization like this.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient developed 6.5 x 8 cm erythematous  induration with indistinct border, left lateral deltoid
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Bright red rash under both arm pits and elbow area
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: PATIENT DESCRIBED SEVERE (EXCRUCIATING) PAIN IN SHOULDER/ARM IN WHICH THIS VACCINE WAS GIVEN. LASTED SEVERAL DAYS., COULD HARDLY LIFT HER ARM.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Dyspnoea, Erythema, Feeling hot, Malaise
Clinical narrative: Approximately 2 mins after vaccination, patient stated not feeling well, "body burning up" patient was red all over body. she stated she had trouble breathing initially and swelling. her lower back began to hurt really bad. it looked like she was having back spasms. she was in a lot of pain. upon seeing initial symptoms, pharmacy contacted 911 for paramedics. As her symptoms were progressing and getting worse, 1 dose of Epinephrine 0.3mg was given to patient while waiting for paramedics. Paramedics arrived and transported her to medical facility.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms, Pain, Swelling
Clinical narrative: Approximately 2 mins after vaccination, patient stated not feeling well, "body burning up" patient was red all over body. she stated she had trouble breathing initially and swelling. her lower back began to hurt really bad. it looked like she was having back spasms. she was in a lot of pain. upon seeing initial symptoms, pharmacy contacted 911 for paramedics. As her symptoms were progressing and getting worse, 1 dose of Epinephrine 0.3mg was given to patient while waiting for paramedics. Paramedics arrived and transported her to medical facility.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt. had the above vaccine administered on 8/14/19.  The vaccine was given to early due to pt. having Hep B vaccine and MMR on 8/12/19. Pt. will be contacted by our office and monitored for reaction.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Musculoskeletal pain, Swelling
Clinical narrative: shoulder pain and swelling
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Pain in extremity, Rash, Skin irritation, Tenderness
Clinical narrative: Patient stated she came back to pharmacy 2 days after administration. Arm was red and irritated, arm was hurting. Pharmacist on duty recommended bendryl cream. Patient came back to pharmacy on 08/14/19 with mild rash on arm, sensitive to touch, raised, and patch spots. Patient was sent to primary care physician for follow up. Primary Care physician Diagnosed as potential shingles.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Erythema, Nausea, Neck pain, Peripheral swelling
Clinical narrative: Redness of upper arm.  Swelling and hot to touch.  Tender.  Pain refers to neck and ear.  Itching in upper arm.  Some nausea.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm, Tenderness
Clinical narrative: Redness of upper arm.  Swelling and hot to touch.  Tender.  Pain refers to neck and ear.  Itching in upper arm.  Some nausea.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Gestational diabetes, Headache, Injection site pain, Malaise
Clinical narrative: Pregnant: gestational diabetes, due 10/21/2019, 3 previous full term pregnancies with live births vaginally.  Symptoms from recent vaccination (tdap but I don't know the specific details): headaches, nausea, extreme soreness on upper right arm, muscle aches and pains, feeling like I am sick
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea
Clinical narrative: Pregnant: gestational diabetes, due 10/21/2019, 3 previous full term pregnancies with live births vaginally.  Symptoms from recent vaccination (tdap but I don't know the specific details): headaches, nausea, extreme soreness on upper right arm, muscle aches and pains, feeling like I am sick
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Insomnia, Lethargy, Pain
Clinical narrative: Patient stated starting the night of the vaccine he became very lethargic, and achy. States that he had chills but is not sure if he had a fever. He could not sleep due to the pain so he took to "bufferin." The next day  he still had a lot of pain and lethargy. Around 4 PM he was able to get out of the house and started feeling better. He came by the pharmacy around 7 PM and looked well and said he is feeling better.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Lethargy, Loss of consciousness, Pyrexia
Clinical narrative: Patient complained of fever, chills, lethargy, soreness at the injection site and the patient passed out at home.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: PAINFUL LEFT ARM SINCE VACCINATION.  LEFT ARM IS HEAVY SOME TIMES. SLOWLY GETTING BETTER. DOING RANGE OF MOTION EXCERCISES.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient received her the influenza shot and went walking around the store. A little while later, her uncle came back to the pharmacy to inform us that she collapsed in the aisle. EMS was called and assessed her condition. She was awake and coherent. Pharmacist spoke with the uncle and he said she has been compliant with seizure medication, but still gets 3-5 seizures per month.  Patient was taken away from store via ambulence.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: When I returned home from the urgent care my right arm was exceptionally painful. When I woke up two hours later I couldn't lift my arm and had to brace my wrist to keep from having tremendous pain. I called the urgent care facility and reported my trouble and was told to ice my arm and that it was a typical reaction. I have had four children without even tylenol- at all during or after my deliveries. The tremendous pain was constant and sharp and I assured the nurse that it was unlike any of the other (probably 7 or 8) other DTaP vaccines that I have had in the past. She said that I should return to the facility to be checked out. Since I was leaving the beach to return home I was never examined. My husband is a physical therapist and he spent the next day trying to keep some passive movement going to keep my shoulder from becoming stiff. I was completely unable to use my arm, lift, rotate, etc. in any capacity for three days. On the morning of the fourth day (today) I was finally able to begin moving my arm on my own, yet I still have pain.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Pyrexia
Clinical narrative: Per father, pt spiked a fever 7/25/19 and then another fever of 101.5 accompanied by stomach pain on 8/6-8/7/19. Per Dr., the only indication to avoid the second dose of HPV would be a serious adverse reaction, we are still going to recommend she get the second dose.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: rash/erythema
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: Rash
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Adverse reaction, Injection site mass
Clinical narrative: left arm reaction
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Fatigue, Oedema, Swelling
Clinical narrative: edema, red and swollen showed Saturday and edema started Sunday. Very tired. Patient had the edema resolve before the appoint. MD thinks it was an immune reaction.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Swollen site of injection area (left vastus lateralis) Bump Mild bruised
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site swelling, Vaccination complication
Clinical narrative: Swollen (R) thigh that is related likely to vaccine DTaP or IPV - Treated with Benadryl
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Immediate post-injection reaction, Malaise, Posture abnormal, Presyncope
Clinical narrative: Patient received Menactra vaccine without incident. Immediately following the Gardasil vaccine, he stated that he didn't feel well and nearly fainted, with his body falling forward. I was able to sit him upright in the chair and continue to keep him talking to me. After about 20 minutes he walked out on his own. He did not drive home, some one came for him.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Amylase, Arthralgia, Blood thyroid stimulating hormone, C-reactive protein, Diarrhoea
Clinical narrative: This was second injection in series. Within 24 hours Left arm whole arm swelled, red rash feverish skin. Over next few days became nauseated, diarrhea body & joint aches & extreme fatigue. Symptoms continued all month to present day. 8-7-19, Symptoms slowly improving
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Laboratory test, Nausea, Pain, Peripheral swelling
Clinical narrative: This was second injection in series. Within 24 hours Left arm whole arm swelled, red rash feverish skin. Over next few days became nauseated, diarrhea body & joint aches & extreme fatigue. Symptoms continued all month to present day. 8-7-19, Symptoms slowly improving
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Red blood cell sedimentation rate, Skin warm, Urine analysis
Clinical narrative: This was second injection in series. Within 24 hours Left arm whole arm swelled, red rash feverish skin. Over next few days became nauseated, diarrhea body & joint aches & extreme fatigue. Symptoms continued all month to present day. 8-7-19, Symptoms slowly improving
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Customer returned to pharmacy next day, said had fever last night over 100 degrees. Referred patient to contact MD.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Pt stated it felt itchy the next day of injection (Saturday) or Sunday (2 days after injection) She noticed a bump & redness around the area, it got as big as 7cm, pt iced area for 20mins 3x a day for 1 day. Area is now (as of 8/14/19) 4cm, still itchy and bump is smaller.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever to 104.1; vomiting x 2 days
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: Patient stopped by the pharmacy on 08/14/19 informing pharmacists that she seemed to have an allergic reaction of injection site reaction to the SHINGRIX vaccine 2nd dose she received on 08/08/19. She consulter her physician who told her to use ice pack and take BENADRYL. Upper arm looked red and irritated with minor swelling. She said it was not painful but bothered her and slightly itchy. Patient will follow up with MD if symptom still persists after BENADRYL dose on 08/15/19. Reviewed steps all protocol steps were followed and completed by RPH correctly for safety for patient and pharmacist.
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Right side - red, swollen treatment - ice
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: -Pt. reports stomach upset following admin. on 8/7 -Pt. reports itching, redness, soreness, and knot @ injection site starting 8/12/19 -pt. first contacted pharmacy on 8/14/19 @ ~6:30 pm
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypersensitivity, Pruritus generalised, Rash, Scratch, Vaccination complication
Clinical narrative: PATIENT STOPPED BY THE PHARMACY ON 08/13/19 WITH HOME CARE NURSE TO INFORM PHARMACIST THAT SHE SEEMED TO HAVE AN ALLERGIC REACTION TO THE FLU VACCINE. UPON EXAMINING HER ARM THERE WAS A SMALL RASH NEAR THE INJECTION SITE BUT SCRATCH MARKS AT OTHER AREAS OF THE BODY AS WELL. PATIENT REPORTED TO BE ITCHING ALL OVER BODY, TOOK BENADRYL WHICH SEEMED TO HAVE HELPED BUT STILL SOME ITCHING PERSISTS. PATIENT WILL FOLLOW UP WITH MD IF SYMPTOM STILL PERSISTS AFTER BENADRYL DOSE ON 08/15/19. REVIEWED STEPS ALL PROTOCOL STEPS WERE FOLLOWED AND COMPLETED BY RPH CORRECTLY FOR SAFETY FOR PATIENT AND PHARMACIST.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin lesion, Skin warm
Clinical narrative: Pt receive Pneumovax 3 days ago, Pt said (R) arm got swollen, erythematous and warm. He had been taking Benadryl, (R) arm lesion measures 30 cm x 10 cm, just one lesion, warm to touch, pt said that is getting smaller.