chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 69 year old patient received dose of Adacel/No AE; Initial information was received on 26-Jun-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 69 years old female patient who received a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided. On 25-Jun-2020, patient received concomitant medication included VARICELLA ZOSTER VACCINE RGE (CHO) [SHINGRIX].  On 25-Jun-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U6676AA, expiry date: 16-May-2022] via an intramuscular route in left deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration. (It was reported vaccine requirements were for 65 and younger).  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: 62.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Limb discomfort, Myalgia
Clinical narrative: MMR dispensed 5/14/2020 - Right arm achy started that day upper arm. Progression of lessening of achiness. General discomfort upper & lower arm intermittent -> certain movement cause sharp pain-in upper muscular not shoulder joint.
Age: 48.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient Received Combo vaccine of Dtap & IPV (Quadracel) and called our office the next day to report a fever of 102.1'F. Gave tepid Bath & Tylenol, Fever down to 99'F. Mom states he vomited that night but no longer having any sx.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Immediate post-injection reaction, Swelling, Urticaria
Clinical narrative: Swelling occured immediately after injection of vaccine. Hive formed next to site of injection. Dr. evaluated. Benadryl given. waited in office for 30 mins. Hive went away, arm was red by site. No pain. No swelling. No trouble breathing.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Swelling, Swelling face
Clinical narrative: Approximately 30 minutes after administration (once at home) mother noticed facial swelling and swelling of neck. Patient was taken to ED where it was also noted that she had redness and swelling at injection site on right thigh
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour, Decreased eye contact, Irritability
Clinical narrative: Parents report that baby was "not himself" for about 24 hours after vaccines. He was fussy, clingy and father states he was not making good eye contact.
Age: 22.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Feeling hot, Loss of consciousness, Syncope
Clinical narrative: PATIENT EXPIENCED SYNCOPE, WITH FAINTING , FEELING WARM , LOST OF CONCIOUSNESS.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: C-reactive protein, Full blood count, Henoch-Schonlein purpura, Liver function test, Streptococcus test
Clinical narrative: on 6/17/2020 developed symptoms consistent with HSP
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Urine analysis
Clinical narrative: on 6/17/2020 developed symptoms consistent with HSP
Age: 5.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Child had swelling at the vaccine site and also had some warmth to the skin.   Treated with Prednisolone and Benadryl
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Urticaria, Varicella post vaccine
Clinical narrative: Per patient's chart   She noted red area about 1" in diameter starting yesterday Pt given Varicella vaccination in (L) thigh 06/16/2020 - ten days ago Mom is certain there was no red area in the spot prior to yesterday Pt was playing outside yesterday, however, mom is certain pt did not get an insect bite. Mom describes as a hives several times before stating appearance may be more like a pimple Mom did gently squeeze to see if anything would come out Mom checked temp - pt is afebrile She is itching the area but is otherwise not overly bothered by it Pt is acting normally Mom is concerned red area may be an indication of allergy to varicella or reaction to vaccine  PEr note from urgent care Patient was diagnosed with chicken pox
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure, Syncope
Clinical narrative: Patient fainted and was having convulsions
Age: 1.17
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Crying, Irritability, Rash, Rash erythematous
Clinical narrative: Per note Patient was seen in the office yesterday for a WCC and received immunizations.. Father states the patient is cranky this morning and had red dots all over his back and there are dots starting to appear on his chest. spoke to mom as unable to reach dad. she states that patient was with her last night and she did not see the rash. she "assumes" it started this am. dad sent her a picture and looks like it is white dots surrounded by redness. she doesn't think he has a fever or any other sx's other than being "grumpy" and crying a lot. discussed possible se from the vaccines. can monitor for now and if develops difficulty breathing then would need to go the ED. if develops fever, new sx's, worsening rash then she is to c/b. can give him benadryl 12.5mg/5ml ( cautioned may cause sedation but in some children can make them hyper). also cool baths w/ aveno, or oatmeal or baking soda. tylenol/advil for discomfort. mom states understanding and agreement
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: Approximately 8 hrs after vaccination, pt developed a 9 cm X 6 cm raised, indurated, erythemic localized injection site reaction which worsened over the next 24 hrs. to include subjective c/o right upper arm numbness. Pt advised to take Claritan, benadryl, and HCT 1% cream with modest improvement, Once seen at Hospital Occupational Medicine Center today, pt was advised to take Claritan 10 mg in the morning, apply Triamcinolone  0.3% ointment to affected area TID. to QID, then take benadryl 25 mg at HS until follow-up on 7/6/2020. Pt advised she may also apply cool compresses to area for comfort. Pt denied CP, SOB, fever, facial edema, difficulty breathing or swallowing.  DTRs 2+ and intact to RUE. 2 point discrimination intact to RUE.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Full blood count, Measles post vaccine, Pyrexia, Rash
Clinical narrative: she developed onset of bodily rash in the past 24 hours extending from scalp to upper thighs including GU region.  Non pruritic in description.  Mother states that child was exposed to 10-month-old infant with high fever and subsequent pinpoint rash last week prior to the onset of rash this week in this particular child.  Diagnosis for the 10-month-old was viral and no treatment was given.  MMR dosing was given on 06/19/2020 at this child's routine 12 month exam.  Given live vaccine at the time and the development of today's rash, highly suspicious for vaccine related measles rash.
Age: 11.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Malaise, Syncope, Vomiting
Clinical narrative: At approximately 2:40 pm Patient and Father in waiting room after getting vaccines, waiting on certificate of immunization. Father yelled for help. Father stated patient fainted but he caught him before he could fall. Patient was standing then became sick.  Patient then vomited a small amount of clear liquid. Father states patient had not eaten anything all day. Patient  offered water and cracker. Patient declined the crackers but drank the water and felt better afterwards.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Corneal abrasion, Eye pain, Vision blurred
Clinical narrative: Patient states that he began to have blurry vision in the evening on 6/23/20. The next day his vision was worse and the eye was painful. He saw Dr. on 6/24/20 and was told he has a corneal abrasion. Patient states that he could not see for 3 days. He says his vision and the pain have improved, but he is not 100% back to normal yet. Patient also states that he did not have any trauma to the eye to cause the corneal abrasion.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm and Fever 100-101 since immunization administered, has not taken any medication for fever. Advised to take Tylenol and call MD.
Age: 1.17
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Whole body erythematous maculopapular rash appeared <12 hours after administration. Treated with benadryl q6h and observation. Rash improved with treatment, still present at time of form submission.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Heart rate increased, Nausea, Pruritus, Vomiting
Clinical narrative: STAFF COMPLAINED OF ITCHINESS UNDER SKN, FAST HEARBEAT, DIZZINESS, NAUSEA AND VOMITTING
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: PT began to experience pain and sought further treatment at ED
Age: 20.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Rash, Skin warm
Clinical narrative: Rash and warm to the touch the day after.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pt had PPSV 23 administerd on 09/10/2015 with no adverse reaction. Pt reports her L arm area of injection swelled to "size of baseball". Applied cold packs and swelling decreased but tenderness still present at site today - 07/01.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: FEVER, CHILLS
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses of Shingrix vaccine in error. First dose received 1/8/20, second dose 5/14/20, and third dose received 7/1/20.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: FEVER AND CHILLS EXPERIENCED SAME NIGHT RECEIVED VACCINE
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Swelling
Clinical narrative: LOCALIZED SWELLING AND REDNESS.  PATIENT IS TO TAKE BENADRYL, IBUPROFEN AND ICE AREA
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Malaise, Pain
Clinical narrative: Patient called 7/1/20 around 6pm stating that she hadn't been feeling well today (aches, chills) and took her temperature, which was 100.3 F. Asked if she was experiencing shortness of breath or dry cough, patient says she has a longstanding dry cough due to allergies. Out of an abundance of caution and due to overlapping symptoms with coronavirus, instructed patient to follow up with her doctor if fever does not resolve and/or symptoms worsen within the next day.
Age: 67.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Fatigue, Headache, Pain, Pyrexia, Urinary incontinence
Clinical narrative: Pt presented for following Sx: fever (up to 103.9), body aches, headaches, bladder incontinence, fatigue. Onset of Sx occurred Monday evening after receiving Tdap and Prevnar vaccines.
Age: 19.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Patient reported a headache, nausea, and vomiting around 3 PM. I called her later that evening around 7:30 PM and she said she had fully recovered without having to visit a doctor.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Developed an 8 x 3 inch wide red itchy rash. Increased in severity through 8/1/ 20
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Extremely sore arm, achiness on the entire left side, headache, chills, nausea
Age: 1.67
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Asthenia, Decreased appetite, Pyrexia, Skin warm, Somnolence
Clinical narrative: Patient has been rubbing a fever of 100.9, drowsiness, lack of appetite, weak, whole body is hot.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, swelling at inj. site within several hours. Significant band of erythema, itching on inner aspect of bicep in affected arm. Treated conservatively with tylenol, cold compresses: benadryl if needed.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin discolouration, Vaccine positive rechallenge
Clinical narrative: Patient stopped in to mention that after his Shingles vaccine he had noticed, both on the first vaccination and the 2nd vaccination, that he gets a darkening of his skin (almost like dark spots) on the lower extremity of the arm that was vaccinated He stated that it was more pronounced on the 1st vaccine than the 2nd. He has not brought it to the attention of a physician...he states that it is not bothersome it is just something that he has noticed. He states that his skin is returning to normal slow but sure.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient came in on 6/29/20 and wanted to let me know that after receiving the shot on 6/27/20 he had pain in his shoulder and had a hard time moving his arm. He thinks it is going to be okay. He can move it a little more now.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: 9 or 10 more cases of shingles since 2019 and 2020; Shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3B2S5, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (refer case US2020076418).   On 25th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix and less than 4 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The patient received vaccine in left deltoid. The patient received Valtrex prescription of 1gm total of 20 tablets, then her doctor also placed her on 500mg  daily for suppression. The patient stated that she was requesting compensation and reimbursement for Shingrix because since getting the first dose of Shingrix she has had 9 or 10 more cases of shingles since 2019 and 2020 and she had to take a medication to suppress the shingles. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020076418:Original Case : US2020076418
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 9 or 10 more cases of shingles since 2019 and 2020; Shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3B2S5, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (refer case US2020076418).   On 25th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix and less than 4 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The patient received vaccine in left deltoid. The patient received Valtrex prescription of 1gm total of 20 tablets, then her doctor also placed her on 500mg  daily for suppression. The patient stated that she was requesting compensation and reimbursement for Shingrix because since getting the first dose of Shingrix she has had 9 or 10 more cases of shingles since 2019 and 2020 and she had to take a medication to suppress the shingles. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020076418:Original Case : US2020076418
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angioedema, Urticaria
Clinical narrative: pt called on 6/30/2020 @ 1024am reporting that she had rash/hives all over her body with itching. She reported to be taking 50mg of benadryl and using her hydroxyzine 10mg prescription. she was advised to come in to the office to be seen. her provider saw the patient and was given dexamethasone 8mg IM and oral methylprednisolone dosepack 4mg to begin on 7/1/2020, continue the benadryl at home and her prescription of hydroxyzine. she was informed to use Epi pen if shortness of breath and to avoid 2nd shingrix vaccine
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: pt called on 6/30/2020 @ 1024am reporting that she had rash/hives all over her body with itching. She reported to be taking 50mg of benadryl and using her hydroxyzine 10mg prescription. she was advised to come in to the office to be seen. her provider saw the patient and was given dexamethasone 8mg IM and oral methylprednisolone dosepack 4mg to begin on 7/1/2020, continue the benadryl at home and her prescription of hydroxyzine. she was informed to use Epi pen if shortness of breath and to avoid 2nd shingrix vaccine
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Developed pruritic red rash (not urticarial) that was symmetric on thighs and trunk.
Sex: U
Vaccine: RV5
Symptoms: Faeces discoloured
Clinical narrative: The parents believe there may possibly be blood in the patient's stool; Faeces discoloured; This spontaneous report was received from a physician concerning a 4-month-old patient, gender unknown. No concurrent conditions, medical history, historical drug, concomitant therapies and drug reactions/allergies were provided.  On and unknown date, the patient was vaccinated with the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, for prophylaxis (  lot number and expiration date were not reported). Other suspect therapies included acetaminophen (TYLENOL) for an unknown indication (dose, frequency, lot number and expiration date were not reported).  On an unknown date, it was reported that there was "possibly blood in the patient's stool" (Haematochezia) and discoloration to the patient's stool (Faeces discoloured). It was unknown by the reported if treatment was given for the adverse events. At the time of the report it was unknown if the patient had recovered from the haematochezia and faeces discoloured. The causal relationship between Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) and the events was not provided.  Upon internal review, the haematochezia was considered to be medically significant.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer and described the occurrence of shingles in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix. On 21st January 2020, 118 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The NDC number was provided as 58160-0823-11. The patient received Shingrix and had Shingles on 21st January 2020, 29th January 2020 and 1st March 2020. The patient was put on medicine for 6 months and had 10 *5 they talked into shots. The patient still got 6*5 for shot plus. The reporter thinks he/she deserve money back after both doses. For tolerances of 2nd dose, refer case US2020AMR112954, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR112954:same reporter
Age: 67.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: the antibody test results were negative; This case was reported by a physician via sales rep and described the occurrence of therapy non-responder in a 68-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis and HBV (Engerix B adult) for prophylaxis.   Concurrent medical conditions included covid-19 pneumonia.   On 15th October 2018, the patient received the 1st dose of Engerix B adult. On 15th November 2018, the patient received the 2nd dose of Engerix B adult. On 9th April 2019, the patient received the 3rd dose of Engerix B adult. On 1st May 2019, 198 days after receiving Engerix B adult, 167 days after receiving Engerix B adult and 22 days after receiving Engerix B adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The patient received the Engerix-B vaccine beginning in 2018 and after each of his three doses, he ran antibody tests.   Each time the antibody test results were negative. The reporter did not had a valid lot number but would call back with that information.   The reporter consented to follow up.  This case has been linked to US2020109778, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020109778:Same reporter
Age: 67.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: antibody test results were negative; drug dose administration interval too short; Drug dose administration interval too long; This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a 67-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis and HBV (Engerix B adult) for prophylaxis.   On 15th October 2018, the patient received the 1st dose of Engerix B adult. On 16th July 2019, the patient received the 2nd dose of Engerix B adult. On 18th October 2019, the patient received the 3rd dose of Engerix B adult. On 16th July 2019, 274 days after receiving Engerix B adult, unknown after receiving Engerix B adult and not applicable after receiving Engerix B adult, the patient experienced drug dose administration interval too long. On 18th October 2019, the patient experienced drug dose administration interval too short. On 18th June 2020, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long and drug dose administration interval too short were unknown.  Additional details were provided as follows: The patient received the same Engerix-B as he did and at the same time, but did not had an antibody test and her test was also negative.  The patient received 2nd dose late, which led to lengthening of vaccination schedule. The patient received 3rd dose early, which led to shortening of vaccination schedule. The Reporter did not had a valid LOT but would call back with that information.   The case number was given to provide that information to the GSK Response Team. The reporter consented to follow up.  This case linked with US2020109771, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020109771:Same reporter
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Cheilitis, Eyelid rash, Genital rash, Rash pruritic
Clinical narrative: Patient's mother stated that patient began complaining of an itchy rash around his eyes, lip, and genitals. Patient reported that the itching began around 1830 - 1900 the same day he was vaccinated. Patient's mother states that there is no rash on his arms, where he received the immunizations. She states that it "looks like poison ivy," and reports that they went to a lake house two days before coming in for vaccinations. Patient's mother reports that patient has had no difficulty breathing or swallowing, has had no difficultly walking, and has had no impairment to his vision. Patient's mother reported that she gave the patient Benadryl, which helped with the itching. This nurse has attempted to contact patient's mother to follow up on the patient's condition, but has been unsuccessful.  This nurse is unsure if patient's mother ended up taking the patient to a doctor's office for treatment/follow-up.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Varicella
Clinical narrative: patient now has chicken pox all over left leg
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Swelling, Varicella
Clinical narrative: patient now has chicken pox all over left leg
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient presented to the ER with severe arm swelling and redness. Patient received  a prescription for an eight day course of prednisone and sent home.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Patient was only given the diluent
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: Headache, chills, sever muscle ache, fatigue, redness and hardness at the site of injection for 4 days The redness at the site of injection lasted for about a week.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Myalgia
Clinical narrative: Headache, chills, sever muscle ache, fatigue, redness and hardness at the site of injection for 4 days The redness at the site of injection lasted for about a week.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Mobility decreased, Nausea
Clinical narrative: Severe arm pain, dizziness, nausea, vomiting, fever, chills, shakes, headache Inability to move arm (movement now restored but very painful)
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Tremor, Vomiting
Clinical narrative: Severe arm pain, dizziness, nausea, vomiting, fever, chills, shakes, headache Inability to move arm (movement now restored but very painful)
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, upto 101.7, entire body aches. Adverse effects laste for 1 1/2 days. Woke up on morning of 7/2 and felt fine.
Age: 66.0
Sex: M
Vaccine: PNC
Symptoms: Cellulitis, Erythema, Laboratory test, Oedema, Pain in extremity
Clinical narrative: Pain in arm 3 days s/p vaccine - proceded quickly to redness, hot + edema. In ED for cellulitis + admitted for 3 days IV antibiotics. Now home on oral antibiotics Right deltoid.
Age: 66.0
Sex: M
Vaccine: PNC
Symptoms: Skin warm
Clinical narrative: Pain in arm 3 days s/p vaccine - proceded quickly to redness, hot + edema. In ED for cellulitis + admitted for 3 days IV antibiotics. Now home on oral antibiotics Right deltoid.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, In vitro fertilisation, No adverse event, Pregnancy test positive
Clinical narrative: patient who was starting the process of ln vitro fertilization was administered V ARIV AX, the patient took pregnancy test which was positive.; No additional adverse events; This spontaneous prospective pregnancy report was received from a nurse, who refers to a 29-year-old female patient, who was starting the process of in vitro fertilization. The patient's pertinent medical history included depression and anxiety and she had no known allergies. Her concomitant therapies included bupropion (BUPROPION) and unspecified prenatal vitamins. On an unknown date, the patient became pregnant. Based on pregnancy gestation, the patient's last menstrual period (LMP) was calculated on 28-APR-2020 and the estimated date of delivery (EED) was calculated on 02-FEB-2021. The pregnancy outcome was pending. Fetal outcome was unknown at the time of the report. On 02-JUN-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, subcutaneously, for prophylaxis, lot # S036636, expiration date 14-NOV-2021 (strength, dose, frequency were not reported), the vaccine was reconstituted with sterile diluent. On the same date, reported as later that afternoon, the patient took a home pregnancy test, which was positive. Initial exposure to varicella virus vaccine live (oka/merck) (VARIVAX) was at 5 weeks of gestation period. No additional adverse events were reported. The patient had no lab diagnostics or studies performed. The patient sought medical attention and she took advantage of counseling.
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Antibody test negative, Hepatitis B antibody negative, Rubella antibody negative
Clinical narrative: patient had titers drawn on an unspecified date and the results showed "no titers shown to hepatitis b, rubella or varicella."; patient had titers drawn on an unspecified date and the results showed "no titers shown to hepatitis b, rubella or varicella."; patient had titers drawn on an unspecified date and the results showed "no titers shown to hepatitis b, rubella or varicella."; This spontaneous report was received from a nurse referring to a 21 years old male patient. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On an unknown date, the patient was administered unspecified varicella virus vaccine live (oka/merck) (manufacturer unknown) (strength, dose, route were not reported, batch/lot# and expiration date were unknown), hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, route were not reported, batch/lot# and expiration date were unknown) and rubella vaccine (manufacturer unknown) (strength, dose, route were not reported, batch/lot# and expiration date were unknown) for prophylaxis.  On an unknown date, the patient had (unspecified) titers drawn and the results showed "no titers shown to hepatitis b, rubella or varicella." The outcome of the events was not provided. The causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse effects were reported in any patients; An unknown number of patients, received an unknown number of doses of VARIVAX following a temperature excursion; This spontaneous report has been received from a physician assistant concerning an unknown number of patients of unknown age and gender. The patients' concomitant therapies included sterile diluent. The patients' concurrent conditions and previous medical history were not reported.    From 30-MAR-2020 to 26-APR-2020, varicella virus vaccine live (oka/merck)(VARIVAX), was exposed to a range of temperature excursion between -4°C up to 0°C for 30 minutes. Information was extracted from data logger.   On 08-MAY-2020, two  patients were vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021321, expiration date 09-JUL-2021 for prophylaxis (dose, strength, formulation and patient route of administration were not reported) following a temperature excursion (product storage error). A total of 17 hours of maximum temperature excursion was reported of of -9°C to 8°C (0°C).  On 05-JUN-2020, an additional patient (reported as employee) was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021321, expiration date 09-JUL-2021 for prophylaxis (dose, strength, formulation and patient route of administration  were not reported) following a temperature excursion (product storage error). A total of 28.5 hours of maximum temperature excursion was reported.  Due to the defrost cycle approximately once every 26 hours, there was a 30-60 minute excursion above -15°C. On most of those days, the amount of time spent between 0°C and -9°C is 30 minutes  No other adverse effects were reported in any patients.   This case was non-valid due to lack of patients' identifiers.  This is one of two  reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer referring to a patient (pt) of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 02-MAY-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not reported and causality assessment was assessed as related.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effects reported; the patient received his second dose of VAQT A on 06/29/2020; This spontaneous report was received from a medical assistant referring to a male patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided.  On 11-MAY-2020, the patient received his first dose of hepatitis a vaccine, inactivated (VAQTA) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. On 29-JUN-2020, the patient received his second dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S023220, expiration date 20-OCT-2020; strength, dose and route were unknown) for prophylaxis (Inappropriate schedule of vaccine administered). No additional adverse effects reported.   It was reported that hepatitis a vaccine, inactivated (VAQTA) was inform in the product section as the strength of the hepatitis a vaccine, inactivated (VAQTA) was unknown. No product quality complaint (PQC). The outcome of the events was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain relievers for reaction to shingles shot; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. The patient was treated with analgesic, nos (Pain Reliever (Drug Name Unknown)). On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient experienced adverse event after shingle shot and asked whether it was ok to take pain relievers for reactions to the shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: now shingles has become a part of pain; now shingles has become a part of pain; rash on left side y ribs and under left breast.; Suspected vaccination failure; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (received now Olumiant for three weeks). Concomitant products included baricitinib (Olumiant).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Olumiant for three weeks for rheumatoid arthritis.  The patient reported now the patient had shingles. The patient had all the vaccines but now shingles had become a part of pain and rash on left side of ribs and under left breast. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; flare ups of shingles; This case was reported by a other health professional via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient asked for the reason for getting flare ups of shingles even though the patient received Shingrix. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccine positive rechallenge
Clinical narrative: Shingles; This case was reported by a consumer and described the occurrence of shingles in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (received 1st dose on 25th September 2019, refer case US2020AMR112938).   On 18th March 2020, the patient received the 2nd dose of Shingrix. On 16th April 2020, 29 days after receiving Shingrix, the patient experienced shingles. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The NDC number was provided as 58160-0823-11. The patient received Shingrix and had Shingles on 16th April 2020 and 22nd May 2020. The patient was put on medicine for 6 months and had 10 *5 they talked into shots. The patient still got 6*5 for shot plus. The reporter thinks he/she deserve money back after both doses.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster, Malaise, Pyrexia, Rash
Clinical narrative: Cellulitis; fever; rash on my Buttocks; shingles; I am so sick; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (1st dose received on 6th April 2020, refer case US2020113036).   On 6th June 2020, the patient received the 2nd dose of Shingrix. In June 2020, 8 days after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), fever, rash, shingles and sickness. The patient was treated with antibiotics nos and antivirals nos. On an unknown date, the outcome of the cellulitis and sickness were unknown and the outcome of the fever and rash were not recovered/not resolved and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the cellulitis, fever, rash, shingles and sickness to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. On 14th June 2020, patient went to urgent care clinic because of a fever and a rash on buttocks and was diagnosed with Cellulitis. The patient was prescribed with an antibiotic. The patient returned to the clinic on 18th June 2020 because the fever and rash were worse and was told that she had shingles. The patient was prescribed an antiviral. The patient did not believed on them. The patient told that, they must warn patients that they could get shingles immediately after getting the vaccine. The patient had to stop taking all her medications for 2 weeks while taking both antibiotics and antivirals. The patient was wished that she was dead, and was so sick. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020113036:Same patient, 1st dose
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Fatigue
Clinical narrative: Dizzy; Fatigue; Diarrhea; This case was reported by a consumer and described the occurrence of dizziness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) solution for injection in pre-filled pen for crohn's disease.   On an unknown date, the patient received Shingrix and Humira (subcutaneous) at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness, fatigue and diarrhea. Humira was continued with no change. On an unknown date, the outcome of the dizziness, fatigue and diarrhea were unknown.   It was unknown if the reporter considered the dizziness, fatigue and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix and Humira, the patient experienced dizziness, fatigue and diarrhea. The reporter considered the dizziness, fatigue and diarrhea to be reasonable possibile to Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Cataract, Cataract operation
Clinical narrative: Cataract; This case was reported by a pharmacist via call center representative and described the occurrence of cataract in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cataract (serious criteria GSK medically significant). On an unknown date, the outcome of the cataract was unknown.   It was unknown if the reporter considered the cataract to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had cataract. The patient would received 2nd dose of Shingrix on 19th June 2020 but the patient also had been schedule with cataract surgery 5 days later. The reporter was consented to follow up. No further details were reported by reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Rash, Rash erythematous
Clinical narrative: redness and soreness at the site of the injection; soreness at the site of the injection; rash under her left breast.; bubbles; itched; 5 to 6 raised areas; overly tired; red rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox, tuberculosis (had tuberculosis at one year of age), shingles (had shingles twice in the past), pain (The pain was so excruciating one time she was hospitalized for three days and put on an IV.) and heart rate high. Previously administered products included Zostavax with an associated reaction of herpes zoster (administered when she was 60 years of age and developed a case of shingles a few years after the vaccination.) and HEPATITIS VACCINE (had hepatitis at four years of age). Concomitant products included analgesic, nos (Pain Medication).   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site erythema, injection site pain, rash, blistery rash, itchy rash, raised rash, tiredness and red rash. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the rash, blistery rash, itchy rash, raised rash, tiredness and red rash were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, rash, blistery rash, itchy rash, raised rash, tiredness and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed some redness and soreness at the site of the injection by the next morning but it resolved after a couple of days. She had surgery in January and was advised to speak to her doctor before proceeding with the 2nd dose, then Covid broke out. She was unable to get the 2nd dose until the end of May.   Then last week, she noticed a rash under her left breast and had bubbles on it and itched.   It was the size of a couple of quarters if you put them together in which there were 5 to 6 raised areas.   In the last few days, it seems to be going away and no more bubbles and the redness was lessening and was itchy. The patient has been using a cream on it to help with the itching. The reporter consented to follow up. This case US2020AMR108078 is a duplicate of US2020107171. All future correspondence will be submitted to US2020107171.