chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: FLU3, TTOX
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: a 79 year old female was administered Fluzone High-Dose on 08Nov2019 and again on 15Nov2019 instead of the tetanus shot/No AE; a 79 year old female was administered Fluzone High-Dose on 08Nov2019 and again on 15Nov2019 instead of the tetanus shot/No AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 79 years old female patient who was vaccinated with a 0.5ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] Pre-filled syringe on 08-Nov-2019 lot number: UJ300AB and Expiry date: 26-Jun-2019) via intramuscular route in the left deltoid and again received the same shot instead of TETANUS TOXOID shot on 15-Nov-2019.   Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong vaccine administered and extra dose administered.   Pharmacist states that she injected a 79 year old female with Fluzone High-Dose on 08Nov2019. The patient came back in on 15Nov2019 to get a Tetanus shot and the medical assistant accidentally pulled the Fluzone High Dose shot again instead and injected it instead of the tetanus shot.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth, Pruritus
Clinical narrative: itchiness; with warmth; they had injection site redness, with warmth to touch and one of them said that the redness; injection site redness; the word hives spread down their arm; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer..  This case is linked to cases 2019SA327309 and 2019SA327308.  This case involves female patient (age not reported) who experienced itchiness (pruritus), they had injection site redness, with warmth to touch and one of them said that the redness (vaccination site inflammation) and  the hives spread down their arm (vaccination site urticaria), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6719KA via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious itchiness (pruritus), they had injection site redness, with warmth to touch and one of them said that the redness (vaccination site inflammation), the hives spread down their arm (vaccination site urticaria), with warmth  (vaccination site warmth) and injection site redness (vaccination site erythema) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests were not reported.  Final diagnosis was pruritus, vaccination site inflammation and vaccination site urticarial.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given an expired vaccine to a patient, No AE; Initial  and additional information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 months old male patient who was vaccinated with a dose of expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot UT5897JA, Expiration Date: 30-Jun-2018) (formulation: prefilled syringe) via intramuscular route in the left thigh On 15-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), Varicella and MMR.  It was a potential medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error..
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered ActHIB vaccine for which the ActHIB vial had not yet expired, but the supplied diluent that was used to reconstituted the ActHIB vial had already expired/No AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient who received a 0.5 ml expired dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The Medical history, medical treatments, vaccinations and family history were not provided.   Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 14-Nov-2019, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE [lot U6055AA, expiry date: 19-Oct-2019] via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  It was reported as, on 14-Nov-2019,  the ACT-HIB vaccine [lot number: UI909AA, expiry date: 17-Oct-2019] administered to patient was not expired, but the supplied diluent [lot Number: U6055AA, expiry date: 19-nov-2019] which was used as constituent for vaccine had already expired. [unknown latency] [carton lot UI909AAA].  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: 63.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: gave a 63 year old patient Fluzone High Dose during a visit for the flu vaccine only/NO AE; gave a 63 year old patient Fluzone High Dose/NO AE; gave a 63 year old patient Fluzone High Dose/NO AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 63 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], during a visit for the flu vaccine only.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Nov-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ300AB, expiry date- 26-06-2020 via intramuscular route in the left arm.  It was a case of actual medication error due to inappropriate age at vaccine administration, Wrong vaccine administered and overdose.  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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse needed stability information or their 0.5 mL Fluzone Quad vaccines that experienced multiple temperature excursions ranging from 5-10 minutes/No AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case mentions a nurse needed stability information for their 0.5 ml fluzone quad vaccines that experienced multiple temperature excursions ranging from  5-10 minutes/no AE [Product storage error] for vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot no : UT6654JA, expiration date- 30-Jun-2016) and (lot no : UT6657NA, expiration date- 30-Jun-2016).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  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.
Sex: U
Vaccine: FLUX
Symptoms: Abdominal hernia, Abdominal operation, Cough, Influenza, Neoplasm malignant
Clinical narrative: coughing; abdominal wall hernias; Flu; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 65 years old patient who experienced coughing (cough), abdominal wall hernias (abdominal hernia) and flu (influenza), while  received vaccine INFLUENZA VACCINE.  The patient's past medical history included Abdominal operation. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Neoplasm malignant.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious coughing (cough), abdominal wall hernias (abdominal hernia) and flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was flu, abdominal wall hernias and coughing.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for all the events.  Information on the batch number was requested.
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: fainted; Initial information received on 19-Nov-2019 regarding an unsolicited valid serious case received from a physician.  This case involves an unknown age male patient who experienced fainted (syncope), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a serious fainted (syncope) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  (Other relevant tests included no lab data.)  Final diagnosis was fainted.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for fainted.  Information on the batch number was requested.; Sender's Comments: This case concerns an unknown age male patient who presented with syncope after vaccination with FLUZONE QIV. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination, previous vaccination history with similar episodes and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUR4
Symptoms: Pain in extremity
Clinical narrative: soreness in arm, Arm was noticeably sore especially upon lifting household items; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves patient of unknown demographics who experienced soreness in arm for 10 days [Pain in extremity], while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious soreness in arm for 10 days (pain in extremity) Unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Arm was noticeably sore especially upon lifting household items  Other relevant tests not reported.    Final diagnosis was soreness in arm for 10 days .  It was not reported if the patient received a corrective treatment.  Information on the batch number was requested.  The event outcome was reported as Recovered / Resolved on an unknown date for soreness in arm  for 10 days after receiving flublok vaccine.
Age: 1.5
Sex: F
Vaccine: FLUX
Symptoms: Drooling, Lip swelling, Panic reaction, Retching
Clinical narrative: Swelling of lips, gagging, excessive drooling, feeling of panic
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Patient first called to report on November 22, 2019 at 1400  Patient details state had an adverse reaction to vaccine. Patient reports she has be to a Chiropractor, Physical Therapy and 2 Doctors since the vaccine. We have been trying to contact the patient since November 22, 2019, but has not returned out phone calls, submitting report in a timely manner after phone call with VAERS, with incomplete data to have record
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Vasovagal Syncope with loss of bladder control
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Condition aggravated, Continuous positive airway pressure
Clinical narrative: onset of muscle aches, joint pain, dizziness, fever off and on, chills, generalized weakness that onset less then 24 hours after receiving the vaccine. symptoms were worse, pretty constant on Thursday 11/21/19 and Friday 11/22/19 since the 21st and 22nd spike in sleep apnea episodes, c-pap machine is recording 60-70 apnea episodes per hour, this is very unusual, prior to the vaccine had average recordings of 20-25 episodes per hour.  lack of energy since vaccine administration
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Myalgia, Pyrexia, Sleep apnoea syndrome
Clinical narrative: onset of muscle aches, joint pain, dizziness, fever off and on, chills, generalized weakness that onset less then 24 hours after receiving the vaccine. symptoms were worse, pretty constant on Thursday 11/21/19 and Friday 11/22/19 since the 21st and 22nd spike in sleep apnea episodes, c-pap machine is recording 60-70 apnea episodes per hour, this is very unusual, prior to the vaccine had average recordings of 20-25 episodes per hour.  lack of energy since vaccine administration
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Malaise
Clinical narrative: Side effects; Feeling sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles about 10 yrs ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness and adverse drug reaction. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the sickness and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and had every side effect listed sick for 2 days. The patient said that the second dose may cause even worse side effects because I already have a sufficient immunity against.  The patient can deal with that but worry it may cause more serious problems that might cause me to be hospitalized or worse.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Pyrexia
Clinical narrative: All of the common side effects; Temperature is currently 101.1; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced adverse reaction and fever. On an unknown date, the outcome of the adverse reaction and fever were unknown.   It was unknown if the reporter considered the adverse reaction and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was considered as adult as per vaccine indication. The day before reporting at about 3:00, the patient received Shingrix. The patient experienced all of the common side effects. At the time of reporting, the patient's temperature was 101.1 degrees F. The patient asked how long would the side effects usually last. The patient would report the symptoms to the pharmacist and declined to provide any personal information.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site rash, Pain
Clinical narrative: pain at the injection site; redness at the injection site; rash at the injection site; feeling achy; felt feverish; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number D7797, expiry date 9th July 2021) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site rash, pain and feeling hot. In November 2019, the outcome of the injection site pain, injection site erythema, injection site rash, pain and feeling hot were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site rash, pain and feeling hot to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had feeling achy, feverish, pain at the injection site, redness at injection site.  The patient also said that she had a 4 x 6 inch rash at the injection site. The nurse called back the patient at the time of reporting and patient said that the symptoms were gone.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Injection site rash; injection site redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2019, the patient received Shingrix. On 7th November 2019, 1 days after receiving Shingrix, the patient experienced injection site rash and injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were recovering/resolving.   It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had red 1 to 2 inch rash around the injection site on the right deltoid. It was reported that had progressed to a larger rash of approximately 3 inches and at the time of reporting the rash was lighter in color. No additional symptoms were reported. The reporter consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: It didn't work; I had the shot at 65 and again three years ago and I still got pneumonia; adult received two doses of pneumococcal 13-val conj vac; This is a spontaneous report from a Pfizer-sponsored program. A contactable (Age: 77, Unit: Unknown) old female consumer reported for herself that she received two doses of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot and expiry date unknown), via unspecified routes of administration on unspecified dates at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient stated that "I had the shot at 65 and again three years ago and I still got pneumonia". The outcome was unknown. Information on the batch number has been requested.
Sex: M
Vaccine: FLUX, MENB
Symptoms: Syncope
Clinical narrative: Fainted; This is a spontaneous report from a non-contactable nurse via a Pfizer Sales Representative. A 20-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at 0.5 ml, single in his arm for immunization and influenza vaccine (manufacture unknown) via an unspecified route of administration in arm on an unspecified date at unknown dose for immunization.  The patient's medical history and concomitant medications were not reported. It was reported that they gave meningococcal group b rlp2086 and the patient fainted. Had got the flu shot at the same time in different arms. Happened a couple of weeks ago. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of TRUMENBA and the onset of being fainted cannot be excluded, considering the plausible temporal association and the known adverse event profile of the suspect vaccine.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pruritus, Rash
Clinical narrative: 6 by 4 inches hives on her left arm/she has hives on her left arm that now measure 6X4 inches; one giant red area; she has severe itching to the area; its burning and she has a rash on top of the hives; swelling in the left arm; Reported rash on the top of the hives on the left arm; This is a spontaneous report from a contactable consumer.    A 81-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , intramuscular on 14Nov2019 at 0.5 ml single as vaccination Medical history included allergy to latex, sulpha and cellulose. The patient's concomitant medications were not reported. On 14Nov2019 the patient experienced 6 by 4 inches hives on her left arm. In Nov2019 the hives were taking up over half her arm, they were now going round the back of her arm. Patient stated it was one giant red area, she had severe itching to the area, burning and she had a rash on top of the hives on the left arm. Patient went to the doctor twice and she has been told that the arm is not infected. Patient reported that the hives were worsening: she had hives on her left arm that measure 6X4 inches and seems to be increasing. Patient was using diphenhydramine hydrochloride (BENADRYL) 25mg capsule and triamcinolone cream 0.1% for the hives: She has been told to take diphenhydramine hydrochloride a couple times a day, and she took 2 full doses on 21Nov2019 and a half dose on 22Nov2019 and she stated it was helping her. She also applied triamcinolone quite a bit to cover the area and she has been using the cream for 3 days, and reported that the hives are not disappearing. She clarified that this was the only treatment that she did not feel was working for the hives. On 21Nov2019 she also received a Cortisone shot for swelling in the left arm. The swelling has not gone completely down, but has gone down some.The final outcome of the event hives was not recovering, swelling was recovering and outcome of all the other events was unknown. Patient wanted to know what ingredients in the product may have caused the reaction. She stated that she had a lot of allergies and she did not see anything in the pneumococcal 13-val conj vaccine ingredients that she's allergic to. Information on the batch number has been requested
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: 6 by 4 inches hives on her left arm/she has hives on her left arm that now measure 6X4 inches; one giant red area; she has severe itching to the area; its burning and she has a rash on top of the hives; swelling in the left arm; Reported rash on the top of the hives on the left arm; This is a spontaneous report from a contactable consumer.    A 81-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , intramuscular on 14Nov2019 at 0.5 ml single as vaccination Medical history included allergy to latex, sulpha and cellulose. The patient's concomitant medications were not reported. On 14Nov2019 the patient experienced 6 by 4 inches hives on her left arm. In Nov2019 the hives were taking up over half her arm, they were now going round the back of her arm. Patient stated it was one giant red area, she had severe itching to the area, burning and she had a rash on top of the hives on the left arm. Patient went to the doctor twice and she has been told that the arm is not infected. Patient reported that the hives were worsening: she had hives on her left arm that measure 6X4 inches and seems to be increasing. Patient was using diphenhydramine hydrochloride (BENADRYL) 25mg capsule and triamcinolone cream 0.1% for the hives: She has been told to take diphenhydramine hydrochloride a couple times a day, and she took 2 full doses on 21Nov2019 and a half dose on 22Nov2019 and she stated it was helping her. She also applied triamcinolone quite a bit to cover the area and she has been using the cream for 3 days, and reported that the hives are not disappearing. She clarified that this was the only treatment that she did not feel was working for the hives. On 21Nov2019 she also received a Cortisone shot for swelling in the left arm. The swelling has not gone completely down, but has gone down some.The final outcome of the event hives was not recovering, swelling was recovering and outcome of all the other events was unknown. Patient wanted to know what ingredients in the product may have caused the reaction. She stated that she had a lot of allergies and she did not see anything in the pneumococcal 13-val conj vaccine ingredients that she's allergic to. Information on the batch number has been requested
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dehydration, Fatigue, Nausea
Clinical narrative: pt came in reporting that she had to go to the ER after receiving her 2nd shingrix. She stated that she had chills, nausea, weakness, pain all over the body, and fatigue. While at the ER, they informed her that she was dehydrated and had drug toxicity. She was treated with fluids at the hospital and is feeling better now.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Toxicity to various agents
Clinical narrative: pt came in reporting that she had to go to the ER after receiving her 2nd shingrix. She stated that she had chills, nausea, weakness, pain all over the body, and fatigue. While at the ER, they informed her that she was dehydrated and had drug toxicity. She was treated with fluids at the hospital and is feeling better now.
Age: 26.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Herpes zoster
Clinical narrative: Pt went home after vaccinations, then within three days developed shingles on his left arm/shoulder and throughout arm. Pt went to an urgent care center who clinically confirmed that it was shingles and lasted for about two weeks.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Chest X-ray, Echocardiogram, Pericarditis, Ultrasound scan
Clinical narrative: Acute Pericarditis
Age: 8.0
Sex: M
Vaccine: UNK
Symptoms: Vaccination site erythema
Clinical narrative: unknown flu vaccine details as given at pmd, reported from Agency  erythema 11cm x 6cm over L arm at site at vaccine
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Patient presented to me, RN (Mom) Friday 11/22/19 night 2130 with a 50 cent piece area on Left gluteal @ Tdap injection site, very red, swollen, hot to the touch. Area still red & not much size decrease, no heat, still red on 11/25/19AM. Size is the same.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Muscle spasms, Pain
Clinical narrative: Person states that she developed chills, diarrhea and cramping, body aches 5 hours after the injection. Symptoms have resolved.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: patient is reporting hearing loss in her left ear
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient experienced a high fever, chills, aches approximately 5 hours after receiving the the vaccine. The symptoms lasted approximately 24 hours. She did not seek medical attention,
Age: 1.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given flu vaccine x2 doses at the same office visit. No known adverse side effects to pt.
Age: 4.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Computerised tomogram abnormal, Parotitis
Clinical narrative: Presented to ER on 11/26 with Rt Parotitis w/o stone (CT confirmed)
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose of VAQTA; This spontaneous report has been received from a certified medical assistant reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 25-NOV-2019, the patient was vaccinated with an unspecified expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) for prophylaxis lot#R032910 and expiration date 18-NOV-2019 (dose, and route of administration were not reported). The outcome of expired product administered was unknown.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: flu like symptoms; fever; chills; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 10 hrs after receiving Shingrix and Shingrix, the patient experienced influenza-like symptoms, fever and chills. On an unknown date, the outcome of the influenza-like symptoms, fever and chills were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever and chills to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter had noticed the flu like symptoms (fever and chills) with a number of patients that started about 10 to 12 hours after 1st or 2nd dose and lasted for about 10 to 12 hours. The reporter gave consent to follow up via mail. This case has been linked with case US2019AMR209590, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: extended swelling in his arm; arm pain; decreases agility in arm; redness; This case was reported by a physician via sales rep and described the occurrence of swelling arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced swelling arm, pain in arm, mobility decreased and erythema. On an unknown date, the outcome of the swelling arm, pain in arm, mobility decreased and erythema were recovered/resolved.   It was unknown if the reporter considered the swelling arm, pain in arm, mobility decreased and erythema to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in an unknown arm. The patient had pain and decreased agility in arm for 1 week.  Redness and swelling lasted about 5 to 7days.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: bell's palsy; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. Limited information was provided. No further information was reported. This is 1 of 4 cases, reported by the same reporter.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Tremor
Clinical narrative: syncopal with shaking lasting apx 2 seconds then rapid return to responsiveness.  PSOP 99 RA BP 78/56  then 102/50
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Nausea, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Before receiving the HPV immunization, this RN had administered the flu shot and meningococcal vaccine in her LA.  Client then received HPV IM in RA and tolerated it well, client did say it was the most painful shot she received of the  three, but tolerated all shots well. After stating the shot was painful, the client was rubbing her arm. After about 30 seconds, the client's face and lips got very pale and then she slumped forward and to the right, into her brother's lap, and then proceeded to slide down to the floor with this RN protecting and guiding client's upper body and head safely to the ground.  Client did not respond to name at that time. Once client was laying on ground, client started responding to her name being called by mother and RN within 15 seconds. Client oriented x3 upon responding, but feeling nauseated, color returning to face at this time. Client assisted to sitting position, with head between her legs. Client given water and orange juice and encouraged to move slowly after sitting for 10 minutes. Mother states client did not eat breakfast before appointment. Client felt better after sitting for the 10 minutes and was able to walk out of clinic.
Age: 12.0
Sex: M
Vaccine: FLUN4, HEP, HPV9, MNQ, TDAP
Symptoms: No adverse event
Clinical narrative: Flumist was inadvertently given to client who had indicated "asthma" on screening form. Discovered during forms review on the following day. Called (left voice message) and texted 11/22/19, 11/25/19, and 11/26/19 with no response. 11/27/19 sent letter to parent. Unable to reach parents; no adverse outcome known.
Age: 79.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Skin warm
Clinical narrative: 17cm x 10cm erythematous, warm to the area, no open areas, no induration
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Noted diffuse urticaria and wheals to upper thighs, face, lower back and buttocks after flu vaccine given. Treated with benadryl, ice packs. No wheezing or facial swelling.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient got a dose of flu vaccine previously in another facility somewhere else on 11/14/2019. He received a second dose vaccine on 11/26/2019 in our facility. contacted patient no adverse effects reported
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Blood test, Laboratory test normal, Rash, Urticaria
Clinical narrative: Rash/hives from the right wrist up to the right elbow.  Over the next 7 days the area affected extended up to the right armpit.  Then over the course of the next several weeks the rash extended to the left arm (wrist to armpit) and both legs (from the knee down).  Then in the following 6-8 weeks the rash extended to the lower back (up to the lower tip of the shoulder blades) and the groin area.  As of today's date (11-27-2019) the rash is still active in all of the areas mentioned above.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Chills, Hallucination, Pain, Pain in extremity
Clinical narrative: In the evening of 11/18 after receiving the Prevnar13 vaccine, patient developed fever, chills and hallucinations. Woke up the next morning on 11/19 with terrible all over body pain. Patient called our office on 11/20 pain was only in her lower legs, pain improved when walking and taking ibuprofen 600mg three times to four times daily as directed by Dr. Patient called again on 11/22 to report her pain in her lower legs had improved but it was still present. At this time the patient requested we list the Prevnar13 vaccine as an allergy in her chart and wanted this reported as an adverse event. Dr. agreed.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: In the evening of 11/18 after receiving the Prevnar13 vaccine, patient developed fever, chills and hallucinations. Woke up the next morning on 11/19 with terrible all over body pain. Patient called our office on 11/20 pain was only in her lower legs, pain improved when walking and taking ibuprofen 600mg three times to four times daily as directed by Dr. Patient called again on 11/22 to report her pain in her lower legs had improved but it was still present. At this time the patient requested we list the Prevnar13 vaccine as an allergy in her chart and wanted this reported as an adverse event. Dr. agreed.
Age: 27.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Red area @ inj site. Slightly hard bump 1.5 to 2 inches in diameter, hot to touch, sometimes itches but does not scratch. 5/10 pain on moving, touching, dressing. 100.5 F fever 11/26 (one day after inj). Denies fever today but may be having chills. Pt advised to use ice, Tylenol or ibuprofen, Benadryl, and hydrocortisone cream.
Age: 27.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Red area @ inj site. Slightly hard bump 1.5 to 2 inches in diameter, hot to touch, sometimes itches but does not scratch. 5/10 pain on moving, touching, dressing. 100.5 F fever 11/26 (one day after inj). Denies fever today but may be having chills. Pt advised to use ice, Tylenol or ibuprofen, Benadryl, and hydrocortisone cream.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Associate was given a flu vaccine. She stated the vaccine was given too high up on her right arm and she has continued to have pain in right upper arm
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient reports arm pain continuously since flu shot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt came to the office for injections. Pt recieved dtap/ipv, influenza, and MMR/varicella on 11/18/2019. Pt was given dtap/ipv on rt thigh. Influenza vaccine was given on Lt arm and MMR/varicella was given on Lt thigh.  Pt and mother came for office visit two days later on 11/20/19. Pt mom reports redness, itching and swelling near injection site on both thighs. Redness and swelling was shown more on the Rt thigh. Pt was given symptomatic treatment. Pt was prescribed benadryl and triamcinolone acetonide topical cream.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Insomnia, Middle insomnia
Clinical narrative: Patient visited us at the store on 11/22/19 and talked to the Pharmacist on duty to discuss what he experienced after a flu shot administration on 11/8/19. He said right after receiving the vaccine two weeks ago, he had felt moderate to severe pain and muscle stiffness on his left arm where he had been vaccinated, causing him limited mobility on that arm and having pain moving and reaching across the opposite shoulder. He said there were nights that he can't sleep or wake up in the middle of the night because of the pain. He hasn't seen a doctor yet for these symptoms. Pharmacist suggested if he want to take NSAIDS like Advil or Aleve to help with the pain but he said he would only take NSAIDS if he feels it to be necessary. A Quality Assurance and Safety Report was already submitted on 11/22/19 about the patient's concerns and symptoms. He had been getting his yearly flu shot and this was the first time that he had experienced this shoulder pain. He understands this occurrence is usually expected after a vaccine administration but his symptoms still persist over two weeks after. He just wanted an assurance that these symptoms are just temporary and will be resolved soon. Pharmacy Risk Management Team had started working on this case and they will be reaching out to the patient to help him on this situation and fully address his concerns.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Patient visited us at the store on 11/22/19 and talked to the Pharmacist on duty to discuss what he experienced after a flu shot administration on 11/8/19. He said right after receiving the vaccine two weeks ago, he had felt moderate to severe pain and muscle stiffness on his left arm where he had been vaccinated, causing him limited mobility on that arm and having pain moving and reaching across the opposite shoulder. He said there were nights that he can't sleep or wake up in the middle of the night because of the pain. He hasn't seen a doctor yet for these symptoms. Pharmacist suggested if he want to take NSAIDS like Advil or Aleve to help with the pain but he said he would only take NSAIDS if he feels it to be necessary. A Quality Assurance and Safety Report was already submitted on 11/22/19 about the patient's concerns and symptoms. He had been getting his yearly flu shot and this was the first time that he had experienced this shoulder pain. He understands this occurrence is usually expected after a vaccine administration but his symptoms still persist over two weeks after. He just wanted an assurance that these symptoms are just temporary and will be resolved soon. Pharmacy Risk Management Team had started working on this case and they will be reaching out to the patient to help him on this situation and fully address his concerns.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: SWELLING OF THE ARM AND DIFFICULTY LIFTING ARM AFTER 7 DAYS
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Skin warm
Clinical narrative: 66 year old male presents today with allergic reaction to Pneumovax 23, Lot # S026366.  He was given the vaccine on Monday at appt.  Pneumovax 23 was administered  in left deltoid. Flu Vaccine was received in September at Pharmacy.  He stated, " He noticed the Redness, swelling and warmth to bicep, under arm and up shoulder area this morning after showering. Area on bicep looks like a cellultis. No irritation at injection site and No body rash noted. Dr. notified of reaction.  Instructed patient on  OTC anti-histamines, cool wrap to arm and elevation. Patient and wife verbalized understanding.   Instructed  to call if no signs of improvement.  Called director at  Health Department and reported reaction. Also called, Infection Disease. Emailed at pharmacy.  Completed reaction on Portal and completed Vaccine Adverse Event Reporting System (VAERS) online .
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoea, Blood culture negative, Full blood count normal, Influenza virus test negative, Mechanical ventilation
Clinical narrative: Apnea event requiring noninvasive respiratory support and resuscitation. 11/16/19 at 0330 Infectious screen negative History of apnea of prematurity
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Respiratory syncytial virus test negative, Resuscitation
Clinical narrative: Apnea event requiring noninvasive respiratory support and resuscitation. 11/16/19 at 0330 Infectious screen negative History of apnea of prematurity
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, warm
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: ARM ALL THE WAY DOWN TO BELOW ELBOW WAS SLIGHTLY SWOLLEN AND RED.  LOOKED LIKE A BURN AND APPEARS THAT THE PORES ARE OPEN.  PATIENT ICED IT DAY AFTER VACCINATION.  SLIGHTLY SORE BUT NO REAL PAIN.  48 HOURS LATER IS STILL RED BUT IMPROVING.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: swelling, pruritis and mild erythema at the injection site (confirmed as deltoid).
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain in injection site with some radiating down arm. Has continued for >1 month
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient complains she has had shooting pain in immunization arm for a week straigh
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: A few minutes after receiving vaccine, patient said he was itching and began rubbing his upper chest. Patient not having any problems with breathing or wheezing. Redness and hives present upper chest (2nd rib area).
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Woke up with rash on arms, front of torso, posterior upper Leg Present on knees and elbows C/O itching - states looks and feels like mosquito Bites