chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: given punctured IPOL post excursion with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 4 unknown age and unknown gender patient who was given punctured IPV (VERO) [IPOL] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was reported that that 4 patients were given punctured IPV (VERO) (lot V1A024M; Expiration Date :17-Feb-2024) post excursion with no reported adverse event (product storage error) (unknown latency).  Action taken : not applicable.  Outcome: Unknown.   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 the 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: 14.0
Sex: M
Vaccine: FLU4, FLUC3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 14 year old male fluzone high-dose quadrivalent administered instead of Flucelvax Quadrivalent  with no reported adverse event; 14 year old male fluzone high-dose quadrivalent administered instead of Flucelvax Quadrivalent  with no reported adverse event; Initial information received on 01-Nov-2022 processed along with 2 live follow-ups regarding an unsolicited valid non-serious case received from a pharmacist. GMI case: 01347406   This case involves a 14-year-old male patient to whom INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] administered instead of Flucelvax Quadrivalent  with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA455035 and 2022SA456571(same reporter).    On 31-Oct-2022, the 14-year-old male patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot: UJ93788, expiry date: 30-Jun-2022) via intramuscular route in unknown administration site for immunization with no reported adverse event  instead of Flucelvax Quadrivalent  (Wrong product administered, Product administered to patient of inappropriate age) at same day latency.   It was reported that "Pharmacist is checking the safety of FLUZONE HIGH-DOSE QUADRIVALENT when administered to people younger than 65. She states that she is not yet sure if the HIGH-DOSE was administered to a younger patient but wants to have the information. Pharmacist states that last night, an elderly patient came in, and they prepared a FLUZONE HIGH-DOSE vaccine for her, but then she said she thought she might have already gotten it, so they did not administer. Prepared syringe was placed back in the refrigerator. Two other patients came in later; a 45-year-old woman and a 14-year-old boy, who both received flu shots. Pharmacist then noticed that the FLUZONE HIGH-DOSE syringe was no longer in the refrigerator. She states that the intern was supposed to be giving Flucelvax Quadrivalent to the patients < 65, and at first the intern was sure that she had given that to both patients. But they can't find the HIGH-DOSE QUADRIVALENT, so the intern may have gotten the vaccines mixed up. She wanted to check the safety of the FLUZONE HIGH-DOSE QUADRIVALENT being given to younger people."  Action taken: Not applicable for both suspects.  At time of reporting, the outcome was Unknown for both events.     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 the guidelines. 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: 1.33
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Wrong patient received product
Clinical narrative: extra dose of fluzone qiv np was inadvertently administered,with no reported adverse event; extra doses of the vaccine was administered as it was the wrong child,with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 months old male patient who had extra dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] was inadvertently administered, with no reported adverse event and extra doses of the vaccine was administered as it was the wrong child, with no reported adverse event.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and HEPATITIS A VACCINE INACT (VAQTA) for Prophylactic vaccination.  On 28-Oct-2022, the patient received a 0.5ml QY dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7701NA and expiry date:30-Jun-2023) via intramuscular route in unknown administration site for prophylactic vaccination.  On 28-Oct-2022 the patient developed a non-serious event of extra dose of fluzone qiv np was inadvertently administered, with no reported adverse event (extra dose administered) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 28-OCT-2022 the patient developed a non-serious extra dose of the vaccine was administered as it was the wrong child, with no reported adverse event (wrong patient received product) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: not applicable.  Outcome: Unknown  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 the guidelines. 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: FLU4
Symptoms: Product use issue
Clinical narrative: fluzone hd qiv was given to a 62 year old patient in error with no reported adverse event; Initial information was received on 01-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 62 years old female patient who stated influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] was given in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Nov-2022, the patient received a suspect influenza quadrival a-b high dose hv vaccine at a dose of 0.7 ml once (lot UJ882AB, expiry date - 30-Jun-2023) via intramuscular route in the left deltoid for Immunization.  On an unknown date the patient stated a non-serious event of influenza quadrival a-b high dose hv vaccine was given in error with no reported adverse event (product use issue) (unknown latency) following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received the fluzone hd qiv to 59 years old with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 59 years old female patient who received the fluzone hd qiv (INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2022, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot UJ924AD, expiration date: 30-Jun-2023 via intramuscular route in the left deltoid as Immunization  On 17-OCT-2022 the patient who was 59 years old received the fluzone hd qiv with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event     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 the guidelines. 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: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received the fluzone hd qiv to 58 years old with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 58 years old male patient who had received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2022, the patient received 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation was unknown, lot UJ924AD and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for Immunization.  On 17-Oct-2022 the patient developed a non-serious event of received the fluzone hd qiv to 58 years old with no reported adverse event (product administered to patient of inappropriate age)(Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: was not applicable.  Outcome: Unknown   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 the 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: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site haematoma, Injection site pruritus
Clinical narrative: hematoma at the site, and a red, itchy area also at the site.; hematoma at the site, and a red, itchy area also at the site; hematoma at the site, and a red, itchy area also at the site; when the vaccine was administered, a good amout of "serum" leaked out and ran down; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who experienced hematoma at the site, and a red, itchy area also at the site., hematoma at the site, and a red, itchy area also at the site, hematoma at the site, and a red, itchy area also at the site and when the vaccine was administered, a good amout of "serum" leaked out and ran down  while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma and Immune system disorder.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Immunisation.  On 21-OCT-2022 , the patient received a  0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE  (lot U7549AA; expiry date: 04-NOV-2024)  via intramuscular route in the deltoid nos.   On 21-OCT-2022 the patient developed a non-serious events hematoma at the site, and a red, itchy area also at the site. (injection site haematoma), (injection site erythema), (injection site pruritus) , when the vaccine was administered, a good amout of "serum" leaked out and ran down  (incorrect dose administered) (latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  Corrective treatment: the patient was treated with ice and it resolved.   At time of reporting, the outcome was Unknown for the event incorrect dose administered and recovered/resolved for rest of the events.    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 the 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: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired dose of Fluzone High-Dose Quadrivalent was administered with no reported adverse event; Initial information received on 02-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 72 years old female patient who had an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 27-Oct-2022, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation was unknown, lot UJ731AA and expiry date: 30-Jun-2022) via intramuscular route in unknown administration site for Influenza, Immunization.  On 27-Oct-2022 the patient developed a non-serious event of an expired dose of fluzone high-dose quadrivalent was administered with no reported adverse event (expired product administered) (Latency: same day). Reporter was requesting efficacy and the need to re-administer.  Action taken : not applicable.  Outcome: Unknown  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 the 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: 24.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: nurse administered dose of Tenivac on 01NOV2022 and it had expired 08OCT2022 with no reported adverse event; Initial information received on 02-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 24 years old female patient whose nurse administered dose of tenivac (DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT) on 01nov2022 and it had expired 08oct2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications: none   On 01-Nov-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot U6831AA, expiration date: 08-Oct-2022, via intramuscular route in the right arm as Immunization  On 01-NOV-2022 the nurse administered dose of tenivac on 01nov2022 and it had expired 08oct2022 with no reported adverse event (expired product administered) same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Caller wanted to know if it will cause any effects for the patient. Should the re-administer with non expired TENIVAC?  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event     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 the 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: 21.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site discharge
Clinical narrative: Patient received Flucelvax Quad PFS and the day after administration it started to leak from her the arm/ it started to leak from her arm on the place where the vaccine was administered; This spontaneous case was received on 17-Oct-2022 from a pharmacist via Communications (reference number: SEQW22-04566) and concerned a 21-year-old, female patient.   The patient had no relevant medical history and was not taking any concomitant medications.   On 12-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml; route of administration: intramuscular (IM); anatomical location and indication not reported). The batch number reported was 942437 and expiration date was 30-Jun-2023.  On 13-Oct-2022, one day after receiving Flucelvax Quadrivalent, it started to leak from patient's arm, on the place where the vaccine was administered.   On the same date, the patient recovered from the event of 'vaccination site extravasation'. As reported, it was just a drop from the patient's arm and then it stopped.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A 21-year-old female patient was vaccinated with Flucelvax Quadrivalent. One day following vaccination, patient reported a drop leaking from her arm. Causal role of the suspect vaccine is assessed as possible related, due to plausible temporal relationship and an absence of confounders.; Sender's Comments: A 21-year-old female patient was vaccinated with Flucelvax Quadrivalent. One day following vaccination, patient reported a drop leaking from her arm. Causal role of the suspect vaccine is assessed as possible related, due to plausible temporal relationship and an absence of confounders.
Age: 44.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Diarrhea (suspected side effect of flu vaccine as this never occurred with previous 4 COVID shots), fatigue, mild soreness/redness/swelling at injection site, fever 102.5°F
Age: 44.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Pyrexia
Clinical narrative: Diarrhea (suspected side effect of flu vaccine as this never occurred with previous 4 COVID shots), fatigue, mild soreness/redness/swelling at injection site, fever 102.5°F
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chills, Dizziness, Electrocardiogram
Clinical narrative: At work(Nurse), I started feeling nervous, lightheaded, weak, sweating and my chest was pounding. I sat down and the symptoms did not subside. I stood up and stumbled to the door to get help, blacked out and fell into a wall. Was told I was unconscious for ~20 minutes, very pale/grey, very sweaty, irregular breathing, very tachycardic. A respiratory therapist put a pulse oximeter on me and my oxygen saturation was in the low to mid-80s, they applied an oxygen cannula. Taken to ED by hospital's code team, IVs placed, fluids given, CT scan, EKG, labs drawn. While recovering, I had uncontrollable shaking and shivers. Start of event to time of ED discharge ~3.5 hours.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Full blood count, Hyperhidrosis, Irregular breathing, Loss of consciousness
Clinical narrative: At work(Nurse), I started feeling nervous, lightheaded, weak, sweating and my chest was pounding. I sat down and the symptoms did not subside. I stood up and stumbled to the door to get help, blacked out and fell into a wall. Was told I was unconscious for ~20 minutes, very pale/grey, very sweaty, irregular breathing, very tachycardic. A respiratory therapist put a pulse oximeter on me and my oxygen saturation was in the low to mid-80s, they applied an oxygen cannula. Taken to ED by hospital's code team, IVs placed, fluids given, CT scan, EKG, labs drawn. While recovering, I had uncontrollable shaking and shivers. Start of event to time of ED discharge ~3.5 hours.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Nervousness, Oxygen saturation decreased, Pallor, Skin discolouration
Clinical narrative: At work(Nurse), I started feeling nervous, lightheaded, weak, sweating and my chest was pounding. I sat down and the symptoms did not subside. I stood up and stumbled to the door to get help, blacked out and fell into a wall. Was told I was unconscious for ~20 minutes, very pale/grey, very sweaty, irregular breathing, very tachycardic. A respiratory therapist put a pulse oximeter on me and my oxygen saturation was in the low to mid-80s, they applied an oxygen cannula. Taken to ED by hospital's code team, IVs placed, fluids given, CT scan, EKG, labs drawn. While recovering, I had uncontrollable shaking and shivers. Start of event to time of ED discharge ~3.5 hours.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Tremor
Clinical narrative: At work(Nurse), I started feeling nervous, lightheaded, weak, sweating and my chest was pounding. I sat down and the symptoms did not subside. I stood up and stumbled to the door to get help, blacked out and fell into a wall. Was told I was unconscious for ~20 minutes, very pale/grey, very sweaty, irregular breathing, very tachycardic. A respiratory therapist put a pulse oximeter on me and my oxygen saturation was in the low to mid-80s, they applied an oxygen cannula. Taken to ED by hospital's code team, IVs placed, fluids given, CT scan, EKG, labs drawn. While recovering, I had uncontrollable shaking and shivers. Start of event to time of ED discharge ~3.5 hours.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Blood electrolytes normal, Blood glucose increased, Bundle branch block right, Ear pain
Clinical narrative: Pt reports receiving seasonal influenza vaccine (received a facility, specific influenza vaccine type UNKNOWN, information not available; however, had to select one in order to submit report) four days prior to ED presentation today, 9 Nov 2022.  54yo F with hx of HTN, HLD, DMT2 who presents with L facial droop. Per patient, yesterday developed L shoulder pain radiating to L ear, awoke today with L facial weakness and droop including upper and lower L face (ie including forehead) with tearing of the L eye, decreased taste on the L anterior tongue.  Reports history of prior Bell's Palsy of unclear etiology but patient denies association with vaccination.  Neuro exam otherwise unremarkable, no loss of sensation. Normal TMs bilaterally. Vitals with HTN, otherwise normal.   No other illness symptoms, no hx of HSV infection or symptoms, no history concerning for exposure to lyme disease.  Treated with prednisone 60mg x7 days, eye drops, and erythromycin ointment for L eye at nighttime due to incomplete closure of eyelids. Discharged with instructions to follow-up with PCP.  Patient also reports getting a COVID booster within the last month, but could not specific the date, was prior to influenza vaccination; she does not have record of which COVID vaccination she received.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Eyelid function disorder, Facial paralysis, Facial paresis, Full blood count normal
Clinical narrative: Pt reports receiving seasonal influenza vaccine (received a facility, specific influenza vaccine type UNKNOWN, information not available; however, had to select one in order to submit report) four days prior to ED presentation today, 9 Nov 2022.  54yo F with hx of HTN, HLD, DMT2 who presents with L facial droop. Per patient, yesterday developed L shoulder pain radiating to L ear, awoke today with L facial weakness and droop including upper and lower L face (ie including forehead) with tearing of the L eye, decreased taste on the L anterior tongue.  Reports history of prior Bell's Palsy of unclear etiology but patient denies association with vaccination.  Neuro exam otherwise unremarkable, no loss of sensation. Normal TMs bilaterally. Vitals with HTN, otherwise normal.   No other illness symptoms, no hx of HSV infection or symptoms, no history concerning for exposure to lyme disease.  Treated with prednisone 60mg x7 days, eye drops, and erythromycin ointment for L eye at nighttime due to incomplete closure of eyelids. Discharged with instructions to follow-up with PCP.  Patient also reports getting a COVID booster within the last month, but could not specific the date, was prior to influenza vaccination; she does not have record of which COVID vaccination she received.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Hypertension, Hypogeusia, Lacrimation increased, Metabolic function test, Metabolic function test abnormal
Clinical narrative: Pt reports receiving seasonal influenza vaccine (received a facility, specific influenza vaccine type UNKNOWN, information not available; however, had to select one in order to submit report) four days prior to ED presentation today, 9 Nov 2022.  54yo F with hx of HTN, HLD, DMT2 who presents with L facial droop. Per patient, yesterday developed L shoulder pain radiating to L ear, awoke today with L facial weakness and droop including upper and lower L face (ie including forehead) with tearing of the L eye, decreased taste on the L anterior tongue.  Reports history of prior Bell's Palsy of unclear etiology but patient denies association with vaccination.  Neuro exam otherwise unremarkable, no loss of sensation. Normal TMs bilaterally. Vitals with HTN, otherwise normal.   No other illness symptoms, no hx of HSV infection or symptoms, no history concerning for exposure to lyme disease.  Treated with prednisone 60mg x7 days, eye drops, and erythromycin ointment for L eye at nighttime due to incomplete closure of eyelids. Discharged with instructions to follow-up with PCP.  Patient also reports getting a COVID booster within the last month, but could not specific the date, was prior to influenza vaccination; she does not have record of which COVID vaccination she received.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Renal function test
Clinical narrative: Pt reports receiving seasonal influenza vaccine (received a facility, specific influenza vaccine type UNKNOWN, information not available; however, had to select one in order to submit report) four days prior to ED presentation today, 9 Nov 2022.  54yo F with hx of HTN, HLD, DMT2 who presents with L facial droop. Per patient, yesterday developed L shoulder pain radiating to L ear, awoke today with L facial weakness and droop including upper and lower L face (ie including forehead) with tearing of the L eye, decreased taste on the L anterior tongue.  Reports history of prior Bell's Palsy of unclear etiology but patient denies association with vaccination.  Neuro exam otherwise unremarkable, no loss of sensation. Normal TMs bilaterally. Vitals with HTN, otherwise normal.   No other illness symptoms, no hx of HSV infection or symptoms, no history concerning for exposure to lyme disease.  Treated with prednisone 60mg x7 days, eye drops, and erythromycin ointment for L eye at nighttime due to incomplete closure of eyelids. Discharged with instructions to follow-up with PCP.  Patient also reports getting a COVID booster within the last month, but could not specific the date, was prior to influenza vaccination; she does not have record of which COVID vaccination she received.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Burning sensation, Chronic spontaneous urticaria, Mechanical urticaria, Pruritus, Rash
Clinical narrative: Spontaneous Chronic Uticaria started randomly, hives and rashes throughout my body. Itching, burning, throat tightness all started and only has relief with anti-histamines. Dermatographia started as well. Now on daily anti histamines to control reactions. Still occurs daily.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat tightness, Urticaria
Clinical narrative: Spontaneous Chronic Uticaria started randomly, hives and rashes throughout my body. Itching, burning, throat tightness all started and only has relief with anti-histamines. Dermatographia started as well. Now on daily anti histamines to control reactions. Still occurs daily.
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Burning sensation, Discomfort, Mechanical urticaria, Pain in extremity, Pruritus
Clinical narrative: Starting  Oct 28, ten days after Moderna Bivalent booster (And 4 days after flu shot given by pharmacy, but we suspect cause was COVID19 booster), (I, the) pt noticed itchy erythema with raised wheals present on various spots around his body, notably around the underarms, the waistband, ankles, and hands. The itchiness, redness, and wheals grew on scratching.  Hands were especially itchy and occasionally slightly painful with a burning sensation (without noticeable swelling).  No fever, normal pulse and BP, respirations normal. No difficulty breathing, though pt experiences slight discomfort (maybe very tightening in the throat) Pt had not changed any detergent or bedding or had any notable changes in diet. No previous allergic-like reactions to vaccines.  Determined that itchy wheals would appear wherever a focused pressure was applied, with skin response and appearance of wheal within 1 minute, persisting for around an hour (longer, if the site was touched or scratched). Further experimentation showed that gentle lines made with fingernail or other thin object produced very defined wheals along path, consistent with Dermatographic Urticaria.    Pt treated with topical hydrocortisone cream (after 1 day) and 25mg diphenhydramine (after 4 days) taken every 4-5 hours as needed.   Condition was fairly pronounced with lots of itchy inflamed areas for the first 7 days, with a peak around day 5. Around day 8 it seemed less severe, with reduced itchiness globally and inflammation in the hands, and patient rarely needed the diphenhydramine or hyrdrocortisone, though the patient was also by then practicing not scratching (as much as possible) as that would quickly cause a 'chain reaction' of itchiness.   By day 10, the initial appearance of the wheal on drawing seemed noticeably slower and less itchy, though still appeared, albeit lower in pronounced height from the skin. Hands seemed less often irritated.   On day 11, pt finally went in to urgent care just to confirm diagnosis and get some treatment. Pt was confirmed with diagnosis of dermatographic urticaria and prescribed dexamethasone (12mg, with another 12mg in 3 days if still experiencing symptomatic urticaria) and fexofenadine.   Pt is writing this report on day 12 and is still symptomatic, albeit to a slightly more manageable degree. Pt has not yet picked up the newly prescribed medicines.
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Urticaria
Clinical narrative: Starting  Oct 28, ten days after Moderna Bivalent booster (And 4 days after flu shot given by pharmacy, but we suspect cause was COVID19 booster), (I, the) pt noticed itchy erythema with raised wheals present on various spots around his body, notably around the underarms, the waistband, ankles, and hands. The itchiness, redness, and wheals grew on scratching.  Hands were especially itchy and occasionally slightly painful with a burning sensation (without noticeable swelling).  No fever, normal pulse and BP, respirations normal. No difficulty breathing, though pt experiences slight discomfort (maybe very tightening in the throat) Pt had not changed any detergent or bedding or had any notable changes in diet. No previous allergic-like reactions to vaccines.  Determined that itchy wheals would appear wherever a focused pressure was applied, with skin response and appearance of wheal within 1 minute, persisting for around an hour (longer, if the site was touched or scratched). Further experimentation showed that gentle lines made with fingernail or other thin object produced very defined wheals along path, consistent with Dermatographic Urticaria.    Pt treated with topical hydrocortisone cream (after 1 day) and 25mg diphenhydramine (after 4 days) taken every 4-5 hours as needed.   Condition was fairly pronounced with lots of itchy inflamed areas for the first 7 days, with a peak around day 5. Around day 8 it seemed less severe, with reduced itchiness globally and inflammation in the hands, and patient rarely needed the diphenhydramine or hyrdrocortisone, though the patient was also by then practicing not scratching (as much as possible) as that would quickly cause a 'chain reaction' of itchiness.   By day 10, the initial appearance of the wheal on drawing seemed noticeably slower and less itchy, though still appeared, albeit lower in pronounced height from the skin. Hands seemed less often irritated.   On day 11, pt finally went in to urgent care just to confirm diagnosis and get some treatment. Pt was confirmed with diagnosis of dermatographic urticaria and prescribed dexamethasone (12mg, with another 12mg in 3 days if still experiencing symptomatic urticaria) and fexofenadine.   Pt is writing this report on day 12 and is still symptomatic, albeit to a slightly more manageable degree. Pt has not yet picked up the newly prescribed medicines.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Decreased appetite, Headache, Malaise, Pyrexia
Clinical narrative: Woke up at 4:30am the morning after my shot vomiting profusely, including bile. I also vomited at 10am, as well as 12:30pm. Throughout the day my body felt weaker, I had a 100°F fever (which is a rare symptom for me to get a fever). I had a pounding headache that lasted for four days. I lost my appetite for five days, unable to keep much food or water down for two days. I thought I was going to die, but couldn?t afford to go to the hospital so I waited it out. I tested negative for covid at home.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test negative, Sleep disorder, Vomiting
Clinical narrative: Woke up at 4:30am the morning after my shot vomiting profusely, including bile. I also vomited at 10am, as well as 12:30pm. Throughout the day my body felt weaker, I had a 100°F fever (which is a rare symptom for me to get a fever). I had a pounding headache that lasted for four days. I lost my appetite for five days, unable to keep much food or water down for two days. I thought I was going to die, but couldn?t afford to go to the hospital so I waited it out. I tested negative for covid at home.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine given in error instead of bivalent .
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine given in error instead of bivalent .
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine given in error instead of bivalent.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Blood test, Colitis microscopic, Colonoscopy abnormal, Magnetic resonance imaging
Clinical narrative: Issues with my stool for 8 months.  After finally having a colonoscopy done, I was diagnosed with Lymphocytic Colitis
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Stool analysis, Ultrasound scan
Clinical narrative: Issues with my stool for 8 months.  After finally having a colonoscopy done, I was diagnosed with Lymphocytic Colitis
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Headache; fever; body ache; diarrhea; malaise; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache, fever, general body pain, diarrhea and malaise. On an unknown date, the outcome of the headache, fever, general body pain, diarrhea and malaise were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever, general body pain, diarrhea and malaise to be related to Shingrix.     Additional Information: GSK receipt date: 31-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received first dose of shingrix vaccine 31 hours prior to the reporting.  He/she still had headache, fever, body ache, diarrhea, malaise. The patient stated that this was no fun.  .
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTERED VACCINE STORED AT A  MINIMUM TEMPERATURE OF (PLUS) 40.6 DEGREES FAHRENHEIT TO A MAXIMUM TEMPERATURE OF (PLUS) 48.7 DEGREES FAHRENHEIT FOR 32  MINUTES; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: 07-FEB-2023) dose was not reported, administered on 03-NOV-2022 for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported. On 03-NOV-2022, the patient experienced administered vaccine stored at a minimum temperature of (plus) 40.6 degrees fahrenheit to a maximum temperature of (plus) 48.7 degrees fahrenheit for 32 minutes. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine stored at a minimum temperature of (plus) 40.6 degrees fahrenheit to a maximum temperature of (plus) 48.7 degrees fahrenheit for 32 minutes and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20221116238.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Bivalent vaccines have undergone several temperature excursions; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions ), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 15-Sep-2022 at 5:12 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Sep-2022 at 5:12 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions ) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions ), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions ) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    No concomitant product reported by the reporter.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. Bivalent vaccines stored in the refrigerator that underwent several temperature excursions in August 2022.Refrigeration excursions were identified, state vaccine was housed in the units. . Manufactures were notified and the state department was made aware of the situation. No adverse reactions were reported for any of the patients at the time of the report.  No treatment medication reported by the reporter.
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: Discomfort, Sensitive skin, Temperature intolerance
Clinical narrative: Discomfort in various parts of upper body on exposure to cold, taking off clothes, sitting down on a cold chair, drying with a towel after a shower, touching skin, lasting for just a second
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: injection site red and enlarging; injection site sweling and enlarging; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient reported that he/she had Injection site red and swollen and enlarging 3 days after he/she received injection.  The patient asked as was that to be expected. Additional supportive information:  Follow up would not possible, as no contact details were available.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refrigeration excursions identified/undergone several temperature excursions; No adverse event; vaccine underwent several temperature excursions and administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccine underwent several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2022 at 5:13 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 04-Aug-2022 at 5:13 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccine underwent several temperature excursions and administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccine underwent several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (vaccine underwent several temperature excursions and administered to patient).    No concomitant medication was provided. It was unknown if the patient ever been diagnosed with or tested positive for COVID-19. The patient was administered the vaccine in the deltoid muscle. The vaccines were stored in the Refrigerator. There were 2 unbroken cartons with 20 vials. Date vial was moved from freezer to refrigerator on 7-Sep-2022.  Vials were not visualized for Visual inspection.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted.   Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.  It was reported that no adverse reactions were reported to their knowledge for the patient. Treatment medication was not provided by the reporter.