chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect dose administered, Product preparation issue, Pruritus, Swelling
Clinical narrative: swollen; itchy; arm was red; experienced a welt that formed; inadvertently administered the Shingrix Diluent component only without lyophilized component; inadvertently administered the Shingrix Diluent component only without lyophilized component; This non-serious case was reported by a nurse via call center representative and described the occurrence of swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 4BX77, expiry date 02-JUL-2024) for prophylaxis.   On 19-MAY-2023, the patient received the 2nd dose of Shingrix (right arm). On 19-MAY-2023, immediately after receiving Shingrix, the patient experienced swelling (Verbatim: swollen), pruritus (Verbatim: itchy), erythema of extremities (Verbatim: arm was red), welts (Verbatim: experienced a welt that formed), inappropriate preparation of medication (Verbatim: inadvertently administered the Shingrix Diluent component only without lyophilized component) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered the Shingrix Diluent component only without lyophilized component). The outcome of the swelling, pruritus, erythema of extremities, welts, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the swelling, pruritus, erythema of extremities and welts to be related to Shingrix.     It was unknown if the company considered the swelling, pruritus, erythema of extremities and welts to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-MAY-2023 The registered nurse reported that on the day of reporting, the patient inadvertently received a dose of Shingrix diluent component only without lyophilized component and stated that immediately after administration in right arm, the patient experienced a welt that formed and arm was red, itchy and swollen.  The reporter mentioned that this was an attempt at the second dose of Shingrix for the patient. The reporter called to inquire how to proceed and asked could they use a different kind of diluent for the patient. The reporter did not consent to follow up. The patient inadvertently received a dose of Shingrix diluent component only without lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: swollen; itchy; arm was red; experienced a welt that formed; inadvertently administered the Shingrix Diluent component only without lyophilized component; inadvertently administered the Shingrix Diluent component only without lyophilized component; This non-serious case was reported by a nurse via call center representative and described the occurrence of swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 4BX77, expiry date 02-JUL-2024) for prophylaxis.   On 19-MAY-2023, the patient received the 2nd dose of Shingrix (right arm). On 19-MAY-2023, immediately after receiving Shingrix, the patient experienced swelling (Verbatim: swollen), pruritus (Verbatim: itchy), erythema of extremities (Verbatim: arm was red), welts (Verbatim: experienced a welt that formed), inappropriate preparation of medication (Verbatim: inadvertently administered the Shingrix Diluent component only without lyophilized component) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered the Shingrix Diluent component only without lyophilized component). The outcome of the swelling, pruritus, erythema of extremities, welts, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the swelling, pruritus, erythema of extremities and welts to be related to Shingrix.     It was unknown if the company considered the swelling, pruritus, erythema of extremities and welts to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-MAY-2023 The registered nurse reported that on the day of reporting, the patient inadvertently received a dose of Shingrix diluent component only without lyophilized component and stated that immediately after administration in right arm, the patient experienced a welt that formed and arm was red, itchy and swollen.  The reporter mentioned that this was an attempt at the second dose of Shingrix for the patient. The reporter called to inquire how to proceed and asked could they use a different kind of diluent for the patient. The reporter did not consent to follow up. The patient inadvertently received a dose of Shingrix diluent component only without lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient got the first dose of Shingrix before the Covid Pandemic but never got the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose before the Covid pandemic).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient got the first dose of Shingrix before the Covid Pandemic but never got the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-MAY-2023 The reporter reported that patient never got the 2nd dose of Shingrix.  The reporter wanted to know if she should restart the series. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient was administered a dose of the diluent portion of Menveo, without mixing with the lyophilized component; patient was administered a dose of the diluent portion of Menveo, without mixing with the lyophilized component; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA771A, expiry date 31-JAN-2024) for prophylaxis.   On 19-MAY-2023, the patient received Menveo. On 19-MAY-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered a dose of the diluent portion of Menveo, without mixing with the lyophilized component) and inappropriate dose of vaccine administered (Verbatim: patient was administered a dose of the diluent portion of Menveo, without mixing with the lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-MAY-2023 At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received a dose of the diluent portion of Menveo, without mixing with the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Patient had accidentally received an expired dose of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received DTPa (Infanrix) (batch number 7ec55, expiry date 29-APR-2023) for prophylaxis.   On 18-MAY-2023, the patient received Infanrix. On 18-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Patient had accidentally received an expired dose of Infanrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-MAY-2023 The reporter was an office manager. The patient had accidentally received an expired dose of Infanrix, which led to expired vaccine used. The reporter wished to know how to proceed. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive his second dose within the recommended time frame of 2 to 6 months; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive his second dose within the recommended time frame of 2 to 6 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-MAY-2023 Due to pandemic conditions, the patient did not receive his second dose of Shingrix within the recommended time frame of 2 to 6 months (late dose). The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Shingrix third dose was given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 559H5, expiry date 23-SEP-2023) for prophylaxis.   In DEC-2022, the patient received the 3rd dose of Shingrix. In DEC-2022, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Shingrix third dose was given). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 19-MAY-2023 The reporter asked for any information about the administration of a third dose of Shingrix to patient. The reporter mentioned that the third dose was given back in December 2022. The reporter consented to follow up. The patient received 3rd dose of Shingrix, which led to extra dose administered.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of Engerix-B was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received HBV (Engerix B) (batch number K329E, expiry date 24-APR-2023) for prophylaxis.   On 19-MAY-2023, the patient received Engerix B. On 19-MAY-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired dose of Engerix-B was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 19-MAY-2023 The reporter consented to follow up via email. The patient received a dose of Engerix B, which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pruritus, Skin exfoliation, Skin lesion
Clinical narrative: DIFFICULTY SLEEPING; ITCHING; PAIN; SORES ON SKIN; SKIN WAS SLOUGHING OFF; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced difficulty sleeping, itching, pain, sores on skin, and skin was sloughing off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty sleeping, itching, pain, sores on skin and skin was sloughing off was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: WIDESPREAD CUTANEOUS REACTION; This spontaneous report received from a consumer via a company representative concerned an 80 year old female. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced widespread cutaneous reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of widespread cutaneous reaction was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin, Jaundice, Weight gain poor
Clinical narrative: Jaundice, bilirubin in high risk zone; Slow weight gain; This spontaneous case was reported by a consumer and describes the occurrence of JAUNDICE (Jaundice, bilirubin in high risk zone) and WEIGHT GAIN POOR (Slow weight gain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030M20A) for COVID-19 prophylaxis.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Penicillin allergy and Drug allergy (Allergy to Sulfa).    No Medical History information was reported.   On 10-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On 10-Mar-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JAUNDICE (Jaundice, bilirubin in high risk zone) and WEIGHT GAIN POOR (Slow weight gain). At the time of the report, JAUNDICE (Jaundice, bilirubin in high risk zone) and WEIGHT GAIN POOR (Slow weight gain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood bilirubin: in high risk zone.         26-March-21 Mother tested positive for Group B Strep.  Mother glucose tolerance and ultrasounds were found normal.  Prenatal medication was administered by parent from Aug 2020 , ongoing is Yes.   No concomitant medication provided.  No treatment information listed.   This case was linked to MOD-2021-013572 (Parent-Child Link).   See case MOD-2021-013572 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Upon internal review on 23-May-2023, significant corrections performed. Reporter, event and product details updated. Lab data added. On 22-Jul-2021: Follow-up received contain No new information
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myeloid leukaemia, Acute respiratory failure
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 9/6/2021 ACUTE MYELOID LEUKEMIA
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation, Chronic kidney disease, Glomerular filtration rate, Hypoxia
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/18/2022 CKD STAGE 3A (GFR 45-59) HYPOXIA 12/2/2022 CKD STAGE 3A (GFR 45-59) ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/18/2022 ATRIAL FIBRILLATION, PAROXYSMAL HYPOXIA 12/2/2022 ATRIAL FIBRILLATION, PAROXYSMAL
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently gave a 6 year old the vaccine for 12 years and older.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient received 2nd dose of updated covid booster of Moderna Bivalent vaccine. Patient is 49 years old, and works with immunocompromised and is not eligible or fall under: "People aged 65 years and older may get a 2nd dose of updated Pfizer-BioNTech or Moderna COVID-19 vaccine." per CDC guidelines.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bacterial test negative, Chlamydia test negative, Fungal infection, Laboratory test normal, Neisseria test negative
Clinical narrative: I had vaginal itching and discharge that I knew to be like a yeast infection from experience. I had an expired fluconazole tablet from a previous prescription, so I took that and it seemed to go away. Maybe about a month later on March 25, I had green vaginal discharge that also looked like a yeast infection. My sister is a women's health nurse practitioner (NP) and prescribed me fluconazole. I took that and it got better. I went to GYN on March 28 to be tested for yeast, bacterial vaginosis, chlamydia and gonorrhea. NP thought it looked like bacterial vaginosis (BV) as well and prescribed metronidazole gel and more fluconazole to treat yeast infections expected with BV treatment. I used the gel for 1/5 nights before finding out that all tests were negative (I had already treated the yeast infection before testing).  I stopped using the gel. I developed a vaginal odor and discharge congruent with bacterial vaginosis. I didn't have time to go to the GYN, so around mid April, I ended up treating it with the metronidazole gel that I still had. After the first night of using the metro gel, I developed a yeast infection as expected and treated it with the fluconazole. I took one more fluconazole on the fifth/last day of treatment. Everything seemed cured until I developed another yeast infection around mid May. I treated that with one more fluconazole tablet and have been cured since.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sexually transmitted disease test, Vaginal discharge, Vaginal odour, Vulvovaginal pruritus
Clinical narrative: I had vaginal itching and discharge that I knew to be like a yeast infection from experience. I had an expired fluconazole tablet from a previous prescription, so I took that and it seemed to go away. Maybe about a month later on March 25, I had green vaginal discharge that also looked like a yeast infection. My sister is a women's health nurse practitioner (NP) and prescribed me fluconazole. I took that and it got better. I went to GYN on March 28 to be tested for yeast, bacterial vaginosis, chlamydia and gonorrhea. NP thought it looked like bacterial vaginosis (BV) as well and prescribed metronidazole gel and more fluconazole to treat yeast infections expected with BV treatment. I used the gel for 1/5 nights before finding out that all tests were negative (I had already treated the yeast infection before testing).  I stopped using the gel. I developed a vaginal odor and discharge congruent with bacterial vaginosis. I didn't have time to go to the GYN, so around mid April, I ended up treating it with the metronidazole gel that I still had. After the first night of using the metro gel, I developed a yeast infection as expected and treated it with the fluconazole. I took one more fluconazole on the fifth/last day of treatment. Everything seemed cured until I developed another yeast infection around mid May. I treated that with one more fluconazole tablet and have been cured since.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Neuropathy peripheral, Rheumatoid arthritis
Clinical narrative: RHEUMATOID FLARE OF THE RIGHT ANKLE, KNEE AND HIP  NEUROPATHY FLARE OF THE RIGHT FOOT AND CALF
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Immunisation, Off label use, Pain in extremity
Clinical narrative: RHEUMATOID FLARE OF THE RIGHT ANKLE, KNEE AND HIP  NEUROPATHY FLARE OF THE RIGHT FOOT AND CALF
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: GAVE THE PATIENT MONVALIUANT VACCINE BUT THE CDC SAID NO MORE MONVALUIANT AFTER 4/19/23 BUT PATIENT IS FINE NO SIGNS OF ANYTHING
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse outcome.  Pt had already received full hep B series, but needed to start Hep A.  Given Twinrix instead of just Hep A.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pfizer Comirnaty monovalent inadvertently given. No side effects reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pt came in requesting for tetanus shot through pre appointment booking. techincian, administered covid-19 moderna bivalent instead.  pt also received the boostrix shot as well for the correct shot she requested  Pt did not experience any adverse events.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Mobility decreased, Neuropathy peripheral, Ophthalmoplegia, Pain
Clinical narrative: Drop foot, back surgery, neuropathy in both feet, ocular issues, chronic pain, loss of mobility
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peroneal nerve palsy, Spinal operation, Spinal stenosis
Clinical narrative: Drop foot, back surgery, neuropathy in both feet, ocular issues, chronic pain, loss of mobility
Age: 31.0
Sex: F
Vaccine: COVID19-2, TDAP
Symptoms: Back pain, Dizziness, Dyspnoea, Fatigue, Migraine
Clinical narrative: PT STATES SHE DEVELOPED HIVES ON LEGS AND ARMS SHE RECIEVED BOOSTRIX AND MODERNA BIVALENT IMZ ON EVENING OF 5/19/23. SHE TOOK BENADRYL AND HIVES WENT AWAY. SHE STATES SHE WAS FATIGUED ON  5/20/23 AND 5/21/23. ON 5/22/23 SHE EXPERIENCED DIZZINESS, BLURRED VISION, AND NAUSEA WHILE DRIVING. SHORTLY AFTER THOSE SYMPTOMS SHE DEVLOPED A MIGRAINE. ON 5/23/23 SHE IS EXPERIENCING SEVERE BACK PAIN AND SOB.  SHE ASKED IF SHE SHOULD GO TO ER. I TOLD HER TO DO SO IF SHE IS IN THAT MUCH PAIN.
Age: 31.0
Sex: F
Vaccine: COVID19-2, TDAP
Symptoms: Nausea, Urticaria, Vision blurred
Clinical narrative: PT STATES SHE DEVELOPED HIVES ON LEGS AND ARMS SHE RECIEVED BOOSTRIX AND MODERNA BIVALENT IMZ ON EVENING OF 5/19/23. SHE TOOK BENADRYL AND HIVES WENT AWAY. SHE STATES SHE WAS FATIGUED ON  5/20/23 AND 5/21/23. ON 5/22/23 SHE EXPERIENCED DIZZINESS, BLURRED VISION, AND NAUSEA WHILE DRIVING. SHORTLY AFTER THOSE SYMPTOMS SHE DEVLOPED A MIGRAINE. ON 5/23/23 SHE IS EXPERIENCING SEVERE BACK PAIN AND SOB.  SHE ASKED IF SHE SHOULD GO TO ER. I TOLD HER TO DO SO IF SHE IS IN THAT MUCH PAIN.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Injection site rash, Mycobacterium tuberculosis complex test, Rash, Skin warm
Clinical narrative: Small rash at 2 days after injection at injection site, that grew at 3 days. After 5.5 days, rash was over most of upper arm between elbow and shoulder and was very warm to the touch.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Vein collapse
Clinical narrative: Small rash at 2 days after injection at injection site, that grew at 3 days. After 5.5 days, rash was over most of upper arm between elbow and shoulder and was very warm to the touch.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Arthralgia, Blepharospasm, Confusional state, Fatigue
Clinical narrative: Severe confusion, loss of memory, fatigue, muscle pain, joint pain, rash on abdomen, chest, upper thighs, underarms., & eye twitching.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: Severe confusion, loss of memory, fatigue, muscle pain, joint pain, rash on abdomen, chest, upper thighs, underarms., & eye twitching.
Age: 76.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Cellulitis, Erythema, Induration, Pain in extremity, Pyrexia
Clinical narrative: patient had initial achy arm, felt tactile fever, felt firmness and painful then got less painful but about day 4 more red and presented to clinic day 6 with continued worsening redness. treated for cellulitis given getting worse and day 6.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Face injury, Fall, Hypoaesthesia, Mobility decreased
Clinical narrative: Pt states that about 7 hours after receiving this vaccine she had experienced adverse effects including feeling dizzy and numbness in the legs and arms. She said that she was on the toilet at the time and had fell to the floor and onto her face, scabbing up her face and nose. She then stated that she had to drag herself from the bathroom to her bedroom and up onto her bed but doesn't recall how she got there. She did not seek medical care for this and when asked how she was feeling she said that she feels better than she did on Friday but not 100% yet.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nasal injury
Clinical narrative: Pt states that about 7 hours after receiving this vaccine she had experienced adverse effects including feeling dizzy and numbness in the legs and arms. She said that she was on the toilet at the time and had fell to the floor and onto her face, scabbing up her face and nose. She then stated that she had to drag herself from the bathroom to her bedroom and up onto her bed but doesn't recall how she got there. She did not seek medical care for this and when asked how she was feeling she said that she feels better than she did on Friday but not 100% yet.
Age: 36.0
Sex: M
Vaccine: HEPAB
Symptoms: Alopecia
Clinical narrative: 5/16 telephone call from supervisor canceling 3rd Twinrix due to patient telling her he developed alopecia after 2nd dose. Asked her to have patient call me but he hasn't.
Age: 43.0
Sex: U
Vaccine: HEP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administered incorrect PEDS vaccine on a 43 y/o patient. Missed reading the box correctly, sticker was covering the age limits on the vaccine Box.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt came to appt on 5/3/23 & showed nurse the redness & swelling that has improved in her R delt.
Age: 1.0
Sex: U
Vaccine: UNK
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Fever 103, diarrhea
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient given Adult dose of Covid vaccine. Should have been given 5-11 dose  No Adverse reaction
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given .5ml of Moderna vaccine instead of .25ml, for 2nd covid booster. No adverse reactions reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given .5ml of Moderna vaccine instead on .25ml for 2nd covid booster. No adverse reaction reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given .5ml of Moderna vaccine instead of .25ml for 2nd covid booster.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given .5ml instead of .25ml of Moderna vaccine for 2nd covid booster.
Age: 41.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Asthma, Blood test, Cardiovascular disorder, Cardiovascular symptom, Condition aggravated
Clinical narrative: Post menopausal hemorrhage that started next morning and continues for 1.5 years. It reversed my menopause and restarted endometriosis and PCOS, resulting in asthma, cardiovascular symptoms. I?ve been to ER three (3) times in the past year as a result, and now my only option is to remove uterus, ovaries, and Fallopian tubes because of the damage they accumulated due to pathological blood supply to tissues. I can?t even get the hysterectomy in the state of Utah, as there is a backlog of post menopausal bleeding women waiting for a hysterectomy. Who is helping us when every doctor I have seen both is helpless in the face of vaccine ?being new and understudied? and REFUSE to put on our records that symptoms have started immediately after receiving the vaccine? There is massive manipulation  of public health record regarding vaccine related health issues and Department of Health is ignoring the issue. Pfizer covid-19 mRNA vaccine has reversed my menopause and that has lead to pulmonary, cardiovascular, and gynecological problems every healthcare provider is ignoring being related to the COVID-19 vaccination. Pfizer assumed no responsibility upon contact and refused to help.
Age: 41.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Electrocardiogram, Endometriosis, Fallopian tube disorder, Female reproductive tract disorder, Immediate post-injection reaction
Clinical narrative: Post menopausal hemorrhage that started next morning and continues for 1.5 years. It reversed my menopause and restarted endometriosis and PCOS, resulting in asthma, cardiovascular symptoms. I?ve been to ER three (3) times in the past year as a result, and now my only option is to remove uterus, ovaries, and Fallopian tubes because of the damage they accumulated due to pathological blood supply to tissues. I can?t even get the hysterectomy in the state of Utah, as there is a backlog of post menopausal bleeding women waiting for a hysterectomy. Who is helping us when every doctor I have seen both is helpless in the face of vaccine ?being new and understudied? and REFUSE to put on our records that symptoms have started immediately after receiving the vaccine? There is massive manipulation  of public health record regarding vaccine related health issues and Department of Health is ignoring the issue. Pfizer covid-19 mRNA vaccine has reversed my menopause and that has lead to pulmonary, cardiovascular, and gynecological problems every healthcare provider is ignoring being related to the COVID-19 vaccination. Pfizer assumed no responsibility upon contact and refused to help.
Age: 41.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Lung disorder, Ovarian injury, Polycystic ovaries, Postmenopausal haemorrhage, Ultrasound scan
Clinical narrative: Post menopausal hemorrhage that started next morning and continues for 1.5 years. It reversed my menopause and restarted endometriosis and PCOS, resulting in asthma, cardiovascular symptoms. I?ve been to ER three (3) times in the past year as a result, and now my only option is to remove uterus, ovaries, and Fallopian tubes because of the damage they accumulated due to pathological blood supply to tissues. I can?t even get the hysterectomy in the state of Utah, as there is a backlog of post menopausal bleeding women waiting for a hysterectomy. Who is helping us when every doctor I have seen both is helpless in the face of vaccine ?being new and understudied? and REFUSE to put on our records that symptoms have started immediately after receiving the vaccine? There is massive manipulation  of public health record regarding vaccine related health issues and Department of Health is ignoring the issue. Pfizer covid-19 mRNA vaccine has reversed my menopause and that has lead to pulmonary, cardiovascular, and gynecological problems every healthcare provider is ignoring being related to the COVID-19 vaccination. Pfizer assumed no responsibility upon contact and refused to help.
Age: 41.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Uterine injury
Clinical narrative: Post menopausal hemorrhage that started next morning and continues for 1.5 years. It reversed my menopause and restarted endometriosis and PCOS, resulting in asthma, cardiovascular symptoms. I?ve been to ER three (3) times in the past year as a result, and now my only option is to remove uterus, ovaries, and Fallopian tubes because of the damage they accumulated due to pathological blood supply to tissues. I can?t even get the hysterectomy in the state of Utah, as there is a backlog of post menopausal bleeding women waiting for a hysterectomy. Who is helping us when every doctor I have seen both is helpless in the face of vaccine ?being new and understudied? and REFUSE to put on our records that symptoms have started immediately after receiving the vaccine? There is massive manipulation  of public health record regarding vaccine related health issues and Department of Health is ignoring the issue. Pfizer covid-19 mRNA vaccine has reversed my menopause and that has lead to pulmonary, cardiovascular, and gynecological problems every healthcare provider is ignoring being related to the COVID-19 vaccination. Pfizer assumed no responsibility upon contact and refused to help.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Chills, Computerised tomogram head, Dizziness, Echocardiogram
Clinical narrative: Acute onset chills, nausea, fatigue, dizziness, headache. Evaluated extensively with head CT, labs, cardiac EKG and echocardiogram.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Gamma-glutamyltransferase increased, Headache, Hepatitis
Clinical narrative: Acute onset chills, nausea, fatigue, dizziness, headache. Evaluated extensively with head CT, labs, cardiac EKG and echocardiogram.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis viral test positive, Laboratory test abnormal, Leukopenia, Nausea, White blood cell count
Clinical narrative: Acute onset chills, nausea, fatigue, dizziness, headache. Evaluated extensively with head CT, labs, cardiac EKG and echocardiogram.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dermal filler reaction
Clinical narrative: i had no initial reaction to any of the shots which is why this is so strange. I had a reaction 6 months after shot 3 targeting the fillers in my face.
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temerature excursion; This spontaneous report was received from an office manager and refers to a 11-year-old female patient. No information on patient medical history, current conditions and concomitant medications was provided.  On 31-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis (product storage error and no adverse event).  Temperature excursion total time was 25 minutes. There were 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  This is one of several reports received from the same reporter.  This is an amended report. The aware date was changed from 10-MAY-2023 to 09-MAY-2023.  The aware date had to be changed from 10-MAY-2023 to 09-MAY-2023. This report is copy of case #2305USA004531, which is deteled from our files and was copied into this case. ; Sender's Comments:  US-009507513-2304USA002221:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; patient was given a dose of VAQTA after the dose was stored improperly.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 02-MAY-2023, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, 0.5 ml (series), lot # x003791, expiration date 01-JUN-2024, as prophylaxis (injection anatomical location, and route of administration were not provided) (Product storage error). The improperly stored vaccine underwent a temperature excursion for 7 hours at 34-degree Fahrenheit. It was unknown if there were any previous excursions. No additional adverse events or product quality complaint (PQC) were reported (No adverse event).
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: Temperature excursion total time: 25 mins, 3 excursions on dates 09-SEP-2022 for 8 minutes 16-SEP-2022 for 5 minutes 03-JAN-2023 for 12 mins; No issues, no adverse events on patient; This spontaneous report was received from an office manager and referred to a 14 years old male patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purchased with public and private founds and were given in private doctor's office/ hospital. The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter.
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: Temperature excursion total time: 25 mins, 3 excursions on dates 09-SEP-2022 for 8 minutes 16-SEP-2022 for 5 minutes 03-JAN-2023 for 12 mins; No issues, no adverse events on patient; This spontaneous report was received from an office manager and referred to a 11 years old male patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purchased with public and private founds and were given in private doctor's office/ hospital. The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not reported.   On 17-MAY-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA)  0.5 milliliter, once, lot #x004813, expiration date: 28-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided), which was improperly stored with a temperature excursion of 46.74F during a time frame of 2 minutes (Product storage error). There was no previous temperature excursion. No additional adverse events (AE) were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant and referred to a patient with unknown age and gender. The patient's concurrent conditions, concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.  The hepatitis a vaccine, inactivated (VAQTA) was improperly stored during a temperature excursion. Temperature was 46.74 Fahrenheit degree (F). Time frame was 2 minutes. Previous temperature excursion did not occur. On 03-MAY-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (0.5 milliliter (ml), lot # was reported as X004813, expiration date was reported as 28-JUL-2024, route and anatomical location were not provided) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 02-MAY-2023, the patient was vaccinated with Hepatitis A Vaccine, inactivated (VAQTA) intramuscular injection (0.5 ml/ once, lot#: x004813, expiration date: 28-JUL-2024; route of administration, and anatomical location were not reported) for prophylaxis. The vaccine administered was improperly stored at 46.74F for 2 minutes (product storage error). No additional adverse events (AEs) were reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Completed 2 Doses and Titers Does Not Show Protective Immunity; Initial Report Received on 08-Aug-2019  A reporter reported that a patient (age, gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient did not get immunity after two doses of Heplisav.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC #, route, and site not reported).   On an unspecified date, the patient was reported to not get immunity after two doses of Heplisav.   No additional information was reported.    Company Comment: The company assessed the event as non-serious. The event is not immunologically confirmed as the dosing, time to titer and results of the titers are not available.; Sender's Comments: The company assessed the event as non-serious. The event is not immunologically confirmed as the dosing, time to titer and results of the titers are not available.
Sex: U
Vaccine: HEP
Symptoms: Viral titre
Clinical narrative: Completed 2 Doses and Titers Does Not Show Protective Immunity; Initial Report Received on 15-Jan-2022  A medical assistant reported that a patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the did not show protective immunity.  No relevant medical history was reported.  No concomitant medications were reported.  On 06-Jul-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported).  On 09-Aug-2021, the patient received the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported).    In Jan-2022, titers taken did not show protective immunity.  No additional information was reported.   Company Comment: The company assessed the event as non-serious. The event is not immunologically confirmed as the results of the titers is not available.; Sender's Comments: The company assessed the event as non-serious. The event is not immunologically confirmed as the results of the titers is not available.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Received Heplisav-B 4 weeks ago, Received 2nd Dose of Engerix-B; Initial Report Received on 22-Feb-2023.  A pharmacist reported that a patient (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) as the first dose for hepatitis B immunization.  The patient received Engerix-B as the second dose for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 20-Jan-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) from a pharmacist.    On 17-Feb-2023, 29 days (4 weeks) after having been vaccinated with HEPLISAV-B, the patient came back to receive the second dose.  There was a mix up at the pharmacy, when the patient came back, the patient received Engerix-B as the second dose.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received Moderna bivalent dose BUD; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna bivalent dose BUD) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna bivalent dose BUD) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna bivalent dose BUD) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna bivalent dose BUD).    No concomitant medications were reported.  No treatment medications were reported.