chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Gastrointestinal disorder, Hypokalaemia
Clinical narrative: Patient is an 80-year-old gentleman who is a patient with a history of chronic hyponatremia, HTN,  presents with lethargy and weakness and nausea; noted to have hyponatremia, in the setting of a week of COVID-19 related GI symptoms. He had no respiratory symptoms, saturated well on RA, did not require COVID specific therapy. Sodium slowly improved with IV hydration and holding hydrochlorothiazide. BP has been elevated in the hospital, but patient reports good control at home, and typically has elevated BP at doc appointments. He is medically stable for discharge.   Hyponatremia Hypokalemia + Suspect secondary to dehydration and poor oral solute due to COVID - admitted with Na 118, now at 130, with IV hydration; baseline per him is in mid-high 120s - continue to hold hydrochlorothiazide at discharge - nausea due to COVID improved and appetite is improving - K improved to normal   Covid infection - Presented with: Nausea, mild diarrhea, anorexia - Symptom onset: 10/1/2023 - Positive COVID-19: 10/3/2023 at home, 10/9  - Vaccination status: Moderna SARS-CoV-2 Vaccination     01/29/2021, 02/26/2021, 10/29/2021, 04/14/2022 - CXR on admission showed Nonacute two-view chest with chronic postsurgical changes. - Oxygen status: Room air - Decadron: Does not qualify without pneumonitis - Remdesivir: Does not qualify without pneumonitis - DVT prophylaxis: Xarelto   PAF  Sinus node dysfunction PPM in place + Status post dual-chamber Medtronic pacemaker 3/2/2022; follows with OPG electrophysiology - cont Flecainide for rhythm control, Metoprolol for rate control, and Xarelto for AC   Insulin-dependent diabetes mellitus + Levemir 10 units nightly, Janumet twice daily, pioglitazone daily -8 units nightly with sliding scale holding p.o. meds - BG well-controlled; resume home regimen at discharge - diabetic diet Essential hypertension - BP elevated but patient states all his home readings are well-controlled; his BP at doctors appointments is typically high due to "white coat HTN" - cont Losartan and Metoprolol; hold hydrochlorothiazide
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hyponatraemia, Lethargy, Nausea, SARS-CoV-2 test positive
Clinical narrative: Patient is an 80-year-old gentleman who is a patient with a history of chronic hyponatremia, HTN,  presents with lethargy and weakness and nausea; noted to have hyponatremia, in the setting of a week of COVID-19 related GI symptoms. He had no respiratory symptoms, saturated well on RA, did not require COVID specific therapy. Sodium slowly improved with IV hydration and holding hydrochlorothiazide. BP has been elevated in the hospital, but patient reports good control at home, and typically has elevated BP at doc appointments. He is medically stable for discharge.   Hyponatremia Hypokalemia + Suspect secondary to dehydration and poor oral solute due to COVID - admitted with Na 118, now at 130, with IV hydration; baseline per him is in mid-high 120s - continue to hold hydrochlorothiazide at discharge - nausea due to COVID improved and appetite is improving - K improved to normal   Covid infection - Presented with: Nausea, mild diarrhea, anorexia - Symptom onset: 10/1/2023 - Positive COVID-19: 10/3/2023 at home, 10/9  - Vaccination status: Moderna SARS-CoV-2 Vaccination     01/29/2021, 02/26/2021, 10/29/2021, 04/14/2022 - CXR on admission showed Nonacute two-view chest with chronic postsurgical changes. - Oxygen status: Room air - Decadron: Does not qualify without pneumonitis - Remdesivir: Does not qualify without pneumonitis - DVT prophylaxis: Xarelto   PAF  Sinus node dysfunction PPM in place + Status post dual-chamber Medtronic pacemaker 3/2/2022; follows with OPG electrophysiology - cont Flecainide for rhythm control, Metoprolol for rate control, and Xarelto for AC   Insulin-dependent diabetes mellitus + Levemir 10 units nightly, Janumet twice daily, pioglitazone daily -8 units nightly with sliding scale holding p.o. meds - BG well-controlled; resume home regimen at discharge - diabetic diet Essential hypertension - BP elevated but patient states all his home readings are well-controlled; his BP at doctors appointments is typically high due to "white coat HTN" - cont Losartan and Metoprolol; hold hydrochlorothiazide
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: New 0.25ml Moderna for age 6mo-4yr single dose vial had 0.50ml and patient was given full 0.50ml instead of 0.25ml.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Blood test normal, C-reactive protein normal, Full blood count normal
Clinical narrative: Guillian Barre Syndrome was diagnosed by MRI on 10/16/23 by MRI. Patient had knee pain, numbness, and unable to walk 24 hours after vaccination and has not been previously sick or have a chronic illness. Patient was treated with IVIG once daily for 5 days, patient is still currently having numbness, but has been able to bear weight with walker, but is mainly in wheelchair at this current time.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Influenza virus test negative
Clinical narrative: Guillian Barre Syndrome was diagnosed by MRI on 10/16/23 by MRI. Patient had knee pain, numbness, and unable to walk 24 hours after vaccination and has not been previously sick or have a chronic illness. Patient was treated with IVIG once daily for 5 days, patient is still currently having numbness, but has been able to bear weight with walker, but is mainly in wheelchair at this current time.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Lumbar puncture normal, Magnetic resonance imaging spinal abnormal, Metabolic function test normal, Red blood cell sedimentation rate normal, SARS-CoV-2 test negative
Clinical narrative: Guillian Barre Syndrome was diagnosed by MRI on 10/16/23 by MRI. Patient had knee pain, numbness, and unable to walk 24 hours after vaccination and has not been previously sick or have a chronic illness. Patient was treated with IVIG once daily for 5 days, patient is still currently having numbness, but has been able to bear weight with walker, but is mainly in wheelchair at this current time.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Walking aid user, Wheelchair user
Clinical narrative: Guillian Barre Syndrome was diagnosed by MRI on 10/16/23 by MRI. Patient had knee pain, numbness, and unable to walk 24 hours after vaccination and has not been previously sick or have a chronic illness. Patient was treated with IVIG once daily for 5 days, patient is still currently having numbness, but has been able to bear weight with walker, but is mainly in wheelchair at this current time.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none at this time
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.50ml dose from the 0.25ml single dose vials.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Anxiety, Confusional state, Dyskinesia, Fear
Clinical narrative: I was asleep, I suddenly woke up at 3am and my feet were moving weird and I got up to walk and I was very confused and had really bad anxiety. I was walking around the house on the verge of a panic attack. For about a week I had very vivid dreams and nightmares. It scared me to death and I thought I might die. I never wake up in the night like that, ever!
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Sleep disorder
Clinical narrative: I was asleep, I suddenly woke up at 3am and my feet were moving weird and I got up to walk and I was very confused and had really bad anxiety. I was walking around the house on the verge of a panic attack. For about a week I had very vivid dreams and nightmares. It scared me to death and I thought I might die. I never wake up in the night like that, ever!
Age: 61.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: got over 65 high dose .he is only 61 but had no adverse effects. will talk to oncologist next visit
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.50ml dose from the 0.25ml single dose vials.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no reaction at this time
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Patient age verified but high dose vaccine given by mistake
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented with redness on the arm where the vaccine was injected reported swelling and itching.
Age: 6.0
Sex: M
Vaccine: COVID19, FLUN4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient received 0.5ml of Covid vaccine instead of recommended 0.25ml for their age.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Injection site erythema, Injection site warmth, Pain, Pyrexia
Clinical narrative: Patient began having fever, body aches, chills and a redness reaction below the injection site that is warm to the touch.
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Joint swelling, Pain, Peripheral swelling
Clinical narrative: Patient had his arm swell down to his elbow as well as redness and pain, wife treated him with Benadryl
Age: 4.0
Sex: M
Vaccine: COVID19, FLUN4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient received 0.5ml of Covid shot instead of the recommended 0.25ml for their age.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none at this time
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe hives began 6 days after the injection. I had a 40 mg injection of Kenelog on the 5th day after the hives began.  I am still breaking out in hives.  I have been taking Allegra twice a day to  control the itching and hive breakouts.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Vomiting
Clinical narrative: DONOR STATED SHE HAD NAUSEA AND VOMITING 1 HR AFTER DONATING. DONOR ALSO STATED SHE DRANK APPLE CIDER VINEGAR WHEN SHE GOT HOME.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.5ml of Covid Vaccine instead of the recommended 0.25ml for their age.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Arthritis, Condition aggravated
Clinical narrative: About two days after receiving the RSV vaccine, despite no other symptoms whatsoever, I had pain in my right wrist which has been recently diagnosed with arthritis. It lasted for about 2 1/2 days and went away as quickly as it came.  Mentioned to the pharmacist, who said he had heard similar reports even though arthritis pain was not listed in the literature as a possible side effect.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.5ml of Covid Vaccine instead of recommended 0.25ml for their age.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling cold
Clinical narrative: Approximately 8 hours after the vaccine my temperature starting to increase, and I experienced shivers.  By 12 hours after, I had a temperature of 106.5F and was visibly shivering.  Within 24 hours my temp had returned to normal 97.5 but my body still felt cold.  By the next day I was perfectly normal again.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: PATIENT GOT VACCINE, IMMEDATELY FELT DIZZY AND PASSED OUT FOR COUPLE MINUTES. hUSBAND WAS BY HER AND RPH.  CALLED 9-1-1, SHE FELT OK AFTER 15 MINUTES. PARAMAEDICAS CHECKED HER OUT AND SHE WAS FINE.    PATIENT DID NOT EAT ANYTHING ALL DAY AND WAS PROBABLY DEHYDRATED,
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Chills, body aches all over, heavy fatigue, sweats, low grade fever
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Echocardiogram, General symptom
Clinical narrative: Heart attack Symptoms
Age: 12.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient received 5y- 11 y dose for the covid vaccine. She was supposed to receive 12 and older dose.  No symptoms. No signs.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.5ml of Covid Vaccine instead of the recommended 0.25ml for their age.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose normal, Chills, Headache, Malaise, Myalgia
Clinical narrative: Acute onset of headache, malaise, myalgia and chills 15 minutes after injection. Administered 25 mg Diphenhydramine 25mg deep IM injection, 1L Normal Saline 0.9% IV fluids administered via bolus, monitored vital signs and airway with no complications. Patient responded well to treatment rendered.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site, got bigger throughout the day
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: Severe bodily shaking (rigours)for approximately 2 hours.  Had same reaction after every shot but less severe.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Wrong product administered
Clinical narrative: Pharmacy conducting an onsite vaccination clinic at a school. Student sits down at the nurses station to receive vaccines. The two vaccinators are handed a consent form with first name written on it. The two vaccinators ask the student what her name is and the student points to name on the consent form and says her name. Consent form had documentation of parental consent for meninigitis and tetanus vaccines. Nurse reviews information about meningitis and tetanus vaccines with the student and asks if she has any questions. Student says no so the two vaccinators administer the two shots. The student then gets up to walk away, and the school nurse informs the two vaccinators and the student that the consent form belonged to a different student with the first name. The student  who was just vaccinated was supposed to have received a flu and a COVID vaccine, not meningitis and tetanus. School nurse contacted the mother and explained what happened. Later, the student reported not experiencing any adverse reactions other than soreness at the sites of the injections.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Nausea, Pruritus, Skin erosion, Swelling face
Clinical narrative: hives on neck, cheeks, behind ears and on scalp. itching on areas described before plus arms, legs, chest and back. Face also appeared reddeded and puffy. My scalp is somewhat raw from scratching in my sleep.  nausea when i got up in the morning.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: hives on neck, cheeks, behind ears and on scalp. itching on areas described before plus arms, legs, chest and back. Face also appeared reddeded and puffy. My scalp is somewhat raw from scratching in my sleep.  nausea when i got up in the morning.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Chills, Pyrexia, Sleep disorder
Clinical narrative: I have extreme anxiety that will not go away! I cannot sleep and it wont go away. I feel like someone turned a knob up on my anxiety level. I have the flu shot every year and I have never reacted. This is extreme for me. I also have a low grade fever and chills. This all started on the 23rd of Oct and it is still going on today (Nov. 1st). I am fixing to see my doctor for it. My aunt got the same exact flu shot and she is having the same side effects.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, COVID-19, Death, Dyspnoea, Encephalopathy
Clinical narrative: to ED from nursing home c/o SOB, sats 70s, had tested + COVID 2 days prior, + pneumonia, D-dimer 9, ? PE,   ; TX: decadron, vit C, zinc, lovenox, Rocephin, Zithromax, not eligible for remdesivir d/t elevated LFTs; develops encephalopathy, family requests hospice, pt worsened with bradycardia/hypotension and expired in hospital
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Hypotension, Liver function test increased, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: to ED from nursing home c/o SOB, sats 70s, had tested + COVID 2 days prior, + pneumonia, D-dimer 9, ? PE,   ; TX: decadron, vit C, zinc, lovenox, Rocephin, Zithromax, not eligible for remdesivir d/t elevated LFTs; develops encephalopathy, family requests hospice, pt worsened with bradycardia/hypotension and expired in hospital
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on upper torso, front and back along with back of scalp
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccine site was and is still very sore and hurts to touch. Swelling and redness has decreased
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Cough, Encephalopathy, Fatigue, Fibrin D dimer increased
Clinical narrative: to ED c/o fever, cough, fatigue, myalgias, abd pain, elevated D-dimer 8.1, + pneumonia, probability of PE; TX: remdesivir, decadron, rocephin, doxy, maxipime, vit c, inhalers, lovenox; develops encephalopathy, discharged.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pneumonia, Pyrexia
Clinical narrative: to ED c/o fever, cough, fatigue, myalgias, abd pain, elevated D-dimer 8.1, + pneumonia, probability of PE; TX: remdesivir, decadron, rocephin, doxy, maxipime, vit c, inhalers, lovenox; develops encephalopathy, discharged.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, C-reactive protein, COVID-19, Clostridium test negative, Decreased appetite
Clinical narrative: to ED c/o diarrhea, poor appetite, weakness, low grade fever, all thought to be r/t COVID, CRP 8.52 TX: zinc, singulair, zithromax, zosyn for diarrhea (c.diff ruled out). No steroids or remdesivir, discharged home
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: to ED c/o diarrhea, poor appetite, weakness, low grade fever, all thought to be r/t COVID, CRP 8.52 TX: zinc, singulair, zithromax, zosyn for diarrhea (c.diff ruled out). No steroids or remdesivir, discharged home
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: to ED c/o SOB, wheezing, TX: 5lpm O2, duo nebs, pulmicort, singulair, zithromax, rocephin, steroids, vit C, zinc, remdesivir. D/C'd home
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Cardiac arrest, Cough, Death, Diarrhoea
Clinical narrative: to ED c/o fatigue, cough, congestion, diarrhea, hypoxia, + pneumonia. TX: decadron, O2 15lmp NRB, remdesivir, tocilizumab, CRP elevated, develops cardiac arrest, intubation, multiorgan failure and progressive shock, family pursued comfort measures and pt expired in hospital
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Endotracheal intubation, Fatigue, Hypoxia, Multiple organ dysfunction syndrome, Pneumonia
Clinical narrative: to ED c/o fatigue, cough, congestion, diarrhea, hypoxia, + pneumonia. TX: decadron, O2 15lmp NRB, remdesivir, tocilizumab, CRP elevated, develops cardiac arrest, intubation, multiorgan failure and progressive shock, family pursued comfort measures and pt expired in hospital
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Shock
Clinical narrative: to ED c/o fatigue, cough, congestion, diarrhea, hypoxia, + pneumonia. TX: decadron, O2 15lmp NRB, remdesivir, tocilizumab, CRP elevated, develops cardiac arrest, intubation, multiorgan failure and progressive shock, family pursued comfort measures and pt expired in hospital
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Myalgia, Pyrexia
Clinical narrative: to ED c/o SOB, fever 101, fatigue, myalgia, O2 2lpm. TX: decadron, lasix, vit C, lovenox, zinc. Left AMA
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; A spontaneous report was received from a nurse on 28SEP2023 regarding a 62-year-old female patient who had "diarrhea" (PT: Diarrhoea) following the administration of oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 12SEP2023, the patient took the first dose of Vivotif followed by the second dose on 14SEP2023 and the third on 16SEP2023. On 18SEP2023, the last day of administration, the patient had diarrhea about every 30 minutes before taking the dose and still she took the last dose on the same day. After taking the dose the patient again had diarrhea and did not have any vomiting.  The outcome of the reported event was unknown, at the time of this report.  No action was taken with Vivotif with respect to the reported event.  No additional information was reported.  Significant follow-up information was received from the nurse on 11OCT2023.  The patient's medical history included stomach ulcers (patient was not sure whether she had stomach ulcers or not), cystic COVID infection, "unknown" gastric bloating and allergies included hay fever. Reportedly, the patient recovered from COVID Infection.  Her concomitant medications included progesterone, omeprazole, skin vitamins, hairs and nails vitamins, vitamin C (ascorbic acid), calcium, and L-carnitine. (levocarnitine).  It was reported that the patient did not take any treatment for diarrhea.  It was updated that the patient recovered from the reported event on an unknown date in 2023.  Company comment: It was reported that a female consumer received Vivotif for immunisation and on the day of the fourth dose, the patient had diarrhea (diarrhoea) before taking the dose and still she took the dose after which she again had diarrhea. She had recovered from the reported event. Considering the case information, the role of Vivotif cannot be ruled out and the causality of diarrhoea is assessed as possible. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a female consumer received Vivotif for immunisation and on the day of the fourth dose, the patient had diarrhea (diarrhoea) before taking the dose and still she took the dose after which she again had diarrhea. She had recovered from the reported event. Considering the case information, the role of Vivotif cannot be ruled out and the causality of diarrhoea is assessed as possible. The case is considered non-serious as per medical assessment.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of allergic reaction in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-FEB-2023, the patient received the 1st dose of Shingrix. On 30-MAR-2023, 32 days after receiving Shingrix, the patient experienced allergic reaction (Verbatim: allergic reaction). The outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     It was unknown if the company considered the allergic reaction to be related to Shingrix.   Additional Information: GSK receipt date: 23-Oct-2023 The patient received a dose of Shingrix and reported that had allergic reaction. No additional information was provided. The reporter consented to follow-up.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: medical assistant reported that a 12 year old female patient accidentally received a dose of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 23-OCT-2023, the patient received Infanrix. On 23-OCT-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: medical assistant reported that a 12 year old female patient accidentally received a dose of Infanrix). The outcome of the inappropriate age at vaccine administration 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: 23-Oct-2023 The reporter consented to follow-up via email. The patient received a dose of Infanrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 77.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Asthenia, Chills, Dizziness, Erythema, Influenza like illness
Clinical narrative: dizzy; weak; left arm swelling; fever; chills; flu-like symptoms; 3 red spots on left arm; soreness left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of red spotty rash in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (INFLUENZA SHOT) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 21-OCT-2023, the patient received the 1st dose of Shingrix (left arm) and INFLUENZA SHOT (right arm). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced red spotty rash (Verbatim: 3 red spots on left arm), pain in arm (Verbatim: soreness left arm), dizziness (Verbatim: dizzy), weakness (Verbatim: weak), swelling arm (Verbatim: left arm swelling), fever (Verbatim: fever), chills (Verbatim: chills) and influenza-like symptoms (Verbatim: flu-like symptoms). The patient was treated with paracetamol (Tylenol). In OCT-2023, the outcome of the dizziness, weakness, swelling arm, fever, chills and influenza-like symptoms were resolved. The outcome of the red spotty rash and pain in arm were not resolved.   It was unknown if the reporter considered the red spotty rash, pain in arm, dizziness, weakness, swelling arm, fever, chills and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the red spotty rash, pain in arm, dizziness, weakness, swelling arm, fever, chills and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK receipt date: 24-Oct-2023 The caller stated that she got a dose of Shingrix and she also got the Flu shot in right arm on the same day.  She stated that in October 2023, hours later she had soreness and 3 red spots on left arm that had not resolved.  She also mentioned that she had swelling of left arm, fever and chills, flu-like symptoms, dizzy and weak.  She had been taking Tylenol. It was unknown if the reporter considered the red spotty rash, pain in arm, dizziness, weakness, swelling arm, fever, chills and influenza-like symptoms to be related to flu shot. The reporter consented to follow-up.
Age: 77.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: dizzy; weak; left arm swelling; fever; chills; flu-like symptoms; 3 red spots on left arm; soreness left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of red spotty rash in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (INFLUENZA SHOT) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 21-OCT-2023, the patient received the 1st dose of Shingrix (left arm) and INFLUENZA SHOT (right arm). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced red spotty rash (Verbatim: 3 red spots on left arm), pain in arm (Verbatim: soreness left arm), dizziness (Verbatim: dizzy), weakness (Verbatim: weak), swelling arm (Verbatim: left arm swelling), fever (Verbatim: fever), chills (Verbatim: chills) and influenza-like symptoms (Verbatim: flu-like symptoms). The patient was treated with paracetamol (Tylenol). In OCT-2023, the outcome of the dizziness, weakness, swelling arm, fever, chills and influenza-like symptoms were resolved. The outcome of the red spotty rash and pain in arm were not resolved.   It was unknown if the reporter considered the red spotty rash, pain in arm, dizziness, weakness, swelling arm, fever, chills and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the red spotty rash, pain in arm, dizziness, weakness, swelling arm, fever, chills and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK receipt date: 24-Oct-2023 The caller stated that she got a dose of Shingrix and she also got the Flu shot in right arm on the same day.  She stated that in October 2023, hours later she had soreness and 3 red spots on left arm that had not resolved.  She also mentioned that she had swelling of left arm, fever and chills, flu-like symptoms, dizzy and weak.  She had been taking Tylenol. It was unknown if the reporter considered the red spotty rash, pain in arm, dizziness, weakness, swelling arm, fever, chills and influenza-like symptoms to be related to flu shot. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: didn't receive her second dose until JUN-2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (about four years ago, received first dose).   In JUN-2023, the patient received the 2nd dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: didn't receive her second dose until JUN-2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2023 The reporter was a patient. The patient received first dose of Shingrix about four year ago from reporting time and due to cost she did not received her second dose until June 2023. The reporter did not consent to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not go back to get the second dose of the series; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2018).   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 go back to get the second dose of the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-Oct-2023 Reporter called with question about Shingrix.  Did not consent to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Thrombosis
Clinical narrative: BLOOD CLOT; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a male of unspecified age, race and ethnicity. 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, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after vaccination the patient experienced a blood clot when he had covid (suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000302026.; Sender's Comments: V0:20231076953-Blood clot. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 ). At the time of the report, COVID-19 (COVID-19 ) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment medication were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746929 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746929:Case for SPIKEVAX 2023-2024 PFS
Sex: M
Vaccine: UNK
Symptoms: Illness
Clinical narrative: He just got the shot, and he got sick a month later; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (He just got the shot, and he got sick a month later) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced ILLNESS (He just got the shot, and he got sick a month later). At the time of the report, ILLNESS (He just got the shot, and he got sick a month later) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that patient got sick first, did had his COVID-shot a month ago. Believe it was Moderna. He just got the shot, and he got sick a month later, and then all of his entire family got it.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-747570 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747570:Case for neighbors
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048221A and 939902) for COVID-19 prophylaxis.     The patient's past medical history included Hysterectomy (partial) in 2014. Previously administered products included for Product used for unknown indication: Pfizer (EN6204) on 26-Mar-2021 and Pfizer (EWaSO) on 17-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included High cholesterol (05-Unk-2005, Under control w/current medications) and Endometriosis (In 2014 partial hysterectomy & Noretindrone until 6/23 kept it at bay until approx. 2 weeks after 9/27/23 booster) since 1997.   On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2023-746576 (Patient Link).
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Gait inability, Hypotension, Muscular weakness, Sleep inertia, Somnolence
Clinical narrative: BP which was very low (97/56). Symptoms cleared in about 2 hours. BP high 168/90; Extreme muscle weakness (unable to walk); grogginess; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Extreme muscle weakness (unable to walk)), SLEEP INERTIA (grogginess) and BLOOD PRESSURE ABNORMAL (BP which was very low (97/56). Symptoms cleared in about 2 hours. BP high 168/90) in a 71-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 80777-0102-96) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Hospitalized) in July 2023.    On 26-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 27-Oct-2023, the patient experienced GAIT INABILITY (Extreme muscle weakness (unable to walk)) and SLEEP INERTIA (grogginess). On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (BP which was very low (97/56). Symptoms cleared in about 2 hours. BP high 168/90). At the time of the report, GAIT INABILITY (Extreme muscle weakness (unable to walk)) and SLEEP INERTIA (grogginess) was resolving and BLOOD PRESSURE ABNORMAL (BP which was very low (97/56). Symptoms cleared in about 2 hours. BP high 168/90) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 97/56    very low and 168/90    high.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient had extreme muscle weakness (unable to walk) and grogginess. Two days later, the patient's blood pressure was very low (97/56). Symptoms cleared in about 2 hours. Blood pressure was high 168/90. The patient had several co-morbidities and was hospitalized with COVID in mid-July 2023 It was unknown if the patient experienced any additional symptoms or events.
Sex: U
Vaccine: UNK
Symptoms: Vaccination complication
Clinical narrative: patient had Moderna the M.A said there was an issue because the patient got moderna; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (patient had Moderna the M.A said there was an issue because the patient got moderna) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (patient had Moderna the M.A said there was an issue because the patient got moderna). At the time of the report, VACCINATION COMPLICATION (patient had Moderna the M.A said there was an issue because the patient got moderna) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment medication was not reported.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Cold sweat, Joint stiffness, Musculoskeletal stiffness, Neck pain
Clinical narrative: Cold sweats; Hand swelling; Elbows and shoulders have been stiff and sore/His neck and knees have been painful and stiff is well; His neck and knees have been painful and stiff is well; Elbows and shoulders have been stiff and sore; Joints started hurting all over; This spontaneous case was reported by a pharmacist and describes the occurrence of COLD SWEAT (Cold sweats), PERIPHERAL SWELLING (Hand swelling), MUSCULOSKELETAL STIFFNESS (Elbows and shoulders have been stiff and sore/His neck and knees have been painful and stiff is well), NECK PAIN (His neck and knees have been painful and stiff is well) and ARTHRALGIA (Elbows and shoulders have been stiff and sore) in a 66-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 50 microgram. On 03-Oct-2023, the patient experienced COLD SWEAT (Cold sweats), PERIPHERAL SWELLING (Hand swelling), MUSCULOSKELETAL STIFFNESS (Elbows and shoulders have been stiff and sore/His neck and knees have been painful and stiff is well), NECK PAIN (His neck and knees have been painful and stiff is well), ARTHRALGIA (Elbows and shoulders have been stiff and sore) and ARTHRALGIA (Joints started hurting all over). At the time of the report, COLD SWEAT (Cold sweats), PERIPHERAL SWELLING (Hand swelling), MUSCULOSKELETAL STIFFNESS (Elbows and shoulders have been stiff and sore/His neck and knees have been painful and stiff is well) and ARTHRALGIA (Elbows and shoulders have been stiff and sore) had not resolved and NECK PAIN (His neck and knees have been painful and stiff is well) and ARTHRALGIA (Joints started hurting all over) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  On 03-Oct-2023, the patient's joints started hurting all over and he woke up with cold sweats. His hands also had become swollen. The patient's hand swelling persisted. He reports his elbows and shoulders have been stiff and sore. His neck and knees have been painful and stiff was well. As recent as 10/29/23 patient still had pain and swelling in his hands and was having problems not able to close his hands. It was unknown if the patient experienced any additional symptoms or events.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Peripheral swelling
Clinical narrative: Cold sweats; Hand swelling; Elbows and shoulders have been stiff and sore/His neck and knees have been painful and stiff is well; His neck and knees have been painful and stiff is well; Elbows and shoulders have been stiff and sore; Joints started hurting all over; This spontaneous case was reported by a pharmacist and describes the occurrence of COLD SWEAT (Cold sweats), PERIPHERAL SWELLING (Hand swelling), MUSCULOSKELETAL STIFFNESS (Elbows and shoulders have been stiff and sore/His neck and knees have been painful and stiff is well), NECK PAIN (His neck and knees have been painful and stiff is well) and ARTHRALGIA (Elbows and shoulders have been stiff and sore) in a 66-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 50 microgram. On 03-Oct-2023, the patient experienced COLD SWEAT (Cold sweats), PERIPHERAL SWELLING (Hand swelling), MUSCULOSKELETAL STIFFNESS (Elbows and shoulders have been stiff and sore/His neck and knees have been painful and stiff is well), NECK PAIN (His neck and knees have been painful and stiff is well), ARTHRALGIA (Elbows and shoulders have been stiff and sore) and ARTHRALGIA (Joints started hurting all over). At the time of the report, COLD SWEAT (Cold sweats), PERIPHERAL SWELLING (Hand swelling), MUSCULOSKELETAL STIFFNESS (Elbows and shoulders have been stiff and sore/His neck and knees have been painful and stiff is well) and ARTHRALGIA (Elbows and shoulders have been stiff and sore) had not resolved and NECK PAIN (His neck and knees have been painful and stiff is well) and ARTHRALGIA (Joints started hurting all over) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  On 03-Oct-2023, the patient's joints started hurting all over and he woke up with cold sweats. His hands also had become swollen. The patient's hand swelling persisted. He reports his elbows and shoulders have been stiff and sore. His neck and knees have been painful and stiff was well. As recent as 10/29/23 patient still had pain and swelling in his hands and was having problems not able to close his hands. It was unknown if the patient experienced any additional symptoms or events.
Age: 61.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Atrioventricular block, Carotid artery occlusion, Fatigue
Clinical narrative: The patient was extremely tired since the time that she had taken her Spikevax vaccine; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (The patient was extremely tired since the time that she had taken her Spikevax vaccine) in a 61-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    The patient's past medical history included Cardiovascular disorder (The patients carotids were partially blocked.) and Heart block (her heart was partially blocked.). Concomitant products included ESCITALOPRAM, GABAPENTIN, ALPRAZOLAM (XANAX), ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and TRAZODONE for an unknown indication.   On 27-Oct-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 27-Oct-2023, the patient experienced FATIGUE (The patient was extremely tired since the time that she had taken her Spikevax vaccine). At the time of the report, FATIGUE (The patient was extremely tired since the time that she had taken her Spikevax vaccine) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       It was reported that patient receives other vaccines in the four weeks prior to COVID-19 vaccine.  It was reported that suspect vaccine lot number and expiry date was not available. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.