chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 24Jun2023 to 28Jun2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Nausea, Off label use
Clinical narrative: The patient recived first dose was BNT162B2 and second dose was Moderna; The patient recived first dose was BNT162B2 and second dose was Moderna; felt nauseaous when eating; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization; Moderna (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 30Jun2023, outcome "recovering", described as "felt nauseaous when eating"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "The patient recived first dose was BNT162B2 and second dose was Moderna". Therapeutic measures were not taken as a result of nausea.  Additional information: She felt nauseous when eating. She is also anti-vaccines. If COVID prior vaccination: No. If COVID tested post vaccination: No and If other vaccine in four weeks: No.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ehlers-Danlos syndrome
Clinical narrative: hyper mobile Ehlers Danlos; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID/tested positive for COVID", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: Apr2020, for COVID-19 immunization; Bnt162b2 (Dose 2, Single), for COVID-19 immunization; Bnt162b2 (Dose 3, Single), for COVID-19 immunization. The following information was reported: EHLERS-DANLOS SYNDROME (non-serious), outcome "unknown", described as "hyper mobile Ehlers Danlos".  Additional information: It was reported that patient had confirmed hyper mobile Ehlers Danlos. The event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: hyper mobile Ehlers Danlos; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID/tested positive for COVID", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: Apr2020, for COVID-19 immunization; Bnt162b2 (Dose 2, Single), for COVID-19 immunization; Bnt162b2 (Dose 3, Single), for COVID-19 immunization. The following information was reported: EHLERS-DANLOS SYNDROME (non-serious), outcome "unknown", described as "hyper mobile Ehlers Danlos".  Additional information: It was reported that patient had confirmed hyper mobile Ehlers Danlos. The event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I have had a very bad headache ever since my first booster shot on 25Mar2022. That's a very long time to have a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 25Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "I have had a very bad headache ever since my first booster shot on 25Mar2022. That's a very long time to have a headache".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 infection/unknown exposure/ 3 pfizer vaccination; COVID-19 infection/unknown exposure/ 3 pfizer vaccination; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (caused and prolonged hospitalization, medically significant), COVID-19 (caused and prolonged hospitalization, medically significant) all with onset 26Jul2022, outcome "recovered" (29Jul2022) and all described as "COVID-19 infection/unknown exposure/ 3 pfizer vaccination". The patient was hospitalized and prolonged hospitalization for drug ineffective, covid-19 (start date: 26Jul2022, discharge date: 29Jul2022, hospitalization duration: 4 day(s)). Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association and known drug profile, a contributory role of suspect drug cannot be excluded for the reported events, COVID-19 and DRUG INEFFECTIVE.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pancreatic failure
Clinical narrative: pancreatic insufficiency; a rise in this condition since COVID 19 vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient in her high 60's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for Covid-19 immunization. The following information was reported: PANCREATIC FAILURE (medically significant), outcome "unknown", described as "pancreatic insufficiency"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "a rise in this condition since COVID 19 vaccine". Patient with preexisting IBS developed pancreatic insufficiency. Her doctor was unsure if it was from the vaccine but had seen a rise in this condition since COVID 19 vaccine was administered. After COVID vaccine she never had COVID prior to diagnosis. The events "pancreatic insufficiency" and "a rise in this condition since covid 19 vaccine" required physician office visit.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Gave Moderna pink cap/ yellow label as primary
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Dyspnoea, Respiratory distress, Tachypnoea, Urticaria, Wheezing
Clinical narrative: About 10 to 15 minutes following vaccine administration, patient started to develop diffuse urticaria, SOB, tachypnea, and wheezing. Considering symptoms and rapid onset, IM epinephrine (0.01mg/kg) was given. Patient seemed to have immediate improvement of respiratory distress. Patient was brought over the ED by provider and sign out was given to ED attending physician. Patient was seen immediately in ED.
Age: 0.92
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Gave Moderna pink cap/ yellow label as primary
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product administration error, Vaccination error
Clinical narrative: Vaccine error: Higher dose of COVID vaccine (Orange Pfizer COVID vaccine for age 5-11yo) was given to a 2yo patient at approximately 13:50 on 7/6/23 during well child visit with PCP.  During monitoring period of >15 min post-vaccination, child was playful in the room and overall well appearing. Notified parent/guardian of administration error. Per CDC guidance, recommended that patient continue vaccination series as scheduled with appropriate age-based dose (Maroon Pfizer COVID vaccine for 6mo-4yo) with next dose in 3 weeks.  However, may deviate/delay from recommended schedule should patient experience prolonged side effects or adverse reactions from high dose received today.  Parent/guardian verbalized understanding.
Age: 0.5
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Gave Moderna pink cap /yello label as primary
Age: 0.75
Sex: F
Vaccine: COVID19, MMR
Symptoms: No adverse event
Clinical narrative: No adverse reaction reported.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Gave Moderna pink cap/ yellow label as primary
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse reaction reported to department.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse reaction reported to department.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Urticaria
Clinical narrative: patient woke up with hives that itched.  Patient was going home to take benadryl and hydrocortisone cream
Age: 65.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Headache, Injection site pruritus, Pain, Swelling
Clinical narrative: pt developed symptoms the same night of given vaccines. took tylenol sunday for pain and icing as well. has not taken any other medicines until today 07/06/23; couseled to continue supportive care of icing and tylenol or advil for the swelling. some itching at injection site. may use benadryl; slight headache this morning 07/06/23 8am;
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray normal, Diarrhoea, Dyspnoea, Gastrointestinal tract irritation, Laboratory test normal
Clinical narrative: Hives (full body) including scalp,  difficulty breathing, runny nose sneezing, diarrhea, GI irritation  continuous hives. Today is 07/06/23 and worse by the day.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, Sneezing, Urticaria
Clinical narrative: Hives (full body) including scalp,  difficulty breathing, runny nose sneezing, diarrhea, GI irritation  continuous hives. Today is 07/06/23 and worse by the day.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: Patient did not experience any adverse events or symptoms.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Feeling cold, Injection site pain, Loss of consciousness, Posture abnormal, Syncope
Clinical narrative: Patient received vaccines, then she sat in the waiting area, approximately 5 minutes later she fainted while sitting down, her head was leaning to the side of the wall on the left side. As I approached her , she woke up and was alert and did not know she passed out. She passed out for approximately 10 to 15 seconds. We called paramedics and when paramedics arrived, they checked all her vital signs and everything else. They deemed that she was okay to go home and did not need to go to ER. She said she felt fine except for little coldness and pain at injection site.
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Headache, Nausea, Throat irritation, Tongue pruritus
Clinical narrative: Itchy throat, itchy tongue, slight loss of breath, headache, nausea
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Convalescent, Fatigue, Loss of personal independence in daily activities, Malaise, Orthostatic hypotension
Clinical narrative: Patient developed significant worsening of fatigue exhaustion patient was nearly completely bed rest for approximately 4 months; barely get able to take care of himself; complete body pains fevers; developed tachycardia orthostatic hypotension heart racing palpitations; patient had never been this sick before all symptoms started within 5 hours of getting his second maternal vaccine.  Patient's never been this exhausted tired or sick before; patient has not made a complete recovery he's still having significant problems .
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia, Rest regimen, Tachycardia
Clinical narrative: Patient developed significant worsening of fatigue exhaustion patient was nearly completely bed rest for approximately 4 months; barely get able to take care of himself; complete body pains fevers; developed tachycardia orthostatic hypotension heart racing palpitations; patient had never been this sick before all symptoms started within 5 hours of getting his second maternal vaccine.  Patient's never been this exhausted tired or sick before; patient has not made a complete recovery he's still having significant problems .
Age: 0.17
Sex: F
Vaccine: HEP, MNQ, PNC13, RV5
Symptoms: No adverse event, Product administration error, Wrong product administered
Clinical narrative: Pentacel was ordered but not administered, Menveo vaccine was given in error. Patient waited 20 minutes after vaccine and No reacrion was noted at this time.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Confusional state, Dyspnoea, Encephalopathy, Hypoxia
Clinical narrative: Reported Symptoms: Confusion; Encephalopathy; Tachypnea; Troponin increased; Narrative: Patient received three Pfizer COVID 19 vaccine in Feb/Mar 2021 and Jan 2022. The patient presented to the ED on 2 November 2022 with shortness of breath. The patient was admitted with hypoxia, encephalopathy, and elevated troponin due to COVID and the patient was treated with remdesivir and dexamethasone. The patient was discharged in 17 November 2022 in stable condition. Reported per EUA. Other relevant HX:  Other: encephalopathy, elevated troponins, COVID 19
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachypnoea, Troponin increased
Clinical narrative: Reported Symptoms: Confusion; Encephalopathy; Tachypnea; Troponin increased; Narrative: Patient received three Pfizer COVID 19 vaccine in Feb/Mar 2021 and Jan 2022. The patient presented to the ED on 2 November 2022 with shortness of breath. The patient was admitted with hypoxia, encephalopathy, and elevated troponin due to COVID and the patient was treated with remdesivir and dexamethasone. The patient was discharged in 17 November 2022 in stable condition. Reported per EUA. Other relevant HX:  Other: encephalopathy, elevated troponins, COVID 19
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cough, Dyspnoea, Hypoxia, Malaise
Clinical narrative: Reported Symptoms:  10011232:COUGHING; 10016558:FEVER;  10043088:TACHYPNEA; 10084380:COVID-19 PNEUMONIA;    Narrative: Patient received COVID 19 vaccine in 2021  per history and physical note.   The patient presented to the ED on 5 November 2022 with cough, hypoxia, malaise, shortness of  breath and fever.   The patient was
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tachypnoea
Clinical narrative: Reported Symptoms:  10011232:COUGHING; 10016558:FEVER;  10043088:TACHYPNEA; 10084380:COVID-19 PNEUMONIA;    Narrative: Patient received COVID 19 vaccine in 2021  per history and physical note.   The patient presented to the ED on 5 November 2022 with cough, hypoxia, malaise, shortness of  breath and fever.   The patient was
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Confusional state, Encephalopathy, Tachycardia
Clinical narrative: Reported Symptoms: 10010300:CONFUSION;  10014625:ENCEPHALOPATHY;  10043071:TACHYCARDIA; 10084268:COVID-19;    Narrative: Patient received three doses of Pfizer and one dose of Moderna COVID 19 vaccine.  The  patient presented to the ED on 6 November 2022 with confusion and  tachycardia.  The patient was admitted with COVID 19.   The patient was  treated with diltiazem.  The patient was discharged on 16 November 2022 in  stable condition.  Reported per EUA.  Other Relevant HX:  Other: covid encephalopathy
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Cardiac dysfunction, Cardiac murmur, Echocardiogram abnormal, General physical health deterioration
Clinical narrative: First indication of something wrong was abnormal bloodwork. Second was a heart ECHO for undiagnosed cardiac murmurs. This moved on to heart chamber dysfunction, then heart muscle disorder and AL amyloidosis patient continued to decline.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle disorder, Primary amyloidosis
Clinical narrative: First indication of something wrong was abnormal bloodwork. Second was a heart ECHO for undiagnosed cardiac murmurs. This moved on to heart chamber dysfunction, then heart muscle disorder and AL amyloidosis patient continued to decline.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Induration, Injection site discolouration, Injection site rash, Injection site reaction
Clinical narrative: patient received vaccine on 6-23-23 - she reported being fine for the rest of the day.  She said the symptoms started the next day 6-24-23.  She reported a hot, red, hard, and painful injection site.  Over the next 3 days she stated that the red area continued to grow.  She also experienced body aches, nausea, and low fever.  Over the following couples days she reported the area to begin to turn purplish and developed bumps which became itchy.  After that date it began to improve.  Patient did report that she had a chronic health condition of Fibromyalgia which she believes makes her sensitive to certain medications and vaccines.  I reviewed her injection site when I was collecting data from her to submit to VAERS and it is looking much better.  You can still see a small outline of skin that is colored slightly redder than the surrounding skin but overall looks to be healing nicely.  She reported that she used ice, ibuprofen, and acetaminophen to treat the rash she had developed.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site warmth, Pain, Pruritus, Rash macular, Skin warm
Clinical narrative: patient received vaccine on 6-23-23 - she reported being fine for the rest of the day.  She said the symptoms started the next day 6-24-23.  She reported a hot, red, hard, and painful injection site.  Over the next 3 days she stated that the red area continued to grow.  She also experienced body aches, nausea, and low fever.  Over the following couples days she reported the area to begin to turn purplish and developed bumps which became itchy.  After that date it began to improve.  Patient did report that she had a chronic health condition of Fibromyalgia which she believes makes her sensitive to certain medications and vaccines.  I reviewed her injection site when I was collecting data from her to submit to VAERS and it is looking much better.  You can still see a small outline of skin that is colored slightly redder than the surrounding skin but overall looks to be healing nicely.  She reported that she used ice, ibuprofen, and acetaminophen to treat the rash she had developed.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: patient received vaccine on 6-23-23 - she reported being fine for the rest of the day.  She said the symptoms started the next day 6-24-23.  She reported a hot, red, hard, and painful injection site.  Over the next 3 days she stated that the red area continued to grow.  She also experienced body aches, nausea, and low fever.  Over the following couples days she reported the area to begin to turn purplish and developed bumps which became itchy.  After that date it began to improve.  Patient did report that she had a chronic health condition of Fibromyalgia which she believes makes her sensitive to certain medications and vaccines.  I reviewed her injection site when I was collecting data from her to submit to VAERS and it is looking much better.  You can still see a small outline of skin that is colored slightly redder than the surrounding skin but overall looks to be healing nicely.  She reported that she used ice, ibuprofen, and acetaminophen to treat the rash she had developed.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: patient received vaccine on 6-23-23 - she reported being fine for the rest of the day.  She said the symptoms started the next day 6-24-23.  She reported a hot, red, hard, and painful injection site.  Over the next 3 days she stated that the red area continued to grow.  She also experienced body aches, nausea, and low fever.  Over the following couples days she reported the area to begin to turn purplish and developed bumps which became itchy.  After that date it began to improve.  Patient did report that she had a chronic health condition of Fibromyalgia which she believes makes her sensitive to certain medications and vaccines.  I reviewed her injection site when I was collecting data from her to submit to VAERS and it is looking much better.  You can still see a small outline of skin that is colored slightly redder than the surrounding skin but overall looks to be healing nicely.  She reported that she used ice, ibuprofen, and acetaminophen to treat the rash she had developed.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: patient received vaccine on 6-23-23 - she reported being fine for the rest of the day.  She said the symptoms started the next day 6-24-23.  She reported a hot, red, hard, and painful injection site.  Over the next 3 days she stated that the red area continued to grow.  She also experienced body aches, nausea, and low fever.  Over the following couples days she reported the area to begin to turn purplish and developed bumps which became itchy.  After that date it began to improve.  Patient did report that she had a chronic health condition of Fibromyalgia which she believes makes her sensitive to certain medications and vaccines.  I reviewed her injection site when I was collecting data from her to submit to VAERS and it is looking much better.  You can still see a small outline of skin that is colored slightly redder than the surrounding skin but overall looks to be healing nicely.  She reported that she used ice, ibuprofen, and acetaminophen to treat the rash she had developed.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: patient received vaccine on 6-23-23 - she reported being fine for the rest of the day.  She said the symptoms started the next day 6-24-23.  She reported a hot, red, hard, and painful injection site.  Over the next 3 days she stated that the red area continued to grow.  She also experienced body aches, nausea, and low fever.  Over the following couples days she reported the area to begin to turn purplish and developed bumps which became itchy.  After that date it began to improve.  Patient did report that she had a chronic health condition of Fibromyalgia which she believes makes her sensitive to certain medications and vaccines.  I reviewed her injection site when I was collecting data from her to submit to VAERS and it is looking much better.  You can still see a small outline of skin that is colored slightly redder than the surrounding skin but overall looks to be healing nicely.  She reported that she used ice, ibuprofen, and acetaminophen to treat the rash she had developed.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash, Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: patient received vaccine on 6-23-23 - she reported being fine for the rest of the day.  She said the symptoms started the next day 6-24-23.  She reported a hot, red, hard, and painful injection site.  Over the next 3 days she stated that the red area continued to grow.  She also experienced body aches, nausea, and low fever.  Over the following couples days she reported the area to begin to turn purplish and developed bumps which became itchy.  After that date it began to improve.  Patient did report that she had a chronic health condition of Fibromyalgia which she believes makes her sensitive to certain medications and vaccines.  I reviewed her injection site when I was collecting data from her to submit to VAERS and it is looking much better.  You can still see a small outline of skin that is colored slightly redder than the surrounding skin but overall looks to be healing nicely.  She reported that she used ice, ibuprofen, and acetaminophen to treat the rash she had developed.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ehlers-Danlos syndrome
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Had previous COVID", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID". Patient presented with sore throat, stuffiness, sneezing, some dizziness and mild headache. Also had an intense bout of nausea the day before the sore throat started. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Had previous COVID", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID". Patient presented with sore throat, stuffiness, sneezing, some dizziness and mild headache. Also had an intense bout of nausea the day before the sore throat started. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrating an expired daptacel vaccine with no reported adverse event; Initial information received on 27-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown age and gender who was administered an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (strength: standard) (lot number: expiry date not reported) via unknown route in unknown administration site for Immunization.  On an unknown date the patient was administered an expired daptacel vaccine with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired DAPTACEL was administered with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 year old male patient to whom expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Prophylactic vaccination (immunization).  On 29-Jun-2023, the patient received 0.5 mL expired dose 4 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: C5893AA; Expiry date: 21-Jun-2023) via intramuscular route in left thigh for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired daptacel was administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: MEN
Symptoms: Abdominal pain upper, Asthenia, Headache, Rash, Urticaria
Clinical narrative: rash on back; had hives on his back a couple of days; headaches; stomach aches; weakness; Initial information received  on 03-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age male patient who experienced headaches, stomach aches, weakness, rash on back and had hives on his back a couple of days after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Jun-2023, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (batch/lot number, expiry date, strength, route: not reported) in unknown administration site for prophylactic vaccination (immunization). Information on the batch number was requested.  On 30-JUN-2023 the patient developed events headaches (headache), stomach aches (abdominal pain upper) and weakness (asthenia) (latency: 1 day) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  On 01-JUL-2023 the patient developed events rash on back (rash) and had hives on his back a couple of days (urticaria) (latency: 2 days) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired daptacel with no reported adverse event; Initial information received on 05-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA206010.  This case involves a 1 years old female patient who was administered expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A Vaccine) for Prophylactic vaccination; and Hepatitis B Vaccine (Hepatitis B Vaccine) for Prophylactic vaccination.  On 23-Jun-2023, the patient received 0.5 ml (1X) (Dose 4) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: C5893AA; Expiry date: 21-Jun-2023) (With an unknown strength) via unknown route in the right thigh for Immunization  On 23-Jun-2023, the patient was administered expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine with no reported adverse event (expired product administered) (Latency: same day)  It was reported, Caller says that vaccine that had expired June 21,2023 was accidentally administered to 5 patients. Caller would like to get information on next steps. The doses were all administered by medical assistants. It was not the same medical assistant who gave the expired doses to the five patients. Patient was administered expired Daptacel on 23Jun2023 for her fourth dose in the series. The dose was administered by a medical assistant in the right thigh. The patient received concomitant vaccination against hepatitis A and hepatitis B that day.   Action taken: not applicable.  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA206192:01679504 US-SA-2023SA206192:01679483 US-SA-2023SA206192:01679488
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine that had expired was accidentally administered to patients with no reported adverse event; Initial information received on 05-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient and caller reported that the diphtheria-15/tetanus/5 Ac Pertussis Vaccine [Daptacel] that had expired was accidentally administered to patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hib Vaccine for Prophylactic vaccination.  On 28-Jun-2023, the patient received a dose 3 at a dose of 0.5 ml of suspect  diphtheria-15/tetanus/5 Ac Pertussis Vaccine Suspension for injection (expiry date: 21-Jun-2023, lot C5893AA) via unknown route in the left thigh for Immunization and expired vaccine was accidentally administered with no reported adverse event (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Limb discomfort, Pain, Peripheral swelling, Skin warm
Clinical narrative: Patient received vaccination on Friday, 6/30/23. Patient said she experienced some diarrhea and arm heaviness the first 3 days. She stated that she took Aleve to assist with some of the pain that she was having (she believes on Monday and Tuesday). On Tuesday and Wednesday after the vaccination, patient reported feeling like her arm was hot, so she put an ice pack onto her arm. She noticed her arm was swollen on the forearm part by her elbow (away from the vaccination site). Patient stated that the swelling goes 3/4 around her arm.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: sepsis, extended stay (30 days)
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling face, Urticaria
Clinical narrative: Patient developed facial swelling and urticarial rash shortly after injections were administered which revolved with Benadryl.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reactions - incorrect age dosage given for age group.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: hospitalization, swelling of left side of face
Age: 58.0
Sex: M
Vaccine: SMALLMNK
Symptoms: New daily persistent headache
Clinical narrative: Headaches occurring every day
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Apathy, Asthenia, Feeling abnormal, Mental impairment, Myalgia
Clinical narrative: He got his vaccine, he was oaky.  When he woke up on Thursday morning he was weak, muscle aches, lack of energy, not able to mentate correctly, feels feverish, headache, just does not have any motivation at all whatsoever.  He just this morning started taking some Advil, he had no motivation yesterday to do anything.  He is queazy and was forcing himself to eat and drink to take the Advil.    He has had many vaccines and experimental vaccines and has never felt this bad after a vaccine.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: He got his vaccine, he was oaky.  When he woke up on Thursday morning he was weak, muscle aches, lack of energy, not able to mentate correctly, feels feverish, headache, just does not have any motivation at all whatsoever.  He just this morning started taking some Advil, he had no motivation yesterday to do anything.  He is queazy and was forcing himself to eat and drink to take the Advil.    He has had many vaccines and experimental vaccines and has never felt this bad after a vaccine.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Epilepsy
Clinical narrative: EPILEPSY, UNSPECIFIED
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Basophil count decreased, Basophil percentage
Clinical narrative: Patient developed muscle soreness, limited ROM
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Bilirubin conjugated, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal
Clinical narrative: Patient developed muscle soreness, limited ROM
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Patient developed muscle soreness, limited ROM
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Blood test abnormal, Blood urea normal, C-reactive protein increased, Carbon dioxide normal, Differential white blood cell count
Clinical narrative: Patient developed muscle soreness, limited ROM
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Eosinophil count normal, Eosinophil percentage, Full blood count abnormal, Glomerular filtration rate normal, Haematocrit normal
Clinical narrative: Patient developed muscle soreness, limited ROM
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Haemoglobin normal, Inflammatory marker increased, International normalised ratio increased, Joint range of motion decreased, Liver function test abnormal
Clinical narrative: Patient developed muscle soreness, limited ROM
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Lymphocyte count, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: Patient developed muscle soreness, limited ROM
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Mean platelet volume normal, Metabolic function test, Monocyte count, Monocyte percentage, Myalgia
Clinical narrative: Patient developed muscle soreness, limited ROM
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Neutrophil percentage, Platelet count normal, Protein total normal, Prothrombin time prolonged, Red blood cell count normal
Clinical narrative: Patient developed muscle soreness, limited ROM
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Red blood cell sedimentation rate increased, Red cell distribution width normal, White blood cell count normal, X-ray limb normal
Clinical narrative: Patient developed muscle soreness, limited ROM
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 19.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccines was expired.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Systemic inflammatory response syndrome
Clinical narrative: Hospitalization for SIRS likely due to COVID-19 on dates 6/27/2023 to 7/6/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Vaccines was expired.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angioedema, Hypersensitivity
Clinical narrative: ANGIOEDEMA, INIT ALLERGIC REACTION, INIT
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: Hospitalization for Pneumonia due to COVID-19 on dates  7/1/2023- 7/5/2023. Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MILD
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Son received his 4 year vaccinations. Dtap, mmr, varicella,  and IPV. Unsure of which shot was put in each let. His left leg started swelling and was red within an hour and has continued to spread. Its now across his entire thigh. Red and swollen and raised. I've outlined in pen each time it spreads. It's hard and warm to the touch. He complains that it hurts to touch. It is now Friday and it spread over last night and it looks bruised now as well.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Injection site warmth
Clinical narrative: Son received his 4 year vaccinations. Dtap, mmr, varicella,  and IPV. Unsure of which shot was put in each let. His left leg started swelling and was red within an hour and has continued to spread. Its now across his entire thigh. Red and swollen and raised. I've outlined in pen each time it spreads. It's hard and warm to the touch. He complains that it hurts to touch. It is now Friday and it spread over last night and it looks bruised now as well.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: wrong vaccine given. patient needed TDap not TD
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Prostate cancer, Prostatic specific antigen increased
Clinical narrative: Patient had elevated psa 2 months later and now has prostate cancer
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Blood test abnormal, Goitre, Graves' disease, Hyperthyroidism
Clinical narrative: Hyperthyroid, Grave Disease
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Ultrasound thyroid abnormal, Weight decreased
Clinical narrative: Hyperthyroid, Grave Disease
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebral artery occlusion, Cerebrovascular accident, Facial paresis, Symptom recurrence
Clinical narrative: ACUTE STROKE DUE TO OCCLUSION OF BILAT CEREBELLAR ARTERIES ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY BILAT FACIAL MUSCLE WEAKNESS 3/12/2023  &  1/17/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS