chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the patient is vaccinated and boosted. He's had COVID three times this year; the patient is vaccinated and boosted. He's had COVID three times this year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient 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; BNT162b2 (BNT162B2), as dose number unknown, 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 (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "the patient is vaccinated and boosted. He's had COVID three times this year".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 2 rashes on both sides of face, one on each side, inside cast, on right arm, it has, muscle and behind the muscle area, all around the arm/have sores that popped over about eight, it's in each one; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Feb2023 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: RASH (non-serious) with onset 2023, outcome "unknown", described as "2 rashes on both sides of face, one on each side, inside cast, on right arm, it has, muscle and behind the muscle area, all around the arm/have sores that popped over about eight, it's in each one".  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: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Herpes zoster
Clinical narrative: shingles; 16th time having shingles (herpes zoster); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023SA031067 (Sanofi).  Initial information was received on 24Jan2023 regarding an unsolicited valid non-serious case received from a consumer/Non-HCP. This is linked to cases 2023SA031061 and 2023SA029739. This case involves a 61 years old female patient who experienced developed shingles a couple of days after received the vaccination: 16th time having shingles while receiving vaccines pneumococcal vaccine CONJ 20V (CRM 197) Prevnar 20 and meningococcal W 135 (T CONJ) vaccine (Menquadfil). The patients past medical treatment included takes acyclovir daily prophylactically. The patients past vaccination(s) included MMR in Nov2022 and MENACTRA with on a 5 year cycle. The patients past medical history and family history were not provided. At the time of the event, the patient had ongoing Asplenia since Jun2012 and Diabetes mellitus (DM) for two years. On 02Jan2023, the patient received a dose Of suspect Prevnar 20 not produced by Sanofi Pasteur with Unknown formulation, strength, dose, route, batch number and expiry date for prophylactic vaccination. On 19Jan2023, the patient received a dose of 0.5 ml dose 4 of suspect meningococcal A-C-Y-W 135 (T CONJ) vaccine solution for injection (lot: U7459AE, expiry date: 30Nov2024) via intramuscular route in the left deltoid for immunization. On 19Jan2023, the patient developed shingles a couple of days after received the menquadfi vaccination, 16th time having shingles (herpes zoster) following the administration of meningococcal A-C-Y - W 135 (T CONJ) vaccine and 17 days following the administration of Prevnar 20. It was reported "Caller previously reported to Sanofi Medical Information that she developed shingles a couple of days after she received the M ENQUADFI vaccination. She received the MENQUADFI vaccine on 19Jan2023. The report was taken and submitted to PV on 24Jan2023. The caller stated that her shingles have mostly cleared up. She mentioned that she is prone to shingles since she lost her spleen in 2012. This was her 16th time having Shingles. The caller noted that they are not sure if her most recent encounter with Shingles was caused by the MENQUADFI vaccine. but her doctor recommended that she report it anyway". Action taken with meningococcal vaccine (menquadfi) and pneumococcal vaccine CONJ 20V (CR M 197) (PREVNAR 20) was not applicable. The patient was treated with acyclovir (aciclovirl for Herpes zoster). At time Of reporting, the outcome was Recovering/Resolving. Additional information was received on from consumer/Non-HCP. Outcome was updated to recovering. Clinical course updated & text amended accordingly.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunodeficiency, Neoplasm malignant, Systemic lupus erythematosus
Clinical narrative: Lupus; Had surgery for cancer; immunocompromised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 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 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: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Lupus"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Had surgery for cancer"; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised". Therapeutic measures were taken as a result of neoplasm malignant.  Clinical course details: The patient said that she has Lupus and has had surgery for cancer last year and was also on chemotherapy and radiation. She has had the Pfizer Covid shot four times and was asking if she could get the fifth shot of the vaccine. Sending precautionary AE - immunocompromised.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: my first test for Covid, titled Covid; my first test for Covid, titled Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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 (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "my first test for Covid, titled Sars-Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: my first test for Covid, Covid. Clinical course: Reporter stated, "I will not get another vaccine. I had an adverse reaction to the first Pfizer shot: a neighbor got COVID after all the jabs: My Brother also and he was sick for 16 days. More and more and don't say it's variants: The scientists should have been aware of this. It's the same virus because my first test for Covid, titled Covid. Top Doctor if one got the disease after the inoculation: Does one get Malaria, Small Pox Or Polio after the inoculation?"  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID after all the jabs; got COVID after all the jabs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "got COVID after all the jabs". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness
Clinical narrative: My Brother also and he was sick for 16 days; My Brother also and he was sick for 16 days; My Brother also and he was sick for 16 days; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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 (medically significant), COVID-19 (medically significant), ILLNESS (non-serious), outcome "unknown" and all described as "My Brother also and he was sick for 16 days".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Venous thrombosis limb
Clinical narrative: Lower extremity venous thrombosis; Initial information received on 22-Feb-2023 by health care professional regarding an unsolicited valid serious case issued from a literature article:  This case is linked to cases 2023SA063143, 2023SA063144, 2023SA063145, 2023SA063147, 2023SA063137 and 2023SA063148 (CLUSTERS).  This case involves a 62 years old male patient (table 1) who experienced lower extremity venous thrombosis while receiving vaccines pfizer biontech COVID-19 (coronavirus 2019) vaccine and influenza vaccine (quadrivalent).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect pfizer biontech COVID-19 vaccine not produced by Sanofi Pasteur (lot number not reported) via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect high-dose influenza vaccine (quadrivalent) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious lower extremity venous thrombosis (venous thrombosis limb) (latency: 26 days). The patient was hospitalized for this event for 3 days.  Action taken with quadrivalent influenza vaccine (influenza vaccine (quadrivalent)) and tozinameran (pfizer biontech COVID-19 vaccine) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Lower extremity venous thrombosis).  At time of reporting, the outcome was Unknown for the event lower extremity venous thrombosis. Reporter's causality: Related; Sender's Comments: Sanofi company comment dated 27-FEB-2023: This case involves a 62 years old male patient (table 1) who experienced lower extremity venous thrombosis while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT). Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Fluzone, reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event; Product was administered to patients post excursion with no reported adverse event; Initial information received  on 14-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult patient of unknown gender where vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. , reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes with no reported adverse event and product was administered to patients post excursion 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 an unknown dose of suspect influenza quadrival a-b vaccine Suspension for injection (strength, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient had a non-serious event of fluzone, reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes with no reported adverse event (product storage error) (onset date: unknown) involving influenza quadrival a-b vaccine.  On an unknown date the patient had a non-serious event of product was administered to patients post excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of influenza quadrival a-b vaccine.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.   Additional information was received on 16-Feb-2023 from other health care professional: case was updated from non-case to Non-valid.  Based on information previously received, the following information [Classification updated from Non-Valid Case to Valid with no AE, as a single adult patient is involved , accordingly age group will be captured as adult.] have been amended.; Sender's Comments:  US-SA-2023SA069591:
Sex: M
Vaccine: FLUX
Symptoms: Immunisation reaction
Clinical narrative: had a really bad reaction to a flu vaccine; Initial information received on 04-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age male patient who had a really bad reaction to influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, expiry and lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event had a really bad reaction to a flu vaccine (Immunisation reaction) (unknown latency) following the administration of influenza vaccine.  It was reported "Caller mentioned that her husband had a really bad reaction to a flu vaccine."  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (had a really bad reaction to a flu vaccine).  At time of reporting, the outcome was Unknown for the event had a really bad reaction to a flu vaccine.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Arthralgia, Cardiac telemetry abnormal, Catheterisation cardiac abnormal, Chest X-ray abnormal
Clinical narrative: For several days after the vaccination shots, patient felt acute shoulder pain that ran down the arm. Several months (less than a year) after the vaccine was administered, patient went the Emergency Room due to acute chest pain. it was later discovered that patient had a heart attack due to 99 percent blockage in the left anterior descending artery of the heart. A stent was placed and the patient was hospitalized for 2 days.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Coronary arterial stent insertion, Coronary artery occlusion, Electrocardiogram abnormal, Full blood count
Clinical narrative: For several days after the vaccination shots, patient felt acute shoulder pain that ran down the arm. Several months (less than a year) after the vaccine was administered, patient went the Emergency Room due to acute chest pain. it was later discovered that patient had a heart attack due to 99 percent blockage in the left anterior descending artery of the heart. A stent was placed and the patient was hospitalized for 2 days.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lipids, Myocardial infarction, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: For several days after the vaccination shots, patient felt acute shoulder pain that ran down the arm. Several months (less than a year) after the vaccine was administered, patient went the Emergency Room due to acute chest pain. it was later discovered that patient had a heart attack due to 99 percent blockage in the left anterior descending artery of the heart. A stent was placed and the patient was hospitalized for 2 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Blood lactic acid normal, Computerised tomogram abdomen normal, Diarrhoea haemorrhagic, Full blood count normal
Clinical narrative: she presented to the ED for fever, bloody diarrhea and LLQ abdominal pain
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test normal, Pyrexia, Scan with contrast normal
Clinical narrative: she presented to the ED for fever, bloody diarrhea and LLQ abdominal pain
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Both shots a year ago, I have them right now/suspected vaccination failure; I have them right now, awful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 02-MAR-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had both shingles shots over a year ago but he/she had shingles right no awful. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles shots, got a mild case of shingles/Suspected vaccination failure; Mild case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-MAR-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had shingles shots but still had a mild case of shingles.  The patient was glad sure that had the shots. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: I got it, went into one eye.; shingles on my head, not bad; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and an unknown time after starting Valtrex, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 27-FEB-2023 Reporter's Comment:  This case was reported by a patient via interactive digital media. The patient had the first shingles shot, so when she/he got it on the left side of her/his head it was not as bad as it could had been. The patient went to doctor first thing got an antiviral Valtrex and had to go to many visits to eye doctors because it went into one eye.  The patient understands the new vaccine was 98.9 percent effective so recommend it, you did not even want to deal with a mild case. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Boostrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 3rd February 2023, the patient received Boostrix. On 3rd February 2023, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-FEB-2023 Reporter's Comment: The reporter was a other healthcare professional who is manager at health facility. The reporter reported that on 3rd February 2023 the female patient received an expired dose of Boostrix vaccine. Additional supportive information: The patient received a Boostrix which was already expired, which led to expired vaccine used.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: accidentally administered pentacel and vaxelis/not administering the intended vaccine resulting in the patient receiving extra dose of DTAP/IPV/HIB, with no reported adverse event; Initial information received on 28-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who experienced accidentally administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] and vaxelis/not administering the intended vaccine resulting in the patient receiving extra dose of dtap/ipv/hib, 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 rotavirus vaccine live reassort oral 5V (Rotateq).  On 28-Feb-2023, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Suspension for injection lot FY2475 expiry date 31-dec-2024 via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "accidentally administered pentacel and vaxelis/not administering the intended vaccine resulting in the patient receiving extra dose of dtap/ipv/hib, with no reported adverse event" (extra dose administered) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event accidentally administered pentacel and vaxelis/not administering the intended vaccine resulting in the patient receiving extra dose of dtap/ipv/hib, 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.; Sender's Comments:  US-SA-2023SA068119:
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Crying, Rash, Rash erythematous, Rash macular
Clinical narrative: About 5-10 min after vaccine administration - unconsoleable crying, blotching red rash in face.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Left upper arm pain at times, mostly when raising arm above shoulder or reaching behind back. The pain gradually became more prevalent and after 4 to 6 weeks the pain increased in area up including left shoulder, with increasingly limited range of motion.  I visited the doctor on 1/20/2023 and was prescribed Methylprednisolone 4mg oral.  After about a week my range of motion increased and my shoulder pain gradually decreased. I am still experiencing upper arm muscle pain when reaching rearward and above my head.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization
Age: 1.92
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patients 3rd dose of COVID Pfizer monovalent was not documented. Patient then received a dose of Pfizer bivalent. (Fourth dose not indicated).
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin reaction
Clinical narrative: Localized skin reaction.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Unevaluable event
Clinical narrative: hospitalization
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cyst rupture, Haemorrhoid operation, Haemorrhoids, Infected cyst
Clinical narrative: I had a little arm soreness for a day. I had to see a gastroenterologist regarding hemorrhoids. It was recommended to have a procedure done called banding. I have completed two of the three sessions. I had a cyst that got infected, and I saw may dermatologist to have it drained. I am currently taking medication and it is draining on it' own. I tested positive for COVID-19 in 02/2023 and 12/2022.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: I had a little arm soreness for a day. I had to see a gastroenterologist regarding hemorrhoids. It was recommended to have a procedure done called banding. I have completed two of the three sessions. I had a cyst that got infected, and I saw may dermatologist to have it drained. I am currently taking medication and it is draining on it' own. I tested positive for COVID-19 in 02/2023 and 12/2022.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in jaw, Sinus disorder
Clinical narrative: I started having a pain in my upper jaw. It seemed to get worse when I pushed on my tooth. I went to the dentist. He couldn't find anything wrong, so I went to a doctor who thought it was a sinus problem related to a CPAP machine that I use. She prescribed a steroid nasal spray, which seems to help some. The pain has improved, but it does still bother me. I'm going to follow up with my doctor in a few months.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electrocardiogram, Palpitations, Tremor
Clinical narrative: I experienced heart palpitations and tremors
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was to receive the bivalent booster but received  the original primary series. no side effects were reported
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was to receive the bivalent booster but received  the original primary series. no side effects were reported
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia, Rash
Clinical narrative: Pt. states that he had rashes, fever, body aches, chills, and fatigue.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches, shivering, fever
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus, both ears, becomes louder when turning head to extremes.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pt was given 0.25 ml of 2nd dose in Primary series of Moderna, No reaction
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: I got an smart watch for my birthday; it told me that I was in A-fib. I made an appointment with my doctor who ordered an EKG that said everything looked fine. He also ordered, a Body Guardian mini monitor for me to wear for two weeks. When I went in for the results it did show that I was in A-fib. am now taking Eliquis and Metoprolol Succinate to help with the A-fib. Currently my blood pressure is normal, and my heart is not showing any signs of A-fib. I was referred to a cardiologist by my family physician to confirm the results and medications. She changed my Metoprolol to twice a day. I do not feel like I am getting better, I have no energy and I am tired all the time.
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4
Symptoms: Anticoagulant therapy, Asthenia, Atrial fibrillation, Cardiac monitoring normal, Electrocardiogram normal
Clinical narrative: I got an smart watch for my birthday; it told me that I was in A-fib. I made an appointment with my doctor who ordered an EKG that said everything looked fine. He also ordered, a Body Guardian mini monitor for me to wear for two weeks. When I went in for the results it did show that I was in A-fib. am now taking Eliquis and Metoprolol Succinate to help with the A-fib. Currently my blood pressure is normal, and my heart is not showing any signs of A-fib. I was referred to a cardiologist by my family physician to confirm the results and medications. She changed my Metoprolol to twice a day. I do not feel like I am getting better, I have no energy and I am tired all the time.
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4
Symptoms: Fatigue
Clinical narrative: I got an smart watch for my birthday; it told me that I was in A-fib. I made an appointment with my doctor who ordered an EKG that said everything looked fine. He also ordered, a Body Guardian mini monitor for me to wear for two weeks. When I went in for the results it did show that I was in A-fib. am now taking Eliquis and Metoprolol Succinate to help with the A-fib. Currently my blood pressure is normal, and my heart is not showing any signs of A-fib. I was referred to a cardiologist by my family physician to confirm the results and medications. She changed my Metoprolol to twice a day. I do not feel like I am getting better, I have no energy and I am tired all the time.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Malaise, Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: I did not have an adverse reaction to the vaccine.  I began feeling sick on 01/25/2023 with terrible sore throat, congestion and runny nose. I tested positive for COVID-19 on 01/27/2023.  Due to other medications, I take, I was not a candidate for Paxlovid. I did take Molnupiravir without any complications. As of today, I feel a lot better without any lingering symptoms.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the vaccine.  I began feeling sick on 01/25/2023 with terrible sore throat, congestion and runny nose. I tested positive for COVID-19 on 01/27/2023.  Due to other medications, I take, I was not a candidate for Paxlovid. I did take Molnupiravir without any complications. As of today, I feel a lot better without any lingering symptoms.
Age: 0.67
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster dose accidentally given 1 week early.  No S/S of reaction.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product preparation error
Clinical narrative: The MA reconstituted sterile diluent with the Acthib powder instead of the sodium chloride diluent and administered vaccine to patient.  The patient did not have any symptoms. After the patient left the clinic is when it was realized how the Acthib was mixed. The manufacture was called and went over the incident & the outcome was that the vaccine given was not valid and would have to be repeated. The manufacture stated that Acthib could be given again as the same day of event. The parent was called and informed of the even that took place & brought the patient back for proper administration of Acthib.  Staff has been trained in reducing healthcare related medical errors by ensuring patient identification, verifying allergies, double checks doses, and ensures other patient safety functions occur as medications are administered to patients.
Age: 80.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Death, Guillain-Barre syndrome, Immunoglobulin therapy, Respiratory failure
Clinical narrative: GBS that caused respiratory failure. Had IVIG, but ultimately died
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient accidently got a second dose of pfizer bivalent vaccine.patient observed with no adversed effects noted.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: +COVID-vaccinated
Age: 71.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Cough, Nasal congestion, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: In November, I started having coughing symptoms three or four days after my grandson was diagnosed with RSV. My coughing symptoms persisted for the next month; I didn't take any real medication other than MUCINEX. I wouldn't describe it as severe, but it was annoying. I later developed COVID-19. My symptoms were extremely mild. I noticed some nasal congestion and a very short interval of soreness in my throat. I tested for COVID-19 and was positive. My temperature only got up to 99 degrees and that only lasted one day. I called my physician and was prescribed PAXLOVID and a steroid. I isolated for five days and tested negative after the five days. I spent one night out of isolation and then felt congested again, so I tested again the next morning and was positive. I isolated another five days but was only mildly symptomatic again and did not take any additional medication.
Age: 71.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: SARS-CoV-2 test positive
Clinical narrative: In November, I started having coughing symptoms three or four days after my grandson was diagnosed with RSV. My coughing symptoms persisted for the next month; I didn't take any real medication other than MUCINEX. I wouldn't describe it as severe, but it was annoying. I later developed COVID-19. My symptoms were extremely mild. I noticed some nasal congestion and a very short interval of soreness in my throat. I tested for COVID-19 and was positive. My temperature only got up to 99 degrees and that only lasted one day. I called my physician and was prescribed PAXLOVID and a steroid. I isolated for five days and tested negative after the five days. I spent one night out of isolation and then felt congested again, so I tested again the next morning and was positive. I isolated another five days but was only mildly symptomatic again and did not take any additional medication.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Diarrhoea, Discharge, Dyspnoea, Headache
Clinical narrative: I possibly had symptoms on Monday the 20th, but I was packing for vacation and didn't really pay attention. On Tuesday the 21st I flew and my throat was sore and I had a headache. I got in at about 10:30 that night and my sister picked me up from the airport. The next morning I was nauseous and had diarrhea and a sore throat. The diarrhea lasted about half a day, but I have Crohn's so it wasn't alarming. My throat was still sore and I had headache, bad congestion and drainage, trouble breathing. My sister and I decided to contact Urgent Care, I found one online and did a telehealth visit. I was sick with symptoms like a bad head cold for about 2-3 days. The doctor told me that I had to contact my doctor about Paxlovid, but because of my chronic conditions I opted not to do that, and that I wasn't contagious after 5 days, and not to retest. I flew home on Tuesday 2/28, I still have nasal drainage, congestion. Its all sinus/head cold type of stuff. If its not better soon Ill call my PCP.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Nasopharyngitis, Nausea, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: I possibly had symptoms on Monday the 20th, but I was packing for vacation and didn't really pay attention. On Tuesday the 21st I flew and my throat was sore and I had a headache. I got in at about 10:30 that night and my sister picked me up from the airport. The next morning I was nauseous and had diarrhea and a sore throat. The diarrhea lasted about half a day, but I have Crohn's so it wasn't alarming. My throat was still sore and I had headache, bad congestion and drainage, trouble breathing. My sister and I decided to contact Urgent Care, I found one online and did a telehealth visit. I was sick with symptoms like a bad head cold for about 2-3 days. The doctor told me that I had to contact my doctor about Paxlovid, but because of my chronic conditions I opted not to do that, and that I wasn't contagious after 5 days, and not to retest. I flew home on Tuesday 2/28, I still have nasal drainage, congestion. Its all sinus/head cold type of stuff. If its not better soon Ill call my PCP.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sinus disorder
Clinical narrative: I possibly had symptoms on Monday the 20th, but I was packing for vacation and didn't really pay attention. On Tuesday the 21st I flew and my throat was sore and I had a headache. I got in at about 10:30 that night and my sister picked me up from the airport. The next morning I was nauseous and had diarrhea and a sore throat. The diarrhea lasted about half a day, but I have Crohn's so it wasn't alarming. My throat was still sore and I had headache, bad congestion and drainage, trouble breathing. My sister and I decided to contact Urgent Care, I found one online and did a telehealth visit. I was sick with symptoms like a bad head cold for about 2-3 days. The doctor told me that I had to contact my doctor about Paxlovid, but because of my chronic conditions I opted not to do that, and that I wasn't contagious after 5 days, and not to retest. I flew home on Tuesday 2/28, I still have nasal drainage, congestion. Its all sinus/head cold type of stuff. If its not better soon Ill call my PCP.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Hypoaesthesia
Clinical narrative: numbness in toes, bottom of feet,  palms of hands and finger tips. Tingling started on Feb, 22, 2023 and persists today (March 9, 2023). So far, the effects do not keep me from working and are annoying.  Also, I have a persistent cough (just keeps hanging on).
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Immunized, got covid
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: I tested positive for COVID-19 on 1/2/23. I had a cough, shortness of breath, nausea, vomiting, diarrhea, fever of 104, and fatigue. I had severe symptoms for about 2 weeks. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID and ondansetron. It took me about 2 months to fully recover.
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test positive, Vomiting
Clinical narrative: I tested positive for COVID-19 on 1/2/23. I had a cough, shortness of breath, nausea, vomiting, diarrhea, fever of 104, and fatigue. I had severe symptoms for about 2 weeks. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID and ondansetron. It took me about 2 months to fully recover.
Age: 56.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Arthralgia, Burning sensation, Incorrect route of product administration
Clinical narrative: After I received the vaccine, I had pain, aches and burning in the right shoulder. I massaged my arm to help with the discomfort. I went to my doctor and was referred to physical therapy. I believe the physical therapy has helped. I believe the injection was done incorrectly.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Diarrhoea, Headache, Malaise, Nasal congestion
Clinical narrative: I had some diarrhea, headache and stuffy nose. I felt rundown to be safe I took a home COVID-19 test and so I set up a telehealth visit no prescription was given due to my mild symptoms.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had some diarrhea, headache and stuffy nose. I felt rundown to be safe I took a home COVID-19 test and so I set up a telehealth visit no prescription was given due to my mild symptoms.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Erythema, Mastitis, Swelling
Clinical narrative: Developed pain in the left breast 4 days after the vaccine, followed by an area of swelling and redness by day 6. Provider was seen on 3/3/23. Mastitis was suspected and I was placed on antibiotics. Symptoms began to resolve after a few days of taking antibiotics. Please note that I was not lactating or breastfeeding, and have never had any prior health issues with my breasts.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Nothing after the vaccine, no reaction at all. I started like sore throat, tired, I thought it was a cold, got headache. I took the home test for COVID-19, and it was positive. I called the doctor (telehealth visit), and she prescribed PAXLOVID. For 2 1/2 weeks I had sore throat, a dry cough, and I was very tired (fatigue). I feel better now, just a little fatigue, for the last 2 days no more cough.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Nothing after the vaccine, no reaction at all. I started like sore throat, tired, I thought it was a cold, got headache. I took the home test for COVID-19, and it was positive. I called the doctor (telehealth visit), and she prescribed PAXLOVID. For 2 1/2 weeks I had sore throat, a dry cough, and I was very tired (fatigue). I feel better now, just a little fatigue, for the last 2 days no more cough.
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Malaise, Muscle spasms, Nasopharyngitis
Clinical narrative: On 02/05/2023, I woke feeling terrible.  I had cold symptoms. I had neck spasms, neck and shoulder up to my ear. I had an appointment last week on 02/27/2023 because it is still bothering me. He examined it and suggested I use heat and gave me exercises and prescribed Flexeril.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Diarrhoea, Influenza virus test negative, Malaise
Clinical narrative: I woke up on the 31 of January with general symptoms of malaise, head congestion, fever late that night into the next day that was over 100F., diarrhea that lingered for a month. I stayed in bed for a couple of days trying to get in touch with my doctor after I had taken a home COVID-19 test that came back positive. I was unable to reach my doctor as it was the New Year holiday until the middle of the week, I was advised that it was too late to take the antiviral. I had received an MRNA influenza shot in November, I am a part of a study. I was tested to make sure I had not gotten the flu that was also negative. I do still have a lingering cough.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I woke up on the 31 of January with general symptoms of malaise, head congestion, fever late that night into the next day that was over 100F., diarrhea that lingered for a month. I stayed in bed for a couple of days trying to get in touch with my doctor after I had taken a home COVID-19 test that came back positive. I was unable to reach my doctor as it was the New Year holiday until the middle of the week, I was advised that it was too late to take the antiviral. I had received an MRNA influenza shot in November, I am a part of a study. I was tested to make sure I had not gotten the flu that was also negative. I do still have a lingering cough.
Age: 68.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Balance disorder, Dysgraphia, Dysstasia, Extremity contracture, Fall
Clinical narrative: In October of 2022, I was having problems getting up out of a chair. I was having problems rolling over in bed. I was having problems with my balance and had fallen twice. My toes were curling significantly in order to keep myself upright and my handwriting had changed completely. It was much smaller and very difficult to read. I went to see the doctor; he diagnosed me with Parkinson's disease. He prescribed Carbidopa-Levodopa. I'm reacting appropriately to the medication. Almost everything has gone back to normal. My handwriting is still not ideal but is legible. I am also still having some issues with balance, but other than that, everything has disappeared.