chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dehydration, Fatigue, Hot flush, Hyperhidrosis
Clinical narrative: hot flashes; sweats; back pain in the lower spine; dehydration; Deep libido; joint pain; exhausted and tired more quickly.; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (hot flashes), HYPERHIDROSIS (sweats), SPINAL PAIN (back pain in the lower spine), DEHYDRATION (dehydration) and LIBIDO INCREASED (Deep libido) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (hot flashes), HYPERHIDROSIS (sweats), SPINAL PAIN (back pain in the lower spine), DEHYDRATION (dehydration), LIBIDO INCREASED (Deep libido), ARTHRALGIA (joint pain) and FATIGUE (exhausted and tired more quickly. ). At the time of the report, HOT FLUSH (hot flashes), HYPERHIDROSIS (sweats), SPINAL PAIN (back pain in the lower spine), DEHYDRATION (dehydration), LIBIDO INCREASED (Deep libido), ARTHRALGIA (joint pain) and FATIGUE (exhausted and tired more quickly. ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient had two Moderna vaccinations against corona and haven't felt the same since then. The patient was not acutely ill, just exhausted and tired more quickly. Mild sweats/hot flashes sometimes. joint pain and back pain in the lower spine. The patient had deep libido. Sometimes there was a feeling of dehydration. Not extreme or short, but the patient felt like the patient had been aged a bit too much. Cancer and things like that have been examined by a family doctor and are luckily negative.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Libido increased, Spinal pain
Clinical narrative: hot flashes; sweats; back pain in the lower spine; dehydration; Deep libido; joint pain; exhausted and tired more quickly.; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (hot flashes), HYPERHIDROSIS (sweats), SPINAL PAIN (back pain in the lower spine), DEHYDRATION (dehydration) and LIBIDO INCREASED (Deep libido) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (hot flashes), HYPERHIDROSIS (sweats), SPINAL PAIN (back pain in the lower spine), DEHYDRATION (dehydration), LIBIDO INCREASED (Deep libido), ARTHRALGIA (joint pain) and FATIGUE (exhausted and tired more quickly. ). At the time of the report, HOT FLUSH (hot flashes), HYPERHIDROSIS (sweats), SPINAL PAIN (back pain in the lower spine), DEHYDRATION (dehydration), LIBIDO INCREASED (Deep libido), ARTHRALGIA (joint pain) and FATIGUE (exhausted and tired more quickly. ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient had two Moderna vaccinations against corona and haven't felt the same since then. The patient was not acutely ill, just exhausted and tired more quickly. Mild sweats/hot flashes sometimes. joint pain and back pain in the lower spine. The patient had deep libido. Sometimes there was a feeling of dehydration. Not extreme or short, but the patient felt like the patient had been aged a bit too much. Cancer and things like that have been examined by a family doctor and are luckily negative.  No treatment medication was reported.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Back pain, Cardiac disorder, Chest pain, Dyspnoea, Laboratory test normal
Clinical narrative: feels like pneumonia (difficulty breathing/when she takes a deep breath she has chest and back pain); The hospital told her it was related to her heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67-year-old female patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), on 25Aug2023 at 17:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (medically significant) with onset Aug2023, outcome "not recovered", described as "The hospital told her it was related to her heart"; PNEUMONIA (medically significant) with onset 25Aug2023 at 23:00, outcome "not recovered", described as "feels like pneumonia (difficulty breathing/when she takes a deep breath she has chest and back pain)". The events "feels like pneumonia (difficulty breathing/when she takes a deep breath she has chest and back pain)" and "the hospital told her it was related to her heart" required physician office visit and emergency room visit. The reporter's mother received PREVNAR 20 around 5pm on 25Aug2023.  She started having difficulty breathing that night at around 11pm. She went to the doctor 27Aug2023 as well as the hospital. The reporter stated when she takes a deep breath she has chest and back pain. She said it feels like pneumonia or like "her lungs grew". The hospital told her it was related to her heart but the tests came out normal. She still felt the same way 28Aug2023 but was getting a little worse now. Whenever she gets stung by a bee she gets a really bad reaction.  The reporter read on the website that a reaction comparison to a bee sting was given as an example and that was what she was having. He was calling to have his mother transported to the hospital.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Painful respiration, Pneumonia
Clinical narrative: feels like pneumonia (difficulty breathing/when she takes a deep breath she has chest and back pain); The hospital told her it was related to her heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67-year-old female patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), on 25Aug2023 at 17:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (medically significant) with onset Aug2023, outcome "not recovered", described as "The hospital told her it was related to her heart"; PNEUMONIA (medically significant) with onset 25Aug2023 at 23:00, outcome "not recovered", described as "feels like pneumonia (difficulty breathing/when she takes a deep breath she has chest and back pain)". The events "feels like pneumonia (difficulty breathing/when she takes a deep breath she has chest and back pain)" and "the hospital told her it was related to her heart" required physician office visit and emergency room visit. The reporter's mother received PREVNAR 20 around 5pm on 25Aug2023.  She started having difficulty breathing that night at around 11pm. She went to the doctor 27Aug2023 as well as the hospital. The reporter stated when she takes a deep breath she has chest and back pain. She said it feels like pneumonia or like "her lungs grew". The hospital told her it was related to her heart but the tests came out normal. She still felt the same way 28Aug2023 but was getting a little worse now. Whenever she gets stung by a bee she gets a really bad reaction.  The reporter read on the website that a reaction comparison to a bee sting was given as an example and that was what she was having. He was calling to have his mother transported to the hospital.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Device leakage
Clinical narrative: adapter piece snapped off the syringe and like couldn't use that vaccine/adapter broke/syringe containing sterile water with screw adapter piece on it,when he screwed it on,it broke off from syringe; would not let any of the sterile water go into the vial and ended up just like squirting out all over the counter; adapter piece snapped off the syringe and like couldn't use that vaccine/adapter broke/syringe containing sterile water with screw adapter piece on it,when he screwed it on,it broke off from syringe; patient received ABRYSVO via subcutaneous route; This is a spontaneous report received from a contactable reporter (Pharmacist), Program ID:.  A 68-year-old female patient received PF-06928316 (ABRYSVO, NDC number: 0069-0344-01), on 28Aug2023 at 03:30 as dose number unknown, 0.5 ml single (Lot number: HF7708, Expiration Date: Feb2025) at the age of 68 years subcutaneous, in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE USE ISSUE (non-serious) all with onset 28Aug2023 at 03:30 and all described as "adapter piece snapped off the syringe and like couldn't use that vaccine/adapter broke/syringe containing sterile water with screw adapter piece on it,when he screwed it on,it broke off from syringe"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Aug2023 at 03:30, described as "patient received ABRYSVO via subcutaneous route"; DEVICE LEAKAGE (non-serious) with onset 28Aug2023 at 03:30, described as "would not let any of the sterile water go into the vial and ended up just like squirting out all over the counter". Additional information: The pharmacist was trying to give Abrysvo vaccine to a patient, but the adapter piece snapped off the syringe and like he couldn't use that vaccine, so he had to open another one to give it to the patient. The pharmacist just wanted to report that. The pharmacist further reported that the adapter piece snapped off of the syringe piece, so it torn the vaccine and he had to give the patient another one. The adapter broke, so the syringe containing sterile water with the screw adapter piece on it, when he screwed it on, it broke off from the syringe and then would not let any of the sterile water go into the vial and ended up just like squirting out all over the counter. The reporter stated that the vaccine was for RSV. The pharmacist gave the vaccine shot at his pharmacy. The reporter was informed not to discard the product as the report would be forwarded for review by the Quality department and if it was determined that the sample would be needed for further evaluation, a pre-paid might be sent within 3 to 10 business days. The pharmacist confirmed that a sample of the product was available to be returned, if requested. The packaging was not sealed and intact, because he opened it up to trying give up the vaccine. The pharmacist kept the box, the syringe, and the adapter and everything that broke.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a few sore arms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  An elderly female 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization, reaction(s): "a few sore arms"; Bnt162b2 (Dose: 02), for Covid-19 immunization, reaction(s): "a few sore arms". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a few sore arms". Additional information: Reporter stated that they did have a relatively high opinion of Pfizer because both hiim and his wife (patient) and had received their COVID 19 shots and boosters from this company and they have had practically NO side effects to date; apart from a few sore arms for a day or two.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300149591 same reporter/AE, different patient;
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: fatigue; headaches; shortness of breath; nausea; flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Aug2023 at 16:00 as dose 1, single (Lot number: GK0928) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 28Aug2023, outcome "not recovered"; INFLUENZA LIKE ILLNESS (non-serious) with onset 28Aug2023, outcome "not recovered", described as "flu like symptoms"; HEADACHE (non-serious) with onset 28Aug2023, outcome "not recovered", described as "headaches"; NAUSEA (non-serious) with onset 28Aug2023, outcome "not recovered"; DYSPNOEA (non-serious) with onset 28Aug2023, outcome "not recovered", described as "shortness of breath". The events "fatigue", "headaches", "shortness of breath", "nausea" and "flu like symptoms" required physician office visit. Therapeutic measures were not taken as a result of fatigue, headache, dyspnoea, nausea, influenza like illness.  Additional Information: The patient has not taken any other vaccination in four weeks. 5 mental health treatment medications were taken in two weeks. The patient has been experiencing fatigue, headaches, shortness of breath and nausea. More flu like symptoms in the mornings and evenings. The patient was diagnosed with covid prior to vaccination and was not diagnosed with covid post vaccination. Has no known allergies
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Palpitations, Skin discomfort
Clinical narrative: I got burning like; my heart is off and on racing; feels like my skin and my brain dropped by; feels like my skin and my brain dropped by; This is a spontaneous report received from a 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), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy to Sulfonamide" (unspecified if ongoing), notes: sulfa allergy because I have an allergy to Sulfonamide (Unspecified Medication). The patient's concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious), outcome "not recovered", described as "I got burning like"; PALPITATIONS (non-serious), outcome "not recovered", described as "my heart is off and on racing"; FEELING ABNORMAL (non-serious), SKIN DISCOMFORT (non-serious), outcome "not recovered" and all described as "feels like my skin and my brain dropped by". The events "my heart is off and on racing" and "feels like my skin and my brain dropped by" required emergency room visit. The event "i got burning like" required physician office visit and emergency room visit.  Additional Information: Patient got burning; Sulfa allergy; Patient had an allergy to Sulfonamide; the reaction to patient's body was saying yes, there is (Sulfonamides). The event was reported as heart was off and on racing; It feels like skin and my brain dropped by; It was becoming unbearable. Further stated, patient got burning like, the only thing that can be described with us it is sulfa allergy because patient has an allergy to Sulfonamide (Unspecified Medication) and asked this doctor if there is sulfonamides in it when patient was seeing a doctor or pharmacist. If there was sulfonamide in this vaccine and he said no but my reaction to patient's body was saying yes, there is (Sulfonamides). Enquired if there was Sulfonamides in this drug. When paraphrased the concern, reporter stated, "Yes and what I need to do to get it to stop because my heart is off and on racing and it is feels like my skin and my brain dropped by." Enquired if patient should go to emergency room, called us because it was becoming unbearable. Patient was informed in case of emergency dial 911 or contact nearby healthcare provider. Reporter stated, "What they all seem to the part of your organizations, product line and I am afraid that I am just going to get run around and not get the problem fixed." Further stated, "I am going to go in the ER because I need this to stop."  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: 35.0
Sex: F
Vaccine: 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) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillen, reaction(s): "known allergies: Amoxicillen", notes: known allergies: Amoxicillen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: 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) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2022 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID, start date: Apr2005; ESTRADOT, start date: Apr2007. Past drug history included: Minocycline, reaction(s): "known allergies: Minocycline", notes: known allergies: Minocycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded. While the vaccine cannot provide full protection with only 1 dose, further clinical and diagnostic information is needed for meaningful medical assessment.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2023 as dose 3 (booster), single (Lot number: FH8030) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.
Sex: U
Vaccine: COVID19
Symptoms: Cholangitis acute
Clinical narrative: Acute cholangitis following mRNA COVID-19 vaccine booster in a patient; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Alzheimer's disease" (ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1 single, Unknown manufacturer), for Covid-19 Immunisation; Covid-19 vaccine (Dose 2 single, Unknown manufacturer), for Covid-19 Immunisation. The following information was reported: CHOLANGITIS ACUTE (medically significant), outcome "unknown", described as "Acute cholangitis following mRNA COVID-19 vaccine booster in a patient".; Sender's Comments: Based on the available information and the temporal association, a causal relationship between the reported event  acute cholangitis and BNT162B2 is considered possible. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: I had an allergic reaction to the Pfizer Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 70-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to sulfa" (unspecified if ongoing); "allergic to fish" (unspecified if ongoing); "allergic to seafood" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "allergic to Cipro". The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "I had an allergic reaction to the Pfizer Covid vaccine". The event "i had an allergic reaction to the pfizer covid vaccine" required emergency room visit.  Additional information: In the ER, the patient was told to not get any more boosters from Pfizer and Moderna. Later the patient was able to get a J& J plus a booster. However, since then, the patient was not able to get any more Covid boosters.   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: M
Vaccine: COVID19, FLUX
Symptoms: Sudden death
Clinical narrative: flu shot doesn't work, and that father died within 24 hours of getting the flu shot; Initial information received on 31-Aug-2023 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient who died within 24 hours of getting the flu shot, while receiving vaccines Influenza Vaccine and Covid-19 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 a dose of suspect Influenza Vaccine produced by unknown manufacturer (formulation, strength: unknown) (lot number, Expiry date: not reported) and suspect Covid-19 Vaccine not produced by Sanofi Pasteur (formulation, strength, lot number, Expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the flu shot doesn't work and patient died within 24 hours of getting the flu shot (sudden death) following the administration of Influenza Vaccine and Covid-19 Vaccine.   Final diagnosis was (fatal) flu shot doesn't work, and that father died within 24 hours of getting the flu shot.  No lab date reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Fatal for the event.  No autopsy was done. The cause of death was reported as Sudden Death.  Seriousness Criteria: This event was assessed as medically significant and was leading to death.; Sender's Comments: Sanofi company comment dated 05-Sep-2023: This case involves an unknown age male patient "who died within 24 hours of getting the flu shot", while receiving vaccines Influenza Vaccine. Furthermore, information regarding condition at the time of vaccination, medical history, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, family history, autopsy details would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: flu shot doesn't work, and that father died within 24 hours of getting the flu shot
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received pentacel, daptacel and act-hib so the dtap and hib portion is doubled with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 2-year-old female patient received pentacel, daptacel and HIB (PRP/T) vaccine [ACT-HIB] so the dtap and hib portion is doubled 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 diphtheria vaccine toxoid, HIB vaccine CONJ (TET TOX), pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), tetanus vaccine toxoid (Pentacel) for Prophylactic vaccination; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination; and hepatitis A vaccine INACT (HEP A IN VAC) for Prophylactic vaccination.  On 22-Aug-2023, the patient received a 0.5 ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength: unknown) (lot: UJ837AAA, expiry date: 30-Oct-2023) via intramuscular route in unknown administration site for Immunization and patient received pentacel, daptacel and act-hib so the dtap and hib portion is doubled with no reported adverse event (extra dose administered) (latency: same day).  It was unknown if any lab data/test results available.  Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive. 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: 4.0
Sex: F
Vaccine: HIBV, UNK
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: administered reconstituted pentacel along with another non-sanofi hib vaccine to a patient concurrently with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4-year-old female patient for whom reconstituted Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] was administered along with another non-sanofi hib vaccine HIB vaccine CONJ (OMPC) [Pedvaxhib] concurrently with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Aug-2023, the patient received a dose of 0.5 ml (Frequency: twice)  dose 1 of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine of standard strength suspension for injection (lot: UJ8768A, Expiry date: 19-Mar-2024) via intramuscular route in left administration site for Immunization along with another non-sanofi hib vaccine PEDVAXHIB not produced by Sanofi Pasteur with unknown strength, batch number & expiry date to a patient concurrently with no reported adverse event (product preparation error) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was 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.
Sex: U
Vaccine: MEN, TDAP
Symptoms: Rash
Clinical narrative: rash; Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Sales Representative).  This case is linked to case 2023SA265313.  This case involves a patient of an unknown age and gender who experienced rash after receiving vaccines Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid [BOOSTRIX] and 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 an unknown date, the patient received a unknown dose of suspects Meningococcal A-C-Y-W135 (T Conj) Vaccine solution for injection and Boostrix (formulation: unknown) not produced by Sanofi Pasteur both with unknown strength, expiry date and lot number via unknown route in unknown administration site for immunization.  On an unknown date, the patient developed rash (unknown latency).  Information on the batch number was requested.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest X-ray normal, Dizziness, Dyspnoea, Fibrin D dimer
Clinical narrative: Presented with SOB, sore throat, dizziness;  onset 12/08/2021.  +Covid  12/11/2021 Dx: Covid PNA Labs: D-dimer: >20; Procal 0.2. CXR: clear TX: 1 Dose of Toci given 12/12; steroids, remdesivir, (12/11/2021 to 12/15/2021) lovenox, sigulair, zinc; Initially HFNC 60/84 O2; down to 3 LPM NC upon d/c
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Procalcitonin, SARS-CoV-2 test positive
Clinical narrative: Presented with SOB, sore throat, dizziness;  onset 12/08/2021.  +Covid  12/11/2021 Dx: Covid PNA Labs: D-dimer: >20; Procal 0.2. CXR: clear TX: 1 Dose of Toci given 12/12; steroids, remdesivir, (12/11/2021 to 12/15/2021) lovenox, sigulair, zinc; Initially HFNC 60/84 O2; down to 3 LPM NC upon d/c
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, COVID-19 pneumonia, Chest X-ray abnormal, Dyspnoea, Endotracheal intubation
Clinical narrative: Presented with SOB; Intubated by EMS PTA; Dx Covid PNA; CXR: patchy infiltrates bilat; Labs: D-dimer: 2.06; CRP: 13.26; Procal: 0.23; Ferritin: 633  Tx: Maxipine, Rocephin, Zithromax, Decadron (10 days); Toci x1; lovenox, levo intitally, extubated 2/1/22; back to baseline of 4L NC upon discharge
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Lung infiltration, Procalcitonin, Serum ferritin increased
Clinical narrative: Presented with SOB; Intubated by EMS PTA; Dx Covid PNA; CXR: patchy infiltrates bilat; Labs: D-dimer: 2.06; CRP: 13.26; Procal: 0.23; Ferritin: 633  Tx: Maxipine, Rocephin, Zithromax, Decadron (10 days); Toci x1; lovenox, levo intitally, extubated 2/1/22; back to baseline of 4L NC upon discharge
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, C-reactive protein increased, COVID-19 pneumonia, Chest X-ray abnormal, Dyspnoea
Clinical narrative: Presented with SOB/fever; DX: Covid PNA Labs: D-Dimer: 0.62; CRP: 11.6; Ferritin: 368 CXR: bil infiltrates   TX: Steroids, remdesivir, lovenox, zinc, singulair; Initially on 5 LPM NC; went up to Bipap and High Flow O2 (60/80); back down to 3 LPM NC at d/c; cont O2 @ home
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Lung infiltration, Positive airway pressure therapy, Pyrexia, Serum ferritin increased
Clinical narrative: Presented with SOB/fever; DX: Covid PNA Labs: D-Dimer: 0.62; CRP: 11.6; Ferritin: 368 CXR: bil infiltrates   TX: Steroids, remdesivir, lovenox, zinc, singulair; Initially on 5 LPM NC; went up to Bipap and High Flow O2 (60/80); back down to 3 LPM NC at d/c; cont O2 @ home
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, COVID-19 pneumonia, Chest X-ray abnormal, Cough, Dyspnoea
Clinical narrative: Presented with cough/SOB, fever, sore throat; DX Covid PNA; CXR: infiltrates and consolidation LABS: D-dimer: 0.65; CRP: 22.86; Ferritin: 453; Tx: doxycycline, rocephin, decadron, remdesivir,  zinc, singulair, Vit C, Vit D, Baricitinib, Lovenox, antitussives, bronchodilators; Intially on 4LPM O2; 1/27 O2 req up to Bipap, FiO2 100%; 1/28 to ICU for resp support/monitoring; 2/6 FiO2 down  to 6LPM NC; 2/7 Out of ICU; d/c to LTAC; remains on 6 LPM O2
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Intensive care, Lung consolidation, Lung infiltration, Oropharyngeal pain
Clinical narrative: Presented with cough/SOB, fever, sore throat; DX Covid PNA; CXR: infiltrates and consolidation LABS: D-dimer: 0.65; CRP: 22.86; Ferritin: 453; Tx: doxycycline, rocephin, decadron, remdesivir,  zinc, singulair, Vit C, Vit D, Baricitinib, Lovenox, antitussives, bronchodilators; Intially on 4LPM O2; 1/27 O2 req up to Bipap, FiO2 100%; 1/28 to ICU for resp support/monitoring; 2/6 FiO2 down  to 6LPM NC; 2/7 Out of ICU; d/c to LTAC; remains on 6 LPM O2
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Positive airway pressure therapy, Pyrexia, Serum ferritin increased
Clinical narrative: Presented with cough/SOB, fever, sore throat; DX Covid PNA; CXR: infiltrates and consolidation LABS: D-dimer: 0.65; CRP: 22.86; Ferritin: 453; Tx: doxycycline, rocephin, decadron, remdesivir,  zinc, singulair, Vit C, Vit D, Baricitinib, Lovenox, antitussives, bronchodilators; Intially on 4LPM O2; 1/27 O2 req up to Bipap, FiO2 100%; 1/28 to ICU for resp support/monitoring; 2/6 FiO2 down  to 6LPM NC; 2/7 Out of ICU; d/c to LTAC; remains on 6 LPM O2
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient was given a vaccine that was over the use by date
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: patient administered vaccine after the use by date had expired
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine administered to the patient after expiration of the use by date
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: vaccine administered after expiration of the use by date
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: None. No symptoms or signs were observed.
Age: 21.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given DTaP instead of Tdap. Patient did not have any adverse reactions to the DTaP, she was just given the wrong vaccine.
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: vaccine administered after the expiration of the use by date
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: vaccine administered after expiration of the use by date
Age: 4.0
Sex: F
Vaccine: COVID19-2, HEPA
Symptoms: Product preparation issue
Clinical narrative: RN) failed to dilute the Covid vaccine prior to administering.  The child received 0.2 ml Pfizer Bivalent vaccine undiluted.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, PNC15
Symptoms: Product preparation error
Clinical narrative: Hib Conjugate vaccine reconstituted with incorrect diluent.  Instead of vaccine being reconstituted with the supplied SALINE DILUENT (0.4% SODIUM CHLORIDE) 0.6mL [UJ797AA exp 9/10/23) it was reconstituted with the STERILE DILUENT (STERILE WATER) 0.7mL [U035269 exp 4/5/2024] supplied for MERCK SHARP AND DOHME CORP LIVE VIRUS VACCINES.  This error has been reported to the Department of Health and repeat vaccination has been recommended to the family.
Age: 0.75
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine was given to soon
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Nausea, Pallor
Clinical narrative: Technician admin vaccine. Mild vasovagal response after 3rd vaccine. Patient reported feeling nauseous, became pale, and hot. Patient was sitting in chair and no LOC. Pharmacist called over to assist in management. Patient provided water. Patient had color return immediately, was still feeling hot. Patient was fanned to help cool and bp was taken. BP 101/78 pulse 61. Patient provided a KitKat. Patient symptoms resolved and felt better; wanted to go outside with husband to get fresh air. We requested patient to wait in area, but patient insisted with husband that they would just like to get fresh air outside and will let us know if they have any other issues. Patient was pleasant with us and husband was also very comforting for wife.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid 19 Breakthrough Infection.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine was given after 12 years of age
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Hypertension, Respiratory failure
Clinical narrative: J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/24/2023 HTN (HYPERTENSION)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Delivery, Live birth, Obstructive sleep apnoea syndrome
Clinical narrative: G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MILD MATERNAL DELIVERY OUTCOME, SINGLETON BIRTH, LIVEBORN
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covis-19 Breakthrough infection  Vaccine site: APOTHECARY
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthritis, Loss of personal independence in daily activities, Muscle spasms, Muscular weakness, Pain
Clinical narrative: Soon after the 2nd dosage of the vaccine I began to get cramping and arthritic symptoms in both my hands.  It lasted for about 90-120 days and then subsided.  However, after the booster shot (3rd dose), the symptoms returned and have not subsided, but instead have worsened.  It is hard to write, use tools or participate in daily life without pain in all my fingers and both thumbs.  My hand strength has weakened significantly and continues to get worse.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Symptom recurrence
Clinical narrative: Soon after the 2nd dosage of the vaccine I began to get cramping and arthritic symptoms in both my hands.  It lasted for about 90-120 days and then subsided.  However, after the booster shot (3rd dose), the symptoms returned and have not subsided, but instead have worsened.  It is hard to write, use tools or participate in daily life without pain in all my fingers and both thumbs.  My hand strength has weakened significantly and continues to get worse.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: I82.409 ACUTE DVT, UNSPECIFIED VEIN 3/28/2023 HX OF DIABETIC FOOT ULCER
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection  Vaccine Site: MEDICAL CENTER
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine given too early. Vaccine given was for ages 5-11 years. Patient was 4 years old at the time of immunization.  Spoke with Mother, patient had no adverse reactions at the time of immunization.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Death
Clinical narrative: COVID-related death/ breakthrough death
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC15
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pentacel was in advertently administered. Patient did not have an adverse event.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given the incorrect vaccines, the provider was informed and the parent was informed. No reactions or adverse events were reported.
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient was given the combo MMRV instead of given  a varivax and a MMRII
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Blood test, Electroencephalogram, Epilepsy, Heavy metal increased, Scan brain
Clinical narrative: After receiving this vaccination on a Monday that same week on Friday, he had two seizures and then the following month he had two seizures because all of the heavy metals were still in his system. His provider never never warned me about the side effects that this vaccine could have, and she never reported it to the CDC. Instead, they intentionally wrongfully diagnosed him with epilepsy instead of a vaccine injury like it was. He was wrongfully, diagnosed and placed on medication. I?ve been fighting with them for years about this. With them, knowing that a seizure to be the outcome to this particular vaccine
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Seizure
Clinical narrative: After receiving this vaccination on a Monday that same week on Friday, he had two seizures and then the following month he had two seizures because all of the heavy metals were still in his system. His provider never never warned me about the side effects that this vaccine could have, and she never reported it to the CDC. Instead, they intentionally wrongfully diagnosed him with epilepsy instead of a vaccine injury like it was. He was wrongfully, diagnosed and placed on medication. I?ve been fighting with them for years about this. With them, knowing that a seizure to be the outcome to this particular vaccine
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccine on Friday, September 1 at 353pm. The morning of Tuesday, September 5, at approximately 930am, the patient contacted the pharmacy discuss her vaccine related adverse event. The patient states she has red, circular swelling, about the size of a golf ball, at the injection site location. It is warm, itchy and somewhat painful to touch. The patient was advised to alternate heat and ice on the injection site. Also, if able, it was recommended she take some otc ibuprofen and acetaminophen to help with the pain and swelling. If the swelling continues, or worsens, over the next 24-48 hours, she should contact her PCP.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site reaction, Malaise, Pain
Clinical narrative: site reaction, low fever, chills, headache, body pain, malaise lasting 48 hrs.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: site reaction, low fever, chills, headache, body pain, malaise lasting 48 hrs.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: The patient experienced a syncopal episode lasting approximately 5-10 seconds. He regained consciousness spontaneously after laying down. The patient took approximately 30 minutes to return to baseline after laying, sitting, drinking some juice, and eating some crackers.
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue  Sore arm 4-5 Days
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired as of 5/30/2023. Patient did not report any adverse symptoms.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Cerebellar infarction, Computerised tomogram head, Magnetic resonance imaging
Clinical narrative: posterior medulla/inferior cerebellar peduncle infarct
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient arrives to back to school vaccine clinic with mom. Mom indicates that patient is in need if a bivalent vaccine. Mom has patients vaccine card in hand which have 3 vaccines listed- non listed as bivalent. Per vaccine card and Mom indication patient given bivalent vaccine dose per CDC guidelines. After clinic it was discovered that patients 3rd COVID vaccine dose was in fact a bivalent dose therefore dose given on 8/19/23 was not needed. Patient was monitored post vaccine per protocol with no adverse event noted.
Age: 75.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Swollen bump that occurred immediately at the site of the injection.  The bump was gone after monitoring the patient for 15 minutes.
Age: 44.0
Sex: M
Vaccine: UNK
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Feinting / passed out.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia, Sensory loss
Clinical narrative: 2 weeks after receive a sub-cutaneous MMR booster in the left lateral deltoid, Employee reported tingling parasthesia, lateral deltoid in an area now measuring 15 x 7 cm.  She notes the tingling when she reaches forward or engages her deltoid muscle.  She notes decreased sensation to light touch in this area at all times, but it did not start until 2 weeks after receiving the MMR on 02 AUG 2023.  No treatment is rendered at this time. It is not clear if these symptoms are related to the vaccination.  It is possible that a superior lateral brachial cutaneous nerve was irritated by the 02 AUG 2023 vaccine.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: Vaccine was given to a patient too young to receive vaccine. Vaccine is intended for ages 12 years and older.   Patient's mother contacted, and reported no adverse reactions from a year ago.