chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Peripheral swelling
Clinical narrative: swelled up, his hands, feet and legs; He had issues with arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: He had issues with arthritis; "Car accidents" (unspecified if ongoing), notes: he played ball, football and baseball and had been in a couple of car accidents. The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelled up, his hands, feet and legs"; ARTHRITIS (non-serious), outcome "unknown", described as "He had issues with arthritis".  Additional information: Caller states that her son had the Pfizer shot and he swelled up, his hands, feet and legs. He had issues with arthritis and he played ball, football and baseball and had been in a couple of car accidents. Caller declined to proceed with report on her son.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Sep2021 as dose 1, single (Lot number: FE3592), in left arm and on 08Oct2021 at 13:15 as dose 2, single (Lot number: FF8839) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "esophageal ca" (unspecified if ongoing), notes: other medical history: esophageal ca; "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 25Apr2022, stop date: 09May2022; DEXAMETHASONE, start date: 05May2022, stop date: 06May2022; OMEPRAZOLE, start date: 25Apr2022, stop date: 09May2022; FERROUS [IRON], start date: 25Apr2022, stop date: 09May2022; ZINC [ZINC SULFATE], start date: 25Apr2022, stop date: 09May2022; VITAMIN B-12, start date: 25Apr2022, stop date: 09May2022; KEYTRUDA, start date: 04May2022, stop date: 04May2022; ALOXI, start date: 04May2022, stop date: 04May2022; LEUCOVORIN [FOLINIC ACID], start date: 04May2022, stop date: 04May2022; OXALIPLATIN, start date: 04May2022, stop date: 04May2022; ADRUCIL, start date: 04May2022, stop date: 06May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Headache, Malaise, Pyrexia
Clinical narrative: partner with COVID sx since 02May2022 and then tested positive on 07May; partner with COVID sx since 02May2022 and then tested positive on 07May; feels seriously ill; hard to breathe; fever; HA; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 28-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 09May2022, outcome "unknown", described as "HA"; MALAISE (non-serious) with onset 09May2022, outcome "unknown", described as "feels seriously ill"; PYREXIA (non-serious) with onset 09May2022, outcome "unknown", described as "fever"; DYSPNOEA (non-serious) with onset 09May2022, outcome "unknown", described as "hard to breathe"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "unknown" and all described as "partner with COVID sx since 02May2022 and then tested positive on 07May". The events "partner with covid sx since 02may2022 and then tested positive on 07may", "feels seriously ill", "hard to breathe", "fever" and "ha" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive; (09May2022) Positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162b2.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: partner with COVID sx since 02May2022 and then tested positive on 07May; partner with COVID sx since 02May2022 and then tested positive on 07May; feels seriously ill; hard to breathe; fever; HA; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 28-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 09May2022, outcome "unknown", described as "HA"; MALAISE (non-serious) with onset 09May2022, outcome "unknown", described as "feels seriously ill"; PYREXIA (non-serious) with onset 09May2022, outcome "unknown", described as "fever"; DYSPNOEA (non-serious) with onset 09May2022, outcome "unknown", described as "hard to breathe"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "unknown" and all described as "partner with COVID sx since 02May2022 and then tested positive on 07May". The events "partner with covid sx since 02may2022 and then tested positive on 07may", "feels seriously ill", "hard to breathe", "fever" and "ha" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive; (09May2022) Positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162b2.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Breast cancer
Clinical narrative: breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 at 09:30 as dose 3 (booster), single (Lot number: FC3180) at the age of 72 years intramuscular, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 11Oct2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Time: 10:00, Anatomical location: Arm, Route of administration: Intramuscular, Batch/lot number: EL9267, Expiry date: 03May2021), administration date: 03Mar2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2, Time: 10:00, Anatomical location: Arm, Route of administration: Intramuscular, Batch/lot number: EN9267, Expiry date: 31Jul2021), administration date: 23Mar2021, when the patient was 72-year-old, for COVID-19 immunization. The following information was reported: BREAST CANCER (medically significant) with onset 25Dec2021, outcome "not recovered". The patient underwent the following laboratory tests and procedures: Biopsy: (25Dec2021) Breast cancer. Therapeutic measures were taken as a result of breast cancer. Clinical course included: Patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FJ4991). She did not receive prior vaccinations. Breast cancer was treated with 3 doses of 1mg Anastrozole on 11Apr2022, 12Apr2021 and 13Apr2022.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: got the 2nd booster shot and asked if it is safe to take the acetaminophen 325mg for pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. 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; Covid-19 vaccine (Dose Number Unknown (BOOSTER), unknown manufacturer), for Covid-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "got the 2nd booster shot and asked if it is safe to take the acetaminophen 325mg for pain".  Additional Information: Patient reported that he got the 2nd booster shot and asked if it is safe to take the acetaminophen 325mg for pain. confirmed he hadn't taken the drug yet and wanted to confirm before taking it. Caller mentioned he went back from the hospital. No transfer (Call got disconnected) Created Form. Caller refused to provide phone number attempted to provide  phone number but caller refused and decided to call his doctor instead.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This one lady didn't have cancer and she was dead in three weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received 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: DEATH (death, medically significant), outcome "fatal", described as "This one lady didn't have cancer and she was dead in three weeks". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical information: Caller is a consumer who states "my sister was going on and on about deaths related to covid injections" later clarifying she was speaking about the Pfizer-Covid19 vaccine. She states "We've had several friends up and die. she's had 4 friends develop cancer quickly and die after receiving the vaccine. This one lady didn't have cancer and she was dead in three weeks." Later adding "I think she's worried about long-term side effects" not those close to administration but "5 months later they got sick and died, people who had cancer and it came back quickly". She states her sister has been doing a lot of research online, but she's not sure what sources she's reading.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: This one lady didn't have cancer and she was dead in three weeks
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Limb discomfort, Muscle twitching, Pain
Clinical narrative: After the second vaccine, it felt like she had bee stings all through her legs for 3 hours.; Her legs were stinging and burning and, it was just like when she got her second vaccination; Her legs were stinging and burning and, it was just like when she got her second vaccination; Her legs started to have twitching, like muscle twitching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 01Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (Dose 1, Lot Number / Expiry Date: Unknown, Route of administration and Anatomical Location: not provided), administration date: 24Jun2021, when the patient was 46-year-old, for COVID-19 immunization; Tetanus shot (Her tetanus shot, like 5 or 6 years ago), for immunization. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "not recovered", described as "After the second vaccine, it felt like she had bee stings all through her legs for 3 hours."; BURNING SENSATION (non-serious), PAIN (non-serious), outcome "not recovered" and all described as "Her legs were stinging and burning and, it was just like when she got her second vaccination"; MUSCLE TWITCHING (non-serious), outcome "not recovered", described as "Her legs started to have twitching, like muscle twitching". Therapeutic measures were taken as a result of limb discomfort, burning sensation, pain, muscle twitching.  Additional information: Reporter stated that, patient did not receive any prior vaccinations (within 4 weeks). Patient has not had any vaccinations since her tetanus shot, like 5 or 6 years ago. No family medical history reported relevant to ae(s). After the second vaccine, it felt like she had bee stings all through her legs for 3 hours, patient felt this the other day when she put her feet up. Patient legs started to have twitching, like muscle twitching. Her legs were stinging and burning and, it was just like when she got her second vaccination. It was clarified that patient experienced events the other day after the vaccination. Reporter stated that, patient was still experiencing events but, it was not as much of the deep throbbing and aching. It was her whole entire limbs of her legs. Patient tried Aleve and stated that it doesn't help.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: U
Vaccine: FLUR4
Symptoms: Product storage error
Clinical narrative: total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C, 30 minutes with a...; Initial information received on 29-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 57 years old and unknown gender patient who was administered Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv] after the vaccine was exposed to a temperature excursion with no reported adverse events.  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 Quadrivalent Recombinant Vaccine (lot QFAA2125, expiry date: 30-Jun-2022) (formulation, strength, dose and route not reported) for immunization.  On an unknown date, the patient was administered Influenza Quadrivalent Recombinant Vaccine  after the vaccine was exposed to a temperature excursion total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C reported, total time out of range is 30 minutes with a minimum of 12.3C and maximum of 15.6C reported. total time out of range is 1 hour with a minimum of negative 1.8C and maximum of 1.8C reported (product storage error) (unknown latency).  Action taken 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.92
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C/1 hour with a minimum of negative 1.8C and maximum of 1.8C (with no reported adverse event); Initial information received on 29-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 months old and unknown gender patient who experienced total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c/1 hour with a minimum of negative 1.8c and maximum of 1.8c (with no reported adverse event) while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  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 DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c/1 hour with a minimum of negative 1.8c and maximum of 1.8c (with no reported adverse event) (product storage error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c/1 hour with a minimum of negative 1.8c and maximum of 1.8c (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.
Age: 1.75
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: He is only 21 months old We gave him the 5th dose of Prevnar 13; He had a Pentacel within 4 weeks with no AE; Initial information received on 28-Apr-2022 regarding an unsolicited valid non-serious courtesy case received from a other health professional.  This case involves a 21 months old male patient who experienced he is only 21 months old we gave him the 5th dose of prevnar 13; he had a pentacel within 4 weeks with no adverse e vent while receiving vaccine Diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  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 Diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection, unknow strength, frequency, dose, expiration date and  lot number not reported via unknown route in unknown administration site for unknown indication.  On an unknown date the patient developed a non-serious he is only 21 months old we gave him the 5th dose of prevnar 13; he had a pentacel within 4 weeks with no ae (inappropriate schedule of product administration) (unknown latency) following the administration of Diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken with Diphtheria, tetanus, ac pertussis, ipv and hib vaccine (Pentacel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (He is only 21 months old We gave him the 5th dose of Prevnar 13; He had a Pentacel within 4 weeks with no Adverse Event).  At time of reporting, the outcome was Unknown for the event he is only 21 months old we gave him the 5th dose of prevnar 13; he had a pentacel within 4 weeks with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTPPVHBHPB, IPV, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature of the refrigerator reached 50 degrees Fahrenheit due to leaving the door ajar; Initial information received on 21-Apr-2022 regarding an unsolicited valid  non-serious case received from a health care professional.  This case is related to 2022SA145411, 2022SA143935.   This case involves Adult patient of unknown demographics who had storage error when temperature of the refrigerator reached 50 degrees Fahrenheit due to leaving the door ajar with no reported adverse event involving the vaccines diphtheria vaccine toxoid, hepatitis b vaccine RHBSAG (yeast), HIB vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid [Vaxelis], diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] and IPV (vero) [Ipol].  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 IPV (VERO) suspension for injection (strength, frequency was unknown, lot T1E871M and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, vaccines diphtheria-2/tetanus/5 AC pertussis vaccine (Batch number: U7276AA, Expiry date: 21-Jan-2024), diphtheria vaccine toxoid, hepatitis b vaccine RHBSAG (yeast), HIB vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero) tetanus vaccine toxoid (Batch number: C5808AA, Expiry date: 14-Jan-2024), IPV (vero) (Batch number: T1E871M, Expiry date: 10-Oct-2022) to be given for immunization were exposed to a temperature of 50 degrees Fahrenheit due to leaving the refrigerator door ajar with no reported adverse event (product storage error). It was not aware by caller as to how long the excursion lasted and was trying to find the information.  Further, it was reported that patient had received IPOL and having an adverse reaction.  Action taken: Not applicable.  It was not reported if any corrective measurements were taken for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 29-Apr-2022 from other health care professional: Case was update from non-valid to valid as number of patient was added, age group was added, clinical course updated, text amended accordingly.; Sender's Comments:  US-SA-2022SA145411:Related case ID (IPOL-open) US-SA-2022SA143935:Related case ID (VAXELIS)
Age: 66.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event, Off label use
Clinical narrative: expired MENACTRA was administered to a 66 year old post-splenectomy patient (with no reported adverse event); off-label use as per local labelling due to administering MENACTRA to a patient who is 66 years old and outside of the approved age group (with no reported adverse event); Initial information received on 28-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 66 years old female patient to whom expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra]. was administered post-splenectomy (with no reported adverse event) and off-label use as per local labelling due to administering menactra to a patient who is 66 years old and outside of the approved age group (with no reported adverse event)   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Apr-2022, the patient received 0.5 mL Dose (if series -2) of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] lot U6920AA, expiry date: 15-Apr-2022 (strength and formulation not reported) via intramuscular route in the left deltoid for Prophylactic vaccination.  Practice manager stated that they administered an expired dose of MENACTRA to a patient (expired product administered) on 28-Apr-2022, latency same day. Practice manager asked how they should proceed and if they would need to re-administer the dose? Practice manager also mentioned that the expired MENACTRA was administered to a 66-year-old post-splenectomy patient. This situation was reported as a medication error due to administering expired MENACTRA to a patient. This situation was reported as an off-label use as per local labelling due to administering MENACTRA to a patient who was 66 years old and outside of the approved age group (product administered to patient of inappropriate age) (onset date 28-Apr-2022, latency same day).   First time product used : No  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Hib portion that was not given/not reconstituted with the Hib powder portion with no reported adverse event; Liquid portion DTaP-IPV of pentacel that was not reconstituted with the Hib powder portion with no reported adverse event; Initial information received on 29-Apr-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 2 months old female patient who experienced hib portion that was not given/not reconstituted with the hib powder portion with no reported adverse event and liquid portion dtap-ipv of pentacel that was not reconstituted with the hib powder portion with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine for Prophylactic vaccination; and pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for Prophylactic vaccination.  On 29-Apr-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at a dose of 0.5 ml; lot U6985AA and expiry date: 10-Jul-2022, lot UJ543AA and expiry date: 10-Jul-2022 and lot UJ543AAA, expiry date: 10-Jul-2022 via intramuscular route in the left vastus lateralis for Immunization.  On 29-Apr-2022 (latency: same day) the patient developed a non-serious hib portion that was not given/not reconstituted with the hib powder portion with no reported adverse event (incorrect dose administered) and also liquid portion dtap-ipv of pentacel that was not reconstituted with the hib powder portion with no reported adverse event (product preparation issue) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken: not applicable.  Outcome: unknown for both the events  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: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: one of the lots for acthib had an expired diluent for march and the vaccine expired in may, 2 months later, physician gave it to a patient with no reported adverse event; Initial information received on 29-Apr-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who experienced one of the lots for acthib had an expired diluent for march and the vaccine expired in may, 2 months later, physician gave it to a patient with no reported adverse event while receiving vaccine HIB (PRP/T) Vaccine [ACT-HIB].  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 HIB (PRP/T) Powder and solvent for solution for injection unknown strength, dose, frequency, expiration date and lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious one of the lots for acthib had an expired diluent for march and the vaccine expired in may, 2 months later, physician gave it to a patient with no reported adverse event (expired product administered) (unknown latency) following the administration of HIB (PRP/T) vaccine.  Action taken with Haemophilus type b (hib) vaccine (act-hib) was not applicable.  It was not reported if the patient received a corrective treatment for the event (one of the lots for acthib had an expired diluent for march and the vaccine expired in may, 2 months later, physician gave it to a patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event one of the lots for acthib had an expired diluent for march and the vaccine expired in may, 2 months later, physician gave it to a patient 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.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Blood test, Chest X-ray, Dyspnoea, Electrocardiogram
Clinical narrative: Atrial Flutter - High Blood Pressure - Shortness of Breathe  (two visits to ER )
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Atrial Flutter - High Blood Pressure - Shortness of Breathe  (two visits to ER )
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site reaction
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Bruising and "Pooling" of vaccine below injection site-Mild, Additional Details: Patients states there was a bruise that formed a line all the way around her arm above her elbow, and just above that she thinks it was the vaccine "pooling".  Resolve within 2 days
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Injection site erythema, Rash, Syncope
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Person with her said she has concerns with injections but hasnt fainted with previous Pfizer Covid injection(s)  I attempted phone call to her residence 8:15pm to check on her but no answer. Event occured est 6:30pm, 911 emergency personel arrived 6:37pm, taken by stretcher 6:48pm
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Person with her said she has concerns with injections but hasnt fainted with previous Pfizer Covid injection(s)  I attempted phone call to her residence 8:15pm to check on her but no answer. Event occured est 6:30pm, 911 emergency personel arrived 6:37pm, taken by stretcher 6:48pm
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong route
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient came to pharmacy to get 2nd booster. Patient was administered 0.5ml instead of 0.25ml of vaccine. At this time patient is not experiencing any out of sorts side effects.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, COVID-19, Chest X-ray normal, Cough, Dyspnoea
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 05/01/2021 and 2nd vaccine on 05/22/2021.  70 y/o male with PMHx of HTN, HLD, COPD, OSA with CPAP presents to ED with c/o SOB and cough x3 days.  Pt O2sat on room air 97%, Afebrile and CXR with no acute findings.  CTA Chest with scattered pulmonary nodules.  Pt admitted and started on IV Steroids and ABX.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary mass, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 05/01/2021 and 2nd vaccine on 05/22/2021.  70 y/o male with PMHx of HTN, HLD, COPD, OSA with CPAP presents to ED with c/o SOB and cough x3 days.  Pt O2sat on room air 97%, Afebrile and CXR with no acute findings.  CTA Chest with scattered pulmonary nodules.  Pt admitted and started on IV Steroids and ABX.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Agonal respiration, Amnesia, Cold sweat, Dizziness, Fatigue
Clinical narrative: Patient received 2 Pfizer boosters. This was his first time receiving Pfizer. Patient remained in waiting room after administration. After about 5 minutes post vaccination, Patient stated he was starting to feel "funny", light headed and dizzy. He thought his B/P was low. Patient had eaten breakfast. Was giving water. B/P was 100/68. Patient was clammy and diaphoretic. Patient briefly passed out in chair and was able to arouse with sternal rub. NPs started to reposition patient with legs up, when patient collapsed. Patient's breathing was irregular and agonal. Both NPs were not able to find a pulse after assessing for 15 seconds by palpation or auscultation. Patient brought to floor; instructed PCT to call 911. 1 NP went to obtain first aid box/ CPR mask; While that was occurring the other started compressions as due to lack of pulse and adequate breathing. (only 1-2 agonal breaths/ min). After 1 round of chest compressions completed, patient arouse. Patient was very drowsy and "tired" and didn't remember anything about the event. B/P was reassessed after a few minutes (130/70).  When EMS arrived, Patient was still drowsy and awake. Transported to the hospital via stretcher and later discharge.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Hypotension, Irregular breathing, Loss of consciousness
Clinical narrative: Patient received 2 Pfizer boosters. This was his first time receiving Pfizer. Patient remained in waiting room after administration. After about 5 minutes post vaccination, Patient stated he was starting to feel "funny", light headed and dizzy. He thought his B/P was low. Patient had eaten breakfast. Was giving water. B/P was 100/68. Patient was clammy and diaphoretic. Patient briefly passed out in chair and was able to arouse with sternal rub. NPs started to reposition patient with legs up, when patient collapsed. Patient's breathing was irregular and agonal. Both NPs were not able to find a pulse after assessing for 15 seconds by palpation or auscultation. Patient brought to floor; instructed PCT to call 911. 1 NP went to obtain first aid box/ CPR mask; While that was occurring the other started compressions as due to lack of pulse and adequate breathing. (only 1-2 agonal breaths/ min). After 1 round of chest compressions completed, patient arouse. Patient was very drowsy and "tired" and didn't remember anything about the event. B/P was reassessed after a few minutes (130/70).  When EMS arrived, Patient was still drowsy and awake. Transported to the hospital via stretcher and later discharge.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulse absent, Resuscitation, Somnolence, Syncope
Clinical narrative: Patient received 2 Pfizer boosters. This was his first time receiving Pfizer. Patient remained in waiting room after administration. After about 5 minutes post vaccination, Patient stated he was starting to feel "funny", light headed and dizzy. He thought his B/P was low. Patient had eaten breakfast. Was giving water. B/P was 100/68. Patient was clammy and diaphoretic. Patient briefly passed out in chair and was able to arouse with sternal rub. NPs started to reposition patient with legs up, when patient collapsed. Patient's breathing was irregular and agonal. Both NPs were not able to find a pulse after assessing for 15 seconds by palpation or auscultation. Patient brought to floor; instructed PCT to call 911. 1 NP went to obtain first aid box/ CPR mask; While that was occurring the other started compressions as due to lack of pulse and adequate breathing. (only 1-2 agonal breaths/ min). After 1 round of chest compressions completed, patient arouse. Patient was very drowsy and "tired" and didn't remember anything about the event. B/P was reassessed after a few minutes (130/70).  When EMS arrived, Patient was still drowsy and awake. Transported to the hospital via stretcher and later discharge.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Agonal respiration, Blood pressure decreased, Pulse absent, Resuscitation
Clinical narrative: Patient received 2 Pfizer boosters. This was his first time receiving Pfizer. Patient remained in waiting room after administration. After about 5 minutes post vaccination, Patient stated he was starting to feel "funny", light headed and dizzy. He thought his B/P was low. Patient had eaten breakfast. Was giving water. B/P was 100/68. Patient was clammy and diaphoretic. Patient briefly passed out in chair and was able to arouse with sternal rub. NPs started to reposition patient with legs up, when patient collapsed. Patient's breathing was irregular and agonal. Both NPs were not able to find a pulse after assessing for 15 seconds by palpation or auscultation. Patient brought to floor; instructed PCT to call 911. 1 NP went to obtain first aid box/ CPR mask; While that was occurring the other started compressions as due to lack of pulse and adequate breathing. (only 1-2 agonal breaths/ min). After 1 round of chest compressions completed, patient arouse. Patient was very drowsy and "tired" and didn't remember anything about the event. B/P was reassessed after a few minutes (130/70).  When EMS arrived, Patient was still drowsy and awake. Transported to the hospital via stretcher and later discharge.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pyrexia
Clinical narrative: 102 fever, severe headache,  severe pain in body and joints
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Fever, Fatigue
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: 2 to 3 events of Acute pain experience in elbows while doing normal exercising.  Acute morning pain in thumb joints, knees and feet.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond Expiration date. However, per Moderna- all vaccines met viability requirements.  Completing VAERS per RA requirements.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Inflammation, Injection site erythema, Migraine
Clinical narrative: The next day severe headache or Migraine. Could not get out of bed. Arm was unusually red and sore. Went to the doctor that week, symptoms lasted 2 weeks. Had an all over body rash, hot and inflamed. Vaccine site stayed red for months. No medication was given, only to take Ibuprofen.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Rash
Clinical narrative: The next day severe headache or Migraine. Could not get out of bed. Arm was unusually red and sore. Went to the doctor that week, symptoms lasted 2 weeks. Had an all over body rash, hot and inflamed. Vaccine site stayed red for months. No medication was given, only to take Ibuprofen.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Chest pain, Echocardiogram, Electrocardiogram abnormal, Pericarditis
Clinical narrative: Pericarditis requiring catheterization due to chest pain and abnormal EKG and 1 day hospitalization.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin I increased
Clinical narrative: Pericarditis requiring catheterization due to chest pain and abnormal EKG and 1 day hospitalization.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Delivery, Exposure during pregnancy, Haemoglobin
Clinical narrative: Hospitalized - for induction of labor;  COVID positive;  fully vaccinated PLUS booster; BRIEF OVERVIEW: Admission Date: 4/27/2022; Discharge Date: 4/28/2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Encounter for induction of labor [Z34.90] Post-dates pregnancy [O48.0] INTRAPARTUM COMPLICATIONS: Medical Problems (from 04/27/22 to present) No problems associated with this episode. PROCEDURES PERFORMED:  Vaginal delivery Tubal ligation:  No HOSPITAL COURSE: Patient underwent an uncomplicated vaginal delivery and was discharged home in stable condition. Delivery Details DELIVERY TYPE: Vaginal, Spontaneous ESTIMATED DUE DATE: Estimated Date of Delivery: 4/20/22 GESTATIONAL AGE AT DELIVERY: 41w0d  G4P3013 DELIVERY PROVIDER: ASSISTING PROVIDER(S):  FINDINGS: NEWBORN STATUS: Living  NEWBORN SEX:  girl Baby Girl A [19141623] Delivery Date/Time:  4/27/22  4:54 PM WEIGHT: 3.56 kg APGAR: 1 minutes 5 minutes 10 minutes  8  9  H/P: ASSESSMENT / PLAN: is a 35 y.o. G4P2012 female at Unknown who presents with: Active Problems: AMA (advanced maternal age) multigravida 35+ Plan: 1. Induction of labor: PEDD- Initial SVE: 2/60/-2- Intact  - Contractions rare - Admit to labor and delivery - IV access - LR 125 ml/hr - Clear liquid diet - CBC, type and screen, syphilis - Cytotec for cervical ripening 2. Fetal well being: -   FHT Category 1 - Cephalic by bedside ultrasound - EFW 7 lb - Pelvis appears adequate and proven to 3.22 3. Maternal well being:  - Stable condition - AMA  -endorses taking baby ASA -COVID +-+ 4/24/2022 -Sniffly nose and mild cough, otherwise asymptomatic -recommend sending placenta  - Hgb on admission: pending.