chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19-2
Symptoms: Impaired gastric emptying
Clinical narrative: gastroparesis; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED GASTRIC EMPTYING (gastroparesis) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED GASTRIC EMPTYING (gastroparesis) (seriousness criterion medically significant). At the time of the report, IMPAIRED GASTRIC EMPTYING (gastroparesis) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     The patient received the initial booster dose of Moderna COVID-19 vaccine, Bivalent. It was reported that the patient had had Moderna COVID-19 Vaccine and had no previous history of gastric problems but ended up with Gastroparesis.  No treatment medications were reported.  Company comment This spontaneous case concerns an adult male patient with no medical history reported, especially no previous history of gastric problems, who received the initial booster dose of bivalent mRNA-1273.222 (BA.4/BA.5) vaccine and experienced the serious, medically significant, unexpected event of impaired gastric emptying, reported as gastroparesis. The events´ onset and the vaccination dates were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. There is no further clinical information provided for medical review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) vaccine is not affected by this report.   Reporter did not allow further contact
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: The caller´s wife came into the call and said that his mother had died after receiving the Moderna vaccine back in 2020.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (The caller´s wife came into the call and said that his mother had died after receiving the Moderna vaccine back in 2020.) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. Dosage text of Moderna COVID-19 Vaccine was reported as unknown. No treatment medication details was reported.  Company comment:  This spontaneous case report concerns a 97-year-old female patient with no medical history provided, who experienced serious (due to fatal outcome and medical significance) unexpected event of Death. Reportedly, the patient died on an unknown date after receiving unknown dose of the mRNA-1273 vaccine. Temporal relationship between fatal outcome and vaccine administration remained unknown. The exact cause of death remained unknown and it also was not known whether an autopsy was performed. The patient's elderly age remains a confounder for the event. The reporter denied further contact. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-714122, US-MODERNATX, INC.-MOD-2023-714201 ( Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714122: US-MODERNATX, INC.-MOD-2023-714201:; Reported Cause(s) of Death: Unknown cause of death
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired gastric emptying
Clinical narrative: gastroparesis; This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED GASTRIC EMPTYING (gastroparesis) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Gastroesophageal reflux disease and Blood pressure high. Concomitant products included LOSARTAN and AMLODIPINE BESILATE (NORVASC) for Blood pressure high, ESOMEPRAZOLE SODIUM (NEXIUM IV) for GERD, CLOPIDOGREL BISULFATE (PLAVIX), FOLIC ACID and VITAMINS NOS for an unknown indication.   On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMPAIRED GASTRIC EMPTYING (gastroparesis) (seriousness criterion medically significant). At the time of the report, IMPAIRED GASTRIC EMPTYING (gastroparesis) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient visited a doctor and was diagnosed with Gastroparesis and was not able to eat normal food, patient had to puree the food before eating it.  Treatment information was not provided.  Company Comment:  This is a spontaneous case concerning a 77-year-old, female patient with current condition of Gastroesophageal reflux disease treated with esomeprazole, who experienced the unexpected serious (medically significant) event of gastroparesis. The event occurred after the administration of the third dose of mRNA-1273 vaccine, however latency is unknown. Patient described that she was not able to eat normal food and need to puree the food. A doctor has diagnosed with gastroparesis and prescribed a special diet. No further relevant information was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.    Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 30-Jan-2023 and was administered on 02-Mar-2023; No adverse event; Patient have received a dose of the Moderna COVID-19 bivalent vaccine from  lot number 045H22A, after a beyond use date of 01-MAR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient have received a dose of the Moderna COVID-19 bivalent vaccine from  lot number 045H22A, after a beyond use date of 01-MAR-2023), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 and was administered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient have received a dose of the Moderna COVID-19 bivalent vaccine from  lot number 045H22A, after a beyond use date of 01-MAR-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 and was administered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient have received a dose of the Moderna COVID-19 bivalent vaccine from  lot number 045H22A, after a beyond use date of 01-MAR-2023), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 and was administered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient have received a dose of the Moderna COVID-19 bivalent vaccine from  lot number 045H22A, after a beyond use date of 01-MAR-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 and was administered on 02-Mar-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that bivalent vial of unknown size was administered to 5 patients beyond the use by date of 01-Mar-2023. The vial was initially stored in refrigerator on 30-Jan-2023. The vial never underwent any temperature excursion.  No adverse reaction was reported by patient.  Treatment medications were not provided.
Age: 1.33
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product administered at inappropriate site, Product administration interrupted, SARS-CoV-2 test
Clinical narrative: Due to various circumstances the patient never received her second Moderna primary series Covid-19 vaccine; covid 19; Vaccine administered at inappropriate site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine administered at inappropriate site) and PRODUCT ADMINISTRATION INTERRUPTED (Due to various circumstances the patient never received her second Moderna primary series Covid-19 vaccine) in a 16-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  On 19-Oct-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2022, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine administered at inappropriate site). In December 2022, the patient experienced COVID-19 (covid 19). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Due to various circumstances the patient never received her second Moderna primary series Covid-19 vaccine). At the time of the report, COVID-19 (covid 19), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine administered at inappropriate site) and PRODUCT ADMINISTRATION INTERRUPTED (Due to various circumstances the patient never received her second Moderna primary series Covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2022, SARS-CoV-2 test: Positive.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No other adverse reactions are reported.  No treatment medications were reported.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture), PRODUCT STORAGE ERROR (Dose administered after 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 51-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Shingrix (right deltoid) on 08-Mar-2023. Past adverse reactions to the above products included No adverse event with Shingrix.  On 08-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 08-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 12 hours post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture), PRODUCT STORAGE ERROR (Dose administered after 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered after 12 hours post puncture).    No concomitant medications were reported.  The patient received 1st dose of Moderna COVID-19 vaccine on 08-Apr-2021, lot number 026A21A and 2nd dose on 05-May-2021, lot number 048B21A.  No treatment medications were reported.
Age: 2.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine; A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine), COVID-19 IMMUNISATION (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine), COVID-19 IMMUNISATION (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine), COVID-19 IMMUNISATION (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine) and COVID-19 IMMUNISATION (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine).    No concomitant medications were reported. Patient received the Pfizer COVID-19 Vaccine for the second dose after receiving Moderna for the first dose. No other adverse events are reported  No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; bivalent vaccine was administered two days after the refrigerated 30 day beyond-use-date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered two days after the refrigerated 30 day beyond-use-date) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 07-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered two days after the refrigerated 30 day beyond-use-date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered two days after the refrigerated 30 day beyond-use-date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered two days after the refrigerated 30 day beyond-use-date).    No concomitant medications were reported.     HCP wanted to know if a dose of the bivalent vaccine was administered two days after the refrigerated 30 day beyond-use-date of the vial should the dose be repeated or not.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2023: Follow up contains no new information.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Had staff member who went to get primary series vaccine and received bivalent instead; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Had staff member who went to get primary series vaccine and received bivalent instead) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Had staff member who went to get primary series vaccine and received bivalent instead) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Had staff member who went to get primary series vaccine and received bivalent instead) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Had staff member who went to get primary series vaccine and received bivalent instead).    No concomitant medications were reported. It was reported that the patient which went to get the Primary series vaccine but received Bivalent dose instead. No treatment details were reported.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 4 doses of the bivalent vaccine which was beyond the 30 day BUD), PRODUCT STORAGE ERROR (vials were initially stored in the refrigerator on 21-Jan-2023 and administered on 26-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) on 16-Nov-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 10-Dec-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose 3) on 26-May-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Epistaxis, Gingival bleeding, Herpes virus infection, Illness
Clinical narrative: Sick; Reactivated Herpes virus; Reactivated Herpes virus; Bleeding nose; Bleeding gums; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, 0.3 ml single (Lot number: ER8734, Expiration Date: 31Jul2021) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes virus" (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Location of injection: right arm, Vaccine administration time: 11:00 AM, Batch/Lot number: EN6199), administration date: 15Mar2021, for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick"; EPISTAXIS (non-serious), outcome "recovered", described as "Bleeding nose"; GINGIVAL BLEEDING (non-serious), outcome "recovered", described as "Bleeding gums"; HERPES VIRUS INFECTION (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "Reactivated Herpes virus".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  This follow-up report is being submitted to amend previously reported information: condition type in medical history updated from "past drug event" to "Historical Vaccine" and narrative updated.  Follow-up (07Mar2023): This is a spontaneous follow up report received from same contactable Consumer and additional consumer. Updated information included: Middle name added for reporter slider 1, patient information, Additional Reporter (Consumer), Relevant medical history (Herpes virus), Events (Sick, Epistaxis, Gingival bleeding, Herpes virus infection and Disease recurrence) were added. Notes of Historical vaccine, Dosage regimen of Suspect Comirnaty updated. At risk classification and event Inappropriate schedule of vaccine administered were removed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318595 same patient, different drug/events.;US-PFIZER INC-202201318604 same patient/drug, different dose/events.;
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Near death experience
Clinical narrative: thought that she was gonna die; Severe allergies 4 days after she got the vaccine, she ended up in the emergency room; This is a spontaneous report received from a contactable reporter(s) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "thought that she was gonna die"; HYPERSENSITIVITY(medically significant), 4 days after the suspect product(s) administration, outcome "unknown", described as "Severe allergies 4 days after she got the vaccine, she ended up in the emergency room". The event "thought that she was gonna die" required emergency room visit. The event "severe allergies 4 days after she got the vaccine, she ended up in the emergency room" required physician office visit and emergency room visit. Clinical course: The caller mentioned that she had the second COVID-19 vaccine. She had a severe reaction (severe allergies 4 days after she got the vaccine) and ended up in the emergency room; she thought that she might die. She was referred to an allergist, and she was advised to get the vaccine so that he could do a skin test to find out what it was in the vaccine that she was reacting to.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events hypersensitivity and near death experience are related to BNT162b2 (BNT162B2) cannot be excluded. This case will be reassessed should additional information become available.
Sex: U
Vaccine: COVID19, PPV
Symptoms: Drug interaction
Clinical narrative: COVID vaccine has countered Pneumonia vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; methylprednisolone sodium succinate (SOLU-MEDROL); atropine sulfate (ATROPINE SULFATE); pneumococcal vaccine (PNEUMOCOCCAL VACCINE), as dose number unknoiwn, single (Batch/Lot number: unknown) for immunisation; fluticasone propionate, salmeterol xinafoate (WIXELA INHUB), (Batch/Lot number: unknown); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), (Batch/Lot number: unknown); ipratropium (IPRATROPIUM), (Batch/Lot number: unknown); pantoprazole (DUPAN), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "COVID vaccine has countered Pneumonia vaccine". The action taken for methylprednisolone sodium succinate, atropine sulfate, fluticasone propionate, salmeterol xinafoate, albuterol [salbutamol], ipratropium and pantoprazole was unknown. Additional information: COVID vaccine has countered Pneumonia vaccine. The Pfizer drug (Unspecified medication) interacted with Wixela.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose Number: 7, 5 ; Pfizer/BioNTech, Dose Number:6 ; Janssen, Dose Number: 4; A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 6 (booster), single (Lot number: GH9694) at the age of 65 years, in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 12Jan2023 as dose 7 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Apr2022 as dose 5 (booster), single (Lot number: 005M21A), in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 15Dec2021 as dose 4 (booster), single (Lot number: 210021A), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "one coronary artery partially blocked" (unspecified if ongoing), notes: other medical history old age. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "not recovered", described as "Moderna, Dose Number: 7, 5 ; Pfizer/BioNTech, Dose Number:6 ; Janssen, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Mar2023) Negative, notes: using both BinaxNOW and FlowFlex; (02Mar2023) Negative, notes: using both BinaxNOW and FlowFlex; (03Mar2023) Negative, notes: using both BinaxNOW and FlowFlex; (04Mar2023) Negative, notes: using both BinaxNOW and FlowFlex; (05Mar2023) both showed very weak positive, notes: using both BinaxNOW and FlowFlex; (06Mar2023) both showed stronger positive, notes: using both BinaxNOW and FlowFlex; (07Mar2023) both showed VERY positive (strongly colored bars), notes: using both BinaxNOW and FlowFlex. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 24Feb2023 to 28Feb2023.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Carpal tunnel" (unspecified if ongoing); "De Quervain's disease" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "depressive disorder" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Feb2023) Negative, notes: tested negative on 19Feb; (23Feb2023) Positive, notes: tested positive again on 23Feb. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient experienced rebound Covid symptoms approximately 1 weeks after completing course of Paxlovid. Completed treatment on 16Feb, tested negative on 19Feb and started experience Covid symptoms / tested positive again on 23Feb.  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.; Sender's Comments: The contributory role of BNT162b2, BNT162b2 omi ba.4-5 to the reported drug ineffective event cannot be excluded since a lack of effect can generally be expected for any medicinal product as a 100% success rate cannot be reasonably assumed in every patient treated.,Linked Report(s) : US-PFIZER INC-202300099813 same reporter/patient, different product/event;
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: From the second shot I was throwing up, I vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2022 as dose  2, single (Batch/Lot number: unknown) at the age of 57 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "major depression" (ongoing), notes: I am currently being treated in mental health department for major depression.; "PTSD" (unspecified if ongoing), notes: PTSD, prior to the shot I do.; "increased Blood pressure" (unspecified if ongoing), notes: As far as I know normal, increased Blood pressure, High cholesterol and Triglyceride.; "High cholesterol" (unspecified if ongoing), notes: As far as I know normal, increased Blood pressure, High cholesterol and Triglyceride.; "Triglyceride" (unspecified if ongoing), notes: As far as I know normal, increased Blood pressure, High cholesterol and Triglyceride. Concomitant medication(s) included: GEMFIBROZIL oral. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical site: left arm , Route of administration: Intramuscular), for Covid-19 immunization, reaction(s): "COVID-19", "Drug ineffective". The following information was reported: VOMITING (non-serious), outcome "unknown", described as "From the second shot I was throwing up, I vomited". Therapeutic measures were taken as a result of vomiting.  Additional information: It was reported that after second shot, the mental health department provided him the shot, he did not know what it was but it helped him go to sleep.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300099674 same product/patient, different dose/events.;US-PFIZER INC-202300100041 same patient, different product/event;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Deafness, Myalgia, Pain in extremity, Vertigo
Clinical narrative: Muscle aches, sore arm and since Vertigo and hearing loss
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Activated partial thromboplastin time, Differential white blood cell count, Erythema, Full blood count, Laboratory test
Clinical narrative: red papular lesions on bilateral arms and upper legs that itch badly.  Purpura rash on ankles and feet.  all non-blanching
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Papule, Prothrombin time, Purpura, Skin lesion, Stool analysis
Clinical narrative: red papular lesions on bilateral arms and upper legs that itch badly.  Purpura rash on ankles and feet.  all non-blanching
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urine analysis
Clinical narrative: red papular lesions on bilateral arms and upper legs that itch badly.  Purpura rash on ankles and feet.  all non-blanching
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Anxiety, Arthralgia, Balance disorder, Bone pain
Clinical narrative: Brain fog, dizzy, disoriented, off balance, fatigue, GI Issues, inflammation, racing heart, insomnia, limb weakness, limb pain, neuropathy, muscle pain, joint pain, anemia, splenomegaly, insomnia, difficulty falling asleep and staying asleep, sleeping long periods of time, tinnitus, hearing loss, internal vibrations, muscle twitching whole body, night sweats, hot flashes, poor exercise deterioration, chest tightness, high blood pressure, headache, leg paralysis, memory issues, noise sensitivity, tingling, numbness, hot spots on soles of feet and hands, menses issues, increased anxiety, increased depression, muscle and bone pain, all over body pain, malaise, neck pain, goose flesh, body feels bruised all over,
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Chest discomfort, Condition aggravated, Deafness, Depression
Clinical narrative: Brain fog, dizzy, disoriented, off balance, fatigue, GI Issues, inflammation, racing heart, insomnia, limb weakness, limb pain, neuropathy, muscle pain, joint pain, anemia, splenomegaly, insomnia, difficulty falling asleep and staying asleep, sleeping long periods of time, tinnitus, hearing loss, internal vibrations, muscle twitching whole body, night sweats, hot flashes, poor exercise deterioration, chest tightness, high blood pressure, headache, leg paralysis, memory issues, noise sensitivity, tingling, numbness, hot spots on soles of feet and hands, menses issues, increased anxiety, increased depression, muscle and bone pain, all over body pain, malaise, neck pain, goose flesh, body feels bruised all over,
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Exercise tolerance decreased, Fatigue, Feeling hot
Clinical narrative: Brain fog, dizzy, disoriented, off balance, fatigue, GI Issues, inflammation, racing heart, insomnia, limb weakness, limb pain, neuropathy, muscle pain, joint pain, anemia, splenomegaly, insomnia, difficulty falling asleep and staying asleep, sleeping long periods of time, tinnitus, hearing loss, internal vibrations, muscle twitching whole body, night sweats, hot flashes, poor exercise deterioration, chest tightness, high blood pressure, headache, leg paralysis, memory issues, noise sensitivity, tingling, numbness, hot spots on soles of feet and hands, menses issues, increased anxiety, increased depression, muscle and bone pain, all over body pain, malaise, neck pain, goose flesh, body feels bruised all over,
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Headache, Hot flush, Hyperacusis, Hypersomnia
Clinical narrative: Brain fog, dizzy, disoriented, off balance, fatigue, GI Issues, inflammation, racing heart, insomnia, limb weakness, limb pain, neuropathy, muscle pain, joint pain, anemia, splenomegaly, insomnia, difficulty falling asleep and staying asleep, sleeping long periods of time, tinnitus, hearing loss, internal vibrations, muscle twitching whole body, night sweats, hot flashes, poor exercise deterioration, chest tightness, high blood pressure, headache, leg paralysis, memory issues, noise sensitivity, tingling, numbness, hot spots on soles of feet and hands, menses issues, increased anxiety, increased depression, muscle and bone pain, all over body pain, malaise, neck pain, goose flesh, body feels bruised all over,
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia, Inflammation, Initial insomnia, Insomnia
Clinical narrative: Brain fog, dizzy, disoriented, off balance, fatigue, GI Issues, inflammation, racing heart, insomnia, limb weakness, limb pain, neuropathy, muscle pain, joint pain, anemia, splenomegaly, insomnia, difficulty falling asleep and staying asleep, sleeping long periods of time, tinnitus, hearing loss, internal vibrations, muscle twitching whole body, night sweats, hot flashes, poor exercise deterioration, chest tightness, high blood pressure, headache, leg paralysis, memory issues, noise sensitivity, tingling, numbness, hot spots on soles of feet and hands, menses issues, increased anxiety, increased depression, muscle and bone pain, all over body pain, malaise, neck pain, goose flesh, body feels bruised all over,
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise, Memory impairment, Menstruation irregular, Monoplegia
Clinical narrative: Brain fog, dizzy, disoriented, off balance, fatigue, GI Issues, inflammation, racing heart, insomnia, limb weakness, limb pain, neuropathy, muscle pain, joint pain, anemia, splenomegaly, insomnia, difficulty falling asleep and staying asleep, sleeping long periods of time, tinnitus, hearing loss, internal vibrations, muscle twitching whole body, night sweats, hot flashes, poor exercise deterioration, chest tightness, high blood pressure, headache, leg paralysis, memory issues, noise sensitivity, tingling, numbness, hot spots on soles of feet and hands, menses issues, increased anxiety, increased depression, muscle and bone pain, all over body pain, malaise, neck pain, goose flesh, body feels bruised all over,
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Muscular weakness, Myalgia, Neck pain, Neuropathy peripheral
Clinical narrative: Brain fog, dizzy, disoriented, off balance, fatigue, GI Issues, inflammation, racing heart, insomnia, limb weakness, limb pain, neuropathy, muscle pain, joint pain, anemia, splenomegaly, insomnia, difficulty falling asleep and staying asleep, sleeping long periods of time, tinnitus, hearing loss, internal vibrations, muscle twitching whole body, night sweats, hot flashes, poor exercise deterioration, chest tightness, high blood pressure, headache, leg paralysis, memory issues, noise sensitivity, tingling, numbness, hot spots on soles of feet and hands, menses issues, increased anxiety, increased depression, muscle and bone pain, all over body pain, malaise, neck pain, goose flesh, body feels bruised all over,
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: Brain fog, dizzy, disoriented, off balance, fatigue, GI Issues, inflammation, racing heart, insomnia, limb weakness, limb pain, neuropathy, muscle pain, joint pain, anemia, splenomegaly, insomnia, difficulty falling asleep and staying asleep, sleeping long periods of time, tinnitus, hearing loss, internal vibrations, muscle twitching whole body, night sweats, hot flashes, poor exercise deterioration, chest tightness, high blood pressure, headache, leg paralysis, memory issues, noise sensitivity, tingling, numbness, hot spots on soles of feet and hands, menses issues, increased anxiety, increased depression, muscle and bone pain, all over body pain, malaise, neck pain, goose flesh, body feels bruised all over,
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Piloerection, Splenomegaly, Tinnitus, Vibratory sense increased
Clinical narrative: Brain fog, dizzy, disoriented, off balance, fatigue, GI Issues, inflammation, racing heart, insomnia, limb weakness, limb pain, neuropathy, muscle pain, joint pain, anemia, splenomegaly, insomnia, difficulty falling asleep and staying asleep, sleeping long periods of time, tinnitus, hearing loss, internal vibrations, muscle twitching whole body, night sweats, hot flashes, poor exercise deterioration, chest tightness, high blood pressure, headache, leg paralysis, memory issues, noise sensitivity, tingling, numbness, hot spots on soles of feet and hands, menses issues, increased anxiety, increased depression, muscle and bone pain, all over body pain, malaise, neck pain, goose flesh, body feels bruised all over,
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue, Single component of a two-component product administered
Clinical narrative: Patient was given the adjuvant suspension component (vial 1 of 2) but it was not reconstituted with the antigen component.  No adverse reactions or symptoms experienced by patient.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Palpitations, SARS-CoV-2 test, Vaccination failure
Clinical narrative: heart started racing; She took a test and she caught the virus/started getting sick/low-grade fever/Coughing; She took a test and she caught the virus/started getting sick/low-grade fever/Coughing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8729), on 20May2021 as dose 2, single (Lot number: EW0175) and on 17Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "pacemaker", start date: 2012 (ongoing), notes: Comments: pacemaker; "Blood pressure" (unspecified if ongoing), notes: Indication for use in the case: Blood pressure. Concomitant medication(s) included: VALSARTAN taken for blood pressure abnormal, start date: 2012 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "She took a test and she caught the virus/started getting sick/low-grade fever/Coughing"; PALPITATIONS (non-serious), outcome "unknown", described as "heart started racing". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Low grade fever; SARS-CoV-2 test: (May2022) Positive, notes: She took a test and she caught the virus; Weight: (unspecified date) weight is 140 something. Therapeutic measures were taken as a result of vaccination failure, covid-19, palpitations. Clinical course: She gave a nurse a ride that didn't take vaccine on a Tuesday, and Wednesday morning she started getting sick. Her heart started racing and had a low-grade fever, ran and got water and Gatorade and took Tylenol. She caught the virus from her. She is saying if she didn't take the 1st (as reported), maybe it could have been worse. She was very sick those 24 hours. Coughing. She took a test and she caught the virus. Patient also had a Flu shot on an unknown date - no further details.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300100075 same reporter/patient, different dose/event;
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight
Clinical narrative: heart started racing; She took a test and she caught the virus/started getting sick/low-grade fever/Coughing; She took a test and she caught the virus/started getting sick/low-grade fever/Coughing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8729), on 20May2021 as dose 2, single (Lot number: EW0175) and on 17Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "pacemaker", start date: 2012 (ongoing), notes: Comments: pacemaker; "Blood pressure" (unspecified if ongoing), notes: Indication for use in the case: Blood pressure. Concomitant medication(s) included: VALSARTAN taken for blood pressure abnormal, start date: 2012 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "She took a test and she caught the virus/started getting sick/low-grade fever/Coughing"; PALPITATIONS (non-serious), outcome "unknown", described as "heart started racing". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Low grade fever; SARS-CoV-2 test: (May2022) Positive, notes: She took a test and she caught the virus; Weight: (unspecified date) weight is 140 something. Therapeutic measures were taken as a result of vaccination failure, covid-19, palpitations. Clinical course: She gave a nurse a ride that didn't take vaccine on a Tuesday, and Wednesday morning she started getting sick. Her heart started racing and had a low-grade fever, ran and got water and Gatorade and took Tylenol. She caught the virus from her. She is saying if she didn't take the 1st (as reported), maybe it could have been worse. She was very sick those 24 hours. Coughing. She took a test and she caught the virus. Patient also had a Flu shot on an unknown date - no further details.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300100075 same reporter/patient, different dose/event;