chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 14Jun2023, expired on 18 Jun2023 and administered on 27Jun2023; No AEs were reported; HCP stated a patient was accidentally administered with an expired dose of Moderna COVID-19 Vaccine Bivalent on 27JUN2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated a patient was accidentally administered with an expired dose of Moderna COVID-19 Vaccine Bivalent on 27JUN2023), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14Jun2023, expired on 18 Jun2023 and administered on 27Jun2023) and NO ADVERSE EVENT (No AEs were reported) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     Patient had recent bulb perforation.  Previously administered products included for Product used for unknown indication: VARICELLA VACCINE and MMR. Past adverse reactions to the above products included No adverse event with MMR and VARICELLA VACCINE. Concurrent medical conditions included Dust allergy (Allergy to dust particles) and Anemia.    On 27-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 27-Jun-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 (HCP stated a patient was accidentally administered with an expired dose of Moderna COVID-19 Vaccine Bivalent on 27JUN2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14Jun2023, expired on 18 Jun2023 and administered on 27Jun2023) and NO ADVERSE EVENT (No AEs were reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated a patient was accidentally administered with an expired dose of Moderna COVID-19 Vaccine Bivalent on 27JUN2023), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14Jun2023, expired on 18 Jun2023 and administered on 27Jun2023) and NO ADVERSE EVENT (No AEs were reported) 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 AEs were reported) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated a patient was accidentally administered with an expired dose of Moderna COVID-19 Vaccine Bivalent on 27JUN2023) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14Jun2023, expired on 18 Jun2023 and administered on 27Jun2023).    No concomitant medication information was provided.  Patient had received Moderna monovalent dose 1 on 2Jun2021 and dose 2 on 30jun2021.  The vial size was reported as 2.5ml.  No treatment drug information was provided.
Age: 30.0
Sex: M
Vaccine: COVID19, MNQ
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives) in a 30-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) (unknown route) 1 dosage form. On 29-Jun-2023, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) was resolving.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  It was unknown if the patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient was administered vaccination and receive side effect of hives after taking the Menactra Vaccination. Only reported allergy was the side affect after vaccination administer.    Treatment Medication use information was not provided by reporter.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP calling and stated they gave 4 expired vaccines to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP calling and stated they gave 4 expired vaccines to patient) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     It was reported that HCP did not report any medical history or condition for the patient. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (031H21A) on 11-Dec-2021 and Moderna COVID-19 Vaccine (059A22A) on 12-Jun-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 10-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 10-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP calling and stated they gave 4 expired vaccines to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP calling and stated they gave 4 expired vaccines to patient) 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 (HCP calling and stated they gave 4 expired vaccines to patient).    No concomitant information was reported. It was reported that the vaccine been expired about 8 or more days. Patient was not aware that she received an expired dose. No treatment information was provided.   This case was linked to MOD-2023-731713, MOD-2023-731685, MOD-2023-731650, US-MODERNATX, INC.-MOD-2023-731713, US-MODERNATX, INC.-MOD-2023-732157 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2023-731713:Same reporter, Same product, Same Batch lot/number MOD-2023-731685:Same reporter, Same product, Same Batch lot/number MOD-2023-731650:Same reporter, Same product, Same Batch lot/number US-MODERNATX, INC.-MOD-2023-731713:Same reporter (Patient 1) US-MODERNATX, INC.-MOD-2023-732157:Monovalent case
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Greater trochanteric pain syndrome, Myalgia, Pain, Sciatica
Clinical narrative: Severe muscle cramps in thighs with sciatic nerve pain / When walk there is muscle pain in upper thighs; trochanteric bursitis left hip/had some inflammation of the trochanteric bursa on the other side; had another bout of pain/Still have problems lying down ever since I took the 2nd shot; There was muscle pain in upper thighs/Myalgia lower body; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Severe muscle cramps in thighs with sciatic nerve pain / When walk there is muscle pain in upper thighs), GREATER TROCHANTERIC PAIN SYNDROME (trochanteric bursitis left hip/had some inflammation of the trochanteric bursa on the other side), PAIN (had another bout of pain/Still have problems lying down ever since I took the 2nd shot) and MYALGIA (There was muscle pain in upper thighs/Myalgia lower body) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03821A) for COVID-19 prophylaxis.     Concurrent medical conditions included Interstitial lung disease (stable), Barrett's esophagus (mostly resolved-no lesions) and Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder, SIMVASTATIN (STATIN [SIMVASTATIN]) for an unknown indication.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced SCIATICA (Severe muscle cramps in thighs with sciatic nerve pain / When walk there is muscle pain in upper thighs), GREATER TROCHANTERIC PAIN SYNDROME (trochanteric bursitis left hip/had some inflammation of the trochanteric bursa on the other side), PAIN (had another bout of pain/Still have problems lying down ever since I took the 2nd shot) and MYALGIA (There was muscle pain in upper thighs/Myalgia lower body). At the time of the report, SCIATICA (Severe muscle cramps in thighs with sciatic nerve pain / When walk there is muscle pain in upper thighs), GREATER TROCHANTERIC PAIN SYNDROME (trochanteric bursitis left hip/had some inflammation of the trochanteric bursa on the other side), PAIN (had another bout of pain/Still have problems lying down ever since I took the 2nd shot) and MYALGIA (There was muscle pain in upper thighs/Myalgia lower body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient thought the events might be from statins but liver enzymes were fine and stopped statins to test that no change reported. Patient was administered with steroid shot.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 1st dose, 2nd dose, 3rd dose: BNT162B2, 4th dose: Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Sep2022, outcome "unknown", described as "1st dose, 2nd dose, 3rd dose: BNT162B2, 4th dose: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19 which included Paxlovid treatment from 22Jun2023 to 27Jun2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 15:45 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Nov2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown). The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "Allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypoaesthesia oral
Clinical narrative: he is experiencing beating headaches; numbness in his mouth; his shoulders started hurting when he does work or exercise like basketball; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "having surgery in his face" (unspecified if ongoing), notes: having surgery in his face 6 years ago. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "he is experiencing beating headaches"; HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "numbness in his mouth"; ARTHRALGIA (non-serious), outcome "unknown", described as "his shoulders started hurting when he does work or exercise like basketball". Additional information: Seriousness was reported as No. Patient was reporting that after getting the Pfizer covid vaccine he was experiencing beating headaches and numbness in his mouth, he also mentioned later on that his shoulders started hurting when he did work or exercise like basketball. His friend told him that patients who took the vaccine have experienced getting heart attacks/blood clots/strokes and that the vaccine was being used for other things such as medical for autism, alzheimers, and/or memory loss. Patient asked if him having surgery in his face 6 years ago and taking the vaccine caused him to experience this. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction, Neoplasm progression, Urticaria
Clinical narrative: My mother had a heart attack; two heart attacks; hives; three strokes; her cancer came back full blown; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (death), outcome "fatal", described as "My mother had a heart attack; two heart attacks"; URTICARIA (death), outcome "fatal", described as "hives"; CEREBROVASCULAR ACCIDENT (death), outcome "fatal", described as "three strokes"; NEOPLASM PROGRESSION (death), outcome "fatal", described as "her cancer came back full blown". The patient date of death was unknown. Reported cause of death: "My mother had a heart attack; two heart attacks", "hives", "three strokes", "her cancer came back full blown". It was not reported if an autopsy was performed. It was the reporter's mother had a heart attack, three strokes, two heart attacks and her cancer came back full blown and then the booster made her break out in hives and grow, it looks like men's balls under her chin. It's toxic, It's killing, It killed her.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: My mother had a heart attack; two heart attacks; hives; three strokes; her cancer came back full blown
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Fatigue, SARS-CoV-2 test
Clinical narrative: 1st one she felt a little foggy and maybe just a little tired; 1st one she felt a little foggy and maybe just a little tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER2613) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (ongoing), notes: Osteoporosis, takes Prolia 60mg subcutaneous injection twice a year. diagnosed 7 years ago.; "Asthma" (ongoing); "arthritis" (unspecified if ongoing), notes: little bit of arthritis doesn't take medication for this. Gets injections like gel injection in knee for arthritis as needed. Doesn't know the name of medication. Not a steroid it's a gel not cortisone. Got 1st injection last Oct2022; "left branch bundle blockage has had all her life" (unspecified if ongoing), notes: left branch bundle blockage has had all her life. takes no medication for this and there is no treatment. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing). The following information was reported: BRAIN FOG (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "1st one she felt a little foggy and maybe just a little tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : Covid vaccine detail : 1st one she had was Oct2021. Clarified she thought first one was 19Mar2021. She had 3 in 2021. March, April and October. All were Pfizer Covid vaccines. 1st one she felt a little foggy and maybe just a little tired.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: 2nd one a lot more fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Lot number: EW0153) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (ongoing), notes: diagnosed 7 years ago.; "Arthritis" (unspecified if ongoing); "left branch bundle blockage" (unspecified if ongoing), notes: L branch bundle blockage had all her life. takes no medication for this and there is no treatment; "Asthma" (ongoing), notes: she developed asthma. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing); PROLIA subcutaneous taken for osteoporosis. Vaccination history included: BNT162b2 (1st one she felt a little foggy and maybe just a little tired), administration date: 19Mar2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "little tired", "felt a little foggy". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "2nd one a lot more fatigued". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information : Covid vaccine: 1st one she had was Oct2021. Clarified she thought first one was 19Mar2021. She had 3 in 2021. March, April and October. All were Pfizer Covid vaccines. 1st one she felt a little foggy and maybe just a little tired. 2nd one a lot more fatigued. 3rd one in October was very similar to 1st one. Then had more, the 4th in Apr2022. Nothing remarkable about it. A little fatigued and a little soreness at site. Then had another one in May2023 and doesn't recall feeling anything but fatigue. Just felt kinda wiped out and tired.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Fatigue, SARS-CoV-2 test
Clinical narrative: 3rd one in October was very similar to 1st one/1st one she felt a little foggy and maybe just a little tired; 3rd one in October was very similar to 1st one/1st one she felt a little foggy and maybe just a little tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (unspecified if ongoing); "left branch bundle blockage" (ongoing), notes: L branch bundle blockage had all her life. takes no medication for this and there is no treatment; "Suffers greatly for anxiety" (ongoing); "has panic attacks for no reason" (unspecified if ongoing); "Asthma" (ongoing), notes: she developed asthma; "Osteoporosis" (ongoing), notes: Diagnosed 7 years ago. Concomitant medication(s) included: XANAX taken for anxiety, start date: 2004 (ongoing); ALBUTEROL [SALBUTAMOL SULFATE] taken for asthma (ongoing); PROLIA subcutaneous taken for osteoporosis. Vaccination history included: BNT162b2 (Dose: 1, lot number: ER2613), administration date: 19Mar2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "1st one she felt a little foggy and maybe just a little tired", "1st one she felt a little foggy and maybe just a little tired"; BNT162b2 (Dose: 2, lot number: EW0153), administration date: 09Apr2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "2nd one a lot more fatigued". The following information was reported: BRAIN FOG (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "3rd one in October was very similar to 1st one/1st one she felt a little foggy and maybe just a little tired". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information : Covid vaccine: 1st one she had was Oct2021. Clarified she thought first one was 19Mar2021. She had 3 in 2021. March, April and October. All were Pfizer Covid vaccines. 1st one she felt a little foggy and maybe just a little tired. 2nd one a lot more fatigued. 3rd one in October was very similar to 1st one. Then had more, the 04Apr2022. Nothing remarkable about it. A little fatigued and a little soreness at site. Then had another one in May2023 and doesn't recall feeling anything but fatigue. Just felt kinda wiped out and tired.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, SARS-CoV-2 test
Clinical narrative: Developed some late-stage type asthma/1st it was exercise asthma/in the last year she developed asthma; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (ongoing), notes: Osteoporosis: takes Prolia 60mg subcutaneous injection twice a year. diagnosed 7 years ago.; "little bit of arthritis" (ongoing), notes: Gets injections like gel in knee as needed, not steroid/cortisone; got 1st  injection in Oct2022; "left branch bundle blockage" (unspecified if ongoing), notes: L branch bundle blockage had all her life. takes no medication for this and there is no treatment.; "Asthma" (ongoing); "post traumatic stress syndrome" (ongoing); "Panic attacks for no reason. Suffers greatly for anxiety" (ongoing), notes: genetic predisposition to general anxiety. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing); PROLIA subcutaneous taken for osteoporosis; XANAX taken for post-traumatic stress disorder, anxiety, start date: 2004. Vaccination history included: BNT162b2 (Dose: 01, Lot: ER2613), administration date: 19Mar2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "1st one she felt a little foggy and maybe just a little tired", "1st one she felt a little foggy and maybe just a little tired"; BNT162b2 (Dose: 02, Lot: EW0153), administration date: 09Apr2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "2nd one a lot more fatigued"; BNT162b2 (Dose: 03, Lot: FH8020), administration date: 19Oct2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "3rd one in October was very similar to 1st one/1st one she felt a little foggy and maybe just a little tired", "3rd one in October was very similar to 1st one/1st one she felt a little foggy and maybe just a little tired"; BNT162b2 (Dose: 04, Lot: FK9894), administration date: 08Apr2022, when the patient was 68-year-old, for COVID-19 Immunization, reaction(s): "Went to outdoor wedding in last September and got pneumonia from kids running around", "Then had more, the 4th in Apr2022. A little fatigued and a little soreness at site", "Then had more, the 4th in Apr2022. A little fatigued and a little soreness at site". The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "Developed some late-stage type asthma/1st it was exercise asthma/in the last year she developed asthma". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Developed some late-stage type asthma. 1st it was exercise asthma. In the last year she developed asthma. No one in the family has asthma. Her Achillies heal was asthma.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Then had another one in May2023 and doesn't recall feeling anything but fatigue. Just felt kinda wiped out and tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04May2023 as dose 6 (booster), single (Lot number: GJ3270) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "little bit of arthritis" (unspecified if ongoing); "Left branch bundle blockage" (unspecified if ongoing), notes: has had all her life, takes no medication for this and there is no treatment; "Post traumatic stress syndrome" (ongoing); "Asthma" (ongoing); "Panic attacks for no reason. Suffers greatly for anxiety" (ongoing), notes: Panic attacks for no reason. Suffers greatly for anxiety; "Osteoporosis" (ongoing), notes: diagnosed 7 years ago. Concomitant medication(s) included: XANAX taken for post-traumatic stress disorder, generalised anxiety disorder, start date: 2004 (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing); PROLIA subcutaneous taken for osteoporosis. Vaccination history included: BNT162b2 (Dose 1, Lot No: ER2613), administration date: 19Mar2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "1st one she felt a little foggy and maybe just a little tired", "maybe just a little tired"; BNT162b2 (Dose 2, Lot No: EW0153), administration date: 09Apr2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "lot more fatigued"; BNT162b2 (Dose 3, Lot No: FH8020), administration date: 19Oct2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "maybe just a little tired", "felt a little foggy"; BNT162b2 (Dose 4, Lot No: FK9894), administration date: 08Apr2022, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "a little soreness at site", "A little fatigued", "Went to outdoor wedding in Maine last September and got pneumonia from kids running around"; BNT162b2, BNT162b2 omi ba.4-5 (Dose 5, Lot No: GH9693), administration date: 05Oct2022, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "In the last year she developed asthma", "Has every Pfizer Covid vaccine put out. Had experience with each but this was more extreme". The following information was reported: FATIGUE (non-serious) with onset May2023, outcome "unknown", described as "Then had another one in May2023 and doesn't recall feeling anything but fatigue. Just felt kinda wiped out and tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Covid vaccine: Then had another one in May2023 and doesn't recall feeling anything but fatigue. Just felt kinda wiped out and tired.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: moderate soreness at injection site; swelling and soreness of infraclavicular lymph node; swelling and soreness of infraclavicular lymph node; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 21Aug2021 as dose 3 (booster), single (Lot number: FC3181) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Date: 28Jan2021, Type/Mfr: Pfizer Covid-19 mRNA, Lot Number: EL9262), administration date: 28Jan2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "moderate soreness at injection site", "swelling and soreness of infraclavicular lymph node", "swelling and soreness of infraclavicular lymph node"; BNT162b2 (Dose: 2, Date: 17Feb2021, Type/Mfr: Pfizer Covid-19 mRNA, Lot Number: EN6200), administration date: 17Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "moderate soreness at injection site", "swelling and soreness of infraclavicular lymph node", "swelling and soreness of infraclavicular lymph node". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "moderate soreness at injection site"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "swelling and soreness of infraclavicular lymph node".  Additional Information: Prior Vaccinations: None. Family Medical History Relevant to Adverse Events (AES): No one in family has had adverse reaction to vaccines of any kind. Relevant Tests and Specific Relevant Test for Thromboembolic Events with Thrombocytopenia: None. The Product did not work as expected. Contracted positive COVID 3 weeks past vaccine Checked. The patient experienced adverse event(s) due to the lack of effect of the product. The patient taken 6 COVID vaccine. All previous were Pfizer except 5 which was Merck. Moderate soreness at injection site. Swelling and soreness of infraclavicular lymph node lymph node experienced with each of the 6 COVID injections.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have been vaccinated and had 3 Pfizer boosters. I recently contracted covid; I have been vaccinated and had 3 Pfizer boosters. I recently contracted covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I have been vaccinated and had 3 Pfizer boosters. I recently contracted covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: high fever for 3 days (about 102); The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (05Jul2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15-year-old 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: PYREXIA (non-serious) with onset 2021, outcome "recovered", described as "high fever for 3 days (about 102)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient mother reported that her daughter had high fever for 3 days (about 102). The event was occurred over 2 years ago after receiving the Covid vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Thyroid mass
Clinical narrative: a nodule removed from my thyroid; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THYROID MASS (medically significant), outcome "unknown", described as "a nodule removed from my thyroid". Therapeutic measures were taken as a result of thyroid mass.  Clinical course: The patient stated that 'I'm having a nodule removed from my thyroid. Any chance this occurred because of your covid vaccine? I imagine you're not allowed to reply for legal reasons."  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Investigation, Seizure
Clinical narrative: multiple seizures; memory loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: AMNESIA (hospitalization) with onset 14Nov2022, outcome "not recovered", described as "memory loss"; SEIZURE (hospitalization, medically significant) with onset 14Nov2022, outcome "unknown", described as "multiple seizures". The events "multiple seizures" and "memory loss" required physician office visit. The patient underwent the following laboratory tests and procedures: neurological test: negative, notes: After various neurological test the results where all negative. Therapeutic measures were taken as a result of seizure, amnesia.  Clinical information: On 02Nov2022 patient received the booster shot for Covid-19. On 14Nov2022 patient suffered Multiple seizures and memory loss was hospitalized. She was treated by the hospital neurology at Hospital and currently by MD. After various neurological test the results where all negative. She has extreme memory loss due to your vaccinations. Our lives destroyed.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Swelling
Clinical narrative: The whole back of my head swelled up; very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 Immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "The whole back of my head swelled up"; MALAISE (non-serious), outcome "unknown", described as "very ill".  Additional information: The patient recently received an inquiry regarding the possibility of taking a booster shot this fall, if recommended. The patient's 1st bivalent shot made very ill. The whole back of head swelled up for over a week. The patient was scared to take another booster now.  The information on the batch/lot number for (BNT162B2, BNT162B2 OMI BA.4-5), has been requested and will be submitted if and when received.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 05-Jul-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves, diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] vaccine that had expired was accidentally administered to 1 year old, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine for Prophylactic vaccination.  On 23-Jun-2023, the patient received a 0.5 ml total dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength: unknown) (lot: C5893AA, expiry date: 21-Jun-2023) via unknown route in left thigh for Immunization and vaccine that had expired was accidentally administered to 1 year old, with no reported adverse event (expired product administered) (latency: same day).  It was unknown if any lab data/tests available.  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Daptacel) 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error
Clinical narrative: expired Adacel vaccine administered with no reported adverse event; Initial information received on 06-Jul-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 34 years old male patient for whom expired diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Jul-2023, the patient received a standard expired dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection at a dose of 0.5 mL total (lot U7093AA, expiry date- 18-JUN-2023) via intramuscular route in the left deltoid for Immunization with no reported adverse event (expired product administered) (latency- same day).  Reportedly, Nurse called to report that a patient was given an expired ADACEL injection and asked for guidelines regarding this.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient states that they have had a full body rash and full body itching that has lasted for longer than a month.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Pt was given the incorrect vaccine, Pt was given quadracel which is for ages 4-6
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: The vaccine was not reconstituted so the DTAP/IPV portion of the vaccine was given without any Hib.  No side effects were noted at the time of vaccination.  Patient was well appearing.
Age: 27.0
Sex: M
Vaccine: HEP, PNC20
Symptoms: Dyspnoea, Pallor, Tachycardia, Visual impairment
Clinical narrative: The hep b vaccine was administered first, followed by the prevnar. Within minutes of the prevnar vaccine, the patient started to experience visual disturbances. tachycardia, and his face was pale. I asked if the patient was having trouble breathing and he said yes. I called EMS and they arrived shortly after. While in transit to the pharmacy, the patient started to feel better. When EMS arrived they offered oxygen but the patient said he didn't need it. EMS medically cleared the patient . Epinephrine was not administered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody increased, Antinuclear antibody positive, Arthralgia, Back pain, Cyst
Clinical narrative: I began having symptoms of pain to back and and shortly after vaccination with Moderna. I had already had a previous reaction to phizer of neuropathy. So I tried Moderna for the den one shot. I had to have a full hysterectomy (after having a partial previous ) due to large cyst that were not present prior to vaccination. I have since developed thyroiditis and have a positive ANA and other autoimmune flags. I have to go to a specialist for more test. My TPO was elevated.  They believe I have markers for lupus or a similar autoimmune disease
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hysterectomy, Laboratory test abnormal, Rheumatoid factor increased, Thyroiditis
Clinical narrative: I began having symptoms of pain to back and and shortly after vaccination with Moderna. I had already had a previous reaction to phizer of neuropathy. So I tried Moderna for the den one shot. I had to have a full hysterectomy (after having a partial previous ) due to large cyst that were not present prior to vaccination. I have since developed thyroiditis and have a positive ANA and other autoimmune flags. I have to go to a specialist for more test. My TPO was elevated.  They believe I have markers for lupus or a similar autoimmune disease
Age: 1.42
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after Before Use Date, which was 02/23/2023
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site rash, Neurological symptom, Rash vesicular
Clinical narrative: Multiple Severe Flu like symptoms, nerve symptoms and then developed a shingles-like rash about 4 - 6? from injection site
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: Pentacel powder (HIB) never mixed with  diluent (dtap-IPV) so pt did not receive HIB portion of vaccine
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: Pentacel: Diluent vial (dtap-IPV) never mixed w/ powder vial (HIB).  Pt Never received the HIB portion of this combo vaccine
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Chest X-ray, Electrocardiogram, Erythema, Full blood count, Laboratory test
Clinical narrative: Acute severe edema, errythema, pain. Fever started 6/20
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Oedema, Pain, Pyrexia, Troponin
Clinical narrative: Acute severe edema, errythema, pain. Fever started 6/20
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; Nurse called regarding MMR II. Nurse reported expired vaccine was administered to a patient. Patient is not reporting signs or symptoms of adverse effects. Expiration date for lot # U017524 was 06/03/2023. Permission to contact HCP was granted. No ad; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 30-JUN-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number U017524, expiration date 03-JUN-2023 (dose and route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.
Age: 0.17
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects have been shown; HCP called to ask about side effects of GARDASIL 9 given to a 2-month-old female. 2-month-old patient received GARDASIL 9 today in the morning of 7/3/2023. No side effects have been shown. HCP gave permission to contact him. No additional AE reported; This spontaneous report was received from a physician referring to a 2-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 03-JUL-2023, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Moderate soreness at injection site; Swelling and soreness of infraclavicular lymph node; Swelling and soreness of infraclavicular lymph node; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 2, single (Lot number: EN6200) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9262), administration date: 28Jan2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Moderate soreness at injection site", "Swelling and soreness of infraclavicular lymph node", "Swelling and soreness of infraclavicular lymph node". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Moderate soreness at injection site"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "Swelling and soreness of infraclavicular lymph node".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300118435 same patient, different dose, same events;