chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) 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)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medications were reported.  The case was reported for 10th out of 77 adult patients who had received the vaccine as reported by the reporter.  It was reported that the vaccine was administered to 77 patients before it was known if the vaccine was ok to use after the excursion.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) 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)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case contains the information of 17th patient out of 77 reported.  Concomitant products were not reported.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) 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)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medications were reported. The case was reported for 12th out of 77 adult patients who had received the vaccine as reported by the reporter.  It was reported that the vaccine was administered to 77 patients before it was known if the vaccine was ok to use after the excursion.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: M
Vaccine: COVID19-2
Symptoms: Chest discomfort, Dyspnoea, Incorrect dose administered, Wrong product administered
Clinical narrative: intended to get a flu shot yesterday but was inadvertently given another Pfizer Covid-19 bivalent booster instead; given another Pfizer Covid-19 bivalent booster instead; shortness of breath; chest discomfort; 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 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive influenza vaccine (INFLUENZA VACCINE). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "Sore arm"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BIVALENT), SINGLE), administration date: 2022, for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "intended to get a flu shot yesterday but was inadvertently given another Pfizer Covid-19 bivalent booster instead"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "given another Pfizer Covid-19 bivalent booster instead"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown".  Additional information: Caller states he already received the Pfizer BioNTech Covid-19 bivalent vaccine 7 weeks ago. He intended to get a flu shot yesterday but was inadvertently given another Pfizer Covid-19 bivalent booster instead. Caller states he is now experiencing shortness of breath and chest discomfort and is concerned about possible cardiac side effects from the vaccine. Caller states he only experienced a sore arm with the first few doses he received. Caller asking if cardiac side effects are known to occur after receiving bivalent doses too close together or if they occur more often in people who have experienced cardiac side effects in the past. The consumer reported experiencing a sore arm after the first four injections of the Pfizer COVID-19 vaccine. The consumer reported getting 5 injections total of the Pfizer covid-19 vaccine, with the 4th and 5th doses being the bivalent booster.  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: Linked Report(s) : US-PFIZER INC-202300013130 same patient, events after different doses of the vaccine;US-PFIZER INC-202300013129 same patient, events after different doses of the vaccine;US-PFIZER INC-202300013128 same patient, events after different doses of the vaccine;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Pain, SARS-CoV-2 test, Urticaria
Clinical narrative: pain; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), 0.3 ml single (Lot number: EW0187) at the age of 70 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "she had cancer" (unspecified if ongoing), notes: She had cancer that had spread to the lymph nodes in both arms; "lymph nodes were removed", start date: Nov2019, stop date: Nov2019, notes: The lymph nodes were removed Nov2019; "Estrogen blocker prevent cancer coming back" (ongoing), notes: Estrogen blocker prevent cancer coming back; "Heartburn" (ongoing). Concomitant medication(s) included: LETROZOLE taken for prophylaxis (ongoing); ESOMEPRAZOLE MAGNESIUM taken for dyspepsia (ongoing). Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 12Oct2021, outcome "recovered" (16Oct2021), described as "hives"; PAIN (non-serious), outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: Caller mentioned that she had Pfizer for all of her previous COVID-19 vaccine shots. She had her lymph nodes removed. She is afraid of experiencing lymphadenopathy. She mentioned that she is currently on physical therapy and still experiences pain. Her family care doctor told her to contact Pfizer and tell her if she should still get another booster.
Sex: F
Vaccine: COVID19
Symptoms: Factor V Leiden mutation
Clinical narrative: heterozygous for Factor V Leiden; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DVT" (unspecified if ongoing), notes: DVT. The patient's concomitant medications were not reported.  The following information was reported: FACTOR V LEIDEN MUTATION (non-serious), outcome "unknown", described as "heterozygous for Factor V Leiden".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 72 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EN5318), on 12Feb2021 as dose 2, single (Lot number: EL9269), in left arm, on 02Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunization. The patient's relevant medical history included: "known_allergies:latex" (unspecified if ongoing); "known_allergies:ACE inhibitors" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course Paxlovid treatment taken for Covid-19 on 28Dec2022..  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Investigation, Muscle twitching, Oxygen saturation
Clinical narrative: developed a jerking motion in both arms and her hands.; In her left eye there is a constant twitch/have a twitch in her left cheek; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Flu", start date: Dec2019 (unspecified if ongoing); "Couldn't breathe", start date: Dec2019 (unspecified if ongoing); "crush injury on left foot", start date: Feb2016 (unspecified if ongoing), notes: crush injury on left foot, Her crush injury occurred in Feb2016.; "Due to that injury, she no longer walks" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for rheumatoid arthritis. Vaccination history included: Bnt162b2 (Dose 1, Does not have vaccine record card to provide any details or NDC/LOT/EXP at time of call.), for COVID-19 Immunization; Bnt162b2 (Dose 2, Does not have vaccine record card to provide any details or NDC/LOT/EXP at time of call.), for COVID-19 Immunization; Shingrix (she also took the Shingrix for shingles vaccine., NDC/LOT/EXP: Unknown), for shingles vaccine. The following information was reported: DYSKINESIA (non-serious), outcome "unknown", described as "developed a jerking motion in both arms and her hands."; MUSCLE TWITCHING (non-serious), outcome "recovered", described as "In her left eye there is a constant twitch/have a twitch in her left cheek". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information : Patient reported that about 2 months after her 3rd COVID-19 vaccine, she developed a jerking motion in both arms and her hands. In her left eye there is a constant twitch. Also after her 3rd COVID vaccine, she did have a twitch in her left cheek, but thankfully it has gone away.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Gait disturbance, Myalgia
Clinical narrative: Joint pain in her knees, wrists, and fingers/knees are hurting me, my fingers are hurting me; Muscle ache; Could hardly walk; 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.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose:1, unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose:2, unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose:3 (booster), unknown manufacture), for COVID-19 immunization. The following information was reported: GAIT DISTURBANCE (non-serious) with onset Jan2023, outcome "unknown", described as "Could hardly walk"; ARTHRALGIA (non-serious) with onset Jan2023, outcome "unknown", described as "Joint pain in her knees, wrists, and fingers/knees are hurting me, my fingers are hurting me"; MYALGIA (non-serious) with onset Jan2023, outcome "unknown", described as "Muscle ache". Therapeutic measures were not taken as a result of arthralgia, myalgia, gait disturbance.  Additional information: The patient had no other conditions. The patient had not other products. The patient had second booster and her 4th shot. The patient said G, looked like GJ6742, not sure as Lot number. The patient stated that she got the booster on 07Jan and has had joint pain in her knees, wrists, and fingers for the past 3 days. It was hard for her to walk because her knees are so bad. For the last 2 days or 3 days, the patient have muscle ache that she could hardly walk. Her knees are hurting her, her fingers are hurting her. The patient queried if she should go to a doctor. The patient had not underwent any investigation. Treatment: patient stated, "No, she was going to the doctor's today." Prior vaccinations (within 4 weeks): Consumer stated, "No."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: 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 Booster Dose Number: 4 / Pfizer / BioNTech Dose Number: 5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9703) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Jan2021 at 10:00 as dose 1, single (Lot number: M013L20A), in left arm, on 02Oct2021 at 10:00 as dose 2, single (Lot number: Mo12M20A), in left arm, on 02Nov2021 as dose 3 (booster), single (Lot number: 017F21A) and on 05May2022 as dose 4 (booster), single (Lot number: 057M21A) for covid-19 immunisation. The patient's relevant medical history included: "Cvd" (unspecified if ongoing), notes: other medical history: Cvd; "arthritis" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Perhaps ibuprofen, reaction(s): "Known allergies: Perhaps Ibuprofen", notes: Known allergies: Perhaps Ibuprofen. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022 at 12:00, outcome "unknown", described as "Moderna Booster Dose Number: 4 / Pfizer / BioNTech Dose Number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Elderly (65+ Years). Other medication in 2weeks was reported as unknown. Patient received Paxlovid treatment from 03Jan2023 to 07Jan2023 for Covid-19.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). A 31-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 3 (booster), single (Lot number: GJ6742) at the age of 30 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EN6200) and on 18Mar2021 as dose 2, single (Lot number: EP7534) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2023, outcome "unknown" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2023) Positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2021 as dose 1, single (Lot number: Ew0167), in left arm, on 26May2021 as dose 2, single (Lot number: Ew0191), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: Ff8841), in right arm and on 23Aug2022 as dose 4 (booster), single (Lot number: FP7138) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers-Danlos" (unspecified if ongoing); "Tarlov cyst disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "narcolepsy" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL, start date: 01Dec2021; NUVIGIL, start date: 01Dec2021; MYRBETRIQ, start date: 01Feb2022, stop date: 05Jan2023; CLARITIN [LORATADINE], start date: 01Dec2021; LYRICA, start date: 01Dec2021. Past drug history included: Tramadol, reaction(s): "Allergy"; Tricyclics, reaction(s): "drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 05Jan2023 to 05Jan2023.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient has not received any other medication in 2 weeks.  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: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Brain cancer metastatic, Neoplasm progression
Clinical narrative: has brain cancer, totally healthy man and decided to have surgery and in 2 weeks tumor grew back bigger than it was.; has brain cancer, totally healthy man and decided to have surgery and in 2 weeks tumor grew back bigger than it was.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN CANCER METASTATIC (medically significant), NEOPLASM PROGRESSION (non-serious), outcome "unknown" and all described as "has brain cancer, totally healthy man and decided to have surgery and in 2 weeks tumor grew back bigger than it was.". Clinical Information: Called about the toxic injections that Pfizer makes, upon clarifying caller clarified calling about the COVID-19 toxic injections. Brother-in-law had brain cancer, totally healthy man and decided to have surgery and in 2 weeks tumour grew back bigger than it was. Declined to complete report. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, 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: "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 30Nov2021, stop date: 01Jan2023; METOPROLOL, start date: 30Nov2021; BUPROPION, start date: 31Dec2020.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Other medication in 2 weeks. Patient had no Known Allergies. Patient received COVID 19 Treatment of Paxlovid from 01Jan2023 to 06Jan2023  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Central nervous system lesion, Multiple sclerosis, Peripheral swelling, Spinal disorder
Clinical narrative: multiple sclerosis; He reported lesions on the brain and his spine; He reported lesions on the brain and his spine; Also swelling of his feet.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A male 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: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID- 19 Immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "recovered with sequelae"; CENTRAL NERVOUS SYSTEM LESION (non-serious), SPINAL DISORDER (non-serious), outcome "recovered with sequelae" and all described as "He reported lesions on the brain and his spine"; PERIPHERAL SWELLING (non-serious), outcome "recovered with sequelae", described as "Also swelling of his feet.". The events "multiple sclerosis", "he reported lesions on the brain and his spine" and "also swelling of his feet." required physician office visit. Therapeutic measures were taken as a result of multiple sclerosis, central nervous system lesion, spinal disorder, peripheral swelling. Clinical course: The patient stated after his second dose that he received a diagnosis of multiple sclerosis. He reported lesions on the brain and his spine. Also swelling of his feet. Ae resulted in Doctor or other healthcare professional office/clinic visit. Patient recovered with lasting effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose number unknown (booster), single (Lot number: GJ2524) at the age of 30 years, in left arm 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient received Paxlovid (anti-viral) for COVID-19 treatment, from 22Dec2022 to 27Dec2022.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: Vaccine administered beyond use date; Vaccine administered beyond use date; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 22-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Jan2023 as dose number unknown (booster), single (Lot number: GH9703) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 03Jan2023, outcome "unknown" and all described as "Vaccine administered beyond use date".  Additional Information: The vaccine beyond use date was 30Nov2022 and the vaccine was administered on 03Jan2023. The vaccine was kept stored in the refrigerator within range and in a sealed vial. The caller requests stability information. Callback attempt on 11Jan2023 at 12:16 PM: Successful. Caller on the line reporting that a 22-year-old female received the grey cap covid-19 bivalent vaccine past the beyond use date. Beyond use date was 30Nov2022 and vaccine was administered on 03Jan2023. Vaccine had been stored in the refrigerator and in sealed vials. Product storage error. Based off the delivery date, the vaccines were delivered on 21Sep2022 and put into a fridge. The vaccines are only good for 10 weeks once refrigerated.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I got Covid where I almost nearly died, in July. Even after I got the vaccine months before; I got Covid where I almost nearly died, in July. Even after I got the vaccine months before; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got Covid where I almost nearly died, in July. Even after I got the vaccine months before". Clinical course: The patient reported that she knew that it was not a vaccine, because it did not work like a vaccine. She wanted to know, how long did it take the jab, the Pfizer jab to come out of body. It must get out of your system, because it needed boosters added. She got covid where she just nearly died in Jul, so she knew that it did not work, noting that. She got 2 shots only, against her will, and she got Covid where she almost nearly died, in Jul. Even after she got the vaccine months before. When she got her vaccines as a little girl, she never got the measles, mumps and polio. She also reported that she knew a lot of people are dying [from the vaccine], and her son ended up in the hospital for 1 week due to the Pfizer vaccine last year. Since her son took his last jab in Dec and ended up in the hospital for one week on his deathbed. She just wanted to make sure, does it eventually make it out of your body because all these people are dropping to their feet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: saw my son, at 17, plummet to the floor; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FALL (hospitalization), outcome "unknown", described as "saw my son, at 17, plummet to the floor". The patient was hospitalized for fall (hospitalization duration: 7 day(s)).  Clinical course: Caller provided, "I know a lot of people are dying" [from the vaccine], "and my son ended up in the hospital for 1 week due to the Pfizer vaccine last year. Since my son took his last jab in Dec and ended up in the hospital for one week on his deathbed. because all of these people are dropping to their feet." she stated, "I saw my son, at 17, plummet to the floor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: 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 drug ineffective, covid-19.  Clinical course: Patient no received any other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Long Covid", start date: 2020 (unspecified if ongoing), notes: Other medical history: Long Covid; "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "chronic fatigue syndrome", start date: 2020 (unspecified if ongoing), notes: Other medical history: chronic fatigue syndrome (since Covid infection 2020); "migraines" (unspecified if ongoing), notes: Other medical history: migraines; "shortness of breath" (unspecified if ongoing), notes: Other medical history: shortness of breath; "BPV" (unspecified if ongoing), notes: Other medical history: BPV; "high cholesterol" (unspecified if ongoing), notes: Other medical history: high cholesterol; "anxiety" (unspecified if ongoing), notes: Other medical history: anxiety; "depression" (unspecified if ongoing), notes: Other medical history: depression; "PTSD" (unspecified if ongoing), notes: Other medical history: PTSD. Concomitant medication(s) included: AMLODIPINE; SERTRALINE; ALPRAZOLAM; VITAMIN C [ASCORBIC ACID]; ACETAMINOPHEN; VITAMIN D3. Past drug history included: Propranolol, reaction(s): "Allergy", notes: known allergies: Propranolol; Imitrex, reaction(s): "Allergy", notes: known allergies: imitrex; Relpax, reaction(s): "Allergy", notes: known allergies: relpax; Hctz, reaction(s): "Allergy", notes: known allergies: hctz; Phenergan, reaction(s): "Allergy", notes: known allergies: phenergan; Prednisone, reaction(s): "Allergy", notes: known allergies: prednisone; Buspirone, reaction(s): "Allergy", notes: known allergies: buspirone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment yes, Reporter type patient, If vaccine received yes, Other medication in 2weeks yes, Product COVID 19 Treatment start date 04Jan2023, treatment stop date 09Jan2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300014654 Same patient, different product and event;
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Investigation, Memory impairment, Speech disorder
Clinical narrative: memory issues; got more mixed up/ got confused; Is repeating herself more; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). An 80-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), (ongoing) (Lot number: FK3383, Expiration Date: 31Oct2023) at 11 mg daily, oral for arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), administration date: Mar2021, when the patient was 79 years old, for COVID-19 immunization. The following information was reported: SPEECH DISORDER (non-serious) with onset Oct2021, outcome "not recovered", described as "Is repeating herself more"; CONFUSIONAL STATE (non-serious) with onset Oct2021, outcome "not recovered", described as "got more mixed up/ got confused"; MEMORY IMPAIRMENT (non-serious) with onset Oct2021, outcome "not recovered", described as "memory issues". The events "memory issues" and "got more mixed up/ got confused" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The action taken for tofacitinib citrate was dosage not changed. Therapeutic measures were taken as a result of memory impairment. Therapeutic measures were not taken as a result of confusional state, speech disorder.  Additional information: the reporter did not know if it is related to her age or medication or the COVID shots, did not know what is causing her memory issues. If someone calls she cannot remember who it was. The reporter went with the patient to her doctors appointments because she does not remember what was said.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19-2
Symptoms: Menstruation irregular
Clinical narrative: menstrual cycle irregularities after receiving the COVID-19 vaccine and the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: Bnt162b2 (Primary immunization series complete, she is experiencing menstrual cycle irregularities after receiving the COVID-19 vaccine and the booster.), for COVID-19 immunization, reaction(s): "Menstrual cycle abnormal". The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "menstrual cycle irregularities after receiving the COVID-19 vaccine and the booster".  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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine brand=Pfizer / BioNTech, vaccine dose number=4/Treatment of COVID-19; Vaccine brand=Pfizer / BioNTech, vaccine dose number=4/Treatment of COVID-19; vaccine brand other=moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown), on 19Apr2021 as dose 2, single (Batch/Lot number: unknown), on 19Nov2021 as dose 3, single (Batch/Lot number: unknown) and on 19Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Jul2022, outcome "unknown", described as "vaccine brand other=moderna"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "vaccine brand=Pfizer / BioNTech, vaccine dose number=4/Treatment of COVID-19"; COVID-19 (medically significant), outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, vaccine dose number=4/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2023) Negative, notes: tested negative on an antigen test yesterday; (11Jan2023) Positive, notes: tested positive on an antigen test today. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event: tested negative on an antigen test yesterday and then tested positive on an antigen test today. It was unknown if patient recovered. Patient did not take other medication was in 2weeks. Patient received a treatment of Paxlovid for COVID-19 since 02Jan2023 to 07Jan2023.Relevant Med History was reported as none and no other known allergies were reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "ITP" (unspecified if ongoing), notes: ITP; "Anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: 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 drug ineffective, covid-19 with antiviral (Pfizer) treatment start date was 11Jan2023.  Clinical information : It was reported as, No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.