chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dispensed 28 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) outcome was unknown.     or mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that patient had no known allergies.  Concomitant medication was not reported.  Reporter reported that they dispensed 28 doses of expired Moderna Covid-19 vaccine. These were administered on 06Apr2022 & 08Apr2022 with Lot: 012H21B and expiration date:18Mar2022.  No treatment medications were reported   This case was linked to MOD-2022-541343, MOD-2022-544282, MOD-2022-544310 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dispensed 28 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient had no known allergies.     On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Patient had not been diagnosed with COVID-19 vaccine previously. Patient was not taking any prescription, over the counter medications, dietary supplements and herbal remedies at the time of vaccination. No adverse events were reported by the patient after the vaccination. The vial didn't had any temperature excursion issue. Date on which the vaccine was placed in refrigerator was unknown.  No treatment drug information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given expired dose of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired dose of Moderna vaccine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (HTN), Hyperlipidemia (HLD), Type 2 diabetes mellitus (T2 DM), Irritable bowel syndrome (IBS) and Penicillin allergy (Penicillins).    On 23-Mar-2022 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2022 at 1:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired dose of Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired dose of Moderna vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. It reported that the patient has not experienced an adverse event to the knowledge of clinical staff, as per HCP the vial didn't undergo any temperature excursions, vaccination site reported as deltoid.  No treatment medications were reported.   This case was linked to MOD-2022-543908 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired dose of moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given an expired dose of moderna vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia and Hypertension.    On 23-Mar-2022 at 1:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2022 at 1:40 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given an expired dose of moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given an expired dose of moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  The patient had not experienced an adverse event to the knowledge of clinical staff. Patient did not received any other vaccine. No known drug allergy was reported. The vial did not undergone any temperature excursion issue.  No treatment medication reported by reporter.   This case was linked to MOD-2022-543908 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dispensed 28 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient had no known allergy. It was reported that patient had never been diagnosed/ tested positive for COVID-19. Patient had no chronic or long-standing health conditions. Patient had no acute illness at the time of vaccination and up to one month before.  On 06-Apr-2022 at 9:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022 at 9:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. It was reported that patient had no adverse event from the vaccine on 6 Apr 2022.  The vial did not undergo any temperature excursions. On unknown date the vial was initially stored in the refrigerator.  No treatment medication information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We dispensed 28 doses of expired Moderna covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We dispensed 28 doses of expired Moderna covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No known allergies.     On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We dispensed 28 doses of expired Moderna covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We dispensed 28 doses of expired Moderna covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Patient had never been diagnosed/tested positive for Covid-19. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient did not report any adverse event after vaccine administered.  No temperature excursions were reported. No treatment medication was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion, Blood test abnormal, Emotional disorder, Investigation, Vaginal haemorrhage
Clinical narrative: I got aborted after getting two-shot; Vaginal Bleeding/ continuedly bleeding; 20 times blood works; I was emotional damaged; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 30-year-old female patient (pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD TEST ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "20 times blood works"; EMOTIONAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "I was emotional damaged"; VAGINAL HAEMORRHAGE (non-serious) with onset 2021, outcome "unknown", described as "Vaginal Bleeding/ continuedly bleeding"; ABORTION (hospitalization, medically significant) with onset Nov2021, outcome "unknown", described as "I got aborted after getting two-shot". The event "i got aborted after getting two-shot" required emergency room visit. The patient underwent the following laboratory tests and procedures: 20 times blood work: Unknown, notes: abnormal.  Clinical Course: Admission to hospital was required due to the event. Patient not sure, Still Experiencing and affect next pregnancy. Vaginal Bleeding complete abortion at the hospital's Emergency dept. Patient finished covid Pfizer vaccination on 28Jun2021 and patient was pregnant on Nov2021 Doctor asked her if Patient had gynaecological diseases. None, she just gave a birth and her first baby born 1 years. She was healthy never had any problems. she was so observed 3 weeks 20 times blood work. Stayed in the bed. Continuedly bleeding. Finally her doctor said she cant save this baby and she was sent to emergency room for abortion. This year march patient saw the news about Pfizer side effects cause gynaecological diseases' was emotional damaged. Patient got recovery check and asked her doctor if its because of Pfizer and she said yes. Patient need Pfizer pay for it because her baby was innocent.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: developed a fever/felt warm; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 12-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "developed a fever/felt warm". Additional information: the patient developed a fever. His mom thinks he was overreacting. He had the shot and then went to the buffet for dinner and said he felt warm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: there is more pain for the patient compared to other vaccines he administers; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "there is more pain for the patient compared to other vaccines he administers".  Additional information: After administering any dose of Prevnar 13, the doctor states that there was more pain for the patient compared to other vaccines he administers. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 Apr2022; tested positive for COVID-19 Apr2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (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 Apr2022, outcome "unknown" and all described as "tested positive for COVID-19 Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Headache, Nausea, Oropharyngeal pain
Clinical narrative: COVID-19 infection; lack of vaccine efficacy confirmed through positive test; Sore throat; headache; fever; dizziness; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: EW0162), in left arm and on 07May2021 as dose 2, single (Lot number: EW0179) at the age of 34 years, in left arm, all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Dec2021 as dose 3 (booster), single (Lot number: 070H21A) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 10Apr2022 at 19:00, outcome "recovering", described as "COVID-19 infection"; OROPHARYNGEAL PAIN (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering", described as "Sore throat"; DIZZINESS (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering"; PYREXIA (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering"; VACCINATION FAILURE (medically significant) with onset 10Apr2022 at 19:00, outcome "recovering", described as "lack of vaccine efficacy confirmed through positive test"; NAUSEA (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Nov2021) Negative, notes: Nasal Swab Binax now; (25Mar2022) Negative, notes: Nasal Swab Binax now; (12Apr2022) Positive, notes: Nasal Swab Siemens Clinitest,. Therapeutic measures were taken as a result of covid-19, vaccination failure, oropharyngeal pain, headache, pyrexia, dizziness, nausea.  Additional information:  He received Ibuprofen and rest treatment for adverse events. He did not receive covid prior vaccination. He had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He did not receive any other medications within 2 weeks of vaccination. He was not diagnosed with COVID-19 Prior to vaccination. The patient has been tested for COVID-19, after the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 infection; lack of vaccine efficacy confirmed through positive test; Sore throat; headache; fever; dizziness; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: EW0162), in left arm and on 07May2021 as dose 2, single (Lot number: EW0179) at the age of 34 years, in left arm, all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Dec2021 as dose 3 (booster), single (Lot number: 070H21A) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 10Apr2022 at 19:00, outcome "recovering", described as "COVID-19 infection"; OROPHARYNGEAL PAIN (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering", described as "Sore throat"; DIZZINESS (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering"; PYREXIA (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering"; VACCINATION FAILURE (medically significant) with onset 10Apr2022 at 19:00, outcome "recovering", described as "lack of vaccine efficacy confirmed through positive test"; NAUSEA (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Nov2021) Negative, notes: Nasal Swab Binax now; (25Mar2022) Negative, notes: Nasal Swab Binax now; (12Apr2022) Positive, notes: Nasal Swab Siemens Clinitest,. Therapeutic measures were taken as a result of covid-19, vaccination failure, oropharyngeal pain, headache, pyrexia, dizziness, nausea.  Additional information:  He received Ibuprofen and rest treatment for adverse events. He did not receive covid prior vaccination. He had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He did not receive any other medications within 2 weeks of vaccination. He was not diagnosed with COVID-19 Prior to vaccination. The patient has been tested for COVID-19, after the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Muscle spasms, Tremor
Clinical narrative: severe chills; shaking like he cannot get warm; like muscle cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (125651).  A 76-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation; tafamidis (VYNDAMAX). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 2, Manufacturer unknown, NO adverse events to the prior 2 vaccine shots.), for Covid-19 immunization, reaction(s): "No adverse event"; Covid-19 vaccine (Dose 1, Manufacturer unknown, NO adverse events to the prior 2 vaccine shots.), for Covid-19 immunization, reaction(s): "No adverse event". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "severe chills"; TREMOR (non-serious), outcome "unknown", described as "shaking like he cannot get warm"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "like muscle cramps". The action taken for tafamidis was unknown.  Additional Information: Reporter classified events as Non-serious. Reporter reports her husband, at various times has experienced some severe chills, shaking like he cannot get warm, like muscle cramps. Pt takes Vyndamax but caller mentioned if this could be from the Pfizer COVID Booster Vaccine that he has received 07Dec2021. Caller states since the booster shot this has been happening. NO adverse events to the prior 2 vaccine shots. Since the booster shot it seems like every 2 - 3 weeks he has episodes like this and it lasts 3-4 days and then he is okay for a while and then it comes right back.This time it seems like he was down weekend before last, sat-Tuesday and then he was okay and then Friday it started all over again. Reporter is aware not a lot is known about this "stuff. Patient was in the provider's office last Tuesday coming off all of that, the provider advised several patients have done that. The caller wants to known what is it. Is it because of the booster or is it something else. She does not feel that he is trying to find out about his patients. Its like he does not care anymore. Very frustrating when you cannot get anyone to help you.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 32-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient was pregnant at time of vaccination. The patient's relevant medical history included: "Panhypopitutirism" (unspecified if ongoing); "Known allergies- Avocado" (unspecified if ongoing), notes: Avocado allergy. The patient was 27 pregnant at the event onset. Concomitant medication(s) included: DESMOPRESSIN; HYDROCORTISONE; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Cerebrovascular accident, Headache, Visual impairment
Clinical narrative: I don't know if it done something to my brain; had a stroke; I had a pain start in my temple go through to the other side of my head; I could not see; I was reading something on a computer and my vision I could not read what was on the screen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: FF2583) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Rosuvastatin, notes: 20 milligrams, a statin and a low dose Aspirin. Vaccination history included: BNT162b2 (Dose 1, single Lot:EN6204, Patient had the first two Pfizer shot without any problem what so ever), administration date: 24Mar2021, when the patient was 84-year-old, for COVID-19 Immunization, reaction(s): "No adverse effect"; BNT162b2 (Dose 2, single, Lot: EW0162, Patient had the first two Pfizer shot without any problem what so ever), administration date: 14Apr2021, when the patient was 84-year-old, for COVID-19 Immunization, reaction(s): "No adverse effect"; Shingles shot (year and half ago patient had the shingles shot). The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset Oct2021, outcome "recovered", described as "I could not see; I was reading something on a computer and my vision I could not read what was on the screen"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "I had a pain start in my temple go through to the other side of my head"; CEREBROVASCULAR ACCIDENT (medically significant) with onset Oct2021, outcome "unknown", described as "had a stroke"; CEREBRAL DISORDER (non-serious), outcome "unknown", described as "I don't know if it done something to my brain". Therapeutic measures were not taken as a result of cerebrovascular accident, headache, visual impairment, cerebral disorder. Clinical course: The patient had no reaction with first or the second Pfizer shot but with the third one 48 hours after patient had the shot patient was sitting at the counter patient had a pain start in her temple go through to the other side of her head and patient could not see. Patient was reading something on a computer and her vision and could not read what was on the screen. It lasted all that long patient walked over to sit on the couch saying to herself what in the world just happening to her and then it went away.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (unknown if pregnant) received BNT162b2 (COMIRNATY), 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 blood pressure" (unspecified if ongoing), notes: controlled well with medication. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) positive.  Clinical Course: The patient while being quarantined had developed mild to moderate Covid symptoms. symptoms developed by patient were headache and low-grade fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 41-year-old male patient received BNT162b2 (COMIRNATY), 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: "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive.  Additional comment: The reporter accompanied by her husband, her son and a friend have all been vaccinated and boosted with Pfizer Covid vaccine. While vacationed together on a cruise ship the week from 05Apr2022 to 12Apr2022, they were notified on 12Apr2022 having been tested positive for Covid. They were therefore removed from the shipped and self quarantined in a hotel. Since being quarantined they have all developed mild to moderate Covid symptoms. Symptoms developed by patient:  mild headache and runny nose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34-year-old female patient (unknown if pregnant) received BNT162b2 (COMIRNATY), 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 immunisatiThis is a spontaneous report received from a contactable reporter(s) (consumer or other non HCP). A 34-year-old female patient (unknown if pregnant) received BNT162b2 (Comirnaty), 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 immunization. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: drug ineffective (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) positive. Clinical Information: the reporter accompanied by her husband, her son and a friend have all been vaccinated and boosted with Pfizer COVID-19 vaccine. While vacationed together on a cruise ship the week from 05Apr2022 to 12Apr2022, they were notified on 12Apr2022 having been tested positive for COVID-19. They were therefore removed from the shipped and self-quarantined in a hotel. Since being quarantined they have all developed mild to moderate COVID-19 symptoms. Symptoms developed by patient was runny nose, congestion, cough and low-grade fever. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received on. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) positive.  Clinical Information: The reporter accompanied by her husband, her son and a friend have all been vaccinated and boosted with Pfizer Covid vaccine. While vacationed together on a cruise ship the week from 05Apr2022 to 12Apr2022, they were notified on 12Apr2022 having been tested positive for Covid. They were therefore removed from the shipped and self quarantined in a hotel. Since being quarantined they have all developed mild to moderate Covid symptoms. Symptoms developed by patient was runny nose, congestion, cough and low grade fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Gait disturbance, Investigation
Clinical narrative: Chest pain; Unsteady gait; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 83 years intramuscular, 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 (Dose 1, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: CHEST PAIN (hospitalization) with onset 13Apr2022, outcome "unknown"; GAIT DISTURBANCE (hospitalization) with onset 13Apr2022, outcome "unknown", described as "Unsteady gait". The events "chest pain" and "unsteady gait" required physician office visit. The patient underwent the following laboratory tests and procedures: Test: (Apr2022) Unknown. Therapeutic measures were taken as a result of chest pain, gait disturbance.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events chest pain, gait disturbance and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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. Other Case identifier(s): 22K-163-4247283-00.  A 55-year-old female patient received BNT162b2 (BNT162B2), as dose 3, (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (ongoing). The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jan2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jan2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: This required heart catheterization; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID:.  A 36-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), 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: CARDIAC DISORDER (hospitalization), outcome "unknown", described as "This required heart catheterization". Therapeutic measures were taken as a result of cardiac disorder. Reporter said that:" I can provide all hospital documentation needed to prove this was in conjunction with the shot to receive this help."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Off label use, Suspected COVID-19
Clinical narrative: off label use; Booster dose 4; came down with COVID and unfortunately I got it as well; came down with COVID and unfortunately I got it as well.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old patient received BNT162b2 (BNT162B2), 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) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster dose 4"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "came down with COVID and unfortunately I got it as well"; SUSPECTED COVID-19 (medically significant), outcome "recovered", described as "came down with COVID and unfortunately I got it as well.". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Fever Blister, lower lip and gum; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 at 14:30 as dose 4 (booster), single (Lot number: 9943) at the age of 84 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TDAP, on 30Mar2022; PLACID [ETOPOSIDE]; CRESTOR; METOPROLOL. Vaccination history included: Covid-19 vaccine (Dose: 3, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose:2, Manufacturer: Unknown, Primary immunization complete), for Covid-19 Immunization; Covid-19 vaccine (Dose:1, Manufacturer: Unknown, Primary immunization complete), for Covid-19 Immunization. The following information was reported: ORAL HERPES (non-serious) with onset 14Apr2022, outcome "not recovered", described as "Fever Blister, lower lip and gum". Therapeutic measures were taken as a result of oral herpes with Zovirax. Other vaccine 4 weeks vaccine was on 30Mar2022, Left arm. No covid prior vaccination and no covid tested post vaccination.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got diagnosed with have covid on 15Apr2022; got diagnosed with have covid on 15Apr2022; 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 male patient received BNT162b2 (BNT162B2), on 21May2021 at 19:00 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Apr2021 at 18:00 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes/ type 1 diabetic" (unspecified if ongoing), notes: Diabetes/ type 1 diabetic for 36 years; "eosiniphilesophagitas" (unspecified if ongoing), notes: eosiniphilesophagitas; "1st dose: Moderna/ 2nd dose: BNT162B2" (unspecified if ongoing), notes: 1st dose: Moderna/ 2nd dose: BNT162B2. Concomitant medication(s) included: HUMALOG; OMEPRAZOLE, start date: 10Dec2021. The following information was reported: COVID-19 (medically significant) with onset 15Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "got diagnosed with have covid on 15Apr2022". Therapeutic measures were taken as a result of covid-19.  Clinical Course: She was type 1 diabetic. She was currently using a insulin pump to adjust her blood sugar. Just got diagnosed with have covid on 15Apr2022. purchased PAXLOVID ON 16Apr2022. She took one dose, Reaction/event in terminology (LLT): She was a type 1 diabetic for 36 years. She took one dose at night and right after she took it her blood sugar started skyrocketing. She ended up taking 20 units in shot form and it dropped down to 300. She took Paxlovid at 5:00 pm it was 10:00 pm she had dosed a total of 50 units of insulin, and it has barely dropped. Is this a normal effect of Paxlovid if you have diabetes. She know some drugs like Prednisone skyrockets sugar levels and no matter how much insulin you take it will not lower because of the drug, does Paxlovid have the same effect, since she had taken this, and she had an awful taste in her mouth. Was wondering if that also was caused by Paxlovid. Treatment received for the adverse event was took large dose of insulin through syringe.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3, (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Lot number: F75407) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID infection". Therapeutic measures were taken as a result of covid-19.  Clinical information: Altered sense of taste. May be due to COVID infection or the new med. Had taken 1 dose before this started.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 3 (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 (DOSE: UNKNOWN, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200584328 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Vaccination site pain
Clinical narrative: The patient is experiencing sharp in the left arm/He is feeling pain and numbness from the area of the shot to the tips of his fingers; He is feeling pain and numbness from the area of the shot to the tips of his fingers; He is feeling pain and numbness from the area of the shot to the tips of his fingers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), 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 (Booster #1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "The patient is experiencing sharp in the left arm/He is feeling pain and numbness from the area of the shot to the tips of his fingers"; PAIN IN EXTREMITY (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "He is feeling pain and numbness from the area of the shot to the tips of his fingers".  Additional Information: After second Pfizer booster shot, the patient is experiencing sharp in the left arm and he is feeling pain and numbness from the area of the shot to the tips of his fingers.  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: Injection site pruritus, Vaccination site discomfort, Vaccination site pain
Clinical narrative: I have a discomfort where the shot is and it woke me up the night; with a little bit of a pain; I have a discomfort where the shot is and it woke me up the night; with a little bit of a pain; it itches all the time where the shot is; 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), on 14Apr2022 as dose number unknown, single (Lot number: FK9729) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE DISCOMFORT (non-serious) all with onset 14Apr2022, outcome "unknown" and all described as "I have a discomfort where the shot is and it woke me up the night; with a little bit of a pain"; INJECTION SITE PRURITUS (non-serious) with onset 14Apr2022, outcome "unknown", described as "it itches all the time where the shot is".  Additional Information:  Reporter stated, "I am calling about a side effect with the Pfizer shot (Pfizer COVID-19 Vaccine). I had the shot on the 4th of Apr2022 (later clarified as 14Apr2022) and the side effect is, I have a discomfort where the shot is and it itches and it woke me up the night that I had that with a little bit of a pain. But then it just went in a little bit of discomfort, then it itches, it itches all the time where the shot is, you know and it is a minor discomfort from the shot. So, I do not know what is going on?"  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 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 had no relevant medical history. Concomitant medication(s) included: NIKKI, start date: 14Apr2022; AZELASTINE HYDROCHLORIDE, start date: 14Apr2022, stop date: 16Apr2022; FLUTICASONE, start date: 14Apr2022, stop date: 16Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19. Clinical course: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.