chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jun2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "insomnia" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known Allergies: Ibuprofen"; Aspirin, reaction(s): "Known Allergies: Aspirin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (30Dec2022) Positive, notes: Tested positive on at home test 30Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Patient received Vaccine, Anti viral details: [product=COVID 19 Treatment, Treatment start date Dec2022, Treatment stop date Dec2022, Indication, Treatment of COVID-19]   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (29Dec2022) Positive, notes: Tested positive for covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  clinical course: Patient did 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.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 15:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2022) Negative, notes: Tested Positive 29Dec2022 after 2 negative tests on 21Dec2022 & 24Dec2022; (24Dec2022) Negative, notes: Tested Positive 29Dec2022 after 2 negative tests on 21Dec2022 & 24Dec2022; (29Dec2022) Positive, notes: Tested Positive 29Dec2022 after 2 negative tests on 21Dec2022 & 24Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid treatment from 16Dec2022 to 21Dec2022. . 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jan2021 as dose 1, single, in left arm, on 24Jan2021 as dose 2, single, in left arm and on 01Oct2021 as dose 3 (booster), single at the age of 34 years for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 27Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MIRENA. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "Rebound Covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer 3 rd dose: 01Oct2021/Moderna dose 4: 27Sep2022". Therapeutic measures were taken as a result of vaccination failure, covid-19, interchange of vaccine products.  Clinical course: No treatment  Patient received treatment with paxlovid from 18Dec2022 to 23Dec2022 for treatment of Covid-19.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 42.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 as dose number unknown (booster), single (Lot number: GH9697) at the age of 42 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Nov2021 as dose number unknown, single (Lot number: FF2590), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing), notes: other medical history: Hypercholesterolemia; "chronic acid reflux" (unspecified if ongoing), notes: other medical history: chronic acid reflux. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2010; PANTOPRAZOLE, start date: 01Jan2017. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. No known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint noise, Pain, Pain in extremity
Clinical narrative: my arm was sore, really sored, when I lift it, it sored; knuckle cracking/her arm was cracking/with the left arm, the crack in the knuckle; my body is still aching; it was not her whole body, but from her shoulder and down.; 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 adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 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 (DOSE NUMBER UNKNOWN, SINGLE), administration date: Aug2022, for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: Sep2022, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset Dec2022, outcome "unknown", described as "it was not her whole body, but from her shoulder and down."; JOINT NOISE (non-serious) with onset Dec2022, outcome "unknown", described as "knuckle cracking/her arm was cracking/with the left arm, the crack in the knuckle"; PAIN IN EXTREMITY (non-serious) with onset Dec2022, outcome "recovered" (2022), described as "my arm was sore, really sored, when I lift it, it sored"; PAIN (non-serious) with onset Dec2022, outcome "not recovered", described as "my body is still aching".  Additional information: Patient reported that from 02Dec "unintelligible" then her arm was sore, really sored, when she lifted it, it sored. Patient also had knuckle cracking and stated she never had this problem before. She then mentioned the soreness remained for two weeks. Patient confirmed she was vaccinated on 02Dec, she mentioned she noticed that the main thing was that her arm was cracking, she mentioned she was not going through pain on her body, but that this all began after she received her booster bivalent dose for adults from Pfizer. She mentioned her previous vaccines were also Pfizer's in August and September. She mentioned that it was not her whole body, but from her shoulder and down. After the information was provided, patient then stated she would not recommend for people to take it, the way she feel. She wished she would not have it because with the left arm, the crack in the knuckle, she did not have that issue. She was not doing anything, and the knuckle was cracking, and her body was still aching.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s)  A 33-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: She has had COVID before. The patient's 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 "She has all the shots/they did a covid test and she is positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive.  Clinical course: Caller states that he had a friend, she texted him last night, so upset. 7 texts regarding the fact she felt lousy, horrible. She has had COVID before. She has all the shots and is up to date he states. She is 33 years old and feels lousy. She went to the doctor, they did a covid test and she was positive. She was going to the doctor today and she was very upset about that. he states. He said that he told her the shot does not say you won't get it, it prevents you from dying and that's what it boils down to not dying.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC13, RVX
Symptoms: Pyrexia
Clinical narrative: the baby had 104 fever for 9 hours; This is a spontaneous report received from a contactable reporter (Physician) from medical information team.  A 7-month-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 3, single (Batch/Lot number: unknown) for immunisation; rotavirus vaccine (ROTAVIRUS VACCINE), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (medically significant), outcome "unknown", described as "the baby had 104 fever for 9 hours". The patient underwent the following laboratory tests and procedures: Pyrexia: 104 fever for 9 hours".  Clinical course: Caller mentioned that it was "a 7-month-old baby who was given 3rd dose of Prevnar 13 with rotavirus vaccine on the same day, and the baby had 104 fever for 9 hours". Caller wants to know if there is a contraindication giving the 4th dose of Prevnar 13 for the baby, given that the patient experienced a fever -which caller mentioned that most babies got post-vaccination- after the 3rd dose that was administered with rotavirus vaccine. Caller insisted for recommendation.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine PREVNAR 13 and the reported event "the baby had 104 fever for 9 hours". 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
Symptoms: Seizure
Clinical narrative: The first vaccine her mom had, she had seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: SEIZURE (medically significant), outcome "unknown", described as "The first vaccine her mom had, she had seizure". Therapeutic measures were taken as a result of seizure.  Clinical course: The first vaccine her mom had, she had seizure. So, her mom took seizure medication before getting the second one and did not experience a seizure.  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-202300002579 same patient/drug, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: a 2-year-old son of a couple died after being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown).  A 2-year-old 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: DEATH (death, medically significant), outcome "fatal", described as "a 2-year-old son of a couple died after being vaccinated". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: a 2-year-old son of a couple died after being vaccinated
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy in left axilla; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Depression" (unspecified if ongoing); "GERD" (unspecified if ongoing); "History of right breast cancer DCIS treated with radiation" (unspecified if ongoing), notes: History of right breast cancer DCIS treated with radiation; "History of right breast cancer DCIS treated with radiation" (unspecified if ongoing), notes: History of right breast cancer DCIS treated with radiation; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: METFORMIN; ACTOS; PROZAC; ABILIFY; TRAZODONE. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine; Gabapentin, reaction(s): "Known allergies: Gabapentin", notes: Known allergies: Gabapentin; Celebrex, reaction(s): "Known allergies: Celebrex", notes: Known allergies: Celebrex. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31Dec2022, outcome "recovering", described as "Lymphadenopathy in left axilla". Therapeutic measures were not taken as a result of lymphadenopathy.  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: 52.0
Sex: M
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 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left 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 had no relevant medical history. There were no concomitant medications. 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 with Paxlovid from 19Dec2022 to 23Dec2022.  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: 73.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Apr2022 as dose 4 (booster), single (Lot number: 048L219) 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: "Osteoporosis" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa drugs" (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 "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2022) Negative; (29Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 16Dec2022 to 21Dec2022.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: my friend's mom died with the vaccine you guys gave; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "my friend's mom died with the vaccine you guys gave". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The reporter stated that lot of people the patient know were died because of the vaccine and that the vaccine is not safe for COVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: my friend's mom died with the vaccine you guys gave
Age: 42.0
Sex: F
Vaccine: COVID19, 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 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 42 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: 01Oct2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid started on 21Dec2022 and stopped on 26Dec2022.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bronchitis, Sinusitis
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 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 42 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: 01Oct2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid started on 21Dec2022 and stopped on 26Dec2022.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2022 as dose number unknown, single (Lot number: F35683) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN HCL, start date: Jan2021, stop date: 30Dec2022; AMLODIPINE BESYLATE, start date: Jan2021, stop date: 30Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid for Covid-19 treatment started on 19Dec2022 and stopped on 28Dec2022. No known allergies.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19 with Paxlovid; Treatment of COVID-19 with Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8730), in left arm and on 22Apr2021 as dose 2, single (Lot number: EW0170) at the age of 36 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Nov2021 as dose 3 (booster), single (Lot number: 033F21A), in left arm and on 22Sep2022 as dose 4 (booster), single (Lot number: A57162B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19 with Paxlovid ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive RAT continued. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient had no other medication in 2weeks. Patient was treated with Paxlovid. Rebounded. Negative RAT on 4th day (30Nov2022) of paxlovid course and positive RAT again 4 days (06Dec2022) after paxlovid course had completed accompanied by worsening C19 symptoms. Positive RAT continued until neg test again on 10th day (12Dec2022) after paxlovid course finished.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: ER2613), in Apr2021 as dose 2, single (Lot number: 6K8729) and in Oct2021 as dose 3 (booster), single (Lot number: 301550A) at the age of 46 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in May2022 as dose 4 (booster), single (Lot number: 049L21A) for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), in Oct2022 as dose 5 (booster), single (Lot number: 049D22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Fish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Oct2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received paxlovid treatment for COVID-19 from 21Dec2022 to 26Dec2022.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccine dose 3 and 4 was Moderna Booster; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 60 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EN6206), in left arm and on 06May2021 as dose 2, single (Lot number: EW0173), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Dec2021 as dose 3 (booster), single (Lot number: 05H21A), in right arm and on 30Apr2022 as dose 4 (booster), single (Lot number: 056M21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; METOPROLOL SUCCINATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine dose 3 and 4 was Moderna Booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2022) Positive, notes: tested positive 20Dec2022; (31Dec2022) Positive, notes: Experience Paxlovid Rebound on 31Dec2022 with a positive COVID test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient tested positive on 20Dec2022, started Paxlovid on 21Dec2022-26Dec2022. Experience Paxlovid Rebound on 31Dec2022 with a positive COVID test.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Then day 8 home test came back VERY positive; Unknown results, notes: As of Day 5 was trending better per home test - pink lines faded consistently for two days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Dose 1,2,3 Pfizer BioNTech / dose 4 Moderna, 5 Moderna bivalent; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: En6203), in left arm, on 19Mar2021 as dose 2, single (Lot number: Er8727), in left arm and on 20Sep2021 as dose 3 (booster), single (Lot number: Ew0217) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Apr2022 as dose 4 (booster), single (Lot number: 057m21a), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 08Oct2022 at 13:15 as dose 5 (booster), single (Lot number: 053022a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "thyroid" (unspecified if ongoing), notes: thyroid; "HBP" (unspecified if ongoing), notes: HBP; "COPD" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: contrast dye" (unspecified if ongoing), notes: Known allergies: contrast dye; "Known allergies: molds" (unspecified if ongoing), notes: Known allergies: molds; "Known allergies: pollens" (unspecified if ongoing), notes: Known allergies: pollens. Concomitant medication(s) included: LANTUS, start date: 01Dec2019; OZEMPIC, start date: 13Oct2021; METFORMIN, start date: 01Jan2004; SYNTHROID, start date: 05Aug2019. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Apr2022, outcome "unknown", described as "Dose 1,2,3 Pfizer BioNTech / dose 4 Moderna, 5 Moderna bivalent"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. From 19Dec2022 to 24Dec2022, patient received Paxlovid as treatment of COVID-19.
Age: 67.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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: (unspecified date) Positive, notes: COVID 19 Treatment; (24Dec2022) Negative, notes: had negligible symptoms and a negative covid test on 24Dec2022; (30Dec2022) Positive, notes: positive test with mild symptoms on 30Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information included as patient had negligible symptoms and a negative covid test on 24Dec2022, a day after completing Paxlovid treatment, and a positive test with mild symptoms on 30Dec2022.  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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Vaccine brand=Pfizer / BioNTech, Vaccine dose number=3/ Vaccine brand other=Moderna, Vaccine dose number=4, Vaccine dose number=2, Vaccine dose number=1; 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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asplenic" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, Vaccine dose number=3/ Vaccine brand other=Moderna, Vaccine dose number=4, Vaccine dose number=2, Vaccine dose number=1"; 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.  Additional information: Report about covid treatment: Yes. If vaccine received: Yes. Other medication in 2weeks: No. Product=COVID 19 Treatment, Brand=Paxloxid.   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, SARS-CoV-2 test
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 35-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive COVID results as well as; Negative, notes: At end of course was testing negative and felt no symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
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) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 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 (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "known allergies Sulpha" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Sep2002; STRATTERA, start date: 01Feb2021; ZOLOFT, start date: 04Oct2021. 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: potential Paxlovid rebound. Return of Covid symptoms. Paxlovid rebound. Aches, fatigue, congestion. For event COVID 19, patient received Paxlovid treatment started on 19Dec2022 and stopped on 23Dec2022. Patient received other medication in 2weeks.  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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: MI with no obstructive arteries; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6955) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Has a lot of heart issues" (unspecified if ongoing); "has had MI's before" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ACUTE MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "MI with no obstructive arteries". The patient was hospitalized for acute myocardial infarction (start date: 2021, discharge date: 2021, hospitalization duration: 5 day(s)).  Clinical course: It was reported that, report is not related to a study or programme. The patient's medical history included a lot of heart issues, coronary artery disease, myocardial infarction and she was on concomitant medications including blood thinners and a couple of other heart related medications. No family medical history relevant to adverse events was reported. The patient did not receive other vaccine in four weeks of vaccination. After the patient had the first dose of the Covid vaccine, they called it an MI and she has had MI's before. It was reported as myocardial infarction (MI) with no obstructive arteries and had resulted in hospitalization for 5 days to an unspecified date in 2021 with an unknown outcome. The patient did not remember exact dates or time frame she was hospitalized, and no information was reported regarding the event resulted in for death, life-threatening, prolonged hospitalization, disabling/incapacitating or Congenital anomaly/birth defect. The patient reported she just called because she was angry at herself for receiving this vaccine and thought there are a lot of other people put there with far worse reactions than she had and patient was one of the lucky ones.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event acute myocardial infaction  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jul2022 as dose 3 (booster), single (Lot number: FJ4991) at the age of 69 years, in left arm 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: "Osteopenia" (unspecified if ongoing), notes: Osteopenia, not on meds; "Adult pertussis" (unspecified if ongoing), notes: adult pertussis about 20 years ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Treatment of COVID-19 with Paxlovid (Lot number: Lot 2707493) from 26Dec2022 to 28Dec2022.
Age: 32.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: Body temperature, Chills, Hyperacusis, Off label use, Pain
Clinical narrative: Fever (up to 101F recorded); chills; wet cough; vomiting; sneezing; minor aches; sensitivity to sound/light; sensitivity to sound/light; Other vaccine same date product= Flu; Other vaccine same date product= Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 32 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 03Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE (Lot Number: FF8841)), administration date: 08Dec2021, when the patient was 31-year-old, for covid-19 immunization; BNT162b2 (DOSE 2, SINGLE (Lot Number: EN6199)), administration date: 11May2021, when the patient was 30-year-old, for covid-19 immunization; BNT162b2 (DOSE 1, SINGLE (Lot Number: EN6199)), administration date: 19Apr2021, when the patient was 30-year-old, for covid-19 immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Nov2022, outcome "unknown" and all described as "Other vaccine same date product= Flu"; PYREXIA (non-serious) with onset 28Dec2022, outcome "recovering", described as "Fever (up to 101F recorded)"; CHILLS (non-serious) with onset 28Dec2022, outcome "recovering"; PAIN (non-serious) with onset 28Dec2022, outcome "recovering", described as "minor aches"; HYPERACUSIS (non-serious), PHOTOPHOBIA (non-serious) all with onset 28Dec2022, outcome "recovering" and all described as "sensitivity to sound/light"; SNEEZING (non-serious) with onset 28Dec2022, outcome "recovering"; VOMITING (non-serious) with onset 28Dec2022, outcome "recovering"; PRODUCTIVE COUGH (non-serious) with onset 28Dec2022, outcome "recovering", described as "wet cough". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, productive cough, vomiting, sneezing, pain, hyperacusis, photophobia.