chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: long-term (6 months) urticaria; This is a spontaneous report received from a contactable reporter (Physician) from medical information team.  An adult 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 1, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "long-term (6 months) urticaria".  Additional information: The reporter wanted to know that post the vaccination with dose 3 of BNT162B2, the event of urticaria has been reported before.    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: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cardiac Disorder" (unspecified if ongoing), notes: Caller stated she has APS and is a cardiac patient too; "APS" (unspecified if ongoing), notes: Caller stated she has APS and is a cardiac patient too. The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown".  Additional information: Caller mentioned she had been taking Pfizer products from the very beginning. She mentioned she was vaccinated with the primary series and two boosters, all from Pfizer. She mentioned she got a reaction a couple of times, with nausea and vomiting all night, until 7:30 am. Last booster was in Jul. She mentioned she was concerned about getting the Omicron vaccine and that she was allergic to something vaccine. Caller asked if in stoppers or syringes may have latex. Caller also mentioned she just recently received a Flu shot and asked how long should she wait to get the new Omicron vaccine. Caller also mentioned there were new two variants that have come out. So that was totally absurd, because the virus was constantly mutating, and that people were still getting COVID and Omicron, so it does not prevent anything. Caller expressed her main concern was if she should talk it or not because she was afraid of getting the reaction and to be up all night. She also mentioned her doctors do not know how to treat or prevent the side effects from these vaccines. She asked if the Pfizer product get into the valves of the heart. Caller asked when can she receive the bivalent vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Off label use, Product use issue, Ulnar nerve palsy
Clinical narrative: Two hours after vaccine ulnar nerve paralysis of right hand; INFLUENZA VACCINE given on 18Oct2022; INFLUENZA VACCINE given on 18Oct2022; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2), on 18Oct2022 at 16:30 as dose 4 (booster), single (Lot number: FT9142) at the age of 58 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 18Oct2022 as dose 1, single (Batch/Lot number: unknown), in left deltoid for immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "OSA" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; IBUPROFEN. Vaccination history included: Covid-19 vaccine ("Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 03, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 18Oct2022, outcome "unknown" and all described as "INFLUENZA VACCINE given on 18Oct2022"; ULNAR NERVE PALSY (disability) with onset 18Oct2022 at 18:30, outcome "not recovered", described as "Two hours after vaccine ulnar nerve paralysis of right hand". The event "two hours after vaccine ulnar nerve paralysis of right hand" required physician office visit. Therapeutic measures were taken as a result of ulnar nerve palsy.  Clinical course: Other medications in two weeks: Allopurinol, Mounjaro, ibuprofen. Medrol dose pack was used to treat ulnar nerve paralysis of right hand. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the even ULNAR NERVE PALSY and BNT162B2.  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: U
Vaccine: COVID19
Symptoms: Idiopathic urticaria
Clinical narrative: idiopathic urticaria on Feb2022; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Site of injection: Left Deltoid , Route of administration: Intramuscular, Lot Number: EJ1685), administration date: 19Dec2020, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Anatomical Site of injection: Left Deltoid , Lot Number: EK4176), administration date: 11Jan2021, for COVID-19 immunization. The following information was reported: IDIOPATHIC URTICARIA (non-serious) with onset Feb2022, outcome "not recovered", described as "idiopathic urticaria on Feb2022". Therapeutic measures were taken as a result of idiopathic urticaria.  Additional information: The patient was treated for idiopathic urticaria with Allegra 180 mg, PO daily and Xolair 300 mg, SQ [Subcutaneous] monthly both from Feb2022 for idiopathic urticaria. Patient Age at the time of Vaccination was reported as 44 - 46 Years.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
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 contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Lot number: 30135B4) at the age of 28 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing), notes: other medical history Depression; "Anxiety" (unspecified if ongoing), notes: other medical history: Anxiety; "Allergies" (unspecified if ongoing), notes: other medical history: Allergies. Concomitant medication(s) included: FLUOXETINE [FLUOXETINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "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 and treatment included Paxlovid.; Sender's Comments: Based on the information currently available, a causal association between the reported event COVID-19 and BNT162b2 cannot be excluded.
Age: 78.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 78 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), 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment with Paxlovid. The patient had not taken any medication within two 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years 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 Oct2022, outcome "recovering" and all described as "COVID 19 Treatment". 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: 40.0
Sex: M
Vaccine: 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 40-year-old male patient received BNT162b2 (BNT162B2), on 12May2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Jul2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Dec2021 at 12:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal Allergies" (unspecified if ongoing), notes: Seasonal allergies. The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin", notes: Known allergies: Clindamycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient had not taken any other medications within 2 weeks of starting COVID-19 treatment. Took Paxlovid, felt great. 5 days later, began to have some minor upper respiratory symptoms such as nasal congestion, tested positive for COVID-19 via an antigen rapid test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Patient first three doses were the Moderna COVID vaccines; COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 08Jun2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 64 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Mar2021 as dose 1, single (Lot number: 016B21A), in left arm, on 26Apr2021 as dose 2, single (Lot number: 002C21A), in left arm and on 29Nov2021 as dose 3 (booster), single (Lot number: 018F21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Jun2022, outcome "unknown", described as "Patient first three doses were the Moderna COVID vaccines"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient had no known allergies. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received COVID-19 vaccines.  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: 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 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (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), 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: "Hashimoto's disease, but no treatment required right now" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tagamet, reaction(s): "Known Allergies: Tagamet". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2022) Negative; (20Oct2022) Negative; (22Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Anti-viral details included for COVID-19 treatment (brand: PAXLOVID), treatment start date was on 13Oct2022 and treatment stop date was on 18Oct2022. Patient tested negative on Wed 19Oct and Thursday 20Oct. Patient then tested positive on Sat 22Oct but felt ok. Patient started developing a stuffy nose and fever again on Sunday 23Oct and feel crummy.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: reaction he experienced was close to anaphylaxis; This is a spontaneous report received from contactable reporter(s) (Nurse). Other Case identifier(s): 2022NVX-US-000003757.  An 18-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Apr2021, when the patient was 16 years old, for COVID-19 Immunization, reaction(s): "allergic reaction".  The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "reaction he experienced was close to anaphylaxis".  Clinical course: On 06Oct2022, it was reported that a patient started treatment on an unspecified date in Apr2021 with Pfizer BioNTech COVID-19 Vaccine for COVID-19 immunization. It was reported after the 1st dose, the patient had an allergic reaction, and after the 2nd dose, the reaction he experienced was close to anaphylaxis. No further follow-up is anticipated  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event ANAPHYLACTIC REACTION and BNT162B2.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 11:45 as dose 6 (booster), single (Lot number: GH9694) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20May2022 at 10:45 as dose 5 (booster), single (Lot number: FP4554), 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), 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: "Known allergies: Sulfa and penicillin" (unspecified if ongoing), notes: Known allergies: Sulfa and penicillin; "Known allergies: Sulfa and penicillin" (unspecified if ongoing), notes: Known allergies: Sulfa and penicillin; "CAD" (unspecified if ongoing), notes: CAD; "Mild MAC disease (lungs)" (unspecified if ongoing), notes: Mild MAC disease (lungs); "Osteoarthritis" (unspecified if ongoing); "Mood disorder" (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 Oct2022, outcome "recovered" (Oct2022) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment (Atenolol, Losartan, Bupropion, Venlafaxine, Rosuvastatin, Baby Aspirin, Vit. D, C, B Complex; Biotin; CoQ10, Purified Chondroitin Sulfate). The patient previously receive a COVID-19 Vaccine. Antiviral details: Product: COVID-19 Treatment, brand: Paxlovid, treatment start date: 07Oct2022, treatment stop date: 12Oct2022, indication: Treatment of COVID-19. 1st round of COVID-Day 1 on 6Oct: sore throat - Day 1 only; runny nose and sneezing - Day 2 only; very fatigued until Day 8. If patient recovered: Recovered.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization.  The following information was reported: RASH (non-serious), outcome "unknown".  Additional information: This report was not related to a study or program. Reason for no lot number: of COVID-19 vaccine: Complainant hung up abruptly/transfer incomplete. Consumer stated, "I just have a rash, I took the Pfizer booster (Pfizer COVID-19 vaccine) and then I got a rash. I was wondering how long rash last? will it go away?" Consumer was informed about the role of Pfizer Drug Safety department and Pfizer Medical Information department. Further probing could not be done as the consumer hung up the call abruptly. Hence, limited information available over the call. Reporter type could not be probed over the call hence captured by default as Consumer or other non-health professional.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL3302), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FK9883) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Barrett's oesophagus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with Paxlovid from 10Oct2022 to 14Oct2022 for the treatment of COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling cold
Clinical narrative: Diarrhea; I am cold; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset Oct2022, outcome "recovered" (Oct2022), described as "Diarrhea"; FEELING COLD (non-serious) with onset Oct2022, outcome "unknown", described as "I am cold"; CHILLS (non-serious) with onset Oct2022, outcome "unknown".  Additional information: Patient was wondering because today ended up with diarrhea and patient had cold and chills. Patient had COVID shot on Thursday and clarified as Pfizer COVID vaccine bivalent, the new one that just came out.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Aug2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Feb2022 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Serious: No. The patient did not receive any other medication within 2 weeks of vaccination. The patient received Paxlovid as COVID-19 treatment from 13Oct2022 to 17Oct2022. The patient was previously received a COVID-19 Vaccine. Reported Event: Fever, cough, no taste, no smell, headache and patient was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: really bad chest pain; my heart was beating deep and it hadn't ever done this before but it kept on doing for a couple of hours/My heart started pounding very hard and very fast.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 26-year-old female patient received BNT162b2 (BNT162B2), on 19Oct2022 as dose 1, single (Lot number: FP7138, Expiration Date: 30Nov2022) at the age of 26 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PALPITATIONS (non-serious) with onset Oct2022, outcome "recovered" (2022), described as "my heart was beating deep and it hadn't ever done this before but it kept on doing for a couple of hours/My heart started pounding very hard and very fast."; CHEST PAIN (non-serious) with onset Oct2022, outcome "recovered" (2022), described as "really bad chest pain". Therapeutic measures were not taken as a result of chest pain, palpitations.  Additional Information: It was reported that patient got it was 19Oct2022). Patient got first vaccine, it was the Pfizer (Pfizer COVID-19 Vaccine) and, patient might be having because of the shot, but patient cannot be sure. Patient read that, the last time, patient was sitting on the couch and my heart started pounding very hard and very fast and had really bad chest pain and it felt like it went away after a minute but after that it felt like that her heart was beating deep and it hadn't ever done this before but it kept on doing for a couple of hours. So, patient was wondering, what she should do for it? Is it a side effect or it would not go away? Patient had not taken anything before.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 12:45 as dose 5 (booster), single (Lot number: GH9694) at the age of 80 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 23Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FM9992), 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: "Osteoarthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: SIMVASTATIN, stop date: 16Oct2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLUTICASONE PROPIONATE; OMEPRAZOL; CALCIUM; MAGNESIUM; CRANBERRY; BIOTIN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.   Follow up information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Pain/swelling in left armpit; Pain/swelling in left armpit; Itching and pain at injection site; Itching and pain at injection site; Fever (101.5); Tiredness; Chills; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 19Oct2022 at 22:30, outcome "recovering"; PYREXIA (non-serious) with onset 19Oct2022 at 22:30, outcome "recovering", described as "Fever (101.5)"; HEADACHE (non-serious) with onset 19Oct2022 at 22:30, outcome "recovering"; VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Oct2022 at 22:30, outcome "recovering" and all described as "Itching and pain at injection site"; AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 19Oct2022 at 22:30, outcome "recovering" and all described as "Pain/swelling in left armpit"; FATIGUE (non-serious) with onset 19Oct2022 at 22:30, outcome "recovering", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of axillary pain, swelling, vaccination site pruritus, vaccination site pain, pyrexia, fatigue, chills, headache. Additional information- This report was about COVID-19 vaccine. Patient was not pregnant at the time of vaccination. Vaccination facility type was reported as Pharmacy or Drug Store.  Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient experienced itching and pain at injection site, pain/swelling in left armpit, fever (101.5), tiredness, chills, headache on 19Oct2022 at 22:30. Patient received treatment for the adverse events which included Tylenol and rest. Patient had COVID-19 prior to vaccination. Patient was tested post vaccination which included Nasal Swab test with result as negative on 19Oct2022. Patient was allergic to Sulfa drugs.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Swelling, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Pain/swelling in left armpit; Pain/swelling in left armpit; Itching and pain at injection site; Itching and pain at injection site; Fever (101.5); Tiredness; Chills; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 19Oct2022 at 22:30, outcome "recovering"; PYREXIA (non-serious) with onset 19Oct2022 at 22:30, outcome "recovering", described as "Fever (101.5)"; HEADACHE (non-serious) with onset 19Oct2022 at 22:30, outcome "recovering"; VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Oct2022 at 22:30, outcome "recovering" and all described as "Itching and pain at injection site"; AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 19Oct2022 at 22:30, outcome "recovering" and all described as "Pain/swelling in left armpit"; FATIGUE (non-serious) with onset 19Oct2022 at 22:30, outcome "recovering", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of axillary pain, swelling, vaccination site pruritus, vaccination site pain, pyrexia, fatigue, chills, headache. Additional information- This report was about COVID-19 vaccine. Patient was not pregnant at the time of vaccination. Vaccination facility type was reported as Pharmacy or Drug Store.  Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient experienced itching and pain at injection site, pain/swelling in left armpit, fever (101.5), tiredness, chills, headache on 19Oct2022 at 22:30. Patient received treatment for the adverse events which included Tylenol and rest. Patient had COVID-19 prior to vaccination. Patient was tested post vaccination which included Nasal Swab test with result as negative on 19Oct2022. Patient was allergic to Sulfa drugs.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 12:00 as dose 3 (booster), single (Lot number: GJ2524 Giant 348) at the age of 43 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Oct2021 as dose 2 (booster), single (Lot number: 012F21A CVS#1517), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 06Mar2021 at 09:00 as dose 1, single (Lot number: 1805022), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADVIL 12 HORAS, start date: 04Oct2022, stop date: 11Oct2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022 at 12:00, outcome "unknown"; 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.  Additional information: The patient had no known allergies. Anti-viral details: Paxlovid Product=COVID 19 Treatment, Treatment start date=07Oct2022, Treatment stop date=11Oct2022, Indication=Treatment of COVID-19.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Never had a reaction, other than tenderness at injection site nothing real significant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, LOT: FL9265 or maybe EL9265), administration date: 26Jan2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "tenderness at injection site". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Never had a reaction, other than tenderness at injection site nothing real significant".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Never had a reaction, other than tenderness at injection site nothing real significant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: FL9265 or maybe EL9265, NDC, Expiry date: Unknown), administration date: 26Jan2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "Never had a reaction, other than tenderness at injection site nothing real significant"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: EL9267 or might be EI9267 , NDC, Expiry date: Unknown), administration date: 16Feb2021, when the patient was 80-year-old, for COVID-19 immunization, reaction(s): "Never had a reaction, other than tenderness at injection site nothing real significant". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Never had a reaction, other than tenderness at injection site nothing real significant".  Additional information: No prior vaccinations (within 4 weeks) was administered. AE(s) following prior vaccinations was none. Patient's medical history (including any illness at time of vaccination) was none. Patient reported he did not think so of any family medical history relevant to AE(s). Relevant tests were reported as none. No additional vaccines were administered on same date of the Pfizer Suspect. Patient took first booster shot on 27Sep2021. The Lot was FE2588 or FI2588. NDC and expiry date was unknown. Never had a reaction, other than tenderness at injection site nothing real significant. There was a product complaint to report. Patient was diagnosed with Covid-19 after receiving Covid-19 vaccine and booster shots. Product strength and count size dispensed was not provided. Additional lot numbers: First Dose: FL9265 or maybe EL9265, second Dose: EL9267 or might be EI9267, first Booster: FE2588 or FI2588. It was not provided if a sample of the product available to be returned. The packaging sealed and intact was not provided. Report was not related to a study or programme. Other conditions and investigations were reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 19Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: VUMERITY, start date: 01Sep2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received other medication in 2weeks. The patient had received anti-viral therapy with Paxlovid, from 08Oct2022 to 12Oct2022 for treatment of COVID-19. Full Covid Symptoms returned on 21Oct2022, stronger than initial symptoms. The patient received AE treatment with Dexamethason 4mg Tab. The patient had no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: 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) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 06Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Adhesives" (unspecified if ongoing). Concomitant medication(s) included: HYDROMORPHONE, start date: 07Feb2020. 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 positive test on the 10th day following initial symptoms; Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Adverse event: COVID positive test on the 10th day following initial symptoms and almost complete recovery that only had a minor cough. Return of headache, clogged sinuses, cough, sneeze and runny nose, minor body aches on day 11.
Age: 47.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 at 14:00 as dose 1, single (Lot number: EW0153), in right arm, on 27Apr2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 05Dec2021 at 14:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disorder" (unspecified if ongoing); "long QT syndrome" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "ADD" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: MOBIC, start date: 01Jan2016; SYNTHROID, start date: 01Jan2016; CYTOMEL, start date: 01Jan2016; TRAZODONE, start date: 01Jan2016; LAMICTAL, start date: 01Jan2016; PROPRANOLOL, start date: 01Jan2016; BUSPAR, start date: 01Jan2016; ADDERALL, start date: 01Jan2016. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (23Oct2022) positive, notes: I took 2 antigen self tests, and both came back positive; (23Oct2022) Positive, notes: I took 2 antigen self tests, and both came back positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medications in 2 weeks started in 01Jan2016. Patient received treatment for covid-19 which was Paxlovid from 14oct2022 to 19oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.