chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: the second dose was the worse pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles twice). Previously administered products included shingles vaccine (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-JUL-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient asked that even if we had shingles get vaccine because the  patient had them twice. The patient experienced worst pain after receiving 2nd dose of shingles vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included PFIZER COVID-19 VACCINE with an associated reaction of thrombocytopenia (October 2021 the patient was hospitalized with thrombocytopenia after receiving Pfizer Covid-19 vaccine.) and Bactrim.   On 18th May 2022 11:26, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Jul-2022 Reporter's Comments: The patient was received the Shingrix shot on left deltoid. The reporter was the patient, but we have her in the system as a health care professional because she a (retired) radiation technician.  She reported that she received Shingrix 1st shot (at 11:26 am) on May 18,2022 intramuscularly in her upper left arm.  She mentioned that she experienced a sore arm, but it was nothing to complain about. The reporter did not give consent to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Incomplete course of vaccination
Clinical narrative: has not had 2nd dose,  unsure she will get it; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 3rd December 2021, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced dizziness. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the dizziness was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Jul-2022 Reporter's Comments: The reporter stated that the patient  received her first dose of Shingrix on 2nd January 2021.  The reporter states the next day she began to experience dizziness that then continued for 32 days. The patient states she not had her second dose at this point in time. The patient was unsure she will be getting the second dose. Additional Supportive Information:  The patient not had her second dose at the time of reporting which leads to Incomplete course of vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site inflammation, Injection site pain, Injection site warmth, Pain
Clinical narrative: 4-inch circle at injection site that was inflamed; 4-inch circle at injection site that was hot to the touch; feverish on and off; pain when raising arm/ at bottom of the deltoid; tired/ still tired; arm was sore at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2022, the patient received the 1st dose of Shingrix (intramuscular). On 18th May 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, tiredness and pain in arm. On 20th May 2022, the patient experienced injection site inflammation, injection site warmth and fever. On an unknown date, the outcome of the injection site pain, tiredness and pain in arm were not recovered/not resolved and the outcome of the injection site inflammation, injection site warmth and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site inflammation, injection site warmth, tiredness, fever and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Jul-2022. Reporter's Comments: The case was self reported by the patient. The patient received Shingrix on left arm. The reporter reported that the HCP (health care professional) that gave the Shingrix vaccine gave the shot very low on the deltoid muscle but still within parameters. The reporter reported that right after receiving the Shingrix vaccine her arm was sore at the injection site but nothing unusual. Two days after receiving the Shingrix vaccine she developed a 4 inch circle at the injection site that was inflamed and hot to the touch the patient was also tired and feverish on and off, also reported pain when raising her left arm. On 20th May 2022, 2 days after receiving Shingrix, the patient experienced injection site inflammation, injection site warmth and fever. The symptoms resolved at this point except the patient was still tired and pain at the injection site when raising her left arm. The reporter reported that at 9 weeks out from her Shingrix vaccine, that when she raises her left arm, she still feels pain at the bottom of the deltoid where the shot was given. The reporter had not contacted her HCP about this.  The reporter would like to talk to Safety at GSK before contacting the HCP and deciding to get the second Shingrix vaccine that was due between now and 18th November 2022.  The reporter inquired had anyone else experienced this. The reporter did not consent to follow-up.  The reporter did not give permission to contact HCP, reporter originally gave her street address then retracted it. The reporter would like to be contacted by her cell phone either by text message or leave a message.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 4-inch circle at injection site that was inflamed; 4-inch circle at injection site that was hot to the touch; feverish on and off; pain when raising arm/ at bottom of the deltoid; tired/ still tired; arm was sore at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2022, the patient received the 1st dose of Shingrix (intramuscular). On 18th May 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, tiredness and pain in arm. On 20th May 2022, the patient experienced injection site inflammation, injection site warmth and fever. On an unknown date, the outcome of the injection site pain, tiredness and pain in arm were not recovered/not resolved and the outcome of the injection site inflammation, injection site warmth and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site inflammation, injection site warmth, tiredness, fever and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Jul-2022. Reporter's Comments: The case was self reported by the patient. The patient received Shingrix on left arm. The reporter reported that the HCP (health care professional) that gave the Shingrix vaccine gave the shot very low on the deltoid muscle but still within parameters. The reporter reported that right after receiving the Shingrix vaccine her arm was sore at the injection site but nothing unusual. Two days after receiving the Shingrix vaccine she developed a 4 inch circle at the injection site that was inflamed and hot to the touch the patient was also tired and feverish on and off, also reported pain when raising her left arm. On 20th May 2022, 2 days after receiving Shingrix, the patient experienced injection site inflammation, injection site warmth and fever. The symptoms resolved at this point except the patient was still tired and pain at the injection site when raising her left arm. The reporter reported that at 9 weeks out from her Shingrix vaccine, that when she raises her left arm, she still feels pain at the bottom of the deltoid where the shot was given. The reporter had not contacted her HCP about this.  The reporter would like to talk to Safety at GSK before contacting the HCP and deciding to get the second Shingrix vaccine that was due between now and 18th November 2022.  The reporter inquired had anyone else experienced this. The reporter did not consent to follow-up.  The reporter did not give permission to contact HCP, reporter originally gave her street address then retracted it. The reporter would like to be contacted by her cell phone either by text message or leave a message.
Sex: F
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 contactable reporter(s) (Other HCP) from product quality. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6200), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 29Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: other medical history: High blood pressure; "GERD" (unspecified if ongoing), notes: other medical history: GERD. There were no concomitant medications. Past drug history included: Most antibiotics, reaction(s): "Known Allergies: Most Antibiotics"; Triptans, reaction(s): "Known allergies: Triptans"; Lipitor, reaction(s): "Known allergies: Lipitor"; Pepcid, reaction(s): "Known allergies: Pepcid"; Nifedipine, reaction(s): "Known allergies: Nifedipine"; Ace inhibitors, reaction(s): "Known allergies: ACE inhibitors". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Other medication in 2weeks: No; Antiviral details: [{Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 07Jul2022, Treatment stop date: 11Jul2022, Indication: Treatment of COVID-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An 89-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL8982), on 10Feb2021 as dose 2, single (Lot number: EN6201) and on 24Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 88 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Apr2022 as dose 4 (booster), single (Lot number: 002M21A) for covid-19 immunisation. The patient's relevant medical history included: "2 recent TIAs", start date: 23May2022 (unspecified if ongoing); "2 recent TIAs", start date: 10Jul2022 (unspecified if ongoing); "MGUS" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM, start date: Jan2010. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jul2022, 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) Unknown Results; (Jul2022) positive, notes: Tested positive again on day 11 with symptoms (congestion, cough, etc.). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid Covid 19 treatment from 12Jul2022 to 17Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Computerised tomogram, Interchange of vaccine products, Magnetic resonance imaging
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An 89-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL8982), on 10Feb2021 as dose 2, single (Lot number: EN6201) and on 24Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 88 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Apr2022 as dose 4 (booster), single (Lot number: 002M21A) for covid-19 immunisation. The patient's relevant medical history included: "2 recent TIAs", start date: 23May2022 (unspecified if ongoing); "2 recent TIAs", start date: 10Jul2022 (unspecified if ongoing); "MGUS" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM, start date: Jan2010. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jul2022, 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) Unknown Results; (Jul2022) positive, notes: Tested positive again on day 11 with symptoms (congestion, cough, etc.). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid Covid 19 treatment from 12Jul2022 to 17Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An 89-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL8982), on 10Feb2021 as dose 2, single (Lot number: EN6201) and on 24Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 88 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Apr2022 as dose 4 (booster), single (Lot number: 002M21A) for covid-19 immunisation. The patient's relevant medical history included: "2 recent TIAs", start date: 23May2022 (unspecified if ongoing); "2 recent TIAs", start date: 10Jul2022 (unspecified if ongoing); "MGUS" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM, start date: Jan2010. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jul2022, 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) Unknown Results; (Jul2022) positive, notes: Tested positive again on day 11 with symptoms (congestion, cough, etc.). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid Covid 19 treatment from 12Jul2022 to 17Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; BUPROPION. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim".  The following information was reported: VACCINATION FAILURE (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: Positive, notes: Symptoms plus Positive test; Negative, notes: Had tested negative on home antigen for 2 days before rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  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 the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 75.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure." (unspecified if ongoing). 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) Unknown results, notes: Indication: COVID 19 Treatment; (Jul2022) negative; (19Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: En6203), in right arm, on 26Mar2021 as dose 2, single (Lot number: En6204), in right arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "HBP" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED 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: Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 14Feb2021 as dose 2, single (Lot number: EL9267), in left arm, on 10Oct2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 09Jun2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma (mild; seasonal)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lyrica for Known Allergy: Lyrica. 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient received anti viral product as COVID 19 treatment, brand=Pfizer, treatment start date=02Jul2022 and treatment stop date=06Jul2022.
Age: 81.0
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 contactable reporter(s) (Nurse).  An 81-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6198), on 18Mar2021 as dose 2, single (Lot number: EP7534) and on 04Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "Stage 3 CKD" (unspecified if ongoing); "major depressive disorder" (unspecified if ongoing); "controlled T2DM" (unspecified if ongoing); "hypercoagulability due to atrial fibrillation" (unspecified if ongoing); "atrial fibrillation" (unspecified if ongoing); "Severe obesity" (unspecified if ongoing); "dementia with behavioural disturbance" (unspecified if ongoing); "Behavioural disturbance" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Benign HTN" (unspecified if ongoing); "mild concentric left ventricular hypertrophy" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN 81; BUSPIRONE; GABAPENTIN; MEMANTINE HCL; METFORMIN; METOPROLOL; OXYCODONE; QUETIAPINE; ROSUVASTATIN; WARFARIN. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION FAILURE (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: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included treatment with paxlovid from 14Jul2022 to 16Jul2022.  Clinical course: It was reported that the patient took other medications in 2 weeks.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Drug ineffective, Illness
Clinical narrative: she has three shot of vaccine but still get COVID; she has three shot of vaccine but still get COVID; Fever; Coughing; Sick; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received COVID-19 Vaccine - Manufacturer Unknown, 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: "cholesterol" (unspecified if ongoing), notes: She takes that for cholesterol. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has three shot of vaccine but still get COVID"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; COUGH (medically significant), outcome "unknown", described as "Coughing"; ILLNESS (medically significant), outcome "unknown", described as "Sick"; CHILLS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: "caller's wife is prescribed because she got COVID-19, the Paxlovid drug. Under the it says she should not take and it says the simvastatin (Manufacture name was not clarified over the call). She takes that for cholesterol. That's it, that's the only drug that says that she should not take if you are on that medication that the doctor prescribed before. She takes this COVID (Incomplete Sentence), she has three shots of vaccine (Further not clarified) So, vaccinated but still get COVID because everybody can get back to it. Her brother died from it (Further not clarified). So, concerned about it. she is sick she got horrible chills, fever and coughing and that is why wanted to find out if she can take this treatment for 5 days being on regular medication that is simvastatin. For simvastatin, she took that for cholesterol; the only drug that said that she should not take if you are on that medication that the doctor prescribed before. (unknown if patient has started taking paxlovid with Simvastatin).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: she has three shot of vaccine but still get COVID; she has three shot of vaccine but still get COVID; Fever; Coughing; Sick; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received COVID-19 Vaccine - Manufacturer Unknown, 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: "cholesterol" (unspecified if ongoing), notes: She takes that for cholesterol. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has three shot of vaccine but still get COVID"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; COUGH (medically significant), outcome "unknown", described as "Coughing"; ILLNESS (medically significant), outcome "unknown", described as "Sick"; CHILLS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: "caller's wife is prescribed because she got COVID-19, the Paxlovid drug. Under the it says she should not take and it says the simvastatin (Manufacture name was not clarified over the call). She takes that for cholesterol. That's it, that's the only drug that says that she should not take if you are on that medication that the doctor prescribed before. She takes this COVID (Incomplete Sentence), she has three shots of vaccine (Further not clarified) So, vaccinated but still get COVID because everybody can get back to it. Her brother died from it (Further not clarified). So, concerned about it. she is sick she got horrible chills, fever and coughing and that is why wanted to find out if she can take this treatment for 5 days being on regular medication that is simvastatin. For simvastatin, she took that for cholesterol; the only drug that said that she should not take if you are on that medication that the doctor prescribed before. (unknown if patient has started taking paxlovid with Simvastatin).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 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: "Hairy cell leukemia" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: Sulfa based medication" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; CALCIUM; MAGNESIUM; VITAMIN D [VITAMIN D NOS]. Past drug history included: Zofran, reaction(s): "allergies"; Phenergen, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (20Jul2022) Positive, notes: On day 11.  Clinical course: The vaccine lot was unknown as it was not available/provided to reporter at the time of report completion. Patient took Paxlovid from 10Jul2022 to 14Jul2022 for treatment of COVID-19. She took the medication for 5 days and then tested negative. On day 11 she woke up very congested and took a rapid test and it was very positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: En6203), in left arm, on 03Mar2021 as dose 2, single (Lot number: En6208), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 30145bA), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective and covid-19, included Paxlovid treatment, start date was 07Jul2022 and treatment stop date was 12Jul2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200990572 Same patient, same drug, different event, different dose;
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Headache, Hypertension, Lichen planus
Clinical narrative: I also contracted Lichen Planus as determined by a dermatologist that was directly related to the vaccine; I checked my blood pressure and it was extremely high at 170/122; chest tightness; Within 24 hours after the 2nd vaccine I had a massive headache that persisted for more then 3 days; 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 male patient received BNT162b2 (BNT162B2), on 07Sep2021 as dose 2, single (Lot number: EW0167) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: LISINOPRIL + HIDROCLOROTIAZIDA. Vaccination history included: coviD-19 mrna, lnp-s, pf (pfizer-biontech) (Dose Number: 1, Batch/Lot No: EW0186, Prev dose brand=COVID-19 mRNA, LNP-S, PF (Pfizer-BioNTech) Purple cap, Anatomical location: Left arm), administration date: 17Aug2021, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: HYPERTENSION (medically significant) with onset 09Sep2021, outcome "recovered with sequelae", described as "I checked my blood pressure and it was extremely high at 170/122"; CHEST DISCOMFORT (medically significant) with onset 09Sep2021, outcome "recovered with sequelae", described as "chest tightness"; HEADACHE (medically significant) with onset Sep2021, outcome "recovered with sequelae", described as "Within 24 hours after the 2nd vaccine I had a massive headache that persisted for more then 3 days"; LICHEN PLANUS (non-serious), outcome "unknown", described as "I also contracted Lichen Planus as determined by a dermatologist that was directly related to the vaccine". The events "within 24 hours after the 2nd vaccine i had a massive headache that persisted for more then 3 days", "i checked my blood pressure and it was extremely high at 170/122" and "chest tightness" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 170/122. Therapeutic measures were taken as a result of hypertension.  Clinical course: Reporter stated that, Patient had no Known allergies. Patient did not take any other vaccine in four weeks. Patient called the doctor's office and made an appointment they double checked the pressure and found it to be the same. They had to quadruple his blood pressure meds to get it back down. Patient still cannot go back to the lower dose as he had prior to the vaccine. Shortly after that episode patient contracted Lichen Planus as determined by a dermatologist that was directly related to the vaccine as well. Patient did not test with COVID post vaccination.
Age: 62.0
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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 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: "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 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: tested negative on days 5, 6 and 7; (2022) Positive, notes: on day 11 and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: If vaccine received: Yes, Other medication in 2 weeks: No. Anti-viral details: Product= COVID 19 Treatment, Brand= Pfizer, Treatment start date= 09Jul2022. Treatment stop date= 13Jul2022, Lot number= Don't know, 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: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/ Antigen test was more positive (bright red line) than any previous day; Treatment of COVID-19/ Antigen test was more positive (bright red line) than any previous day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), in Feb2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: asthma; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: kiwi" (unspecified if ongoing), notes: Known allergies: kiwi. Concomitant medication(s) included: ALBUTEROL HFA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/ Antigen test was more positive (bright red line) than any previous day". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (17Jul2022) Negative, notes: Antigen test was negative days 6-7 and continued no symptoms; (18Jul2022) Negative, notes: Antigen test was negative days 6-7 and continued no symptoms; (19Jul2022) Positive, notes: On day 8, I woke up with a sore throat, fever, and nasal congestion. Antigen test was more positive (bright red line) than any previous day. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: It was reported that, other medication in 2 weeks reported as Albuterol inhaler. Patient started Paxlovid on day 2 of symptoms. Symptoms resolved and antigen test had a faint line by day 4. Antigen test was negative days 6-7 and continued no symptoms. On day 8, patient woke up with a sore throat, fever, and nasal congestion. Antigen test was more positive (bright red line) than any previous day. Anti-viral details of product for COVID 19 reported as, treatment started on 12Jul2022, and treatment stopped on 17Jul2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 19May2022 as dose 1, single (Lot number: FM9992) and on 09Jun2022 as dose 2, single (Lot number: FM7553) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, 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) Unknown Results; (20Jul2022) positive, notes: positive COVID test 20Jul2022. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Additional information: The patient received other medication in 2 weeks. The antiviral treatment was started on 08Jul2022 and stop treatment on 12Jul2022. The patient received Ibuprofen medication started on 08Jul2022 and stop treatment on 08Jul2022. The patient had cough and tested positive COVID on 20Jul2022.   No follow-up attempts are needed. No further information is expected.
Age: 80.0
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.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 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. Patient received the vaccination. The patient's relevant medical history included: "Afib" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Patient medical history included Afib with known allergies to Sulfa drugs. Concomitant medication(s) included: ELIQUIS, start date: 09Nov2016, stop date: 11Jul2022; HYDROCHLOROTHIAZIDE, start date: 01Mar2017, stop date: 20Jul2022; CANDESARTAN CILEXETIL, start date: 08Feb2017, stop date: 20Jul2022. Other medications in 2 weeks included Eliquis with brand name Bristol myers squibb from 09Nov2016 to 11Jul2022, Hydrochlorothiazide with brand name Avet from 01Mar2017 to 20Jul2022 and Candesartan Cilexetil with brand name Mylan from 08Feb2017 to 20Jul2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Patient received Paxlovid from 11Jul2022 to 16Jul2022 for treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 65-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), on 29Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "sciatica" (unspecified if ongoing); "restless leg" (unspecified if ongoing); "BCC" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  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 events VACCINATION FAILURE and COVID-19 and BNT162B2.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Infantile vomiting, Multisystem inflammatory syndrome in children, Pyrexia
Clinical narrative: Multisystem inflammatory syndrome in children; fever started 24 hrs lasted for 80 hours ( range from 101-103.5); vomited 2 times; diarrhea on Monday and Tuesday; rash and its getting worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13-month-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 13 months for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 19Jul2022, outcome "unknown", described as "rash and its getting worse"; MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (medically significant), outcome "unknown", described as "Multisystem inflammatory syndrome in children "; PYREXIA (non-serious), outcome "recovered", described as "fever started 24 hrs lasted for 80 hours ( range from 101-103.5)"; INFANTILE VOMITING (non-serious), outcome "unknown", described as "vomited 2 times"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea on Monday and Tuesday". The patient underwent the following laboratory tests and procedures: Body temperature: 101-103.5, notes: So that was 80 hours of fever between 101 and 103.5 approximately. Clinical course: Caller's son who is 13 months old got the Covid vaccine on Friday at doctor's office. He had fever that started 24 hours after getting the vaccine and then lasted until last night. So that was 80 hours of fever between 101 and 103.5 approximately. He vomited twice, once on Sunday and once on Monday. He had diarrhea on Monday and Tuesday and then he started getting rashes yesterday. Rashes are getting worse. Has rashes in a lot of places today. Caller was wondering if there was any information on if this is normal. He also stated that he read 2 % of the people who have received the Pfizer covid vaccine have experienced Multisystem inflammatory syndrome and rash. Identification of the case safety report Serious: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.