chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; DOSE 5 (BOOSTER); DOSE 5 (BOOSTER); DOSE 1,2,3 and 4 as Unknown manufacturer and DOSE 5 (BOOSTER) BNT162b2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 18:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 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. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022 at 18:00, outcome "unknown", described as "DOSE 1,2,3 and 4 as Unknown manufacturer and DOSE 5 (BOOSTER) BNT162b2"; OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 09Sep2022 at 18:00, outcome "unknown" and all described as "DOSE 5 (BOOSTER)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid rebound 5 days after testing negative; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was reported as no. Patient started the Paxlovid from 16Sep2022 and stopped on 21Sep2022 for the treatment of COVID-19. Patient had no known allergies.  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: 83.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: FL3246), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN9581), in left arm and on 13Apr2022 as dose 3 (booster), single (Lot number: FJ9943) at the age of 83 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Patient had no known allergies. 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID (lot number: 2796 as reported) given from 25Sep2022 to 27Sep2022.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Oct2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received paxlovid from 15Sep2022 to 19Sep2022 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional information: Reporter had friends who had the vaccine and then got really sick with COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Product use issue, Pruritus, Urticaria
Clinical narrative: hives; hives are still present. Very itchy and painful.; hives are still present. Very itchy and painful.; off label use; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 11:30 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 18Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: FLOMAX [MORNIFLUMATE]; GEMTESA; SPIRONOLACTONE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 18Sep2022, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 18Sep2022, outcome "unknown"; URTICARIA (non-serious) with onset 19Sep2022, outcome "not recovered", described as "hives"; PRURITUS (non-serious), PAIN (non-serious) all with onset 19Sep2022, outcome "not recovered" and all described as "hives are still present. Very itchy and painful.". The events "hives" and "hives are still present. very itchy and painful." required physician office visit. Therapeutic measures were not taken as a result of urticaria, pruritus, pain.  Additional information: Facility type vaccine: Pharmacy or Drug Store, If other vaccine in four weeks: No, Other medications in two weeks: Flomax, Gemtesa, Spironolactone. Adverse Event: I began to break out in hives the day after the vaccine and the hives are still present. Very itchy and painful. I had a flu vaccine given in my right arm at the same time as the bivalent booster. I have never had a reaction to the flu vaccine. If covid Prior vaccination: No, If covid tested post vaccination: No.  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: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Paxlovid as COVID 19 Treatment; Paxlovid as COVID 19 Treatment; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid as COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  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: Cough, Dyspnoea, Fatigue, Illness, Myalgia
Clinical narrative: Trouble breathing; Lung pain; Coughing; Extreme exhaustion; Muscle pain; Jaw pain; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose: 1), for COVID-19 Immunization, reaction(s): "only sick for 24 hours"; Moderna (Dose: 2), for COVID-19 Immunization, reaction(s): "only sick for 24 hours"; Moderna (Dose: 3), for COVID-19 immunization, reaction(s): "only sick for 24 hours". The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Trouble breathing"; PULMONARY PAIN (non-serious), outcome "unknown", described as "Lung pain"; COUGH (non-serious), outcome "unknown", described as "Coughing"; FATIGUE (non-serious), outcome "unknown", described as "Extreme exhaustion"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; PAIN IN JAW (non-serious), outcome "unknown", described as "Jaw pain"; ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Call in regards to Covid-19 booster. Got it on Friday and she has been very sick since then. Its the fourth day since getting it. Last night, she had trouble breathing. Tested herself with an at home Covid test and she was negative, but she's sick. Wants to report this. Should she go to the doctor? Right now, she has lung pain, coughing, and extreme exhaustion, muscle pain, and jaw pain in particular. Was searching and looking into how long symptoms should last. Had Moderna vaccines for the last three vaccines and was only sick for 24 hours. This was her first Pfizer vaccine. This was the fourth day and she was getting worse. Should it last this long?  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: Pain in jaw, Pulmonary pain, SARS-CoV-2 test
Clinical narrative: Trouble breathing; Lung pain; Coughing; Extreme exhaustion; Muscle pain; Jaw pain; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose: 1), for COVID-19 Immunization, reaction(s): "only sick for 24 hours"; Moderna (Dose: 2), for COVID-19 Immunization, reaction(s): "only sick for 24 hours"; Moderna (Dose: 3), for COVID-19 immunization, reaction(s): "only sick for 24 hours". The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Trouble breathing"; PULMONARY PAIN (non-serious), outcome "unknown", described as "Lung pain"; COUGH (non-serious), outcome "unknown", described as "Coughing"; FATIGUE (non-serious), outcome "unknown", described as "Extreme exhaustion"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; PAIN IN JAW (non-serious), outcome "unknown", described as "Jaw pain"; ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Call in regards to Covid-19 booster. Got it on Friday and she has been very sick since then. Its the fourth day since getting it. Last night, she had trouble breathing. Tested herself with an at home Covid test and she was negative, but she's sick. Wants to report this. Should she go to the doctor? Right now, she has lung pain, coughing, and extreme exhaustion, muscle pain, and jaw pain in particular. Was searching and looking into how long symptoms should last. Had Moderna vaccines for the last three vaccines and was only sick for 24 hours. This was her first Pfizer vaccine. This was the fourth day and she was getting worse. Should it last this long?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/COVID-19 Test: Positive; Treatment of COVID-19/COVID-19 Test: Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 Immunization; 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 Immunization. The patient's relevant medical history included: "MCI" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient had no known drug allergies. Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19/COVID-19 Test: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with both vaccines in this patient cannot be completely excluded.
Age: 69.0
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) (Other HCP).  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Batch/Lot number: unknown), on 07Mar2021 as dose 2, single (Batch/Lot number: unknown), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hip joint replacement" (unspecified if ongoing); "congenital dysplasia" (unspecified if ongoing); "Cervicalgia" (unspecified if ongoing); "Essential hypertension" (unspecified if ongoing); "known allergies: pollen" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Sep2022) Positive, notes: diagnosed with covid 19 with antigen test at home; (24Sep2022) Negative, notes: at home antigen test; (26Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Started Paxlovid 17Sep22 through 22Sep2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 and BNT162B2 OMI BA.4-5 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 and BNT162B2 OMI BA.4-5 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Incorrect dose administered, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; Inappropriate dose of Vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8730), in right arm, on 17Apr2021 as dose 2, single (Lot number: EW0161), in left arm, on 18Aug2021 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 27Jun2022 at 13:00 as dose 5 (booster), single (Lot number: FP7135) at the age of 44 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Feb2022 as dose 4 (booster), single (Lot number: 031J21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing Spondylitis" (unspecified if ongoing), notes: Other medical history: Ankylosing Spondylitis; "prolactinoma" (unspecified if ongoing), notes: Other medical history: Prolactinoma. Concomitant medication(s) included: COSENTYX, stop date: 09Sep2022; METHOTREXATE, stop date: 06Sep2022; MELOXICAM; LEXAPRO; CABERGOLINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [FLUTICASONE PROPIONATE]; FOLIC ACID; VITAMIN D NOS.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Inappropriate dose of Vaccine administered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: my rapid test went from the very faint line back up to strong positive result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient received COVID 19 Treatment Paxlovid on 16Sep2022 and stopped on 20Sep2022. Known allergies reported as No. Other medication in 2 weeks included Multivitamin.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 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), 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: "Known Allergies: Shell Fish" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Pneumonia, Respiratory disorder
Clinical narrative: double pneumonia; respiratory things; breathing issues; an elephant on my chest; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 27Sep2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "an elephant on my chest"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "breathing issues"; PNEUMONIA (medically significant) with onset 2021, outcome "unknown", described as "double pneumonia"; RESPIRATORY DISORDER (non-serious) with onset 2021, outcome "unknown", described as "respiratory things". Clinical course: She had a severe reaction after her first dose that started "2 or 3 hours after." She had "respiratory things, double pneumonia, breathing issues, and it felt like I had an elephant on my chest."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201191760 same reporter/patient/vaccine, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Eye irritation, Sinus headache
Clinical narrative: terrible sinus headache; ear pressure; burning eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (bivalent 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; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), 1st booster), for COVID-19 immunization. The following information was reported: SINUS HEADACHE (non-serious), outcome "unknown", described as "terrible sinus headache"; EAR DISCOMFORT (non-serious), outcome "unknown", described as "ear pressure"; EYE IRRITATION (non-serious), outcome "unknown", described as "burning eyes".  Additional information: The patient has received the Pfizer Covid19 Bivalent booster (as her 2nd booster) and was asking has anyone else reported really terrible sinus headache and ear pressure and burning eyes after the vaccine.  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: Limb discomfort, Muscle strength abnormal
Clinical narrative: Lifting in his arm drops 30% to 60% for 1 or 2 days after he gets the vaccine/ When he gets the vaccine, the lifting capacity drops to 20 to 30 pounds/Useless arm syndrome; Lifting in his arm drops 30% to 60% for 1 or 2 days after he gets the vaccine/ When he gets the vaccine, the lifting capacity drops to 20 to 30 pounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Lifting in his arm drops 30% to 60% for 1 or 2 days after he gets the vaccine/ When he gets the vaccine, the lifting capacity drops to 20 to 30 pounds/Useless arm syndrome"; MUSCLE STRENGTH ABNORMAL (non-serious), outcome "unknown", described as "Lifting in his arm drops 30% to 60% for 1 or 2 days after he gets the vaccine/ When he gets the vaccine, the lifting capacity drops to 20 to 30 pounds".  Additional information: Caller explained the next situation, for which, he stated, has not been able to get a useful answer for: "every time he was received the Pfizer vaccine (including the booster), he got what he calls 'useless arm syndrome'". Patient described himself to be quite strong according to his height and weight. The lifting in his arm drops 30% to 60% for 1 or 2 days after he gets the vaccine. He said he can do much of anything when this happens. Normally, he can lift 35 to 40 pounds with his arm fully extended. When he gets the vaccine, the lifting capacity drops to 20 to 30 pounds, which was inefficient for him. Caller wanted to know why this happened. He wanted to know what the root cause was and how to stop it, and if it can be fixed. Company e-transmitting potential AE duplicate. Apparently, caller was speaking to someone in the company. However, this was a blind-transfer, I didn't speak to anybody before speaking to the caller. Explained that we cannot provide a medical reason of this side effect, or medical recommendations, beyond what was described in the Prescribing Information for side effects or adverse reactions. Referred to HCPs. Caller stated that he was never getting another Pfizer vaccine if you were not giving me this information.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2021 as dose 2, single (Lot number: EW0171) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Melanoma (treated)" (unspecified if ongoing), notes: Melanoma (treated), family history of breast cancer; "Known allergies: Sensitivity to Penicillin" (unspecified if ongoing). The patient's family history included: "Breast cancer" (unspecified if ongoing), notes: family history of breast cancer. Concomitant medication(s) included: LISINOPRIL; TRIAMTERENE/HCTZ. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EP7533; Anatomical location: Right arm), administration date: 03Apr2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 14May2021, outcome "not recovered", described as "Increase in cramping in calves, in hamstrings in back of thighs, and occasionally in hands"; MUSCLE TWITCHING (non-serious) with onset 14May2021, outcome "not recovered", described as "Non-stop twitching in both left and right calves". The events "non-stop twitching in both left and right calves" and "increase in cramping in calves, in hamstrings in back of thighs, and occasionally in hands" required physician office visit. Therapeutic measures were not taken as a result of muscle twitching, muscle spasms.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Twitches are visible on the skin as well as felt internally. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Body temperature, Dyspnoea, Myalgia, Pain
Clinical narrative: Within 8 hours temperature 102.5 / Stayed around 102.1 to 102.7 for 24 hours / temperature around 100 for another 12 hours; extreme muscle aches; Body aches; angina; short of breath; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 11:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 56 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "CHF" (unspecified if ongoing), notes: CHF; "Cardiomyopathy" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: nuts" (unspecified if ongoing); "stents" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Clindamycin, reaction: "known allergies: Clindamycin". Vaccination history included: COVID-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant) with onset Sep2022, outcome "recovering", described as "angina"; DYSPNOEA (non-serious) with onset Sep2022, outcome "recovering", described as "short of breath"; PAIN (non-serious) with onset 22Sep2022 at 19:00, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 22Sep2022 at 19:00, outcome "recovering", described as "Within 8 hours temperature 102.5 / Stayed around 102.1 to 102.7 for 24 hours / temperature around 100 for another 12 hours"; MYALGIA (non-serious) with onset 22Sep2022 at 19:00, outcome "recovering", described as "extreme muscle aches". The patient underwent the following laboratory tests and procedures: Body temperature: (22Sep2022) 102.5, notes: Within 8 hours temperature 102.5; (Sep2022) 102.1, notes: Stayed around 102.1 to 102.7 for 24 hours; (Sep2022) 102.7, notes: Stayed around 102.1 to 102.7 for 24 hours; (Sep2022) 100, notes: Body aches and temperature around 100 for another 12 hours. Therapeutic measures were not taken as a result of angina pectoris, myalgia, dyspnoea. Therapeutic measures were taken as a result of pyrexia, pain. Clinical course: Within 8 hours, the patient had temperature 102.5, extreme muscle aches. Temperature stayed around 102.1 to 102.7 for 24 hours and tapered down slowly for another 12 hours. The patient had body aches and temperature around 100 for another 12 hours. This happened while she was taking 1000mg of acetaminophen. She did not go to the ER (Emergency Room), but she probably should had. Fourteen hours after, she was very short of breath and had angina. She had stents and CHF (Chronic heart failure). The patient did not receive vaccine in four weeks. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Within 8 hours temperature 102.5 / Stayed around 102.1 to 102.7 for 24 hours / temperature around 100 for another 12 hours; extreme muscle aches; Body aches; angina; short of breath; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 11:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 56 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "CHF" (unspecified if ongoing), notes: CHF; "Cardiomyopathy" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: nuts" (unspecified if ongoing); "stents" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Clindamycin, reaction: "known allergies: Clindamycin". Vaccination history included: COVID-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant) with onset Sep2022, outcome "recovering", described as "angina"; DYSPNOEA (non-serious) with onset Sep2022, outcome "recovering", described as "short of breath"; PAIN (non-serious) with onset 22Sep2022 at 19:00, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 22Sep2022 at 19:00, outcome "recovering", described as "Within 8 hours temperature 102.5 / Stayed around 102.1 to 102.7 for 24 hours / temperature around 100 for another 12 hours"; MYALGIA (non-serious) with onset 22Sep2022 at 19:00, outcome "recovering", described as "extreme muscle aches". The patient underwent the following laboratory tests and procedures: Body temperature: (22Sep2022) 102.5, notes: Within 8 hours temperature 102.5; (Sep2022) 102.1, notes: Stayed around 102.1 to 102.7 for 24 hours; (Sep2022) 102.7, notes: Stayed around 102.1 to 102.7 for 24 hours; (Sep2022) 100, notes: Body aches and temperature around 100 for another 12 hours. Therapeutic measures were not taken as a result of angina pectoris, myalgia, dyspnoea. Therapeutic measures were taken as a result of pyrexia, pain. Clinical course: Within 8 hours, the patient had temperature 102.5, extreme muscle aches. Temperature stayed around 102.1 to 102.7 for 24 hours and tapered down slowly for another 12 hours. The patient had body aches and temperature around 100 for another 12 hours. This happened while she was taking 1000mg of acetaminophen. She did not go to the ER (Emergency Room), but she probably should had. Fourteen hours after, she was very short of breath and had angina. She had stents and CHF (Chronic heart failure). The patient did not receive vaccine in four weeks. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination.
Age: 79.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: I have broken out in hives and the hives are still breaking out; Itchy; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 79 years, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Cholesterol" (ongoing), notes: Cholesterol; "thyroid" (ongoing), notes: thyroid. Concomitant medication(s) included: LEVOTHYROXINE; HYDROCHLOROTHIAZIDE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 19Sep2022, outcome "not recovered", described as "I have broken out in hives and the hives are still breaking out"; PRURITUS (non-serious) with onset 19Sep2022, outcome "not recovered", described as "Itchy"; PAIN (non-serious) with onset 19Sep2022, outcome "not recovered". Therapeutic measures were taken as a result of urticaria.  Additional information: Patient had an adverse reaction to the Pfizer Vaccine (Clarified as Pfizer COVID-19 Vaccine Bivalent) that she got on the 18th of, a week ago someday. She had broken out in hives and the hives were still breaking out and she did not know what to do about it. Itchy, breaking out all over. Patient got the fourth dose what they were calling it. She wanted to know what should she do to ease the pain. The patient experienced the events the next morning, she got the Pfizer Vaccine on the 18th and she broke out on hives on the 19th, right now, she was 79 (years). The patient was taking cholesterol and thyroid (Hydrochlorothiazide and levothyroxine) and she have been taking them for years and it never had any adverse reactions. She had a physical test, they were not too long ago. The patient was still experiencing the events. The patient stated that she had flu vaccine a week before Pfizer Vaccine and had no effects from the flu shot. She have been taking Allegra (Manufacturer name not clarified) for hives and specifically for hives and it supposed to last 24 hours but it did not seems to be helping. She was still breaking out.
Age: 69.0
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Aug2022 at 11:00 as dose 4 (booster), single (Lot number: FP7150) at the age of 69 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). Concomitant medication(s) included: SIMVASTATIN, start date: 12Sep2022, stop date: 12Sep2022; MONTELUKAST; DULERA; PRESERVISION AREDS 2.  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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "recurrent aphthous ulcers." (unspecified if ongoing), notes: None, other than recurrent aphthous, ulcers. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 including PAXLOVID given on 21Sep2022 to 24Sep2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.1 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2, BNT162b2 omi ba.4-5  vaccine in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bladder neoplasm, Haemorrhage urinary tract, Lung disorder, Single functional kidney
Clinical narrative: Has experienced urinary bleeding; Has one kidney; Had tumors surgically removed from her bladder; Asthmatic; Now my lungs are starting to travel back downward; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), in 2021 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, SINGLE), administration date: 2021, for COVID-19 immunization, reaction(s): "Elephant on my chest", "Double pneumonia", "Respiratory things/Breathing issues". The following information was reported: HAEMORRHAGE URINARY TRACT (medically significant), outcome "unknown", described as "Has experienced urinary bleeding"; SINGLE FUNCTIONAL KIDNEY (medically significant), outcome "unknown", described as "Has one kidney"; BLADDER NEOPLASM (medically significant), outcome "unknown", described as "Had tumors surgically removed from her bladder"; ASTHMA (non-serious), outcome "unknown", described as "Asthmatic"; LUNG DISORDER (non-serious), outcome "unknown", described as "Now my lungs are starting to travel back downward". Therapeutic measures were taken as a result of bladder neoplasm which included surgical removal. Per clinical course, patient stated she and her 18-year-old son got the two dose primary series of the Pfizer COVID-19 Vaccine about a year ago. The patient's second dose was okay. The CDC told her to get her second dose in the hospital, so she did. But it was okay. She didn't even know she got the thing. Patient stated she was "asthmatic, has one kidney, has experienced urinary bleeding, and had tumors surgically removed from her bladder, all after getting the COVID-19 Vaccine" (as reported). She stated, "now her lungs were starting to travel back downward" (as reported, pending clarification). Patient stated that people have died from these vaccines. She was querying if she and her son can get the old version of the booster instead of the new bivalent booster. Patient stated she was afraid she will have a severe reaction to the new formulation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201191499 same reporter/patient/vaccine, different dose/event;
Age: 59.0
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) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 14:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Apr2021 at 14:15 as dose 2, single (Batch/Lot number: unknown), in left arm, in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09Jun2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholestorol" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergy: Raw eggs" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 16Sep2022; LEXAPRO. Past drug history included: Amoxycillin, reaction(s): "Known allergy: amoxycillin". 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: (unspecified date) Positive, notes: Return of symptoms and positive test; (unspecified date) Positive, notes: Treatment of COVID-19; (23Sep2022) Negative, notes: Tested negative on Friday; (27Sep2022) Positive, notes: Tested positive Tuesday morning, September 27. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID given on 17Sep2022 to 21Sep2022.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 19.0
Sex: M
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150) and on 27Apr2021 as dose 2, single (Lot number: EW0171) at the age of 19 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Nov2021 as dose 3 (booster), single (Lot number: 027H21B) and on 17May2022 as dose 4 (booster), single (Lot number: 038A22A) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. 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: Negative, notes: Moderate symptoms resumed along with a positive test 3 days after negative test; Positive, notes: Moderate symptoms resumed along with apositive test 3 days after negative test. Therapeutic measures were taken as a result of vaccination failure, covid-19.Patient received Paxlovid  treatment start date was 13Sep2022 and  stop date was 17Sep2022. Indication was treatment of COVID-19.  Clinical Information: The patient didnt received any other medication in 2 weeks.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received Pfizer COVID-19 vaccine and tested positive for COVID; received Pfizer COVID-19 vaccine and tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received Pfizer COVID-19 vaccine and tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive for COVID. Clinical course: Patient was updated with vaccines and stuff but just tested positive. Patient works in a nursing home (further clarification unknown) but tested positive for COVID. Patient's aunt advised to call the number for medication for COVID (unspecified medication; unspecified if taken).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.