chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness, Malaise, Pain in extremity
Clinical narrative: flulike symptoms; chills; malaise; arm and shoulder soreness; arm and shoulder soreness; increased itchiness in the left side of neck and torso and back; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dermatitis" (ongoing), notes: Dermatitis -ongoing, taking multivitamin, vitamin c, allegra, fiber pill. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; ALLEGRA. Vaccination history included: Covid-19 vaccine (Dose 3, Unknown Manufacturer), for covid 19 immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for covid 19 immunization; Covid-19 vaccine (Dose 1, Unknown Manufacturer), for covid 19 immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Apr2022, outcome "unknown" and all described as "arm and shoulder soreness"; CHILLS (non-serious) with onset Apr2022, outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious) with onset Apr2022, outcome "unknown", described as "flulike symptoms"; PRURITUS (non-serious) with onset Apr2022, outcome "unknown", described as "increased itchiness in the left side of neck and torso and back"; MALAISE (non-serious) with onset Apr2022, outcome "unknown". Therapeutic measures were taken as a result of influenza like illness, chills, malaise, arthralgia, pain in extremity, pruritus.  Additional information: 52-year-old woman, 5'1 height, 140 lbs, received 4th covid vaccine on left arm on 25Apr2022. Prior to getting vaccine, took an extra strength Tylenol as prophylaxis. Less than 15 hours later, experienced flulike symptoms, chills, malaise, arm and shoulder soreness, and increased itchiness in the left side of neck and torso and back. Dermatitis -ongoing, taking multivitamin, vitamin c, allegra, fiber pill, cream for itchiness. Event took place after use of product.  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: Pruritus
Clinical narrative: flulike symptoms; chills; malaise; arm and shoulder soreness; arm and shoulder soreness; increased itchiness in the left side of neck and torso and back; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dermatitis" (ongoing), notes: Dermatitis -ongoing, taking multivitamin, vitamin c, allegra, fiber pill. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; ALLEGRA. Vaccination history included: Covid-19 vaccine (Dose 3, Unknown Manufacturer), for covid 19 immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for covid 19 immunization; Covid-19 vaccine (Dose 1, Unknown Manufacturer), for covid 19 immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Apr2022, outcome "unknown" and all described as "arm and shoulder soreness"; CHILLS (non-serious) with onset Apr2022, outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious) with onset Apr2022, outcome "unknown", described as "flulike symptoms"; PRURITUS (non-serious) with onset Apr2022, outcome "unknown", described as "increased itchiness in the left side of neck and torso and back"; MALAISE (non-serious) with onset Apr2022, outcome "unknown". Therapeutic measures were taken as a result of influenza like illness, chills, malaise, arthralgia, pain in extremity, pruritus.  Additional information: 52-year-old woman, 5'1 height, 140 lbs, received 4th covid vaccine on left arm on 25Apr2022. Prior to getting vaccine, took an extra strength Tylenol as prophylaxis. Less than 15 hours later, experienced flulike symptoms, chills, malaise, arm and shoulder soreness, and increased itchiness in the left side of neck and torso and back. Dermatitis -ongoing, taking multivitamin, vitamin c, allegra, fiber pill, cream for itchiness. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Pyrexia
Clinical narrative: High fever (102-104); Chills; Knee pain; Back pain; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).   A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on an unknown date as dose 3, single (Lot number: unknown) at the age of 43 years for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? Yes. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown), for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 25Apr2022, outcome "recovering", described as "High fever (102-104)"; CHILLS (non-serious) with onset 25Apr2022, outcome "recovering"; ARTHRALGIA (non-serious) with onset 25Apr2022, outcome "recovering", described as "Knee pain"; BACK PAIN (non-serious) with onset 25Apr2022, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, arthralgia and back pain.  Additional information: Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment taken as a result of pyrexia, chills, arthralgia and back pain included TYLENOL. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): MOD22-012205.  A male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FJ1620) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (Dose number: 01, Lot number: 041B21A), administration date: 24Apr2021, for Covid-19 immunization; Moderna covid-19 vaccine (Dose number: 02, Lot number: 021C21A), administration date: 21Jun2021, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm".  Additional information: The patient having a reaction to the Moderna Covid-19 booster. On 04Apr2022: 2nd booster dose of Moderna Covid-19 vaccine. Sore arm at injection site, 06Apr2022: The patient right hand was swollen and right arm could not bend. He went to the Emergency Room that night, they did blood work, & everything was good, 07Apr2022: Both hands were swollen, like mini boxing gloves. he had pain in both and could not use them. patient took ibuprofen, 08Apr2022: left knee started popping when he tried to straighten it, like on the left side of the kneecap, tried to make a teledoc appointment, but they could not talk and had a bad crook on neck the left side, 09Apr2022: consumer had a teledoc appointment with the nurse practitioner. told them he was better, because of Ibuprofen had taken. They said to call back if he had any more problems, 11Apr2022: The patient had bouts around his body & was losing weight. he lost 14 pounds. 21Apr2022 Today hand is so swollen you cannot see the knuckle, cannot lift arm. It feels like shoulder is out of the socket. Devoted is arranging for a Nurse Practitioner to call today at 3.30p. Dose Number was 2nd booster, Manufacturer: Moderna, Lot number: 033H21A, Dose: booster, Date administered: 04Apr2022  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: felt feverish with no measurable fever; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 2, single (Lot number: EW0158, Expiration Date: Jul2021) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: GERD; "airborne allergies" (unspecified if ongoing), notes: airborne allergies Caller says this was diagnosed when he was a very tiny child. Concomitant medication(s) included: FEXOFENADINE oral taken for rhinitis allergic; LANSOPRAZOLE oral taken for gastroesophageal reflux disease. Vaccination history included: BNT162b2 (First dose , NDC: not provided on the card, EXP: 31Jul2021, LOT: EN6207, his first shot was fine.), administration date: 20Mar2021, when the patient was 58-year-old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 11Apr2021, outcome "recovered" (Apr2021); PYREXIA (non-serious) with onset 11Apr2021, outcome "recovered" (Apr2021), described as "felt feverish with no measurable fever". Therapeutic measures were taken as a result of pyrexia, fatigue.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Malaise
Clinical narrative: feeling lousy about noon the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Nov2021 at 17:00 as dose 3 (booster), single (Lot number: 32030BD) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: GERD; "airborne allergies" (unspecified if ongoing), notes: airborne allergies Caller says this was diagnosed when he was a very tiny child. Concomitant medication(s) included: FEXOFENADINE oral taken for rhinitis allergic; LANSOPRAZOLE oral taken for gastrooesophageal reflux disease. Vaccination history included: BNT162b2 (He says his first dose was 20Mar2021 with NDC: not provided on the card, EXP: 31Jul2021, and LOT: EN6207., first dose, injected in his right arm), administration date: 20Mar2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (He says his second dose was on 10Apr2021 with NDC: not provided on the card, LOT: EW0158, and EXP: July2021.), administration date: 10Apr2021, when the patient was 58-year-old, for COVID-19 Immunization, reaction(s): "felt feverish with no measurable fever", "Fatigue". The following information was reported: MALAISE (non-serious) with onset 19Nov2021, outcome "not recovered", described as "feeling lousy about noon the next day". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He says his feeling lousy did not get better until two days of sleep afterwards. He says for his second booster of the COVID-19 vaccine, which he is in the middle of that now, he took the shot about 5 o'clock yesterday and today he felt woozy before about 10 or so. He says he took two Tylenol last night and two this morning, the 500mg caplets. He says he took it to make his wife happy, they have been married 34 years, and it seemed to make her happy. He says that his wooziness has stayed about the same, and he slept from 11:30 for almost two hours today and will go back to sleep soon. Investigations: Caller says he took his temperature with an infrared thermometer when he was first out of bed this morning and it was 101.7 degrees Fahrenheit, then he took it again and the second temperature was 100.2 degrees Fahrenheit, then his third was 97.3 degrees Fahrenheit, all within 15 minutes down to the last reading, so it might have been elevated from being just out of the bed. He clarifies that it was 101.7 degrees Fahrenheit and then ten minutes later it was 97.3 degrees Fahrenheit.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Fever(102F); Headache; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).   A 14-year-old male patient received bnt162b2 (BNT162B2), on an unknown date as dose 3 (booster), single (Lot number: unknown) at the age of 14 years for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: Unknown), for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 25Apr2022, outcome "recovering", described as "Fever(102F)"; HEADACHE (non-serious) with onset 25Apr2022, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia and headache.  Additional information: Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received TYLENOL as the treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: Lymphedema on both legs; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician).  A 69-year-old female patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "kidney disease" (unspecified if ongoing), notes: I was saying she also has kidney disease. I do not know exactly. The patient took concomitant medications. The following information was reported: LYMPHOEDEMA (non-serious) with onset 01Apr2022, outcome "unknown", described as "Lymphedema on both legs". Therapeutic measures were not taken as a result of lymphoedema.  Additional Information: Reporter stated, " not sure if she have that. Expiry Date of Covid 19 Vaccine: Unknown. Additional Context: Last Name: "(last name withheld)" (Not clarified appropriately. Hence, captured as unknown in tab). Concern: Reporter stated, "she is calling in behalf of the provider Doctor (last name withheld), he wants to report a side effect from the vaccine." Reporter confirmed the product name as Pfizer COVID 19 Vaccine. When probed for adverse event, reporter stated, "So, it was Lymphedema on both legs." Specialty of the Doctor: Reporter stated, "Internal medicine. Reporter was informed about role of Pfizer drug safety department. "The height is 59.5 inches, 59.5 inches. "  Reporter stated, Date of administration: It would be 09Oct2021. Start date of adverse event: Reporter stated, "I think she came to the office but I am not sure, hold on. Okay we can predict as 01Apr of this year." Medical Condition: Reporter stated, "She had hypertension. And kidney disease, would that come in as well. I was saying she also has kidney disease. I do not know exactly." Concomitant: Reporter stated, "Yes, taking a couple. No Lab Test: Reporter stated, "Last two weeks. No Treatment of adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: After 5-day course of Paxlovid I tested negative for COVID on Day 6/7.Continued to test negative until Day 12 when I tested positive again.; After 5-day course of Paxlovid I tested negative for COVID on Day 6/7.Continued to test negative until Day 12 when I tested positive again.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 39 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. 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 "After 5-day course of Paxlovid I tested negative for COVID on Day 6/7.Continued to test negative until Day 12 when I tested positive again.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Patient did not had any known allergies. Patient was treated with Paxlovid from 13Apr2022 to 18Apr2022.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Physiotherapy, Product administered at inappropriate site, Ultrasound scan, Vaccination site pain
Clinical narrative: Dull aches to the left site of the injection site (side of thigh); Anatomical Site of injection- Left quadricep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old female patient received BNT162b2 (BNT162B2), on 06May2021 as dose 2, single (Lot number: EW0179) and on 15Feb2022 as dose 3 (booster), single (Lot number: FJ5683), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hormone replacement" (unspecified if ongoing); "Sleep aid" (unspecified if ongoing). Concomitant medication(s) included: ESTROGENS CONJUGATED; METHYLTESTOSTERONE oral taken for hormone replacement therapy (ongoing); PROGESTERONE taken for hormone replacement therapy (ongoing); TRAZODONE taken for sleep disorder (ongoing); CALCIUM (ongoing). Vaccination history included: BNT162b2 (Dose 1, single; Batch/ Lot number- ER8733; via Intramuscular route in Left deltoid), administration date: 27Mar2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Dull ache", "Her arm never stopped hurting/continuous arm ache", "burning sensation". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 06May2021, outcome "unknown", described as "Anatomical Site of injection- Left quadricep"; VACCINATION SITE PAIN (non-serious) with onset 06May2021, outcome "recovering", described as "Dull aches to the left site of the injection site (side of thigh)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Anatomical site of injection was Left quadricep for dose 2 and dose 3. Patient was taking multivitamin tablets; Progesterone 100 mg and Trazodone 50 mg at present. Relevant tests included Ultrasound with negative results in Apr2021 and Physical therapy assessment with negative results in Apr2021 and with comments as no loss of stomach or range of motion or flexibility noted. Patient received the 2nd and 3rd dose in my left quadriceps, also have dull aches to the left site of the injection site (side of thigh). The pain has subsided somewhat over time, but it has never completely gone away.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Cough, Pulmonary function test
Clinical narrative: Chronic cough; runny nose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9809) at the age of 79 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: COUGH (non-serious) with onset Mar2022, outcome "not recovered", described as "Chronic cough"; RHINORRHOEA (non-serious) with onset Mar2022, outcome "recovered" (2022), described as "runny nose". The events "chronic cough" and "runny nose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cough, rhinorrhoea.  Additional information: Age of onset 79.5 years old. Patient who reported that she developed chronic cough that got worst three weeks after her first Pfizer BioNTech Covid shot. Stated that she was supplied with a Z-pack for five days but the cough did not go away. She was supplied with a Z-pack for five days but the cough did not go away. Later stated that the Z-pack subsided the cough and runny nose for almost three weeks. Stated that she still has the cough. Stated that the cough has improved but she still gets a chronic cough. Stated for almost a whole year was constant with mucus and a runny nose. Stated that the mucous was clear and it still. Stated that the cough comes first and then the runny nose. Later stated that the Z-pack subsided the cough and runny nose for almost three weeks. Stated that she still has the cough. Stated that she has never had Covid and gets tested every month. Product strength and count size dispensed: Unknown strength; 10 count. Dosage text: Two either 100mg or 500mg for five. Treatment: Stated that she went to her primary doctor first. Stated that she went to ear, nose and throat doctor then pulmonologist. Stated went back to ear, nose and throat doctor for follow up. Stated that she reported about the medication and what was going on with it right now. Stated that she took steroids once a day for the inflammation. Stated that the doctor prescribed the steroids for five more days. Product: Stated that she was sure that she threw the packaging away. Investigations: Stated that her pulmonologist had blood work of her lungs done, a CT scan of her sinuses and a breathing test. Stated that her medical doctor sent her to get a asthma test. Stated that she does not have asthma, her sinuses are fine, she does not have breathing issues and her blood work was okay. Stated that all of this was done before she was prescribed the Z-pack.   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Spirometry
Clinical narrative: Chronic cough; runny nose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9809) at the age of 79 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: COUGH (non-serious) with onset Mar2022, outcome "not recovered", described as "Chronic cough"; RHINORRHOEA (non-serious) with onset Mar2022, outcome "recovered" (2022), described as "runny nose". The events "chronic cough" and "runny nose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cough, rhinorrhoea.  Additional information: Age of onset 79.5 years old. Patient who reported that she developed chronic cough that got worst three weeks after her first Pfizer BioNTech Covid shot. Stated that she was supplied with a Z-pack for five days but the cough did not go away. She was supplied with a Z-pack for five days but the cough did not go away. Later stated that the Z-pack subsided the cough and runny nose for almost three weeks. Stated that she still has the cough. Stated that the cough has improved but she still gets a chronic cough. Stated for almost a whole year was constant with mucus and a runny nose. Stated that the mucous was clear and it still. Stated that the cough comes first and then the runny nose. Later stated that the Z-pack subsided the cough and runny nose for almost three weeks. Stated that she still has the cough. Stated that she has never had Covid and gets tested every month. Product strength and count size dispensed: Unknown strength; 10 count. Dosage text: Two either 100mg or 500mg for five. Treatment: Stated that she went to her primary doctor first. Stated that she went to ear, nose and throat doctor then pulmonologist. Stated went back to ear, nose and throat doctor for follow up. Stated that she reported about the medication and what was going on with it right now. Stated that she took steroids once a day for the inflammation. Stated that the doctor prescribed the steroids for five more days. Product: Stated that she was sure that she threw the packaging away. Investigations: Stated that her pulmonologist had blood work of her lungs done, a CT scan of her sinuses and a breathing test. Stated that her medical doctor sent her to get a asthma test. Stated that she does not have asthma, her sinuses are fine, she does not have breathing issues and her blood work was okay. Stated that all of this was done before she was prescribed the Z-pack.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Myocarditis
Clinical narrative: Heart attack; Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 19-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; MYOCARDITIS (medically significant), outcome "unknown".  Clinical Course: The caller stated that another friends 19-year-old son had a heart attack after the vaccine and now had myocarditis for the rest of his life.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: their son had gotten COVID-19 after being vaccinated with the Pfizer covid-19 vaccine; their son had gotten COVID-19 after being vaccinated with the Pfizer covid-19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the parent.  A 15-year-old male patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "their son had gotten COVID-19 after being vaccinated with the Pfizer covid-19 vaccine". Reporter stated minor symptoms only.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A 47-year-old male patient received BNT162b2 (COMIRNATY), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "their husband had gotten COVID-19 after being vaccinated with the Pfizer Covid-19 vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Reporter stated their husband had gotten COVID-19 after being vaccinated. Clinical course: Reporter stated their husband had gotten COVID-19 after being vaccinated with the Pfizer Covid-19 vaccine. Reporter stated minor symptoms only. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: skin rash; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID:   A 73-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown, Lot Number: Not Provided), for Covid-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "skin rash"  Additional information: States she has a 73-year-old patient on the line and he is calling to report when he got the 2nd dose and the booster dose of the Pfizer Covid booster vaccine and got a skin rash after the 2nd dose and after the booster dose, he got night time skin rashes. States he had the 1st dosage more than two months ago and the 2nd dose maybe long ago and so he received the skin rash and wanted to know if anybody reported that they got a skin rash after the vaccine. States his question is if anybody had complained of a rash or get a skin rash after the vaccine and states he is driving at this time.    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: Myocardial infarction
Clinical narrative: 3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MYOCARDIAL INFARCTION (death), outcome "fatal", described as "3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine". The patient date of death was unknown. Reported cause of death: "3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine". It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200624880 same reporter/ drug/ event, different patient;US-PFIZER INC-202200625895 same reporter/ drug/ event, different patient; Reported Cause(s) of Death: 3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: 3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group.  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: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine". The patient date of death was unknown. Reported cause of death: "3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine". It was not reported if an autopsy was performed. Patient was questioning about What's in the vaccine, how much does it take to make your vaccine plus how much the sell does it for, what the inflation on saving lives. Also have you done the day at research on how many people have died of heart attacks form the vaccine. Reporter knew 3 personally. Reporter son is about to take the vaccine and reporter want the post-trial studies. Also, the vaccine is in complete. Reporter wrote own with herbs and a protein. Vaccine is missing the protein that seals the DNA. Vaccine wears off. Non-HCP confirmed that she knows 3 people who died from heart attack within 2 weeks after getting the Pfizer biontech covid-19 Vaccine and that the effects if the vaccine wears off (losing it's effectiveness) due to the missing protein to cover the MRNA. Non-HCP also mentions that she got the Moderna covid-19 Vaccine (with Lime disease medical condition) and she is in bed (reporting negative AE) as a result of the Moderna shot and she is concerned that the children are used as "test subject" for the vaccine. No age and gender information obtained. Non-HCP inquired if the Pfizer BioNtech Covid-19 Vaccine is still in the clinical trial or fully FDA approved and if Pfizer is using children as test subjects without paying consumer. Non-HCP stated that she has a background in applied chemistry and took a little bit of med school and thinks that the vaccine is losing it's effectiveness because there is no protein to protect the MRNA in the body.   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-202200625894 same reporter/ drug/ event, different patient;US-PFIZER INC-202200624880 same reporter/ drug/ event, different patient; Reported Cause(s) of Death: 3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: body aches; felt poorly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for Covid-19 Immunization; Bnt162b2 (First Booster), for Covid-19 Immunization. The following information was reported: PAIN (non-serious), outcome "recovered", described as "body aches"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt poorly".  Additional information: Patient reported that she felt poorly and had body aches the day after receiving the second booster dose of the COVID vaccine. Stated the body aches lasted one day and resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: gotten COVID-19; gotten COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 51-year-old male patient received BNT162b2 (COMIRNATY), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "gotten COVID-19". Reporter stated she had gotten COVID-19 after being vaccinated with the Pfizer covid-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: administered a dose of Adacel post temperature excursion due to a refrigerator malfunction, low temperature reached negative 2.1 celsius from 07-mar-2022 until 31-mar-2022 not due to a human error with no adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from health professional.  This case involves a 55-year-old female patient who was administered a dose of diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] post temperature excursion due to a refrigerator malfunction, low temperature reached negative 2.1 celsius from 07-mar-2022 until 31-mar-2022 not due to a human error with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine rge (cho) (Shingrix) for Immunisation.  On 31-Mar-2022, the patient received a dose of 0.5 ml total Frequency: once of suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot C5963AA expiry date: 18-Jan-2024 via intramuscular route in right deltoid for immunization.  On 31-Mar-2022 the patient was administered a dose post temperature excursion (product storage error) (Latency: same day) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken was not applicable.  Outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01068650: 01068813: 01068814: 01068816: 01068817: 01068825: 01068827: 01068828: 01068830: 01068831: 01068832: 01068835: 01068838:
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: getting a double dose of Poliovirus Vaccine described as the consumer receiving the prescribed Kinrix and a dose of IPOL, which was not prescribed with no reported adverse event; Initial information received on 20-Apr-2022 regarding an unsolicited valid non-serious case received from healthcare professional.  This case involves a 4-year-old female patient who was getting a double dose of poliovirus vaccine described as the consumer receiving the prescribed kinrix and a dose of ipol, which was not prescribed with no reported adverse event while receiving vaccine ipv (vero) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Kinrix) for prophylactic vaccination.  On 20-Apr-2022, the patient received 0.5 ml, once dose of suspect IPV (VERO) (lot T1D481M, expiry date: 22-Jul-2025) via intramuscular route in the left thigh (left leg) as prophylactic vaccination.  On 20-Apr-2022 the patient developed a non-serious event "getting a double dose of poliovirus vaccine described as the consumer receiving the prescribed kinrix and a dose of ipol, which was not prescribed with no reported adverse event (extra dose administered)" same day following the administration of IPV (VERO).  It was reported "Caller stated a patient was given Dtap and Ipol. Caller wanted to know what should they tell the patient. A Clinic calling to report a medication error of getting a double dose of Poliovirus Vaccine described as the consumer receiving the prescribed Kinrix and a dose of IPOL, which was not prescribed. The caller reported that the Kinrix contains DTap and IPV."  Action taken with poliomyelitis vaccine (inactivated) (Ipol) was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown for the event getting a double dose of poliovirus vaccine described as the consumer receiving the prescribed kinrix and a dose of ipol, which was not prescribed with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was exposed to 70 F got 117 hours and 5 minutes. with no adverse event; Initial information received on 18-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced vaccine was exposed to 70 f got 117 hours and 5 minutes. with no adverse event while receiving vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria 2/tetanus/5 ac pertussis vaccine (lot number: U7271AA) (unknown strength, dose, route, dosage form and expiration date) via unknown route in unknown administration site.   On an unknown date the patient developed a non-serious event vaccine was exposed to 70 F got 117 hours and 5 minutes. with no adverse event (Product storage error) (unknown latency) following the administration of diphtheria 2/tetanus/5 ac pertussis vaccine.  Action taken: Not applicable.   Corrective treatment: Not provided.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Product storage error temperature too low with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 55 years old female patient who experienced product storage error temperature too low with no reported adverse event while receiving vaccine Diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza Vaccine (Flu vaccine VII) for Immunisation.  On 24-Mar-2022, the patient received Dose: 2 , 0.5 ml dose of suspect Diphtheria-2/tetanus/5 AC pertussis vaccine (with unknown formulation and strength) (lot C5873AA, expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for Immunization.  On 24-MAR-2022 the patient developed a non-serious product storage error temperature too low with no reported adverse event (product storage error) following the administration of Diphtheria-2/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.