chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash erythematous, Urticaria
Clinical narrative: red, itchy rash/on her chest and spread to her head, neck, ears and back. It also spread in a smaller amount to her arm, wrists, legs and ankles; Welts/Hives; burst blood vessel in her eye; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left on 07Oct2021 at 15:00 (Lot Number: 301568A) as dose 2, single (at the age of 52 years old) for COVID-19 immunization. Medical history included celiac, hypothyroid from 08Jan2017 and ongoing, "adrenal insuff" from 01Aug2020 and ongoing, menopause from 01Nov2018 to an unknown date, seasonal affective disorder (SAD)/anxiety from 01Nov2018 and ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid from 08Jan2017 and ongoing; liothyronine sodium (CYTOMEL) taken for thyroid from 08Jan2017 and ongoing; bupropion hydrochloride (WELLBUTRIN) taken for SAD/Anxiety from 01Nov2018 and ongoing; hydrocortisone taken for adrenal insuff from 01Aug2020 and ongoing; progesterone taken for menopause from 01Nov2018 and ongoing. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular administered in left arm on 16Sep2021 at 11:00 AM (however also reported as 2100) as dose 1 (at the age of 52 years old) for COVID-19 immunization; gluten and experienced allergy. No other vaccine in four weeks/ No Prior vaccinations (within 4 weeks). No COVID prior vaccination. On 18Oct2021 at 12:00 AM, about 10 days after second dose, the patient developed a red, itchy rash. It started on her chest and spread to her head, neck, ears and back. It also spread in a smaller amount to her arm, wrists, legs and ankles. The patient's 2nd vaccine was taken (as recommended) 3 week after her 1st-on 07Oct2021. On 09Oct2021, she woke up with a burst blood vessel in her eye, she had never had one before. It looked awful, but it didn't hurt. Around 16Oct2021, she developed a red itchy rash on her neck plus chest. It spread to her head, face, ears and back. There were welts, hives, red bumps, etc. Her wrists and ankles got small red, itchy dots on them, her ears and chest were hot, itchy and sore. After a few days, it got a little better with ibuprofen and cold compresses. Then it flared up again. She went to a quick care facility and was given a steroid shot, pills and creme to treat a severe allergic reaction. After 10 days, she got a refill because it was still red plus itchy, but not as bad as before she went to the Doctor. The patient underwent lab tests and procedures which included Covid-19: negative on 17Oct2021 and on 29Oct2021, Nasal Swab: negative on 16Oct2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling, Vaccination site erythema, Vaccination site mass
Clinical narrative: Booster; Swollen painful left armpit; Swollen painful left armpit; hard / red / painful lump at vaccine site about the size of a silver dollar; hard / red / painful lump at vaccine site about the size of a silver dollar; hard / red / painful lump at vaccine site about the size of a silver dollar; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FF2590) via an unspecified route of administration, administered in left arm on 25Oct2021 13:30 (at the age of 34-year-old) as dose 3 (booster), single for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication in two weeks included drospirenone (SLYND) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205) on 04Mar2021 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8730) on 01Apr2021, both administered in left arm for covid-19 immunisation at Pharmacy or Drug Store. Patient received first dose of Flu vaccine in left arm on 04Oct2021. On 25Oct2021, the patient experienced swollen painful left armpit, hard / red / painful lump at vaccine site about the size of a silver dollar. Patient did not had covid prior vaccination and was not tested for covid post vaccination. No treatment was received for events. Outcome of events was not recovered at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Booster; Swollen painful left armpit; Swollen painful left armpit; hard / red / painful lump at vaccine site about the size of a silver dollar; hard / red / painful lump at vaccine site about the size of a silver dollar; hard / red / painful lump at vaccine site about the size of a silver dollar; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FF2590) via an unspecified route of administration, administered in left arm on 25Oct2021 13:30 (at the age of 34-year-old) as dose 3 (booster), single for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication in two weeks included drospirenone (SLYND) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205) on 04Mar2021 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8730) on 01Apr2021, both administered in left arm for covid-19 immunisation at Pharmacy or Drug Store. Patient received first dose of Flu vaccine in left arm on 04Oct2021. On 25Oct2021, the patient experienced swollen painful left armpit, hard / red / painful lump at vaccine site about the size of a silver dollar. Patient did not had covid prior vaccination and was not tested for covid post vaccination. No treatment was received for events. Outcome of events was not recovered at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: After the vaccination, for both doses, there was a significant sensation of pressure in chest.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 46-years-old non pregnant female patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, batch/ lot number: ER8733) via an unspecified route of administration on unspecified date in 2021 (at the age of 46 years) as dose 1, single dose for covid-19 immunization. It was reported that no covid prior vaccination and no known allergies. The patient's medical history and concomitant medication were not reported but reported that patient took other medication in 2 weeks from vaccination and no other vaccine administered in four weeks. On unspecified date in 2021, immediately after the vaccination, patient experienced significant sensation of pressure in her chest that lasted approximately 3 to 5 minutes, then went away. No other side effects. It was reported as non-serious. Not tested for covid post vaccination. No treatment received for the events. The outcome of the event was recovered on unspecified date in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Illusion, Myalgia, Pain
Clinical narrative: Second dose: muscle aches, pains; Second dose: muscle aches, pains; Second dose: extreme fatigue; Second dose: difficulty walking; felt like she was hit by a truck; This is a spontaneous report from a contactable other HCP (patient herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6198, Expiration Date: 30Jun2021), via an intramuscular route of administration, administered in Deltoid Right on 11Mar2021 11:00 as dose 2, single for COVID-19 immunisation (Age at Vaccination was 62 years). The patient medical history included breast cancer, haemochromatosis, had a double mastectomy and is post chemo (Chemotherapy), high blood pressure, GERD from an unknown date and unknown if ongoing, lymph nodes removed on her left side on an unspecified date. Concomitant medications included Omeprazole taken for GERD, Tamoxifen taken for anti-cancer, Losartan taken for high blood pressure all from an unspecified start date and ongoing. It was stated that, she did not receive any other new medications within the 2 weeks prior COVID vaccination. she was not on any blood thinners or Aspirin. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269, Expiration Date: 30May2021), via an intramuscular route of administration, administered in Deltoid Right on 20Feb2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 62 years) and experienced no side effects, no arm soreness. On 11Mar2021 14:00, the patient experienced second dose: muscle aches, pains, extreme fatigue, difficulty walking, felt like she was hit by a truck. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FE3690, Expiration Date: 30Nov2021), via an intramuscular route of administration, administered in Deltoid Right (Right upper arm) on 29Oct2021as dose 3, single for COVID-19 immunization and experienced bleeding and bruising. The outcome of the events muscle aches, pains, extreme fatigue, difficulty walking, felt like she was hit by a truck was recovered on 12Mar2021 04:00 (Then about 14 hours later, everything was gone).  Medical conditions: Caller adds none of the conditions mentioned should be related to today vaccine  Description of Product Complaint: Description of complaint: Calling confirms she is a Registered Nurse, but she is calling on behalf of herself in regard to the COVID-19 vaccine. The caller believes the person administering the vaccine hit a blood vessel with that much bleeding.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: originally received the J&J vaccine in June went to get the Pfizer booster 10/30/2021; originally received the J&J vaccine in June went to get the Pfizer booster 10/30/2021; headache; originally received the J&J vaccine in June went to get the Pfizer booster 10/30/2021; chills; This is a spontaneous report from a Non contactable Pharmacist (Healthcare Professional). This Pharmacist reported for a 33-Years-Old male patient received the third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: 32030BD and expiration date not reported), via an Intramuscular route of administration in arm Left anatomical location on 30Oct2021 at 05:30 AM (at the age 33-year-old) as a DOSE 3, (BOOSTER DOSE) SINGLE for covid-19 immunisation. Patient historical vaccine included received the first dose and second of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date not reported), via an unspecified route of administration on an unspecified anatomical location on unspecified date as a dose 1 single and dose 2 single for covid-19 immunisation. The patient medical history included asthma start from unspecified date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had Off label use, Interchange of vaccine products, Booster. Patient who originally received the J&J (COVID-19 VACCINE JANSSEN) vaccine in June went to get the Pfizer booster at the local pharmacy The next evening, on 31Oct2021 developed chills and a headache adverse event start time was 08:00 PM. Patient took treatment of Excedrin. The outcome of the event chills and a headache was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity
Clinical narrative: Sore left arm; fatigue; Dose Number: 3; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FF8841), via an unspecified route of administration in Left arm, on 01Nov2021 10:15 (at the age of 31-year-old), DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medication history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247), via an unspecified route of administration, on 02Feb2021, DOSE 1, SINGLE for COVID-19 immunisation and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247), via an unspecified route of administration, on 23Feb2021, DOSE 2, SINGLE for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Nov2021 10:15 the patient received third dose and at 18:00 the patient experienced sore left arm and fatigue. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: I couldn't walk; Stomach ache; breath was short; sore arm; one very tired; a big bump on the arm; chills; This is a spontaneous report from a contactable consumer(patient). A 58-years-old patient of unspecified gender had received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number EW0171, Expiration date: 30Nov2021), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient was healthy before taking vaccination. The patient previously took bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number unknown, Expiration date: unknown ), dose 1 via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunization and patient had sore arm. On an unknown date in 2021, the second vaccine, one very tired day with the sore arm, a big bump on the arm but that was the side effects that was it was one sore arm and one tired day. When paraphrased the concern, patient stated, "Right, the chills, a small fever, a stomach ache, very tired, a very sore arm. patient even had one day when patient thought like my breath was short, patient was so tired, patient couldn't walk. patient felt for three days. The clinical outcome of the events were unknown. No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: I couldn't walk; Stomach ache; breath was short; sore arm; one very tired; a big bump on the arm; chills; This is a spontaneous report from a contactable consumer(patient). A 58-years-old patient of unspecified gender had received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number EW0171, Expiration date: 30Nov2021), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient was healthy before taking vaccination. The patient previously took bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number unknown, Expiration date: unknown ), dose 1 via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunization and patient had sore arm. On an unknown date in 2021, the second vaccine, one very tired day with the sore arm, a big bump on the arm but that was the side effects that was it was one sore arm and one tired day. When paraphrased the concern, patient stated, "Right, the chills, a small fever, a stomach ache, very tired, a very sore arm. patient even had one day when patient thought like my breath was short, patient was so tired, patient couldn't walk. patient felt for three days. The clinical outcome of the events were unknown. No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received bnt162b2 as second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0202), via an unspecified route of administration in the left arm on 03Jul2021 (at the age of 19-year-old) as single dose for COVID-19 immunization. The patient was not pregnant. Medical history was none. The patient had no known allergies. Concomitant medications included drospirenone, ethinylestradiol betadex clathrate (YAZ) for birth control; measles vaccine, mumps vaccine, rubella vaccine (MMR) taken for an unspecified indication on 24Jun2021 in left deltoid (Lot number: S039311, company: Merck & Co. Inc). The patient previously took first dose of bnt162b2 (Lot Number: EW0177) on 12Jun2021 at the age of 19-year-old in left arm for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store.  On 04Jul2021 (within the next day or two), the patient began having a giant pain underneath her armpit on the left side where it was administered. It continued on like this and on 17Aug2021. The patient went to her primary care doctor for this pain that was constantly under her arm. The patient was still experiencing pain for this at the time of reporting. On 04Jul2021, the patient felt a lump/bump and so did her provider and it still had not gone away. These events resulted in visiting doctor or other healthcare professional office or clinic visit.  Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not resolved.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Bursitis, Condition aggravated, Immunisation
Clinical narrative: administered in Arm Left on 04Nov2021 11:30  as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation.; Dysfunctional left hip, I regarded as a disabling bursitis flare-up (I cannot walk now) of a non-disabling painful condition that had been annoying for about 1-2 mo.; Dysfunctional left hip, I regarded as a disabling bursitis flare-up (I cannot walk now) of a non-disabling painful condition that had been annoying for about 1-2 mo.; This is a spontaneous report from a contactable physician (patient). A 77-year-old (age at vaccination) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 04Nov2021 11:30 (Batch/Lot Number: FH8020) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included prostate cancer (Prostate ca (treatment seems to be successful). MI in 1995) from 1995 to an unknown date, dysfunctional left hip from an unknown date. Concomitant medications included abiraterone acetate (ZYTIGA); denosumab (XGEVA); prednisone and metoprolol all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose (at 77-years-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in right arm on 12Apr2021 10:15 (Batch/Lot number: ER8729) and the second dose (at 77-years-old) administered in left arm on 03May2021 10:30 (Batch/Lot number: EN6205) for covid-19 immunisation. The patient experienced dysfunctional left hip, which he regarded as a disabling bursitis flare-up (he cannot walk now) of a non-disabling painful condition that had been annoying for about 1-2 months on 04Nov2021 22:30. The event was considered disabling. The patient did not receive treatment for the event. The patient did not recover from the event.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza, Influenza virus test, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; Tested positive for flu; This is a spontaneous report from a contactable physician. A 5-decade-old (in her mid-40s) female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration in Aug2021 (the end of Aug2021) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid-19 (covid-19) (medically significant) in 2021 with outcome of unknown, tested positive for covid-19 (drug ineffective) (medically significant) in 2021 with outcome of unknown, tested positive for flu (non-serious) in 2021 with outcome of unknown, shortness of breath (non-serious) in 2021 with outcome of not recovered, severe cough (non-serious) in 2021 with outcome of not recovered. Clinical course reported patient received the 1st dose of Comirnaty during the end of Aug2021 then tested positive for flu and Covid-19. Patient is still experiencing shortness of breath and severe cough. Reporter added that it's been 6 weeks since she received her 1st dose.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported events COVID 19 , Drug ineffective, flu and the suspect drug BNT162B2 cannot be excluded
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Chest pain, Heart rate, Heart rate decreased
Clinical narrative: soaring blood pressures from 240/118 to dipping to 126/66 that lasted for the next week; mild chest pain; Within 72 hrs I started to shake; pulse remained very low; muscle burning; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 23Sep2021 at 19:00 hours (Age at vaccination 47-year-old) as dose 1, single for covid-19 immunization at Pharmacy or Drug Store. Medical history included allergy to chemicals from an unknown date and unknown if ongoing chemical sensitivities to many medical fillers with adverse reactions to other medications. The patient did not have covid prior to vaccination. The patients concomitant medications were not reported. The patient did not take other vaccine within four weeks. On 26Sep2021 at 02:00 hours within 72 hours the patient experienced shake, muscle burning and soaring blood pressures from 240 by 118 to dipping to 126 by 66 that lasted for the next week. Her pulse remained very low with mild chest pain. Patient feel as if she has a chemical sensitivity to this vaccine. Her employer was forcing her to take the second dose even though she feels it may kill her. The adverse events were resulted in doctor or other health care professional office. Patient did not receive any treatment for adverse events. On 26Sep2021 the patient underwent lab tests and procedures which included blood pressure measurement with result from 240 by 118 to dipping to 126 by 66, heart rate with result pulse remained very low. The covid was not tested post vaccination. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Tremor
Clinical narrative: soaring blood pressures from 240/118 to dipping to 126/66 that lasted for the next week; mild chest pain; Within 72 hrs I started to shake; pulse remained very low; muscle burning; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 23Sep2021 at 19:00 hours (Age at vaccination 47-year-old) as dose 1, single for covid-19 immunization at Pharmacy or Drug Store. Medical history included allergy to chemicals from an unknown date and unknown if ongoing chemical sensitivities to many medical fillers with adverse reactions to other medications. The patient did not have covid prior to vaccination. The patients concomitant medications were not reported. The patient did not take other vaccine within four weeks. On 26Sep2021 at 02:00 hours within 72 hours the patient experienced shake, muscle burning and soaring blood pressures from 240 by 118 to dipping to 126 by 66 that lasted for the next week. Her pulse remained very low with mild chest pain. Patient feel as if she has a chemical sensitivity to this vaccine. Her employer was forcing her to take the second dose even though she feels it may kill her. The adverse events were resulted in doctor or other health care professional office. Patient did not receive any treatment for adverse events. On 26Sep2021 the patient underwent lab tests and procedures which included blood pressure measurement with result from 240 by 118 to dipping to 126 by 66, heart rate with result pulse remained very low. The covid was not tested post vaccination. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis
Clinical narrative: Tentatively diagnosed with ALS; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received bnt162b2 (Lot Number: EW0176), via an unspecified route of administration, administered in Arm Left on 24Apr2021 17:00 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was noticed wing scapula on the left side, left arm weakness, and finally tentatively diagnosed with amyotrophic lateral sclerosis (ALS) in Apr2021. The adverse events result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. Therapeutic measures were taken for the adverse event including Physical Theraphy Ortho. The outcome of event was not recovered.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Chest pain, Full blood count, Immunisation
Clinical narrative: Chest pain left side of chest; Dose Number: 1 Moderna /Dose Number: 2 Moderna/ Dose Number: 3 Pfizer; Dose Number: 1 Moderna /Dose Number: 2 Moderna/ Dose Number: 3 Pfizer; Dose Number: 1 Moderna /Dose Number: 2 Moderna/ Dose Number: 3 Pfizer; vaccine received same date: Moderna; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FH8020), in arm left on 25Oct2021 14:15 (at the age of 73-years-old) at dose 3 (booster), single for COVID-19 immunisation; COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE; lot number: 012M20A) in arm left on 25Oct2021 at dose 3, single (reported as Dose Number: 1) for COVID-19 immunisation. Medical history included high blood pressure, cholesterol, prostate. The patient had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received second dose of MODERNA vaccine (lot number: 024M20A) in arm left on 03Mar2021 11:00 (at the age of 73-years-old) and first dose of MODERNA vaccine (lot number: 012m20A) in arm left on 27Jan2021 07:45 (at the age of 73-years-old), both for COVID-19 immunisation. The patient experienced chest pain left side of chest on 26Oct2021 07:00 AM. The event was reported as serious due to hospitalization for 1 day. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient underwent lab tests and procedures, which included nasal swab on 25Oct2021 with unknown results; since the vaccination, the patient had been tested for COVID-19; in Oct2021 complete blood count (CBC) with auto differential, creatine phosphokinase (CK) total and CKMB, comprehensive metabolic panel (CMP), all with unknown results. An unspecified treatment was received for the event. The patient had not recovered from chest pain left side of chest, the outcome of the other event was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Metabolic function test, Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: Chest pain left side of chest; Dose Number: 1 Moderna /Dose Number: 2 Moderna/ Dose Number: 3 Pfizer; Dose Number: 1 Moderna /Dose Number: 2 Moderna/ Dose Number: 3 Pfizer; Dose Number: 1 Moderna /Dose Number: 2 Moderna/ Dose Number: 3 Pfizer; vaccine received same date: Moderna; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FH8020), in arm left on 25Oct2021 14:15 (at the age of 73-years-old) at dose 3 (booster), single for COVID-19 immunisation; COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE; lot number: 012M20A) in arm left on 25Oct2021 at dose 3, single (reported as Dose Number: 1) for COVID-19 immunisation. Medical history included high blood pressure, cholesterol, prostate. The patient had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received second dose of MODERNA vaccine (lot number: 024M20A) in arm left on 03Mar2021 11:00 (at the age of 73-years-old) and first dose of MODERNA vaccine (lot number: 012m20A) in arm left on 27Jan2021 07:45 (at the age of 73-years-old), both for COVID-19 immunisation. The patient experienced chest pain left side of chest on 26Oct2021 07:00 AM. The event was reported as serious due to hospitalization for 1 day. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient underwent lab tests and procedures, which included nasal swab on 25Oct2021 with unknown results; since the vaccination, the patient had been tested for COVID-19; in Oct2021 complete blood count (CBC) with auto differential, creatine phosphokinase (CK) total and CKMB, comprehensive metabolic panel (CMP), all with unknown results. An unspecified treatment was received for the event. The patient had not recovered from chest pain left side of chest, the outcome of the other event was unknown.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient receiveed the first dose of VAQTA on 26-SEP-2019 and had not received the second dose yet; No addittional AE reported; This spontaneous report has been received from the patient concerning himself a male patient of unknown age. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies was not provided.  On 26-SEP-2019, the patient was vaccinated with the first dose hepatitis a vaccine, inactivated (VAQTA) 1 milliliter (mL) as prophylaxis (formulation, vaccination scheme frequency, route of administration, and anatomical location of vaccination, lot number and expiration date were not reported); the patient stated he had not received the second dose yet (inappropriate schedule of product administration); no additional adverse events (AEs) reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received both shots / having breakouts/SUSPECTED VACCINATION FAILURE; having breakouts; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received both Shingrix shots when it first came out and the patient still had breakouts, they were getting worse. The reporter asked could he/she get revaccinated. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had my first Shingrix shot 4-1-21; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st April 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received second shot, which led to incomplete course of vaccination. The patient's wife and patient thought that the got the second shot. The patient enquired could he go ahead and get the second shot.
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Chapped lips, Lip blister, Lip swelling, Oral discomfort
Clinical narrative: Lip blistering; Lip Swelling / bilateral lip swelling; rash below her armpit; Bronchitis; Lip burning; Lip chapping; This case was reported by a physician via call center representative and described the occurrence of lip blister in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced lip blister, lip swelling, rash, bronchitis, burning lips and chapped lips. The patient was treated with methylprednisolone (Medrol Dose Pack) and acyclovir (Acyclovir Oral). On an unknown date, the outcome of the lip blister, bronchitis, burning lips and chapped lips were unknown and the outcome of the lip swelling was not recovered/not resolved and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the lip blister, lip swelling, rash, bronchitis, burning lips and chapped lips to be related to Shingrix.  Additional details were provided as follows: The physician who is an allergist and was on telehealth call with the patient for bronchitis reported that, the patient received 1st dose of Shingrix and developed a rash below her armpit rash. Two weeks later, she experienced lip blister and lip swelling. She also had burning lips and chapped lips. The patient was treated with oral Acyclovir and a Medrol dose Pack. The reporter states that the patient completed the course of medication and then lip swelling returned. The reporter consented to follow up. This case is linked with the case US2021AMR237990, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Lip blistering; Lip Swelling / bilateral lip swelling; rash below her armpit; Bronchitis; Lip burning; Lip chapping; This case was reported by a physician via call center representative and described the occurrence of lip blister in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced lip blister, lip swelling, rash, bronchitis, burning lips and chapped lips. The patient was treated with methylprednisolone (Medrol Dose Pack) and acyclovir (Acyclovir Oral). On an unknown date, the outcome of the lip blister, bronchitis, burning lips and chapped lips were unknown and the outcome of the lip swelling was not recovered/not resolved and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the lip blister, lip swelling, rash, bronchitis, burning lips and chapped lips to be related to Shingrix.  Additional details were provided as follows: The physician who is an allergist and was on telehealth call with the patient for bronchitis reported that, the patient received 1st dose of Shingrix and developed a rash below her armpit rash. Two weeks later, she experienced lip blister and lip swelling. She also had burning lips and chapped lips. The patient was treated with oral Acyclovir and a Medrol dose Pack. The reporter states that the patient completed the course of medication and then lip swelling returned. The reporter consented to follow up. This case is linked with the case US2021AMR237990, reported by same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccine did not work, shingles again/suspected Vaccination Failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient reported that the Shingrix vaccine did not work as she suffered from shingles again (date unknown) and would like to know if she could get the vaccine again. The reporter did not mention anything regarding the shingles outbreak occurring in the specified country or outside of the specified country, only that she had an outbreak. The reporter consented to contact healthcare professional. The reporter consented to follow up. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation for shingles were unknown at the time of reporting. For the shingles episodes experienced in other specified country, refer case CA2021218608.; Sender's Comments:  US-GLAXOSMITHKLINE-CA2021218608:Same reporter
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: adult received 2nd dose of Engerix B, 10mcg; adult received 2nd dose of Engerix B, 10mcg; received 1st dose 8/13/2021, 2nd dose 11/12/2021; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 28-year-old male patient who received HBV (Engerix B 10 mcg) (batch number LM992, expiry date 13th December 2021) for prophylaxis.   Previously administered products included Engerix B 20 (received 1st dose on 13th August 2021, batch no: 4EA77, expiry date:11th September 2022).   On 12th November 2021, the patient received the 2nd dose of Engerix B 10 mcg. On 12th November 2021, unknown after receiving Engerix B 10 mcg, the patient experienced underdose, adult use of a child product and drug dose administration interval too long. On an unknown date, the outcome of the underdose, adult use of a child product and drug dose administration interval too long were unknown.  Additional details were provided as follows: Nurse practitioner reported an adult patient received 2nd dose of Engerix B of 10mcg, which led to underdose and adult use of a child product. The patient also received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule Till the time of reporting, patient did not receive 3rd dose of Engerix B. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: fluid leaked out.; while administering, some fluid leaked out; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 95Z42, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th November 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 16th November 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Fluarix vaccine in unknown deltoid. The pharmacist reported that while administering the Fluarix vaccine to the patient, some of the fluid leaked out, which led to incomplete dose administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose on 2019, had not received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 20th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination. The reporter consented to follow up. This case is linked with the case US2021238459 and US2021238463, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021238459:same reporter US-GLAXOSMITHKLINE-US2021238463:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: THE REFRIGERATOR WAS LEFT OPEN AND UNOPENED VIAL STORED  FOR 15 MINUTES WHICH HAD A TEMPERATURE EXCURSION OF 47.44 DEGREES F; ADMINISTRATION OF VACCINE THAT WAS STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, administered on 18-NOV-2021 15:20 for prophylactic vaccination. No concomitant medications were reported. On 18-NOV-2021, the patient experienced administration of vaccine that was stored outside of the recommended storage conditions. On an unspecified date, the patient experienced the refrigerator was left open and unopened vial stored for 15 minutes which had a temperature excursion of 47.44 degrees f.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The outcome of the administration of vaccine that was stored outside of the recommended storage conditions and the refrigerator was left open and unopened vial stored for 15 minutes which had a temperature excursion of 47.44 degrees f was not reported. This report was non-serious.