chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dysphonia, Dyspnoea, Nausea
Clinical narrative: her voice feels a little weak; having problems breathing; lot of Phlegm; coughing a lot; fingers started tingling; waves of nausea; light headedness; She started to itch; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN8203 and expiration date 30Aug2021), via an unspecified route of administration in left arm on 01Mar2021 at 14:30 (age at vaccination 60-year-old) as single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus, hashimoto's disease, high cholesterol and high blood pressure. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. On 01Mar2021, with a few minutes just driving to the waiting spot she was having problems breathing. There was plenty of staff there in the hospital parking lot to help. They were monitoring her oxygen and her heart also on 01Mar20210, patient experienced lot of phlegm, coughing a lot, fingers started tingling, waves of nausea, light headedness and on 03Mar2021, patients voice felt a little weak. She was treated with Benadryl and an inhaler. The outcome of event having problems breathing, fingers started tingling, light headedness, waves of nausea was recovered on 01Mar2021. The outcome of event lot of Phlegm and coughing a lot was recovering at the time of reporting. The outcome of itching and her voice feels a little weak was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Productive cough, Pruritus
Clinical narrative: her voice feels a little weak; having problems breathing; lot of Phlegm; coughing a lot; fingers started tingling; waves of nausea; light headedness; She started to itch; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN8203 and expiration date 30Aug2021), via an unspecified route of administration in left arm on 01Mar2021 at 14:30 (age at vaccination 60-year-old) as single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus, hashimoto's disease, high cholesterol and high blood pressure. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. On 01Mar2021, with a few minutes just driving to the waiting spot she was having problems breathing. There was plenty of staff there in the hospital parking lot to help. They were monitoring her oxygen and her heart also on 01Mar20210, patient experienced lot of phlegm, coughing a lot, fingers started tingling, waves of nausea, light headedness and on 03Mar2021, patients voice felt a little weak. She was treated with Benadryl and an inhaler. The outcome of event having problems breathing, fingers started tingling, light headedness, waves of nausea was recovered on 01Mar2021. The outcome of event lot of Phlegm and coughing a lot was recovering at the time of reporting. The outcome of itching and her voice feels a little weak was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Pain, Pyrexia
Clinical narrative: Developed rash that got so bad (07Mar) that it covered my whole body running up my face; throat was feeling tight; Shortness of breath of the chest & abdomen; Body aches; fever of 100.4; chills; runny nose; sneezing; This is a spontaneous report from a contactable consumer(patient). A 64-year-old non pregnant female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, lot/batch number: not provided), via an unspecified route of administration on 04Mar2021 at 15:45 into left arm as a single dose for COVID-19 immunization. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, blood cholesterol abnormal from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Patient concomitant medications were Atorvastatin, Metoprolol, Triamterene, Levothyroxine. The patient had allergies to Penicillin, Codeine. Prior to the vaccination, the patient was diagnosed with COVID-19. Patient did not receive any other vaccine within 4 weeks. On 05Mar2021, patient experienced Body aches, fever of 100.4, chills, runny nose sneezing. On 07Mar2021 at 9:00, patient experienced developed rash that got so bad that it covered my whole body running up my face and my throat was feeling tight. Shortness of breath of the chest & abdomen. Then patient seeked medical help on. The patient was visited Emergency room/department or urgent care for the events. Patient was received Steroid shot, Steroid medication, Pepsid, Benadryl for the events. On 07-Mar2021, patient had COVID test (Nasal Swab) with negative result. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rhinorrhoea, SARS-CoV-2 test, Sneezing, Throat tightness
Clinical narrative: Developed rash that got so bad (07Mar) that it covered my whole body running up my face; throat was feeling tight; Shortness of breath of the chest & abdomen; Body aches; fever of 100.4; chills; runny nose; sneezing; This is a spontaneous report from a contactable consumer(patient). A 64-year-old non pregnant female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, lot/batch number: not provided), via an unspecified route of administration on 04Mar2021 at 15:45 into left arm as a single dose for COVID-19 immunization. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, blood cholesterol abnormal from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Patient concomitant medications were Atorvastatin, Metoprolol, Triamterene, Levothyroxine. The patient had allergies to Penicillin, Codeine. Prior to the vaccination, the patient was diagnosed with COVID-19. Patient did not receive any other vaccine within 4 weeks. On 05Mar2021, patient experienced Body aches, fever of 100.4, chills, runny nose sneezing. On 07Mar2021 at 9:00, patient experienced developed rash that got so bad that it covered my whole body running up my face and my throat was feeling tight. Shortness of breath of the chest & abdomen. Then patient seeked medical help on. The patient was visited Emergency room/department or urgent care for the events. Patient was received Steroid shot, Steroid medication, Pepsid, Benadryl for the events. On 07-Mar2021, patient had COVID test (Nasal Swab) with negative result. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: I had a urinary tract infection after each dose.  I have never had a UTI in my life - until these two.My elderly father also received 2 doses of the Pfizer covid vaccine with me, and he had a urinar; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267 and expiration date was not reported) via an unspecified route of administration, administered in arm left on 16Feb2021 12:30 (at the age of 63 years) as a single dose for COVID-19 immunization. Medical history included blood cholesterol increased managed with atorvastatin, drug hypersensitivity from an unknown date and unknown if ongoing along with known allergies that is Penicillin, known allergies that is Soy from an unknown date and unknown if ongoing known. Concomitant medication(s) included atorvastatin (20 mg, 1x/day [daily in evening) taken for Slightly elevated cholesterol, start and stop date were not reported and calcium (ALGAE CALCIUM) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 post vaccination. Historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm left on 26Jan2021 12:30 as 1ST DOSE, SINGLE for COVID-19 immunization. On 16Feb2021, the patient experienced at 18:00 had a urinary tract infection after each dose. Patient never had a UTI in her life until these two. Cranberry juice was used to treat the adverse event. Reporter assessed the event as non-serious. The outcome of the event was recovered on unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: had a urinary tract infection after each dose; This is a spontaneous report from a contactable consumer. This 63-years-old female consumer reported that, a Male patient of an unspecified age received first dose of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN5318), via an unspecified route of administration in the left arm on 26Jan2021 at 12:30 PM as a 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications taken within two weeks included Atorvastatin 20 mg daily in evening; Algae Cal Plus (ALGAE CALCIUM), all were received for an unknown indication from an unspecified date and unknown if ongoing. The patient did not receive any vaccine within 4 weeks prior to the suspect vaccine. he did not have Covid prior vaccination. Patient received 2 doses of the Pfizer covid vaccine, and on 26Jan2021 at 06:00 PM he had a urinary tract infection. He never had a UTI in his life until he received this vaccine. This was just too coincidental. Events resulted in the Doctor or other healthcare professional office/clinic visit. Patient received treatment with antibiotic (unspecified) for the events. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9267), dose 2 via an unspecified route of administration in the left arm on 16FEB2021 at 12:30 as a 2ND DOSE, SINGLE DOSE for COVID-19 immunization. He had not been tested for covid post vaccination. Outcome of the event were Resolved on unspecified date.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Dyspnoea, Fatigue
Clinical narrative: shortness of breath; fatigue; boobs had swelled up and she had considerable pain in them; boobs had swelled up and she had considerable pain in them; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old female patient received first dose bnt162b2 (BNT162B2,PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 19:00 (Batch/Lot number was not reported) as 1ST DOSE,SINGLE for COVID-19 immunization. Medical history included cyst from an unknown date and unknown if ongoing. She was scheduled to have surgery on her tongue for a cyst (discovered prior to vaccine) on 15Mar2021 and is supposed to have her second vaccine on 21Mar2021.The patient's concomitant medications were not reported. On 27Feb2021 the patient experienced boobs had swelled up and she had considerable pain in them, shortness of breath, fatigue on an unspecified date. The patient had a paper that stated if she had complications she couldn't take the second dose takes second dose. Patient stated to know whether to receive the second dose or not. Therapeutic measures were taken as a result of boobs had swelled up and she had considerable pain in them, boobs had swelled up and she had considerable pain in them, shortness of breath, fatigue. Patient had called the doctor had prescribed antibiotics she didn't know for which indication of the antibiotics so she didn't take them. The outcome of the event was Breast Swelling was recovering and the outcome of the events Breast pain, Dyspnoea and fatigue was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Limb injury, Skin laceration
Clinical narrative: Accident with left arm/banging his arm into the chair and it ripped the skin on the top layer of his arm; Accident with left arm/banging his arm into the chair and it ripped the skin on the top layer of his arm; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 77-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EI.9267), via an unspecified route of administration, administered in Arm Left on 09Feb2021 13:30 as single dose for COVID-19 immunisation. The patient was taking COVID Vaccine Right thing to do and also high risk because has Type II Diabetes. Medical history included ongoing Diabetes Type II, Blood pressure high, dry eye, Neuropathy, patient was allergic to a number of medications and allergic to certain things (but not sure if those are considered a vaccine), allergic to Penicillin and Tetracycline and eye stroke (Doctor told to take because has dry eye and was informed could get something referred to as eye stroke). Concomitant medications included BAYER ASPIRIN, 81 ng, daily for Blood pressure, Gabapentin 400 mg, five a day for neuropathy, Glipizide 5 mg, two pills two times daily for Diabetes, Lisinopril 20/25 mg once a day for Blood pressure high, and Systane ultra twice daily for dry eye and eye stroke. The patient previously took tetracycline and experienced drug hypersensitivity. It was reported that patient was not prior vaccinated within 4 weeks. On 02Mar2021, the patient experienced accident with left arm/banging his arm into the chair and it ripped the skin on the top layer of his arm which was considered serious as medically significant event and for which patient visited to local emergency room but not physicians office and the HCP gave him a tetanus shot. The doctor there said he would not have any problems with getting the second shot. It was reported that patient was supposed to get his 2nd dose on 02Mar2021 but due to the storms) they were not able to get the vaccines in on time and his appointment was changed to next Tuesday. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Headache, Illness
Clinical narrative: Chills; fever; severe fatigue; headache; nausea; joint pain; trouble breathing; One week very sick; Was bed ridden since 01Mar2021; This is a spontaneous report from a contactable consumer (Patient). A 83-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: E L3302) via an unspecified route of administration in left arm on 01Mar2021 at 00:00 (age at vaccination 83-year-old) at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, heart disease, cancer survivor, fibromyalgia and high blood pressure. Patient had known allergies. The patients concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. 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 01Mar2021, at 00:00 patient experienced chills, fever, severe fatigue, headache, nausea, joint pain and trouble breathing. Patient was bedridden since 01Mar2021 the day of the shot and was very sick for one week. Therapeutic measures were taken as a result of chills, fever, severe fatigue, headache, nausea, joint pain, trouble breathing, one week very sick, was bed ridden since 01Mar2021. The outcome of event was recovering at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills; fever; severe fatigue; headache; nausea; joint pain; trouble breathing; One week very sick; Was bed ridden since 01Mar2021; This is a spontaneous report from a contactable consumer (Patient). A 83-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: E L3302) via an unspecified route of administration in left arm on 01Mar2021 at 00:00 (age at vaccination 83-year-old) at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, heart disease, cancer survivor, fibromyalgia and high blood pressure. Patient had known allergies. The patients concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. 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 01Mar2021, at 00:00 patient experienced chills, fever, severe fatigue, headache, nausea, joint pain and trouble breathing. Patient was bedridden since 01Mar2021 the day of the shot and was very sick for one week. Therapeutic measures were taken as a result of chills, fever, severe fatigue, headache, nausea, joint pain, trouble breathing, one week very sick, was bed ridden since 01Mar2021. The outcome of event was recovering at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary Infection; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 11Feb2021, as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient experienced urinary Infection. Patient was taking antibiotics. He wanted to confirm if his wife can take the vaccine on the scheduled appointment on 07Mar2021, which is over 21 days interval. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: rash near the injection site; Hives (mild) near site; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9264; Expiration Date: May2021), dose 1 via intramuscular, administered in Arm Left on 06Feb2021 10:50 (at the age of 28 years old) as 1st dose, single dose for COVID-19 immunization. Medical history included asthma, eczema, high cholesterol (It is Hereditary. She was not on medication), attention deficit hyperactivity disorder, depression. Family medical history included: Mother had High blood pressure, high cholesterol, obesity, sleep apnea, kidney stones, heart issues. Concomitant medication(s) included hydroxyzine (HYDROXYZINE) taken for eczema from Jun2017 and ongoing; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestimate (TRI-PREVIFEM) taken for contraception from Oct2019 and ongoing; bupropion (BUPROPION) taken for depression from Jun2020 to Apr2021. Prior vaccinations: None. The patient stated that she was fully vaccinated with the COVID-19 vaccine. After the first dose, on 06Feb2021 15:00, she experienced a rash near the injection site and Hives (mild) near site.She specified she has eczema thus she was not concerned about it then. She asked for what to do and should she consult her HPC or dermatologist.  She also asked how long the rash lasted post vaccination. The patient had allergy medicines, lotions (Unspecified Medications) but nothing was really helping  The patient had been taking Benadryl but that hasn't been doing anything and about take Zyrtec. The patient do suffer from eczema (Medical History) so I am very familiar with kind of stuff so I have things with me, I have allergy medicines, lotions (Unspecified medications) but nothing was really helping. And don't if it really required me to go to the emergency room because the patient don't know what they will tell . The patient feel like they would be like to take the lotion.The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6200; Expiration Date: Jun2021 ), dose 2 via Intramuscular, administered in Arm Left on 03Mar2021at 11:10 as second dose, single dose for COVID-19 immunization.The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included COVID-19 test: negative on 10Nov2020, COVID-19 test: negative on 21Jan2021, COVID-19 test: negative on 17Feb2021. Investigations Nor.The reported assessed the vent as non serious.The clinical outcome of the events was resolved on 07Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Rib fracture, Road traffic accident, X-ray
Clinical narrative: He slipped on black ice on his driveway and fell back and fractured ribs; He slipped on black ice on his driveway and fell back and fractured ribs; He slipped on black ice on his driveway and fell back and fractured ribs; This is a spontaneous report from a non-contactable consumer (Patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 29Jan2021, as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  It was reported that patient stated, he had both Pfizer vaccines and he delighted, he found out after the fact something troubling. The patient was concerned about use of Tylenol and Advil during vaccination period. On 29Jan2021, he received dose 1 of the Pfizer Covid vaccine. On the 10Feb2021, 13 days later following vaccine, he slipped on black ice on his driveway and fell back and fractured ribs. X-rays and was on his way. He started taking Tylenol and Advil on a daily basis, it did not decrease for a while. On 10Feb2021, late in the day as per MD instructions, started taking 3000mg daily Tylenol, 800 to 1200mg daily of Advil. Slowly decreased and stopped taking anything 03Mar2021.  He did lower the Tylenol dose on the 20Feb2021, the day of the second dose of Pfizer vaccine to 2000mg daily, by 28Feb2021, he was at zero with Tylenol, but with Advil, it was less of a decrease. On 20Feb2021, received dose 2, he was at the peak of taking Tylenol and Advil. The patient was concerned that he has had invalidated the dose, or even worse, he has had compromised. taking these 13 days after the first dose, did he invalid the first dose and taking it prior to 2nd dose and a good 10 days after words, had he effectively rendered the vaccine useless, and do he need to get another dose. No product quality complaint reported. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia oral
Clinical narrative: Shortness of breath; dizziness; numb tongue; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6199), dose 1 via an unspecified route of administration in Right arm on 05Mar2021 at 01:00PM (at the age of 81 years) as single dose for COVID-19 immunization. The patient's medical history included known allergies to the Opioids. Concomitant medications taken within two weeks included, Gabapentin 300 mg, paracetamol (TYLENOL 500), Acetylsalicylic Acid (ASPIRIN) 81mg, all were received for an unknown indication from an unspecified date and unknown if ongoing. The patient did not receive any vaccine within 4 weeks prior to the suspect vaccine. She did not have Covid prior vaccination. On 05Mar2021 at 01:15 PM patient experienced, Shortness of breath, dizziness and numb tongue. Patient received treatment for the events. She had not been tested for covid post vaccination. Outcome of all the events were recovered.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Urticaria
Clinical narrative: infestation of hives/ had her 2nd shot 5 days ago and has developed sudden welts all over her body and he believes they are hives,thinks it has gotten worse; irritating itch, thinks it has gotten worse; did not sleep at all; This is a spontaneous report from a contactable lawyer (patient husband). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6201; Expiration Date: unknown), via an unspecified route of administration on 06Mar2021 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot: EL9266 with EX: 5131121) on 13Feb2021 as a single dose for COVID-19 immunisation. After the second shot of vaccination on 06Mar2021, patient developed the itching and the hives began within hours of the itching. Overnight, she had huge infestation of hives/sudden welts all over her body, states it has been about 5 days since she received the 2nd dose of the Pfizer COVID19 Vaccine, believed that are hives and she had been extremely troubled with the irritating itch. Patient was at her son's house and she was feeling an itch and the thing was roaring at home after about a 30 minute drive home. Patient had a fretful night and did not sleep at all and stated that he (reporter) got up at dawn to go to the pharmacy to get what he understood to be responsive remediation for the reported event. HCP advised her to get the Benadryl tablets because topical Benadryl would not respond to that and should be in tablet form, so he got the tablet form and got the oatmeal bath and ice packs to mitigate the itch. Reporter stated that hives and itching are roaring and thinks it has gotten worse since the patient got them and it seems to be spreading and moving around her body and her whole torso was covered with the hives. Reporter enquired for how long to expect the hives, and already been too long that the patient had the hives, these side effects are supposed to last and for any recommendations to address it. The reporter assessed the events as non serious. The outcome of the event did not sleep at all was unknown and the rest of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngeal swelling, Throat tightness
Clinical narrative: My throat swollen up; hard for me to swallow; felt like throat was closing; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 65-year-old female non-pregnant patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: En6205) via an unspecified route of administration and administered in left arm (at the age of 65-years-old) on 09Mar2021 11:00 as 1st dose, single dose for COVID-19 immunization. The patient's medical history included allergies (food allergies, environmental allergies, and allergies to unspecified medication), high blood pressure. The patient did not have and not tested for COVID-19 prior to vaccination. The patient's concomitant medications which were received in two weeks included vitamins, blood pressure meds, allergy meds and received no other vaccines received in four weeks. The patient experienced throat swollen up and hard for me to swallow. Felt like throat was closing on 09Mar2021 on 11:30 AM. Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken for the events throat swollen up and hard for me to swallow, felt like throat was closing with liquid Steroids. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Erythema, Nausea, Oropharyngeal pain
Clinical narrative: neck redness and swelling; neck redness and swelling; Pain; nausea; diarrhea; sore throat; sob; This is a spontaneous report from a non-contactable Nurse. This 45-year-old female Nurse (patient) reported for herself. A 45-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En6200, Expiration date: unknown), via unspecified route, administered on 04Mar2021 03:15 AM (at the age of 45-year-old) as Unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not have COVID-19. No Covid tested post vaccination No. On 05Mar2021 (20 hours 45 minutes after the vaccination), the patient experienced pain, nausea, diarrhoea, sore throat, shortness of breath, neck redness and swelling. Atarax, ibuprofen albuterol treatment received . The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: neck redness and swelling; neck redness and swelling; Pain; nausea; diarrhea; sore throat; sob; This is a spontaneous report from a non-contactable Nurse. This 45-year-old female Nurse (patient) reported for herself. A 45-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En6200, Expiration date: unknown), via unspecified route, administered on 04Mar2021 03:15 AM (at the age of 45-year-old) as Unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not have COVID-19. No Covid tested post vaccination No. On 05Mar2021 (20 hours 45 minutes after the vaccination), the patient experienced pain, nausea, diarrhoea, sore throat, shortness of breath, neck redness and swelling. Atarax, ibuprofen albuterol treatment received . The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling cold, Heart rate, Hypertension, Illness
Clinical narrative: This is a spontaneous report from a contactable consumer. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EN6202) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included Blood pressure high, UTI (Urinary tract infection), PMR (Polymyalgia rheumatica) and Thyroid. Concomitant medications included prednisone taken for polymyalgia rheumatica; levothyroxine taken for thyroid, omeprazole, cetirizine, hydroxyzine taken for an unspecified indication, start and stop date were not reported. It was reported that Consumer stated she got a shot on the 04Mar2021 that was of this month before and then she feel okay and she feel good when she got up Friday morning then the 05Mar2021, then the afternoon she got sick, real sick, where she was shaking really bad and little cold, she was just shaking then my heart was beating really fast and then she tried to calm myself down by taking some medicine (Treatment) and then she had to go to the Hospital on 05Mar2021 at night because it never stop and she went, go to the hospital then her blood pressure was 190 over 120 (hypertension) (medically significant), some and they gave her Advil and Zofran because she was like gone throw up all the time on 05Mar2021. Regarding hospitalization consumer stated that they give me medicines and after hour and so, she got feeling better but they told me not to be surprised, she got sick again because they have had other people of that had their shot and ended up in the hospital, she wasn't the only one. (Further details was not available hence, split was not made). Consumer stated she was wondering if she should get the second shot. she was afraid of being sick. It was supposed to be 25th of this month. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Thyroid function test, Tremor, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EN6202) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included Blood pressure high, UTI (Urinary tract infection), PMR (Polymyalgia rheumatica) and Thyroid. Concomitant medications included prednisone taken for polymyalgia rheumatica; levothyroxine taken for thyroid, omeprazole, cetirizine, hydroxyzine taken for an unspecified indication, start and stop date were not reported. It was reported that Consumer stated she got a shot on the 04Mar2021 that was of this month before and then she feel okay and she feel good when she got up Friday morning then the 05Mar2021, then the afternoon she got sick, real sick, where she was shaking really bad and little cold, she was just shaking then my heart was beating really fast and then she tried to calm myself down by taking some medicine (Treatment) and then she had to go to the Hospital on 05Mar2021 at night because it never stop and she went, go to the hospital then her blood pressure was 190 over 120 (hypertension) (medically significant), some and they gave her Advil and Zofran because she was like gone throw up all the time on 05Mar2021. Regarding hospitalization consumer stated that they give me medicines and after hour and so, she got feeling better but they told me not to be surprised, she got sick again because they have had other people of that had their shot and ended up in the hospital, she wasn't the only one. (Further details was not available hence, split was not made). Consumer stated she was wondering if she should get the second shot. she was afraid of being sick. It was supposed to be 25th of this month. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Breast calcifications, Chills, Computerised tomogram, Dyspnoea
Clinical narrative: calcified lump, left breast, inconclusive; weak; tired; chills; shortness of breath; Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear); Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear); lung nodule; This is a spontaneous report from a contactable consumer (patient). A 79-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EN5318), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 as single dose for covid-19 immunization at Hospital. Medical history included atrial fibrillation, mitral valve stenosis, COPD (chronic obstructive pulmonary disease), ,ggo's , asthma, Known allergies to various medications. Concomitant medications in 2 weeks included Atenolol, Digoxin, Atorvastatin, Eliquis, Lasix, k (Potassium). Patient did not receive any other vaccine in 4 weeks. Patient did not had COVID prior vaccination. Patient did not tested for COVID post vaccination. Patient previously received COVID 19, brand: Pfizer-BioNTechCOVID-19 Vaccine 1st dose in left arm with lot number EL3246 on 21Jan2021, at 10:45. In Feb2021, the patient experienced lung nodule. On 19Feb2021 at 10:00 patient had chills. On 19Feb2021, the patient had Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear). On 19Feb2021 at 10 PM the patient had shortness of breath, abating at 4 am. On 20Feb2021, the patient was weak and tired but beathing easily. On 02March 2021, the patient had calcified lump, left breast, inconclusive. AE resulted in Doctor or other healthcare professional office/clinic visit. Lab test included patient had CT scan of lungs on 03Feb2021. On 05Feb2021 mammogram was done. On 09Feb2021 PET scan GGO change, upper left lobe confirms solidifying. On 02Mar2021 repeat mammo, results calcified lump, left breast, inconclusive. Bronchoscopy was scheduled for biopsy of GGnodule on 18Mar2021. On 19Feb2021 weight at 9 am was 127.5 lbs. On 21Feb2021 weight at 9 am was 120.0 lbs. Itchy lumps disappear 1 week. Treatment received was repeat mammo and biopsy of lung nodule. The patient was recovering for all the events while Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear) was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Mammogram, Papule, Positron emission tomogram
Clinical narrative: calcified lump, left breast, inconclusive; weak; tired; chills; shortness of breath; Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear); Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear); lung nodule; This is a spontaneous report from a contactable consumer (patient). A 79-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EN5318), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 as single dose for covid-19 immunization at Hospital. Medical history included atrial fibrillation, mitral valve stenosis, COPD (chronic obstructive pulmonary disease), ,ggo's , asthma, Known allergies to various medications. Concomitant medications in 2 weeks included Atenolol, Digoxin, Atorvastatin, Eliquis, Lasix, k (Potassium). Patient did not receive any other vaccine in 4 weeks. Patient did not had COVID prior vaccination. Patient did not tested for COVID post vaccination. Patient previously received COVID 19, brand: Pfizer-BioNTechCOVID-19 Vaccine 1st dose in left arm with lot number EL3246 on 21Jan2021, at 10:45. In Feb2021, the patient experienced lung nodule. On 19Feb2021 at 10:00 patient had chills. On 19Feb2021, the patient had Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear). On 19Feb2021 at 10 PM the patient had shortness of breath, abating at 4 am. On 20Feb2021, the patient was weak and tired but beathing easily. On 02March 2021, the patient had calcified lump, left breast, inconclusive. AE resulted in Doctor or other healthcare professional office/clinic visit. Lab test included patient had CT scan of lungs on 03Feb2021. On 05Feb2021 mammogram was done. On 09Feb2021 PET scan GGO change, upper left lobe confirms solidifying. On 02Mar2021 repeat mammo, results calcified lump, left breast, inconclusive. Bronchoscopy was scheduled for biopsy of GGnodule on 18Mar2021. On 19Feb2021 weight at 9 am was 127.5 lbs. On 21Feb2021 weight at 9 am was 120.0 lbs. Itchy lumps disappear 1 week. Treatment received was repeat mammo and biopsy of lung nodule. The patient was recovering for all the events while Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear) was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary mass, Weight
Clinical narrative: calcified lump, left breast, inconclusive; weak; tired; chills; shortness of breath; Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear); Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear); lung nodule; This is a spontaneous report from a contactable consumer (patient). A 79-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EN5318), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 as single dose for covid-19 immunization at Hospital. Medical history included atrial fibrillation, mitral valve stenosis, COPD (chronic obstructive pulmonary disease), ,ggo's , asthma, Known allergies to various medications. Concomitant medications in 2 weeks included Atenolol, Digoxin, Atorvastatin, Eliquis, Lasix, k (Potassium). Patient did not receive any other vaccine in 4 weeks. Patient did not had COVID prior vaccination. Patient did not tested for COVID post vaccination. Patient previously received COVID 19, brand: Pfizer-BioNTechCOVID-19 Vaccine 1st dose in left arm with lot number EL3246 on 21Jan2021, at 10:45. In Feb2021, the patient experienced lung nodule. On 19Feb2021 at 10:00 patient had chills. On 19Feb2021, the patient had Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear). On 19Feb2021 at 10 PM the patient had shortness of breath, abating at 4 am. On 20Feb2021, the patient was weak and tired but beathing easily. On 02March 2021, the patient had calcified lump, left breast, inconclusive. AE resulted in Doctor or other healthcare professional office/clinic visit. Lab test included patient had CT scan of lungs on 03Feb2021. On 05Feb2021 mammogram was done. On 09Feb2021 PET scan GGO change, upper left lobe confirms solidifying. On 02Mar2021 repeat mammo, results calcified lump, left breast, inconclusive. Bronchoscopy was scheduled for biopsy of GGnodule on 18Mar2021. On 19Feb2021 weight at 9 am was 127.5 lbs. On 21Feb2021 weight at 9 am was 120.0 lbs. Itchy lumps disappear 1 week. Treatment received was repeat mammo and biopsy of lung nodule. The patient was recovering for all the events while Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear) was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: lightheadedness; shortness of breath (sensation of sob); This is a Spontaneous report from a non-contactable other Healthcare Professional reporting for a patient. An 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on an unspecified date (At the age of 83-years-old ) as First dose, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, 15 minutes after vaccination, the patient experienced lightheadedness and shortness of breath (sensation of sob). She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling Patient had differential diagnosis of Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns). Water and snacks treatment received. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Erythema, Swelling face, Swollen tongue
Clinical narrative: Swelling of cheeks, tongue and chin; Swelling of cheeks, tongue and chin; Redness or arms and face; chills; shortness of breath; This is a spontaneous report from a contactable consumer reporting for himself. A 58-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Right (At vaccination age 58-year-old) on 12Mar2021 08:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included Heart disease, known allergies: Sulfa meds from an unknown date. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient took other medication in last two weeks. The patient experienced swelling of cheeks, tongue and chin, redness or arms and face, chills, and shortness of breath 12Mar2021 08:15 AM. Therapeutic measures were taken as a result of events which include BENEDRYL and rest. The outcome for all events were recovering.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Illness, Urinary tract infection, Weight
Clinical narrative: I am sick; I am having trouble with urinary tract infection; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 23Feb2021 (72-years-old at the time of vaccination), as a SINGLE DOSE for COVID-19 immunization. The patient's medical history included Blood pressure high. The patient's concomitant medication included Thyroid medication. On an unspecified date, the patient experienced I am sick, and I am having trouble with urinary tract infection. Patient stated that she had to cancel her appointment to get her second vaccine because she was sick. She thought, they just going to call her and let her know appointment she had, instead she had not heard from them. She did not have any email address. Patient stated she did not feel sick from that, she was a heart patient but she was having trouble with urinary tract infection and stuff, so she was on antibiotics, so she told them she was sick, they told her to use that and set up another appointment. Patient stated she finally got her antibiotic, and she was feeling better. Patient stated that she would like to connect with the people who know when she was supposed to come back there, she will be there. On an unspecified date, the patient underwent lab tests and procedures which included body height: 5'3 or 5'4, Her height is 5'3 or 5'4 something like that and weight: 163, her weight is 163 something like that. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.