chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills; I felt some body aches; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration, administered in arm left on 03Feb2021 at 14:30 (at the age of 51-years-old) as unknown, single for COVID-19 immunisation. Medical history included COVID-19 (if Covid prior vaccination: Yes). The patient had no known allergies. Concomitant medication(s) included zinc, vitamin C [ascorbic acid], vitamin D3 and multivitamins. The patient did not receive other vaccine in four weeks. The patient was not tested for COVID post vaccination. On 04Feb2021 at 03:00, the patient experienced chills but he felt none by the next morning. The next day the patient felt some body aches which only lasted that day. The outcome of the events was recovered on 04Feb2021.  Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Faeces discoloured
Clinical narrative: The day after my vaccine ( Thursday) my stool was bright green, I evacuated twice that day and both stools were bright green. On Friday I evacuated once and my stool was a darker green; This is a spontaneous report from a contactable consumer. A 73-year-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9264Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 11:00 (Age at vaccination 73 years) as 1st dose, single for covid-19 immunisation. Medical history included Asthma mild, Renal Calculus, mitral valve regurgitation, prediabetes, hyperlipidemia, liver mass, Allergies to medications, food, or other products: Penicillin. Concomitant medications included simvastatin; ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin b nos (MULTIPLE VITAMINS). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The day after vaccine 04Feb2021 08:00 (Thursday), patient stated her stool was bright green, she evacuated twice that day and both stools were bright green. on 05Feb2021 (Friday) she evacuated once and her stool was a darker green, as green as spinach. She had no eaten or drunk any food that would cause her stool to green. Patient visited physician office for event, she wanted to know if she should go ahead and take a second dosage in 3 weeks. Patient did not receive any treatment for events. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Severe nausea; This is a spontaneous report from a contactable physician (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a 1st dose, single for covid-19 immunisation. Medical history included skin condition (skin disorder). Concomitant medications included methotrexate and infliximab (REMICADE) taken for skin disorder. She reported that she was on remicade which was a monoclonal antibody drug and there was a specific question before the vaccine they ask are you on a monoclonal antibody drug and she says that answer would always be yes for her. After her first COVID vaccine she had severe nausea and that went away. She stated that she would have to try and figure out when her first dose was, she did not remember the date, but her nausea was 2 days later after the first dose and it lasted for about 12 hours. She confirms the nausea was recovered completely at this time.  Information on lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: His blood pressure went extremely low to 88/55; heart rate went to 160; was not a place on his body that did not hurt; charley horses in his legs; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 86-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot Number: EL9264) via intramuscularly on 02Feb2021 at 08:15 as SINGLE DOSE and first dose on 14Jan2021 (Lot number: EL3248) for covid-19 immunisation.The patient's medical history included myocardial infarction (from 2002 to an unknown date Verbatim: Heart attack), prostatic operation (from 2002 to an unknown date Verbatim: Prostate surgery), knee arthroplasty (from Jun2016 to an unknown date Verbatim: Knee replacement), cataract operation (from Feb2013 to an unknown date  Cataract surgery), hypertension (ongoing), cardiac disorder Heart strengthener (ongoing), anticoagulant therapy (ongoing), sinus disorder (ongoing), lung disorder (ongoing), diuretic therapy (ongoing). Concomitant medications included amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing; ubidecarenone (COQ-10) taken for cardiac disorder from an unspecified start date and ongoing; (ASPIRIN) taken for anticoagulant therapy from 2002 and ongoing; Ipratropium (IPRATROPIUM) taken for sinus disorder from 2019 and ongoing; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for sinus disorder from 2019 and ongoing; (FLONASE) taken for sinus disorder from an unspecified start date and ongoing; (BREO) taken for lung disorder from an unspecified start date and ongoing; spironolactone (SPIRONOLACTONE) taken for diuretic therapy from Dec2020 and ongoing; guaifenesin (MUCINEX) taken for lung disorder from Jun2020 and ongoing; leuprorelin acetate (ELIGARD) taken for prostatic specific antigen, neoplasm malignant from an unspecified start date and ongoing; alirocumab (PRALUENT) taken for blood cholesterol from 2018 and ongoing; melatonin (MELATONIN) taken for sleep disorder from 2015 and ongoing. It was reported that, patient was feeling great all day on 02Feb2021. The patient went to bed around 22:00 and at midnight he woke up and there was not a place on his body that did not hurt. He spent the rest of the night hugging a heating pad and had Charlie horses in both of his legs and had to force himself to walk on them. He said that he felt like he played in the super bowl after he got up that morning. He was concerned because the next morning he started having blood pressure activity. His blood pressure went extremely low to 88/55 and heart rate was 160 beats per minute at around 08:30. He took it again at 10:00 and it was 112/75 and pulse was down to 109. It remained at that number pretty stable until around 16:00 and at that time it was like someone upstairs said he was done, he quit hurtling, his blood pressure went back to normal and he felt great again. Outcome of the events was resolved on 03Feb2021.   Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Injection site hypoaesthesia, Nausea, Pyrexia
Clinical narrative: Low grade fever; Arm soreness with some numbness around the injection site; Arm soreness with some numbness around the injection site; Nausea; Elevated heart rate; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 03Feb2021 (at the age of 40-year-old), as unknown, single, in left arm, for COVID-19 immunization at Workplace Clinic. The patient's medical history included glaucoma, bipolar disorder, corticosteroids allergy, and COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021, patient experienced arm soreness with some numbness around the injection site, nausea, and elevated heart rate. Patient received Ibuprofen as a treatment medication. The patient had COVID prior vaccination and was not tested COVID post vaccination. The patient underwent lab test and procedure which included heart rate: elevated, on an unspecified date in Feb2021. The clinical outcome of all the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Low grade fever; Arm soreness with some numbness around the injection site; Arm soreness with some numbness around the injection site; Nausea; Elevated heart rate; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 03Feb2021 (at the age of 40-year-old), as unknown, single, in left arm, for COVID-19 immunization at Workplace Clinic. The patient's medical history included glaucoma, bipolar disorder, corticosteroids allergy, and COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021, patient experienced arm soreness with some numbness around the injection site, nausea, and elevated heart rate. Patient received Ibuprofen as a treatment medication. The patient had COVID prior vaccination and was not tested COVID post vaccination. The patient underwent lab test and procedure which included heart rate: elevated, on an unspecified date in Feb2021. The clinical outcome of all the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Urticaria
Clinical narrative: lightheaded; hives head to toe; This is a spontaneous report from a contactable Nurse and consumer (patient). A 66-years-old non-pregnant female received BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided) via an unspecified route of administration on 12Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medication were not reported. On Jan2021, patient states after injection she was lightheaded and started 2 hours later with hives head to toe. Patient was due for 2nd injection 09Feb2021. The outcome of events was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Condition aggravated, Dysphagia, Hypokinesia, Pain
Clinical narrative: Some of these effects have gotten worse or developed over time; Swelling of the right arm, right side of neck, right shoulder, right side into breast; Swelling of the right arm, right side of neck, right shoulder, right side into breast; Swelling of the right arm, right side of neck, right shoulder, right side into breast; movement decrease; trouble swallowing; pain; This is a spontaneous report from a contactable other hcp/nurse (patient). A 45-years-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1285 and expiry date: unknown) intramuscularly, administered in the right arm on 12Jan2021 15:15, as a single dose for COVID-19 immunization. Medical history included Asthma, Hyperinsulinemia, Hypertension, Obesity and Tachycardia. Known allergies: Lortab and penicillin. Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), metoprolol (METOPROLOL) and amlodipine (AMLODIPINE). The patient experienced Swelling of the right arm, right side of neck, right shoulder, right side into breast, movement decrease, trouble swallowing at times and pain on 13Jan2021 at 03:00 PM. Some of these effects have gotten worse or developed over time. The patient went to the hospital and got put on a steroid pack (Medrol dose pack) and was told to take Benadryl as well. That was after a week of swelling. However, the patients arm was still swollen and was stiff and hurts to move and lay on. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Jan2021, sars-cov-2 test: negative on 21Jan2021, sars-cov-2 test: negative on 26Jan2021, sars-cov-2 test: negative on 28Jan2021, sars-cov-2 test: negative on 02Feb2021. The clinical outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test, Swelling
Clinical narrative: Some of these effects have gotten worse or developed over time; Swelling of the right arm, right side of neck, right shoulder, right side into breast; Swelling of the right arm, right side of neck, right shoulder, right side into breast; Swelling of the right arm, right side of neck, right shoulder, right side into breast; movement decrease; trouble swallowing; pain; This is a spontaneous report from a contactable other hcp/nurse (patient). A 45-years-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1285 and expiry date: unknown) intramuscularly, administered in the right arm on 12Jan2021 15:15, as a single dose for COVID-19 immunization. Medical history included Asthma, Hyperinsulinemia, Hypertension, Obesity and Tachycardia. Known allergies: Lortab and penicillin. Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), metoprolol (METOPROLOL) and amlodipine (AMLODIPINE). The patient experienced Swelling of the right arm, right side of neck, right shoulder, right side into breast, movement decrease, trouble swallowing at times and pain on 13Jan2021 at 03:00 PM. Some of these effects have gotten worse or developed over time. The patient went to the hospital and got put on a steroid pack (Medrol dose pack) and was told to take Benadryl as well. That was after a week of swelling. However, the patients arm was still swollen and was stiff and hurts to move and lay on. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Jan2021, sars-cov-2 test: negative on 21Jan2021, sars-cov-2 test: negative on 26Jan2021, sars-cov-2 test: negative on 28Jan2021, sars-cov-2 test: negative on 02Feb2021. The clinical outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: it was more red, a little bit scaly, kind of a dryness on the splotches; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration, in the left arm on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. on an unknown date, the patient experienced more red, a little bit scaly, kind of a dryness on the splotches, not raised after the first dose. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fall, Nausea, Vomiting, Weight
Clinical narrative: tripped and fell; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient(age at vaccination:74years) received first dose bnt162b2 (BNT162B2,Solution for injection,Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 01Feb2021 15:00 as 1ST DOSE,SINGLE for covid-19 immunisation.Medical history included fibromyalgia from an unknown date and unknown if ongoing Verbatim Fibromyalgia , arthritis from an unknown date and unknown if ongoing Verbatim Arthritis , eye irritation from an unknown date and unknown if ongoing , pruritus from an unknown date and unknown if ongoing ,fungal infection from an unknown date and unknown if ongoing , asthma from an unknown date and unknown if ongoing , insomnia from an unknown date and unknown if ongoing , irritable bowel syndrome from an unknown date and unknown if ongoing  Why was the patient taking Concomitant Products Omeprazole (Verbatim) Irritable bowel syndrome and gastroparesis , impaired gastric emptying from an unknown date and unknown if ongoing Why was the patient taking Concomitant Products Omeprazole (Verbatim) Irritable bowel syndrome and gastroparesis , pain from an unknown date and unknown if ongoing Why was the patient taking Concomitant Products hydrocodone/acetaminophen (Verbatim) bloody pain. Concomitant medications included trazodone (TRAZODONE) taken for insomnia from 2000 and ongoing; zolpidem (ZOLPIDEM) taken for insomnia from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for irritable bowel syndrome, impaired gastric emptying from an unspecified start date and ongoing; salbutamol sulfate (ALBUTEROL SULFATE) taken for asthma from an unspecified start date and ongoing; hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN) taken for pain from 2005 and ongoing; pregabalin (LYRICA) taken for fibromyalgia from an unspecified start date and ongoing; clotrimazole (CLOTRIMAZOLE) taken for fungal infection from 2018 and ongoing; triamcinolone acetonide (TRIAMCINOLONE ACETONIDE) taken for pruritus from an unspecified start date and ongoing; fluorometholone (FLUOROMETHOLONE) taken for eye irritation from an unspecified start date and ongoing. The patient underwent lab tests and procedures which included weight overweight on unspecified date, weight105lbs on Thirty three years ago she weighed 105lbs,weight: gained weight on unspecified date. She has gained weight and gets yeast infections under her breast and tummy.The patient experienced nausea, vomiting on 01Feb2021, diarrhoea on 01Feb2021, tripped and fell on 04Feb2021.The outcome of the events nausea, vomiting, diarrhoea was not recovered and the outcome of the event of fall was recovered. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patients wife). A male patient of an unspecified age received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as unknown single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of unknown.   Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 3 painful, swollen lymph nodes on left clavicle and left side of neck; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 24-years-old non pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number em9810, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 06Feb2021 11:00 as DOSE 2, SINGLE for Covid-19 immunization in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ek9231, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 15Jan2021 18:00 as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On 06Feb2021, the patient experienced 3 painful, swollen lymph nodes on left clavicle and left side of neck. Since the vaccination, the patient has not been tested for COVID-19. The patient was not treated for the events. The outcome of the event was reported as not recovered at the time of report.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling cold, Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: numbness, tingling, burning, itching, and coldness in her hands, palms, abdomen, and in her back; numbness, tingling, burning, itching, and coldness in her hands, palms, abdomen, and in her back; numbness, tingling, burning, itching, and coldness in her hands, palms, abdomen, and in her back; numbness, tingling, burning, itching, and coldness in her hands, palms, abdomen, and in her back; numbness, tingling, burning, itching, and coldness in her hands, palms, abdomen, and in her back; This is a spontaneous report from a non-contactable consumer (patient herself).   A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unknown date, the patient experienced numbness, tingling, burning, itching, and coldness in her hands, palms, abdomen, and in her back. She wants to know if these side effects have been reported with the use of the vaccine. The outcome of the events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Low grade fever; chills; body aches; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 06Feb2021 at 11:45 (Age at vaccination: 50 years) as single dose for covid-19 immunization. Patient did not receive other vaccine in 4 weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Patient had supra drug allergy. Patient concomitant medications were not reported. The patient experienced low grade fever, chills, body aches and fatigue on 07Feb2021 at 04:45. Treatment was not received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Confusional state, Disorientation
Clinical narrative: feeling disoriented; Confused; unable to put words together; This is a spontaneous report from a contactable consumer (patient). A female patient (Age: 82; Unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunization. Medical history included TIA/ministroke. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced feeling disoriented, confused, unable to put words together. It was reported that events experienced shortly after receiving her vaccine She went to the ER and they concluded it was not a stroke. She wanted to know if she can get the second vaccine. The outcome of events was unknown.  Information about lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Swelling face
Clinical narrative: Swelling of the face; itching back; This is a spontaneous report from a contactable Other Health Professional (patient). A 89-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Jan2021 15:00 (at the age of 89-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included Afib, Hypertension, mild allergy to dust and known allergies: detergents with sents from an unknown date and unknown if ongoing. Concomitant medication(s) included apixaban (ELIQUIS); furosemide sodium (FUROSEMIDE [FUROSEMIDE SODIUM]); metoprolol (other medications in two weeks) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. On 18Jan2021 15:00, patient experienced swelling of the face, itching back. The patient visited doctor or other healthcare professional office/clinic for adverse events. Patient received loratadine, prednisone, triamcinolone topical cream as treatment for events. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Jan2021. Therapeutic measures were taken as a result of swelling of the face, itching back. The outcome of events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: hard bump and red rash around the injection site; hard bump and red rash around" the injection site; redness and swelling at injection site; reddness and swelling at injection site; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: EL9265; Expiration Date: May2021), dose 2 via an unspecified route of administration, administered in Arm Left on 02Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: EL3246) in left arm for COVID-19 immunization. Patient received the second dose of the Pfizer-BioNTech COVID-19 vaccine last Friday. She mentioned noticing a hard bump and red rash around the injection site on Saturday, the next day. She asked if these reactions were reported as a side effect of the vaccine. Caller stated she got her vaccine, clarified it was the second dose on Friday, 02Feb2021, stated on 06Feb2021 she had redness at the injection site, states it was swollen yesterday with a red rash around it, states it is not as swollen today. Caller stated yesterday she could feel the thickness of the bump at the site but today it is not as bad. Caller was wondering if this was something she should be concerned about, was it an allergic reaction. Stated with her first dose, she had nothing, just some soreness at the injection site. Caller asked if COVID-19 vaccine was to be repeated next year, would she be able to receive it given her reaction to the second dose of the vaccine. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: general fatigue; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3249), via an unspecified route of administration in left arm on 13Jan2021 at 09:15 AM as single for covid-19 immunisation. Medical history included atrial fibrillation (under treatment). The patient had known allergies to penicillin. Concomitant medications included atorvastatin (LIPITOR) 80mg x1 daily; lisinopril (20mg x1 daily) for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. 2 1/2 weeks after first shot on Jan2021, patient experienced general fatigue with continued till 2 shot. The patient did not receive treatment for the event. The outcome of the event was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: my body was hurting so bad; This is a spontaneous report received from a contactable consumer (Patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. Medical history included elevated heart beat in the 90's. Concomitant medications were not reported. On an unspecified date (Patient got her first covid vaccine last Thursday and on Saturday through Sunday), her body was hurting so bad but she figured it was from the covid shot. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Flatulence
Clinical narrative: It was the worst last Friday night/ feels it in both breasts. It is getting worse; had subtle gas pains that go from her shoulder to her elbows and sometimes she feels it in her left shoulder/ feels like the gallbladder pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 22Jan2021 at 07:30 (at the age of 76 year) as single dose for covid-19 immunisation at hospital. Medical history included ongoing Atrial fibrillation, thyroid problem and asthma. Patient had gallbladder concerns from twenty years ago. Gallbladder removed years ago. Patient's family history includes heart problems and diabetes. Concomitant medication(s) included apixaban (ELIQUIS) taken for atrial fibrillation, digoxin (DIGOXIN) taken for atrial fibrillation, fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, levothyroxine sodium (SYNTHROID) taken for thyroid disorder, metoprolol tartrate (METOPROLOL TARTRATE) taken for atrial fibrillation, prednisone (PREDNISONE) taken for asthma and vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication from an unspecified start date and ongoing and Potassium. Patient was not received any other vaccine prior four weeks of vaccination. She states two weeks ago on Friday she got her first dose vaccine COVID 19 vaccine on 22Jan2021 0730 AM in the left arm. Reports a week later on 29Jan2021 she had subtle gas pains that go from her shoulder to her elbows and sometimes she feels it in her left shoulder too. She added it feels like gas pains and it feels like the gallbladder pain she had when she had her gallbladder removed years ago. She added did not feel it every day It was the worst last Friday night. And she also feels it in both breasts It is getting worse. States she didn't have this until she got the shot, she was going to call her doctor, but she thought Pfizer would have more information about other people reporting this. She was scheduled to receive the second dose on 17Feb2021 at 07:00AM. Seriousness reported as non-serious by reporter. The outcome of the events was reported as not resolved and unknown for It was the worst last Friday night/ feels it in both breasts. It was getting worse.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is much more sore than her arm.; This is a spontaneous report from a contactable consumer (patient) via medical information team reported similar events for two patients. This report is for the patient self. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 07Feb2021 as 1st dose single for COVID-19 immunisation. The medical history of the patient included sinus infection. The concomitant medications of the patient azithromycin for sinus infection on 05Feb2021. On an unspecified date in 2021, the patient experienced sore arm. The patient was concerned because on Friday, 05Feb2021, she went to see an Healthcare professional at an urgent care and was given azithromycin for a sinus infection. She informed the provider she would be receiving the Pfizer COVID-19 vaccine and the provider did not give her an instructions to alter her plans. She reports concern and questioned if the azithromycin would have potentially interacted with the vaccine and made it less effective. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021170289 same drug/reporter/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: 1st shot: muscle pain in upper left arm and left shoulder for 3-4 days; This is a spontaneous report from a contactable other health care professional (patient). A 36-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3248) via an unspecified route of administration on 15Jan2021 at 17:00 in left arm as a single dose for covid-19 immunization. The patient had no medical history. Concomitant medication included escitalopram oxalate (LEXAPRO) 20 mg once per day taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks and had no known allergies. The patient was not diagnosed with covid prior vaccination and was not tested for covid post vaccination. On an unspecified date in 2021, after the first shot, the patient experienced muscle pain in upper left arm and left shoulder for 3 to 4 days. Patient was treated with painkillers and heat for the events. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a non-contactable consumer (Patient). A non-pregnant adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on Feb2021 as dose 2, single for COVID-19 immunization. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration, as dose 1, single for COVID-19 immunization. It was unknown if the patient received other vaccine in four weeks and unknown if patient was diagnosed with Covid prior vaccination. On an unspecified date in Feb2021 (after second dose), patient experienced fever and chills. It was unknown if the patient received treatment for the events. It was unknown if patient was diagnosed with Covid post vaccination. The outcome of the events was recovered.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hyperhidrosis, Nausea, Pain
Clinical narrative: severe cramps in his stomach; sweating to beat the band; almost feels like throwing up; painful and feels like severe gas; This is a spontaneous report from a contactable Consumer (patient). A male an unspecified age patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 08-FEB-2021 09:00 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021 the patient experienced severe cramps in his stomach, sweating to beat the band, almost feels like throwing up. He said it was painful and feels like severe gas. The events outcome was unknown.  Information on the lot/batch number had been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site pain
Clinical narrative: sore/Injection site pain; This is a spontaneous report from a non-contactable pharmacist. This pharmacist reported (herself) similar events for 2 patients. This is 1st of 2 reports.  A female patient (Age 68; Unit Unknown) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No was not reported) via an unspecified route of administration on 05Feb2021 as dose 2, single and patient previously received BNT162B2 for dose 1, single both for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported that she and her husband received both doses of Pfizer vaccine on the 17Jan and the second on 05Feb, neither one of them had experienced any symptoms from either shot arms are barely sore, no fatigue, she was wondering if it was effective. When they had received vaccine it was reported that she was confident that they handled the medication correctly. she had only experienced Injection site pain. Outcome of the event was not recovered (it's still has some soreness when she press on it today).  No follow up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021170581 Same reporter/drug/similar event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient took flu vaccine and she had same reaction. Concomitant medications were not reported. The patient's shoulder was sore at the injection site on an unspecified date and when she went to sleep the pain was still bothering her so she called  and they told her it was okay to take Advil 24 hours after the vaccine, she took 2 Advil, after a couple of days the pain disappeared. The patient was recovered from the event in 2021. Follow-up attempts are completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain in the left arm where I was vaccinated that lasted for 48 hours; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 06Feb2021 at 10:00 AM, as a single dose for COVID-19 immunization at school or student health clinic. The patient did not receive any other vaccine in four weeks. The patient's medical history included osteoporosis and allergies: Penicillin. Concomitant medications included Lisinopril. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 06Feb2021 at 04:00 PM, the patient experienced pain in the left arm where he was vaccinated that lasted for 48 hours. The patient did not receive any treatment for the adverse event. Outcome of the event was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: nose allergy; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Jan2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of the vaccine last 31jan2021 and is scheduled to get this second dose 19feb2021 experienced nose allergy. Doctor prescribed him with nasal steroid spray for his nose allergy. Patient asked if it was safe for him to take this medication before getting the second dose of the vaccine and if he could take it between or after the dose. Patient received treatment with Flonase (fluticasone propionate) for nose allergy. Therapeutic measures were taken as a result of nose allergy. The clinical outcome of events was unknown. Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Tachycardia
Clinical narrative: tachycardia to HR=150; headache; This is a spontaneous report from a contactable Physician. This Physician reported for a female patient. A female patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation:Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date 2021 as dose 1, single for COVID-19 immunization. Medical history included Covid-19 from Mar2020 to an unknown date had a nasty case of Covid in March. The patient's concomitant medications were not reported. On an unspecified date 2021, 24 hrs later after the first vaccine developed tachycardia to HR=150 and then severe headache similar to that which she had when she had Covid. She needed to go to the ER (Institution Name) and asked should she get the 2nd shot in view of her severe to the 1st vaccine. The patient underwent lab tests and procedures which included heart rate resulted as 150 on an unspecified date. The clinical outcome of the events was unknown.  Information on lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Trigger finger
Clinical narrative: Trigger finger; This is a spontaneous report from a contactable consumer (the patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history was not reported, and concomitant medications were not reported. The patient previously took aspirin 81. On an unspecified date, the patient experienced trigger finger. The consumer wanted to know what the contraindication or effect of the vaccine would be from taking aspirin as he read information about "don't take an aspirin on non-steroidal medication before getting the vaccine" and reported that he stopped his 81 mg aspirin to take the first dose of the COVID vaccine for fear that it may have a negative impact on the vaccine. He asks for more information on this. He also wanted to know if getting a steroid injection in each hand would be a problem? Consumer further reported that he has "trigger finger" and was scheduled to receive steroid injections to each hand and he might have steroid injections to his hands for trigger finger since his first dose but reported that he would put that off if it was contraindicated. The patient also enquired about what is the efficacy after second dose. Response: Callback performed. Disclaimers provided. Spoke from attached documentation. Referred to HCP for further discussion and guidance. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: arm was still red since 1st dose; This is a spontaneous report from a contactable consumer (patient husband) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot Number was not reported), via an unspecified route of administration on 19Jan2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm was still red (at the time of report) since her 1st Pfizer COVID vaccine on 19Jan2021 (3 weeks ago). The outcome of the event was not resolved. Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash maculo-papular
Clinical narrative: Diffuse macular papillor rash; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 13Jan2021 (Lot Number: EL1284) (at the age of 35-years-old) as single for COVID-19 immunization in the hospital. Medical history included diabetes mellitus and penicillin allergy. Concomitant medications included metformin, sertraline and propranolol taken for an unspecified indication, start and stop dates were not reported. the patient did not take other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on 23Dec2020 at 07:00 (Lot Number: EH9899) for COVID-19 immunization. The patient has not underwent COVID prior to vaccination and has not been tested since the vaccination. The patient experienced diffuse macular papillor rash on 06Feb2021 08:00. The adverse event was treated with Benadryl. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.