chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Lymphadenopathy, Mammogram, Mammogram abnormal, Ultrasound breast
Clinical narrative: Abnormal mammogram; Abnormal gland swelling on right side breast; Metallic taste in mouth; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm right, administration date 08Mar2021 12:15 (Lot number: EN6198) at the age of 64 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Ovarian cancer" (unspecified if ongoing); "Lymphedema" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergies to bees" (unspecified if ongoing). Concomitant medication(s) included: FAMCICLOVIR; EFFEXOR; VITAMIN D [COLECALCIFEROL]; VITAMIN B6. Past drug history included: Naproxen, reaction(s): "Allergies". The following information was reported: DYSGEUSIA (non-serious) with onset 11Mar2021, outcome "recovering", described as "Metallic taste in mouth"; MAMMOGRAM ABNORMAL (non-serious) with onset 19Mar2021 13:30, outcome "recovering", described as "Abnormal mammogram"; LYMPHADENOPATHY (non-serious) with onset 19Mar2021 13:30, outcome "recovering", described as "Abnormal gland swelling on right side breast". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia, mammogram abnormal, lymphadenopathy.  Additional Information: The patient had metallic taste in mouth starting day 2-and-a-half that continues (recovering). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. Due to abnormal mammogram, the patient had to return. Ultrasound was clean but still saw abnormal gland swelling on right side breast. The patient was administered with the second dose of BNT162B2 (Lot Number: ER8732) on 27Mar2021 at 03:45 PM in right arm. The patient has not been tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Some flu-like symptoms; This is a spontaneous report received from a contactable nurse (patient's wife).  A male patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Some flu-like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Drug eruption
Clinical narrative: Rashes spread around on my arms, chest and on my legs/took a biopsy and came back and said it was 'drug induced; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Feb2021 (Lot number: EN6201, Expiration Date: 20Jun2021) at the age of 79 years as dose 1, single and administered in arm, administration date 29Mar2021 (Lot number: EN6205, Expiration Date: 20Jun2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG ERUPTION (non-serious) with onset 26Mar2021, outcome "unknown", described as "Rashes spread around on my arms, chest and on my legs/took a biopsy and came back and said it was 'drug induced". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of drug eruption.  Additional information: She took a biopsy and came back and said it was 'drug induced' and just another day she took couple other samples. Therapeutic measure for rash taken was prednisolone and patient have been through a whole lot of stuffs that did not work. Patient got rash that started 10 days after his first shot of the Pfizer BioNTech COVID-19 Vaccine and was still continued after his second COVID-19 vaccine and his doctor gave him medication to help and he still have the rash and he was taking steroids now to try to get rid of it." Medication for the rash was prednisolone and he had been through a whole lot of stuffs that did not work. The patient had been through couple of drugs (unspecified medications) steroids, and it did not work. Dermatologist gave a prescription for steroids, 50 mg for 4 days, 40 mg for 4 days and 30 mg for 4 days. Patient do not have any symptom of the COVID, all the patient had was the reaction.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: metal taste; soreness at injection; on the outside of my left arm a pain shot down my arm all the way down my pinky finger; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 15:00 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Milk allergy" (unspecified if ongoing); "Mitral valve replacement", start date: Dec2018 (unspecified if ongoing), notes: mitral valve replacement on 12/2018.; "Atrial fibrillation" (unspecified if ongoing), notes: had AFIB; "lactose allergy" (unspecified if ongoing), notes: lactose allergy. Concomitant medication(s) included: BABY ASPIRIN; METOPROLOL TARTRATE; XARELTO; CLARITIN [LORATADINE] taken for hypersensitivity. The following information was reported: DYSGEUSIA (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "metal taste"; VACCINATION SITE PAIN (non-serious) with onset 09Mar2021, outcome "recovered" (11Mar2021), described as "soreness at injection"; PAIN IN EXTREMITY (non-serious) with onset 09Mar2021, outcome "recovered" (11Mar2021), described as "on the outside of my left arm a pain shot down my arm all the way down my pinky finger"; FATIGUE (non-serious) with onset 09Mar2021, outcome "recovered" (11Mar2021), described as "tired".  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since, the vaccination the patient had not been tested for COVID-19. It was unknown if patient received any treatment for the reported events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: fatigue; slightly achey; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 13:30 (Lot number: ER8730) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRAVASTATIN; CENTRUM [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;IRON;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; CITICHOLINE [CITICOLINE]; XALATAN; TIMOLOL. Vaccination history included: Covid-19 vaccine (DOSE X MANUFACTUERER UNKNOWN (where X=1)), for covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 04Apr2021 11:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 04Apr2021 11:00, outcome "recovering", described as "slightly achey". Therapeutic measures were not taken as a result of fatigue, pain.  Additional information: It was reported that prior to the 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 events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient information about allergies to medications, food or other products was not available. The patient did not receive any treatment for the event.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Having chills and aches like body ache; Having chills and aches like body ache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (Lot number: Unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "Having chills and aches like body ache". The patient wanted to know if it is normal to have that side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Eye swelling, Headache, Photophobia
Clinical narrative: eye balls have swelled, they were hard and large; eye balls have swelled, they were hard and large; eye ball seemed to have taken excessive light; had a sight headache; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 29Mar2021 (Lot number: P217012) at the age of 74 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "cataract" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: EYE SWELLING (non-serious), EYE DISORDER (non-serious) all with onset 30Mar2021, outcome "recovering" and all described as "eye balls have swelled, they were hard and large"; PHOTOPHOBIA (non-serious) with onset 30Mar2021, outcome "recovering", described as "eye ball seemed to have taken excessive light"; HEADACHE (non-serious) with onset 30Mar2021, outcome "recovering", described as "had a sight headache". Therapeutic measures were taken as a result of eye swelling, eye disorder, photophobia, headache.  Additional information: The reporter stated she could not read the lot number. She stated "P and it looks like P217012." The patient have taken diphenhydramine hydrochloride (BENADRYL) 25 mg 2 tablets and aspirin for the events. One of her eye ball seemed to have taken excessive light so she put a patch over her eye.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had like with her 1st dose and her 2nd dose a very sore arm; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 56-year-old female patient received BNT162B2 (BNT162B2), administered in arm right, administration date 11Mar2021 (Lot number: EN6199, Expiration Date: Jun2021) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing); "Tennis elbow" (unspecified if ongoing), notes: Tennis elbow; "moderate carpal tunnel" (unspecified if ongoing), notes: both right and left. The patient took concomitant medications. Past drug history included: Flagyl, reaction(s): "allergic reaction to  Flagyl", notes: She had an allergic reaction to  Flagyl, probably 10 -15 years ago.; Flagyl, reaction(s): "rash", notes: She had a rash with Flagyl, probably 10 -15 years ago. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "recovered" (12Mar2021), described as "she had like with her 1st dose and her 2nd dose a very sore arm". Therapeutic measures were taken as a result of pain in extremity. Additional Information: The patient stated her weight is about 140-145 (unknown units). The patient stated she had like with her 1st dose and her 2nd dose a very sore arm. With the 1st shot it also started immediately after and went away about 24 hours, that it was not days or anything. The patient stated that with the 1st dose she did not take the medication for her arthritis in shoulder, and she took vitamins. After the first dose she took Tylenol 500mg. The adverse events did not require emergency room nor physician office visit. The patient had an allergic reaction to Flagyl, and she had a rash, and it was so many years ago probably 10 - 15 years ago.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021360066 same patient, different vaccine doses/events
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Headache, Pain
Clinical narrative: Headache; Body aches; Stomach cramps; Exhaustion; General weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: 3248) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID, 19, brand=Pfizer BioNTech,, lot number=EL3248,, administration date=09Mar2021,, vaccine location=Left arm,, dose number=1), administration date: 09Mar2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Body aches"; ABDOMINAL PAIN UPPER (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Stomach cramps"; FATIGUE (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Exhaustion"; ASTHENIA (non-serious) with onset 01Apr2021, outcome "not recovered", described as "General weakness". Therapeutic measures were not taken as a result of headache, pain, abdominal pain upper, fatigue, asthenia. Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient wasn't diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Ethnicity information is available. Race information is available.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Administration site pain; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 73-year-old female patient received BNT162B2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Administration site pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight pain at the site/slight pain in the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 13:30 (Lot number: EN6207) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "had COVID-19 infection", start date: Dec2020 (unspecified if ongoing), notes: Patient's Medical History (including any illness at time of vaccination). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Mar2021, outcome "recovered" (16Mar2021), described as "slight pain at the site/slight pain in the injection site".  Additional information: Caller, (withheld) took the 1st dose last 16Mar2021. The 2nd dose will be on 07Apr2021, which was more than 21 days. As per the caller he will have dental procedure for implants on 05Apr2021, and the dentist has prescribed antibiotics prior to the procedure. Adds someone told him that antibiotics might interfere with the vaccine. He was asking if antibiotics will interfere with the 2nd dose vaccine. Mentions the only side effect he had was a slight pain in the injection site that went away that day. Adverse event did not result in Emergency visit and physician office visit. History of all previous immunization with the Pfizer vaccine considered as suspect: none. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. Prior Vaccinations (within 4 weeks): none. Family History: none. Relevant test: none. Prior Vaccinations (within 4 weeks): none. Other Products: No. Investigation Assessment: No.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021368204 same reporter/drug/event, different patients.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 09Mar2021 (Lot number: EN6204) at the age of 39 years as dose 1, single and administration date 30Mar2021 (Lot number: ER8732) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Mar2021, outcome "recovered" (12Mar2021), described as "pain in right arm". The event "pain in right arm" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity. Additional information: Clinical course: The patient got his first vaccine on 09Mar2021 and had a side effect (pain) the following day (10Mar2021) in his right arm. It lasted for 48 hours and went away. Then a week later, it came back 10 times worse than the previous occurrence, and now it's never left/ it's not going away (event still present after dose 2 administration). The patient went to the urgent care and was given steroid to hopefully help with the pain, but it didn't do anything.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Vaccination site pain, Weight
Clinical narrative: Have pain at the site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 24Feb2021 (Lot number: GL9266) at the age of 68 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "cholesterol" (unspecified if ongoing); "Acid Reflux" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease; FLORASTOR [SACCHAROMYCES BOULARDII]; CENTRUM A TO ZINC; VITAMIN D3 1000. Vaccination history included: Flu shot, for flu immunisation; Shingles shot, for immunisation; Pneumonia shot, for immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Have pain at the site". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: slight pain at the site; This is a spontaneous report received from a contactable reporter (Consumer).  A 49 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Mar2021 16:52 (Lot number: EN6207) at the age of 49 years as dose 1, single for covid-19 immunization. Relevant medical history included: "breast implants" (unspecified if ongoing), notes: she has breast implants and so she will be taking antibiotics too. There were no concomitant medications. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "slight pain at the site".  Additional information: The patient had not received any other vaccine within 4 weeks.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021368147 same reporter/drug/event, different patients.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue
Clinical narrative: Muscle fatigue in legs; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 30Mar2021 13:00 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Allergies to penicillin and sulfa drugs" (unspecified if ongoing). Concomitant medications included: NORVASC; TYLENOL. Past drug history included: Erythromycin, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (DOSE 1; 01:00 PM; left arm), administration date: 09Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: MUSCLE FATIGUE (non-serious) with onset 31Mar2021, outcome "recovering", described as "Muscle fatigue in legs". Therapeutic measures were not taken as a result of muscle fatigue.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a workplace clinic facility. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain all over the body; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Pain all over the body".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling tired; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 76 year-old female patient patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Feb2021 11:15 (Lot number: EL9266) at the age of 76 years as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 20Feb2021, outcome "unknown", described as "Feeling tired".  Additional information: The patient had not received any other vaccine within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Rash
Clinical narrative: Rash; Feeling very out of it; Metal taste in the mouth; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling very out of it"; DYSGEUSIA (non-serious), outcome "unknown", described as "Metal taste in the mouth".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Vertigo
Clinical narrative: Intense vertigo; heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 12:00 (Lot number: EN6207) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Latex" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; CLARITINE; AMBIEN. Past drug history included: Codeine, reaction(s): "allergy". Vaccination history included: Bnt162b2 (administration time=12:00 PM, Dose number: 1, lot number=EN6203, brand=Pfizer), administration date: 09Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: VERTIGO (non-serious) with onset 01Apr2021 10:00, outcome "not recovered", described as "Intense vertigo"; PALPITATIONS (non-serious) with onset 01Apr2021 10:00, outcome "not recovered", described as "heart palpitations". The events "intense vertigo" and "heart palpitations" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of vertigo, palpitations. Additional information: The patient received the vaccine in the hospital. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccines within four weeks of the vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscle fatigue, SARS-CoV-2 antibody test
Clinical narrative: major muscle weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Mar2021 08:40 (Lot number: EN6201) as dose 2 , single for covid-19 immunisation. Relevant medical history included: "Urothelial carcinoma", start date: Jul2020 (ongoing); "Last Chemo treatment", start date: 12Jan2021 (ongoing), notes: Began immunotherapy; 23Feb2021, 09Mar2021, 23Mar2021; "Cholesterol" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing); "Heart" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL taken for cardiac disorder (ongoing); ZETIA taken for blood cholesterol (ongoing); LIPITOR [ATORVASTATIN] taken for blood cholesterol (ongoing); NORVASC taken for blood pressure abnormal (ongoing); ASPIRIN taken for cardiac disorder (ongoing); FERROUS SULFATE. Vaccination history included: Bnt162b2 (Dose 1, Single dose, Time: 08:30 am, Lot-EN9581, Site and Route- Left arm, Intramuscular), administration date: 22Feb2021, for Covid-19 Immunisation, reaction(s): "rash". The following information was reported: MUSCLE FATIGUE (non-serious) with onset 18Mar2021, outcome "not recovered", described as "major muscle weakness". The event "major muscle weakness" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle fatigue.  Additional information: The patient has not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. the patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient taking any medications prior to the event being reported as yes.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Nasopharyngitis, Pain in extremity
Clinical narrative: chilled; cold; slight temperature of 100.7; Pain in my arm about 3 hours after first receiving injection and am currently achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 09:45 (Lot number: 9R8733) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); "gallbladder issues" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: seasonal allergies" (unspecified if ongoing); "known allergies: dairy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. Vaccination history included: Bnt162b2 (dose number=1, product=COVID 19, brand=Pfizer, lot number=EN6207, administration date=10Mar2021, administration time=03:15 PM, vaccine location=Right arm), administration date: 10Mar2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 01Apr2021 02:00, outcome "not recovered", described as "chilled"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021 12:45, outcome "not recovered", described as "Pain in my arm about 3 hours after first receiving injection and am currently achy"; NASOPHARYNGITIS (non-serious) with onset 01Apr2021 02:00, outcome "not recovered", described as "cold"; BODY TEMPERATURE INCREASED (non-serious) with onset 01Apr2021 02:00, outcome "not recovered", described as "slight temperature of 100.7". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pain in extremity, nasopharyngitis, body temperature increased.  Additional information: Other medications in two weeks was Stone blaster - herbs for gallbladder. 01Apr, at night was cold. Wore a sweatshirt to bed, have been chilled all day. Took my temperature about12 pm -slight temperature of 100.7. Pain in my arm about 3 hours after first receiving injection and am currently achy. The patient did not have covid prior to vaccination. The patient was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache; Arm soreness; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 25-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 08:30 (Lot number: En6203) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Arm soreness"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue".  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cardiac disorder, Dysgeusia, Dysuria, Headache
Clinical narrative: could not pee; chemical taste in my mouth; headache; lower backache; heart is jumping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 16:00 (Lot number: ER8737) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "CHF" (unspecified if ongoing), notes: CHF; "hypertension" (unspecified if ongoing), notes: hypertension; "hypothyroidism" (unspecified if ongoing), notes: hypothyroidism. Concomitant medication(s) included: LOSARTAN; SPIRONOLACTONE. Vaccination history included: Bnt162b2 (other vaccine 4weeks product=COVID-19/PFIZER-BIONTECH,, other vaccine 4weeks lot number=EN6208,, other vaccine 4weeks vaccine location=Right Arm), administration date: 11Mar2021, when the patient was 70 years old, for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; DYSURIA (non-serious) with onset 03Apr2021, outcome "not recovered", described as "could not pee"; BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "lower backache"; CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "heart is jumping"; DYSGEUSIA (non-serious) with onset 01Apr2021, outcome "not recovered", described as "chemical taste in my mouth". Therapeutic measures were not taken as a result of headache, dysuria, back pain, cardiac disorder, dysgeusia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. Allergies to medications, food, or other products was yes. The patient had other vaccine in four weeks. I have heart failure, hypertension, and hypothyroidism. I take medication and some of this medication is losartan and spironolactone. Within fifteen minutes of the first vaccination I got a slight headache and heart racing. Through the month, my medical conditions got worse. Second vaccination, just a slight headache. Within two days, I could not pee. Luckily, I have diuretics. I stopped taken the spironolactone. Still not peeing the way I should. Just wondering if I got an overload of potassium. Have a lower backache and my heart is jumping. Ten to fifteen minutes after the second dose I did get a chemical taste in my mouth. Still getting the chemical taste in my mouth.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I got little 'disturbed', soreness where the injection spot was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "I got little 'disturbed', soreness where the injection spot was".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immune system disorder, Infusion
Clinical narrative: headaches; his wife also has a compromised immune system/she has a weakened immune system; Patient had to push back her infusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "his wife also has a compromised immune system/she has a weakened immune system"; INFUSION (non-serious), outcome "unknown", described as "Patient had to push back her infusion". Therapeutic measures were taken as a result of headache.  Additional information: While reporting, caller mentions his wife also had a compromised immune system and he did not want to bring it to her since he was out shopping every day. Caller adds that was the only difficult part, where he had to go outside every day. Caller adds when his wife had a condition and medication and had to go to the hospital, 3 weeks after, she had a weakened immune system. Caller adds that his wife writes everything down because she had headaches. She had an infusion and it gives her headaches, so she takes Tylenol. She had to wait two weeks to get the infusion, she pushed back her medication, so that she could get the vaccine. Every time she had the infusion she had headaches, sometimes they give her a Tylenol bag on IV as prep medication before they give her the medication. Sometimes they did this, if they did not then she had a headache for three days. Caller did not provide additional information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: EP6955, Expiration Date: Jun2021) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "type A blood" (unspecified if ongoing), notes: Verbatim: type A blood; "microscopic colitis" (unspecified if ongoing), notes: Verbatim: microscopic colitis; "Pre-diabetic" (unspecified if ongoing), notes: Verbatim: Pre-diabetic; "to help with her anxiety to get to sleep" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN taken for insomnia; ATIVAN taken for insomnia; ASHWAGANDHA [WITHANIA SOMNIFERA ROOT] taken for insomnia; TRINTELLIX taken for anxiety. Vaccination history included: Bnt162b2 (First dose: Received 26Feb2021, lot EN6201, unknown expiration date.), administration date: 26Feb2021, when the patient was 70 years old, for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "recovering", described as "sore arm".  Additional Information: Other concomitants were reported as, Rotazipem with unknown indication and unspecified if ongoing. sleep support, every night for Insomnia. Additional Information for Concomitant Products Trintellix was reported as, started about 1.5 weeks prior to receiving the first dose of the vaccine, to help with her anxiety to get to sleep. Reporter said she received her 1st dose and her 2nd dose schedule appointment is 5 weeks not for 3 weeks. Escalating this because the 2nd dose schedule was given more than 3 weeks. Additional Information: Other concomitants were reported as, Rotazipem with unknown indication and unspecified if ongoing. sleep support, every night for Insomnia. Additional Information for Concomitant Products Trintellix was reported as, started about 1.5 weeks prior to receiving the first dose of the vaccine, to help with her anxiety to get to sleep. Reporter said she received her 1st dose and her 2nd dose schedule appointment is 5 weeks not for 3 weeks. Escalating this because the 2nd dose schedule was given more than 3 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site extravasation, Lymphadenopathy, Underdose
Clinical narrative: only a swollen lymph node under my left arm; some of the vaccine leaked from the injection site; some of the vaccine leaked from the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 17:15 (Lot number: EP6955) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Penicillins, reaction(s): "penicillins allergy", notes: Allergies to medications, food, or other products: penicillins. Vaccination history included: Bnt162b2 (Dose 1, single, Start Date/Time: [Pfizer] 08Mar2021 at 17:30), administration date: 08Mar2021, when the patient was 40 years old, for COVID-19 Immunisation, reaction(s): "arm pain", "swollen lymph node", "fever". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 30Mar2021, outcome "recovering", described as "only a swollen lymph node under my left arm"; UNDERDOSE (non-serious), INJECTION SITE EXTRAVASATION (non-serious) all with onset 30Mar2021, outcome "unknown" and all described as "some of the vaccine leaked from the injection site". Therapeutic measures were not taken as a result of lymphadenopathy, underdose, injection site extravasation.  Additional information: Facility where the most recent COVID-19 vaccine was administered reported as Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Patient has been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Reported that patient received second dose of the Pfizer Covid-19 vaccine this week (at the time of report). Unfortunately, she have reason to believe that some of the vaccine leaked from the injection site. The nurse tried to cover this up and did not tell her or re-administer more of the vaccine. Patient also barely have any symptoms from 2nd vaccine (only a swollen lymph node under left arm), even though she felt significant side effects from first (arm pain, swollen lymph node, fever). Patient was asking about how to proceed, questions was she still protected, need to get re-vaccinated and in which time frame.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: underneath her armpit like the gland that it hurts / very swollen it's like very-very swollen; underneath her armpit like the gland that it hurts / very swollen it's like very-very swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: ER8727) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; AMLODIPINE taken for hypertension; HYDROCHLOROTHIAZIDE taken for hypertension. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "underneath her armpit like the gland that it hurts / very swollen it's like very-very swollen".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Heart rate, Heart rate increased
Clinical narrative: felt a little bit light-headed; heartbeat was increased/ it was elevated; felt uncomfortable; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation, reaction: "no adverse reaction". The following information was reported: DIZZINESS (non-serious) with onset 25Mar2021, outcome "unknown", described as "felt a little bit light-headed"; HEART RATE INCREASED (non-serious) with onset 25Mar2021, outcome "not recovered", described as "heartbeat was increased/ it was elevated"; DISCOMFORT (non-serious) with onset 25Mar2021, outcome "unknown", described as "felt uncomfortable". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, heart rate increased, discomfort.  Additional information: About half an hour after the second dose (also reported as 40 minutes or so), the patient felt a little bit light-headed, heartbeat was increased. The patient stated it was nothing terrible so the patient left the facility. That night, the patient took their pills (unspecified medication) and it was elevated (further clarification was unknown), definitely elevated and the patient felt uncomfortable.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.