chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Nephrotic syndrome
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NEPHROTIC SYNDROME (experiencing nephrotic syndrome) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEPHROTIC SYNDROME (experiencing nephrotic syndrome) (seriousness criterion medically significant). At the time of the report, NEPHROTIC SYNDROME (experiencing nephrotic syndrome) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No adverse event as Medical History was reported.  Treatment of events was not reported. Concomitant medication use was not provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: sore arm; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient self-reported). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on 26Jan2021, as a single dose for COVID-19 immunization. The patient did not experience any adverse effect. The patient's medical history and concomitant medications were not reported. The patient wanted to know how effective the COVID vaccine was after the first dose. Also mentioned that he had previously called regarding this. The patient also wanted to know how alcohol consumption will affect the vaccine and if there were any information and reports of any side effects with alcohol consumption. The patient reported that on 05Feb2021, he had sore arm after the second dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts have been completed and no further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: nausea; vertigo; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 08Feb2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (Patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Feb2021 13:40 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 69-year-old. Medical history included severe allergic reaction to Dimyristoyl Glycerol. The patient's concomitant medications were not reported. The patient experienced nausea and vertigo on 02Feb2021 around 21:30 with outcome of unknown. The events were reported as non-serious.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: nausea; vertigo; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 08Feb2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (Patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Feb2021 13:40 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 69-year-old. Medical history included severe allergic reaction to Dimyristoyl Glycerol. The patient's concomitant medications were not reported. The patient experienced nausea and vertigo on 02Feb2021 around 21:30 with outcome of unknown. The events were reported as non-serious.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Injection site on left arm sore,warm to touch and redness all around the injection site; Injection site on left arm sore,warm to touch and redness all around the injection site; Injection site on left arm sore,warm to touch and redness all around the injection site; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 07Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 70-year-old female patient (Non-pregnant) received second dose of bnt162b2 (BNT162B PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Lot Number: EL9269, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 05Feb2021 (at the age of 70-years-old) as single dose for COVID-19 immunization. Medical history included Known allergies: penicillin. Concomitant medications were not reported. The patient previously took cefalexin monohydrate (KEFLEX [CEFALEXIN]), sulfamethoxazole trimethoprim (BACTRIM). The patient historical vaccine includes BNT162B2, received first dose Lot number: EL3246, administration date: 15Jan2021, vaccine location: Left arm. On 05Feb2021 patient experienced injection site on left arm sore, warm to touch and redness all around the injection site. Patient was not tested COVID positive post vaccination. The outcome of the events was recovering.   Information on the lot/batch number has been requested.  Follow-up (07Feb2021): New information received from same contactable consumer includes: Events, second dose, Known allergies and Lot No. were updated.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a contactable nurse. The nurse reported events for herself and for her sister. This case refers to her sister. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date in Dec2020 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date in Dec2020, 5 hours after receiving the vaccine. The patient was treated with antihistamine. The outcome of the event was not recovered.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile and strong temporal relationship there is reasonable possibility of causal association between the event hypersensitivity and the suspect drug BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of left cheek, lips and entire chin; This is a spontaneous report from a contactable Nurse or other healthcare professional. A 56-years-old non-pregnant female received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 26Jan2021 at 09:30 in the left arm as a single dose for COVID-19 immunization. The past medical history included Diabetes, high cholesterol and eczema. The concomitant medications which were received within 2 weeks of vaccination included Insulin, Crestor, Dupixent, Truliciyy and Tylenol. The patient was allergic to Augmentin, latex and Levaquin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On 27Jan2021 at 12:00, the patient experienced numbness of left cheek, lips and entire chin. The patient did not receive any treatment for the adverse event. The outcome for the event was not recovered.  Information on the lot/batch number has been requested.  Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL0140), via an unspecified route of administration, administered in Arm Left on 13Jan2021 (received at the age of 83-years-old) at 0.3 mL, single for COVID-19 immunisation. Medical history included pacemaker and atrial fibrillation. There were no concomitant medications. The patient had his first Pfizer vaccine shot on 13Jan2021 and was scheduled for the second on Wednesday, 03Feb2021.  Six or seven days after getting the first dose, in Jan2021, he noticed little red spots. He came down with shingles and his doctor has prescribed him valcyclovir.  It's an antiviral medication and he just want to be sure he'll still be able to get the second dose of the vaccine. His physician gave him a miracle medicine for it, Valacyclovir, an antiviral medication, he gathers, and it has done a great job. He has taken it for 3-4 days; the shingles are now leaving. However, he has his next shot, his second shot of the vaccine is this coming Wednesday, and he wondered if anyone at Pfizer can say whether this antiviral for shingles, a pill, is in any way perhaps going to interfere with the COVID second shot. He further stated, "I tell you, that first shot went in like a hot knife through butter!" Outcome of the event was recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu-like symptoms; 102+ degree fever; headaches; body aches; This is a spontaneous report from a Pfizer Sponsored Program. A 74-year-old contactable female consumer reported that she received  the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 11Feb2021 at single dose for COVID-19 immunization. The patient had received the first dose of vaccine BNT162B2 on 24Jan2021.  Medical history included a very rare auto-immune disorder, and strictly limits her contact with other persons. Concomitant drugs were unknown.  After receiving the 2nd dose of vaccine she began to experience flu-like symptoms including 102+ degree fever, headaches, and body aches. She is questioning if receiving the vaccine early is what caused her to experience these symptoms since she was scheduled for second dose on 11Feb2021 instead of 14Feb2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Burning sensation, Chills, Near death experience, Pyrexia
Clinical narrative: flu-like symptoms; 102+ degree fever; headaches; body aches; This is a spontaneous report from a Pfizer Sponsored Program. A 74-year-old contactable female consumer reported that she received  the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 11Feb2021 at single dose for COVID-19 immunization. The patient had received the first dose of vaccine BNT162B2 on 24Jan2021.  Medical history included a very rare auto-immune disorder, and strictly limits her contact with other persons. Concomitant drugs were unknown.  After receiving the 2nd dose of vaccine she began to experience flu-like symptoms including 102+ degree fever, headaches, and body aches. She is questioning if receiving the vaccine early is what caused her to experience these symptoms since she was scheduled for second dose on 11Feb2021 instead of 14Feb2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: flu-like symptoms; 102+ degree fever; headaches; body aches; This is a spontaneous report from a Pfizer Sponsored Program. A 74-year-old contactable female consumer reported that she received  the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 11Feb2021 at single dose for COVID-19 immunization. The patient had received the first dose of vaccine BNT162B2 on 24Jan2021.  Medical history included a very rare auto-immune disorder, and strictly limits her contact with other persons. Concomitant drugs were unknown.  After receiving the 2nd dose of vaccine she began to experience flu-like symptoms including 102+ degree fever, headaches, and body aches. She is questioning if receiving the vaccine early is what caused her to experience these symptoms since she was scheduled for second dose on 11Feb2021 instead of 14Feb2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Body aches; Fever; Nausea; Chills; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EN5318) via an unspecified route of administration as a single dose in right arm on 05Feb2021 at 17:00 for an COVID-19 immunisation. The patient medical history was not reported. The patient had no known allergies. 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 received concomitant medication (names not specified). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021, the patient experienced fever, nausea, chills and body aches. The patient did not receive any treatment for adverse events. The outcome of events was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swelling in the lymph nodes; painful lymph node; This is a spontaneous report from a contactable HCP (patient). A 33-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9264), via an unspecified route of administration, administered in left arm on 04Feb2021 16:00 (at the age of 33-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (Lot number: El1283) on 14Jan2021 at 16:00, administered in right arm. The patient did not receive other vaccines in four weeks. Medical history included asthma and allergy to Sulfa. She did not have COVID prior vaccination. Concomitant medications included sertraline, montelukast sodium (SINGULAIR) and chlorphenamine maleate/ibuprofen/phenylephrine hydrochloride (ADVIL ALLERGY AND CONGESTION RELIEF). On 06feb2021 at 08:00 the patient experienced swelling in the lymph nodes in neck and painful lymph node. The patient reported that when she woke up around 08:30 or 09:00 she noticed swelling in the lymph nodes in her neck. The patient stated that they were tender and painful on one side. She stated it was the left side only in which the vaccine was given in her left arm. The swelling was very visible and is where her neck and shoulder meets. The patient did not receive treatment for events, and she was not COVID tested post vaccination. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Muscle swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Injection site turned red, hard and swelled up; Injection site turned red, hard and swelled up; My axilla and peck muscle was swollen to 3 times it's size; feel a big swollen node; Flu type symptoms; This is a spontaneous report from a contactable other-HCP (Patient). A 57-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via unspecified route of administration, administered in left arm on 04Feb2021 at 09:30 AM (at the age of 57-years) as single dose for COVID-19 immunisation. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249), administered at left arm on 12Jan2021 at 09:45 AM as single dose for COVID-19 immunisation. The patient medical history included osteoarthritis. Patient had no known allergies. Concomitant medications included levothyroxine and acyclovir. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Feb2021 at 11:30 AM (26-hours after vaccination), patient experienced flu type symptoms and at 09:30 PM (36-hours after vaccine), injection site turned red, hard and swelled up. On 06Feb2021 (morning), axilla and peck muscle swollen to 3 times its size. Patient received ibuprofen and Benadryl for treatment, and it went down a little however, patient can still feel a big swollen node that appeared a day before. No specific treatment was given for swollen node. Since the vaccination, patient was not tested for COVID-19. The outcome of all the events was not recovered.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Vomiting
Clinical narrative: Profuse Vomiting; chills; dryness; This is a spontaneous report from a contactable Nurse. A 81-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot Number: Unknown; Expiry Date: Unknown) dose 1 intramuscular, administered in Arm Left on 06Feb2021 16:00 as SINGLE DOSE for COVID19 immunization. Medical history included If covid prior vaccination: Yes. Concomitant medications included apixaban (ELIQUIS); propranolol; chlorthalidone; pravastatin sodium for an unspecified indication. The patient did not receive any other vaccines within 4 weeks. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested positive post vaccination. The patient experienced on 06Feb2021 16:00 profuse vomiting, chills, dryness. The patient did not receive any treatment for adverse event. The outcome of the events were unknown.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pain in extremity, Rhinorrhoea
Clinical narrative: sore arm hours after shot; fatigue/tired; runny nose; coughing/slight cough; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm 05Feb2021 11:15 (82-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included diverticulitis (surgery), kidney cancer small area excised, and prostate cancer radiated. There were no known allergies. Concomitant medications in two weeks included allopurinol, fenofibrate, tamsulosin, and amlodipine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 15Jan2021 11:15 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. There was no other vaccine in four weeks. On 05Feb2021 15:00, patient experienced sore arm hours after shot, fatigue, runny nose, coughing, no temperature the next day. Symptoms abated second day after shot. Still tired and a slight cough. Adverse events did not result in emergency room visit or physician office visit. Patient did not have COVID-19 prior vaccination. Patient did not test for COVID-19 post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: a full body rash; got itchy all over; This is a spontaneous report from a contactable Other Health Professional (patient). A 54-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FL1283) via an unspecified route of administration at left arm on 14Jan2021 17:00 (54-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included allergies to Sulfa. Concomitant medications in two weeks included estrogen NOS/progesterone patch. The patient previously received amoxicillin and experienced allergies, received nitrofurantoin (MACRODANTIN) and experienced allergies. There was no other vaccine in four weeks. Seven days after the first dose of vaccine (event start date was also reported as 14Jan2021), patient got itchy all over and by the next day, she had a full body rash. She continued to get worse. On day 6 of rash, she went to my doctor and was prescribed steroids. It took 6 days of steroids for the rash to fade. She still have rash, but it is very faded. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient had no COVID-19 prior vaccination. Patient did not test for COVID-19 post vaccination. Therapeutic measures were taken as a result of the events and included steroids. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Palpitations, Paraesthesia, Throat tightness
Clinical narrative: My heart was racing.132bpm; I felt lightheaded; tightness in throat; tingling in my arms and hand; This is a spontaneous report from a contactable consumer (Patient). A 42-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 05Feb2021 15:00 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included known allergies to Pineapple, Bananas, onions, several environmental allergies; asthma. Patient didn't have COVID prior vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); cromoglicate sodium (ALLERGY) shot; clarithromycin (CLARITIN); mometasone furoate (FLONASE); fluticasone propionate (PROAIR); all taken for an unspecified indication, start and stop date were not reported. No other vaccines were administered in four weeks. Around 8 minutes after vaccine (as reported) patient felt lightheaded, tightness in throat and tingling in her arms and hand. Her heart was racing.132bpm. She told the workers and was taken by ambulance to the hospital. Adverse events start from 05Feb2021 03:15 PM and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent car. Treatment received included Oxygen, benadryl shot. The outcome of the events was recovering. COVID was not tested post vaccination.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Blood glucose decreased, Chills, Fatigue
Clinical narrative: Muscle pain and joint pain 30 minutes after the vaccine; Muscle pain and joint pain 30 minutes after the vaccine; Glucose dropped dramatically after taking my morning metformin after eating; tiredness; headache; chills; nausea; feeling unwell; Soreness at the infection sight for 2-3 days.; This is a spontaneous report from a contactable Consumer (patient, self-reported).   A 57-years-old (non-pregnant) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- 3302 and expiration date was not reported), via an unspecified route of administration in right arm on 22Jan2021 08:45 (at the age of 57-years-old) as a single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included diabetes mellitus, hypertension. Concomitant medication(s) included calcium carbonate, metformin, hydrochlorothiazide, losartan potassium, spironolactone and colecalciferol. The patient previously took verapamil, lisinopril, amlodipine, atorvastatin and experienced drug hypersensitivity with all. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Jan2021 at 09:15, the patient muscle pain and joint pain 30 minutes after the vaccine. In an unspecified date in Jan2021 at 12:30, she experienced soreness at the infection sight for 2-3 days, glucose dropped dramatically after taking morning metformin after eating. Side effects tiredness, headache, chills, joint pain, muscle pain, nausea, and feeling unwell. Soreness at the infection sight for 2-3 days. The patient was treated with 2 ibuprofen. Vaccine facility type: local facility. In Jan2021, the event- soreness at the infection sight for 2-3 days was recovered and outcome of the events was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Vaccination site pain
Clinical narrative: Muscle pain and joint pain 30 minutes after the vaccine; Muscle pain and joint pain 30 minutes after the vaccine; Glucose dropped dramatically after taking my morning metformin after eating; tiredness; headache; chills; nausea; feeling unwell; Soreness at the infection sight for 2-3 days.; This is a spontaneous report from a contactable Consumer (patient, self-reported).   A 57-years-old (non-pregnant) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- 3302 and expiration date was not reported), via an unspecified route of administration in right arm on 22Jan2021 08:45 (at the age of 57-years-old) as a single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included diabetes mellitus, hypertension. Concomitant medication(s) included calcium carbonate, metformin, hydrochlorothiazide, losartan potassium, spironolactone and colecalciferol. The patient previously took verapamil, lisinopril, amlodipine, atorvastatin and experienced drug hypersensitivity with all. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Jan2021 at 09:15, the patient muscle pain and joint pain 30 minutes after the vaccine. In an unspecified date in Jan2021 at 12:30, she experienced soreness at the infection sight for 2-3 days, glucose dropped dramatically after taking morning metformin after eating. Side effects tiredness, headache, chills, joint pain, muscle pain, nausea, and feeling unwell. Soreness at the infection sight for 2-3 days. The patient was treated with 2 ibuprofen. Vaccine facility type: local facility. In Jan2021, the event- soreness at the infection sight for 2-3 days was recovered and outcome of the events was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: sore arm; chills; exhaustion so bad it almost bordered nausea; This is a spontaneous report from a contactable consumer or other non-HCP. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via an unspecified route of administration in left arm on 04Feb2021 at 07:00 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 04Feb2021 at 22:00, the patient experienced sore arm, chills, and exhaustion so bad it almost bordered nausea. The patient did not receive any treatment for the adverse events. The outcome of events was recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cataract, Chills, Cough
Clinical narrative: Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Cough; loss of appetite; Cataract; 'started feeling really ill'; painful injection site; A 72-years-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9265, Expiration date: unknown), via an unspecified route of administration on 28Jan2021 in left arm at a single dose for covid-19 immunization. The patient's medical history included asthma, nerve injury, chronic nerve damage and blood pressure measurement. Patients concomitant medications included losartan for blood pressure abnormal at the dose of 100 mg per day, atenolol for blood pressure abnormal, albuterol (SALBUTAMOL)) for asthma at the dose of 1.25mg, esomeprazole sodium (NEXIUM) for gastroesophageal reflux disease. On 02Feb2021, she had a cataract implant on the right side. Which was the side her headaches were on. She didn't know if it was from the vaccine or not. Five days later after surgery, on an unspecified date in Feb2021, the patient experienced started feeling really ill. She was pending a procedure on her other eye as well. She got lots of symptoms. The patient experienced tiredness, headache muscle and joint pain, chills, fever, her injection site was painful, and she was feeling unwell. The patient underwent lab tests and procedures which included body temperature which was 101.2. A couple of days after the vaccine she felt well. On 05Feb2021, then all the sudden she just felt tired and couldn't do anything. She was laying and sitting all day. She had no appetite. It had persisted. She didn't have an appetite when she eats. She couldn't taste the food. She didn't feel as bad. She could feel herself getting better. She was taking more vitamin c and more vitamins. On same date, she had a cough. She had been taking Theraflu and lung support for her chest since she developed the cough. She had fever and which was up to 101.2. It kept fluctuating. This morning it was 96. She had muscle and joint every day, but this was triple the pain of her normal pain. She had been drinking a Gatorade. She took nexium for acid reflux, and she had been taking that for a while. That was why she thinks she couldn't taste as much. She got the vaccine because with everything going on, it was the right thing to do. The reporter assessed cataract as medically significant. The outcome of events tiredness, headache, muscle pain, joint pain, fever, feeling unwell was recovering, while chills, painful injection site were recovered, cough and loss of appetite were not recovered and the outcome of started feeling really ill was unknown. She was scheduled for her second dose on 18Feb2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Illness, Malaise
Clinical narrative: Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Cough; loss of appetite; Cataract; 'started feeling really ill'; painful injection site; A 72-years-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9265, Expiration date: unknown), via an unspecified route of administration on 28Jan2021 in left arm at a single dose for covid-19 immunization. The patient's medical history included asthma, nerve injury, chronic nerve damage and blood pressure measurement. Patients concomitant medications included losartan for blood pressure abnormal at the dose of 100 mg per day, atenolol for blood pressure abnormal, albuterol (SALBUTAMOL)) for asthma at the dose of 1.25mg, esomeprazole sodium (NEXIUM) for gastroesophageal reflux disease. On 02Feb2021, she had a cataract implant on the right side. Which was the side her headaches were on. She didn't know if it was from the vaccine or not. Five days later after surgery, on an unspecified date in Feb2021, the patient experienced started feeling really ill. She was pending a procedure on her other eye as well. She got lots of symptoms. The patient experienced tiredness, headache muscle and joint pain, chills, fever, her injection site was painful, and she was feeling unwell. The patient underwent lab tests and procedures which included body temperature which was 101.2. A couple of days after the vaccine she felt well. On 05Feb2021, then all the sudden she just felt tired and couldn't do anything. She was laying and sitting all day. She had no appetite. It had persisted. She didn't have an appetite when she eats. She couldn't taste the food. She didn't feel as bad. She could feel herself getting better. She was taking more vitamin c and more vitamins. On same date, she had a cough. She had been taking Theraflu and lung support for her chest since she developed the cough. She had fever and which was up to 101.2. It kept fluctuating. This morning it was 96. She had muscle and joint every day, but this was triple the pain of her normal pain. She had been drinking a Gatorade. She took nexium for acid reflux, and she had been taking that for a while. That was why she thinks she couldn't taste as much. She got the vaccine because with everything going on, it was the right thing to do. The reporter assessed cataract as medically significant. The outcome of events tiredness, headache, muscle pain, joint pain, fever, feeling unwell was recovering, while chills, painful injection site were recovered, cough and loss of appetite were not recovered and the outcome of started feeling really ill was unknown. She was scheduled for her second dose on 18Feb2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Cough; loss of appetite; Cataract; 'started feeling really ill'; painful injection site; A 72-years-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9265, Expiration date: unknown), via an unspecified route of administration on 28Jan2021 in left arm at a single dose for covid-19 immunization. The patient's medical history included asthma, nerve injury, chronic nerve damage and blood pressure measurement. Patients concomitant medications included losartan for blood pressure abnormal at the dose of 100 mg per day, atenolol for blood pressure abnormal, albuterol (SALBUTAMOL)) for asthma at the dose of 1.25mg, esomeprazole sodium (NEXIUM) for gastroesophageal reflux disease. On 02Feb2021, she had a cataract implant on the right side. Which was the side her headaches were on. She didn't know if it was from the vaccine or not. Five days later after surgery, on an unspecified date in Feb2021, the patient experienced started feeling really ill. She was pending a procedure on her other eye as well. She got lots of symptoms. The patient experienced tiredness, headache muscle and joint pain, chills, fever, her injection site was painful, and she was feeling unwell. The patient underwent lab tests and procedures which included body temperature which was 101.2. A couple of days after the vaccine she felt well. On 05Feb2021, then all the sudden she just felt tired and couldn't do anything. She was laying and sitting all day. She had no appetite. It had persisted. She didn't have an appetite when she eats. She couldn't taste the food. She didn't feel as bad. She could feel herself getting better. She was taking more vitamin c and more vitamins. On same date, she had a cough. She had been taking Theraflu and lung support for her chest since she developed the cough. She had fever and which was up to 101.2. It kept fluctuating. This morning it was 96. She had muscle and joint every day, but this was triple the pain of her normal pain. She had been drinking a Gatorade. She took nexium for acid reflux, and she had been taking that for a while. That was why she thinks she couldn't taste as much. She got the vaccine because with everything going on, it was the right thing to do. The reporter assessed cataract as medically significant. The outcome of events tiredness, headache, muscle pain, joint pain, fever, feeling unwell was recovering, while chills, painful injection site were recovered, cough and loss of appetite were not recovered and the outcome of started feeling really ill was unknown. She was scheduled for her second dose on 18Feb2021.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash, Skin burning sensation
Clinical narrative: suspected shingles; painful rash; skin burning; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (23Mar2021), this case now contains all required information to be considered valid.  A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 26Jan2021 15:00 (Lot Number: EL8982; Expiration Date: May2021) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 29 years).  The patient's medical history and concomitant medications were not reported. The patient experienced painful rash and skin burning on 29Jan2021 14:00 and he stated that he had suspected shingles on an unspecified date. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: achiness & discomfort at the injection site; achiness & discomfort at the injection site; This is a spontaneous report from a contactable female consumer (patient) via Pfizer-sponsored program.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown) on 05Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, on an unspecified date, she received the first dose of the vaccine for covid-19 immunisation.The patient experienced achiness and discomfort at the injection site on Feb2021, non serious and described as follows: she received both inoculations and got the 2nd dose on 05Feb2021. She stated she was currently experiencing side effects like achiness and discomfort at the injection site. The final outcome of the events was reported as unknown. Patient wanted to know if can take Tylenol or Advil and also reported that she put a wrong date on her VSafe. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache
Clinical narrative: light headache; back pains; This is a spontaneous report from a contactable consumer (patient), received via the Pfizer-sponsored program. A contactable consumer reported similar events for two patients. This is the first of two reports.   A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced light headache and back pains on an unspecified date. The patient stated that she took the vaccine with her husband and they've been taking Tylenol for light headache and back pains. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021144715 same reporter/vaccine/events and different patient.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection after the 1st vaccine; This is a spontaneous report from a contactable consumer (Patient) via Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection, Lot# unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 Immunization. Medical history and concomitant medications were not reported. On an unspecified date patient experienced urinary tract infection after the 1st vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: is now showing some red rashes. Got in both arms, greased in elbow; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable female consumer (patient). A female patient of unspecified age had received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had stated that after 2nd dose of vaccine yesterday, approximately on unknown date in Feb2021, (reported as now) showing some red rashes. Got in both arms, greased in elbow. Patient wants to let us know about this if this is okay.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles/ Between Saturday and Sunday I came up with I guess a small amount of the doctor said maybe shingles; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 11Jan2021 as a first dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was asking if he can take the second shot after getting shingles from 06Feb2021. He got the first dose last 11Jan2021 and supposedly to take the second one tomorrow (11Feb2021). Patient asked if the COVID-19 vaccine was the reason behind his shingles. Between Saturday and Sunday, 06Feb2021 and 07Feb2021, patient came up with what he guessed was a small amount of the doctor said maybe shingles. It was then reported that patient was scheduled/supposed to get second Pfizer-Biontech Covid-19 vaccine at the time of the report (11Feb2021) at 10am.  He planned to contact his physician, before his appointment, so was not transferred to Safety. Patient was being alright, he was just seeing those on his shoulder and everything. He was just calling to see would it be alright for him to take that second shot on 11Feb2021 if it was shingles. The outcome of the event was unknown.   Information about the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pain
Clinical narrative: colds; chills; body ache; This is a spontaneous report from a consumer (patient) via a Pfizer-sponsored program.   A male patient of an unspecified age received first dose of BNT162B2 (solution for injection, Lot number: unknown), via an unspecified route of administration on an unknown date, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced side effects such as colds, chills, and body ache. The outcome of the events was unknown.  Information on lot & batch number of the suspect drug if available.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pyrexia
Clinical narrative: Low grade fever; strong muscle aches; still cannot sleep.; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EM9810, Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 06Feb2021 10:00 as single dose for covid-19 immunisation. Medical history included osteoporosis, BRCA 2. patient had known allergies for Sulfa and ceclor. Concomitant medication included estradiol. The patient previously took first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number EL3247), via an unspecified route of administration, on right arm on 15Jan2021 04:30 PM at single dose for COVID-19 immunization. On 06Feb2021 22:00, patient experienced Low grade fever and strong muscle aches throughout body that were so bad as she has not been able to sleep. Patient was not pregnant at the time of vaccination. Patient did not received treatment for the adverse event Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequelae.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: I contracted Covid 10 days after being vaccinated; This is a spontaneous report received from a contactable 57-year-old male consumer (patient) and contactable other health professional. This patient reported for himself that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 30Jan2021 at 14:15 (age at vaccination 57 years) at single dose in left arm for covid-19 immunization. The patient administered vaccine at hospital. The patient's medical history included graves disease and myasthenia gravis. Concomitant medications included levothyroxine and eszopiclone (LUNESTA). On 09Feb2021 at 10:00, the patient had contracted with Covid-19. The patient experienced the event at Doctor or other healthcare professional office/clinic visit. The patient did not take any treatment for the event. The patient laboratory details included PCR and nasal swab both on 09Feb2021 with positive results. Upon follow up on 22Mar2021, it was reported that the patient contracted COVID after first shot. The outcome of the event was not recovered. The Other health professional considered (reporter) that the Pfizer product had a no causal effect to the adverse event.  Follow-up (22Mar2021): New information received from a contactable other HCP. This other HCP reported in response to HCP letter sent which included: Clinical information added   No follow-up attempts are needed; information about lot/batch number cannot be obtained.