chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Mucosal dryness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: dryness; pain and tightness in right leg; pain and tightness in right leg; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on unknown date as dose number unknown single, for COVID-19 immunization. The patient's medical history was not reported. No prior vaccinations reported. The patient concomitant medications were Atorvastatin calcium for the cholesterol from 16 oct to unknown date and Fenofibrate for unknown indication from 16 oct to ongoing (start date year not specified). On 19Dec (year unspecified), the patient had experienced dryness, pain and tightness in right leg. Therapeutic measures were taken for the AE and treatment included physical therapy for 2 months and still experiencing moderate symptoms. Reported issue occurred after use of Pfizer product. It was unknown if events required hospitalization or visit to emergency room. The clinical outcome of the events were unknown.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she is not well; This is a spontaneous report from a contactable consumer received from a program.  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 25Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced she is not well. The outcome of event was unknown.  Information on LOT/BATCH has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste in her mouth; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's husband) via Pfizer sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported) via an unspecified route of administration on 07Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, after the 1st dose 2 -3 hours, the patient experienced metallic taste in her mouth. Patient called the pharmacist and recommend a benadryl 1 tablet. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: The patient had hives after receiving the Trumenba vaccine; This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported. The patient had hives after receiving the trumenba vaccine on an unspecified date. the reporter wanted to know if the patient can get the Pfizer Covid-19 vaccine. The reporter was informed that it would be important to find out what ingredient caused the hives and tocompare the ingredient list of Pfizer and Trumenba vaccine. If there are any similarities then the Pfizer vaccine has been listed to be contradicted in individuals who had a severe allergic reaction to an ingredient in the vaccine. The reporter was told to review this information with an M.D. (medical doctor). The list of ingredients used in the Pfizer vaccine will be forwarded to the reporter. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia
Clinical narrative: At week 4, severe muscle pain in shoulders, arms, legs; Muscle weakness in legs and arms. Week 1 had no symptoms but aches started mildly in week 2, increasing in weeks 3 & 4 to the point that I could barely lift myself out of a chair; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 18Feb2021 at 11:30 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included melanoma surgery in 2008 and cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included simvastatin and ezetimibe both for cholesterol from unknown date to 16Mar2021. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9625) via an unspecified route of administration in the left arm on 28Jan2021 at 11:30 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. On 01Mar2021 at 08:00, at week 4 the patient experienced severe muscle pain in shoulders, arms, legs, and muscle weakness in legs and arms. Week 1 had no symptoms but aches started mildly in week 2, increased in weeks 3 and 4 to the point that the patient could barely lift himself out of a chair. Patient talked with his Primary Care Physician on March 15 and suspected an interaction of the vaccine with the Simvastatin. The patient stopped taking both cholesterol medications on 16Mar2021. On 21Mar2021 patient felt a 25 percent reduction in pain. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe muscle pain in shoulders, arms, legs and muscle weakness in legs and arms, and could barely lift himself out of a chair was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Limb discomfort
Clinical narrative: Sink in my lower right leg/rubbing my right leg and it something did not feel right; Muscle joint ache; Joint was little swollen; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 20Mar2021 about 12 (her appointment was 11:45, on Saturday) (at the age of 61-year-old) as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were reported. On 21Mar2021 at 5:45, patient woke up in the morning and was rubbing right leg and it something did not feel right, had a sink in his lower right leg, muscle joint ache, and joint was little swollen. He took vaccination yesterday morning (20Mar2021). Patient asking that, this vaccination had muscle joint ache, could this be why his joint was little swollen and below that was sunk it, could that be, he guesses what the symptoms were saying. When patient was asked for lab work, he stated as which in the last two weeks now. Therapeutic measures were reported as no. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: COVID Arm - red area at injection site approximately size of silver dollar. First noticed on 9th day after receiving vaccination. Four days later (today) red area still visible; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 11:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included antiphospholipid syndrome, allergic to cat dander and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included warfarin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and lovastatin (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. On 18Mar2021, in the arm which she had received COVID vaccine, the patient noticed a red area at injection site approximately size of silver dollar. The patient first noticed it on ninth day after receiving vaccination. Four days later (on the day of report), the red area was still visible. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event red area at injection site approximately size of silver dollar; first noticed on ninth day after receiving vaccination, four days later (on the day of report) red area was still visible was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Eating disorder, Mastication disorder, Swelling face
Clinical narrative: his face started swelling around the jaw area towards the ear and jaw area; it's hard to eat and chew; it's hard to eat and chew; Along with lower back pain; This is a spontaneous report from a contactable consumer (reported for husband). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Not provided) via an unknown route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received first dose of the Pfizer vaccine about 48 hours ago but last night her face started swelling around the jaw area towards the ear and jaw area, that was hard to eat and chew; along with lower back pain on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash/ rash under her left breast/rash has come up also stated last night; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EM9809, Expiry Date: unknown) an unspecified route of administration, administered in left arm on 25Mar2021 (at the age of 62-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated she received the first dose of the Pfizer covid vaccine on 25Mar2021 on Tuesday and since then a rash has come up also stated last night she developed a rash under her left breast, it seemed to be improving some today. Patient wanted to know whether she should get the second dose of the covid vaccine following her side effects. Outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site pain
Clinical narrative: Arm felt like he had been punched; Injection site pain worsened; This is a spontaneous report from a non-contactable pharmacist. A 32-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the left arm on 19Mar2021 at 13:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 19Mar2021 hours later, the patient's arm felt like he had been punched. The injection site pain worsened the next day but subsided in the evening. The non-serious event had resolved. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events arm felt like he had been punched was recovered on an unknown date in Mar2021 and injection site pain was recovered on 20Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: headache; felt tired; Chills; strong fever peaked around 103 measured; considerable sweating; This is a spontaneous report from a contactable consumer (Patient).  A 46-year-old male received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK5730 and expiry date was not reported), via an unspecified route of administration in left arm, on 23Mar2021 at 15:30 (age at vaccination 46-years-old), as, DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included atorvastatin and losartan taken for an unspecified indication, start and stop date were not reported. No known allergies reported. The patient did not receive any other vaccine in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EJ1685 and expiry date were not reported), via an unspecified route of administration on left arm, on 03Mar2021 at 9:00 AM (age at vaccination: 46-years-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Patient did not had covid prior or post vaccination. The reported that, within few hours of injection, on 23Mar2021 17:30, the patient experienced headache, within 12 hours felt tired and started with Chills within 22 hours severe chills and after 28 hours had a strong fever peaked around 103 measured with a forehead digital thermometer and after 32 hours fever broke and considerable sweating, patient felt great 36 hours later. Patient responded I became aware of these adverse reactions on the 24th and filled out report on the 25th. The patient did not receive any treatment for the events and felt great 36 hours later. On an unspecified date the patient underwent lab tests and procedures which included body temperature which was found to be 103. Outcome of the events was recovered in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; felt tired; Chills; strong fever peaked around 103 measured; considerable sweating; This is a spontaneous report from a contactable consumer (Patient).  A 46-year-old male received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK5730 and expiry date was not reported), via an unspecified route of administration in left arm, on 23Mar2021 at 15:30 (age at vaccination 46-years-old), as, DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included atorvastatin and losartan taken for an unspecified indication, start and stop date were not reported. No known allergies reported. The patient did not receive any other vaccine in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EJ1685 and expiry date were not reported), via an unspecified route of administration on left arm, on 03Mar2021 at 9:00 AM (age at vaccination: 46-years-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Patient did not had covid prior or post vaccination. The reported that, within few hours of injection, on 23Mar2021 17:30, the patient experienced headache, within 12 hours felt tired and started with Chills within 22 hours severe chills and after 28 hours had a strong fever peaked around 103 measured with a forehead digital thermometer and after 32 hours fever broke and considerable sweating, patient felt great 36 hours later. Patient responded I became aware of these adverse reactions on the 24th and filled out report on the 25th. The patient did not receive any treatment for the events and felt great 36 hours later. On an unspecified date the patient underwent lab tests and procedures which included body temperature which was found to be 103. Outcome of the events was recovered in Mar2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: had hives on her face that lasted a day and a half; It was itchy and annoying but they weren't severe; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team.  A 50-unit-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose1, single for covid-19 immunisation. Medical history included allergic to morphine and got itchy, got hives, allergic to penicillin and got itchy, got hives, and ended up in urgent care and allergic to adhesive tape. The patient concomitant medications were not reported. The patient previously took morphine and (benzylpenicillin sodium) PENICILLIN and experienced itchy and hives. On an unspecified date, the patient experienced had hives on her face that lasted a day and a half and it was itchy and annoying but they were not severe. The caller stated she received the first dose of the vaccine and was due for her second dose tomorrow at 13.21. She stated 3 days after the first vaccine she had hives on her face that lasted a day and a half. It was itchy and annoying but they were not severe. She stated she was getting conflicting information on if she should get her second dose. She stated that her primary care was saying yes to get the second dose, another physician (a psychiatrist) said she should not get it, and the pharmacist said it was a gray area since she had a delayed reaction. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Diarrhoea, Feeling abnormal, Feeling of body temperature change
Clinical narrative: swollen face; flushing; 102°F fever; non-stop severe loss of bowel; felt burning hot and cold; loss of appetite; headache; she felt "like a brain fog"; This is a spontaneous report from a contactable other health care professional. A 41-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Mar2021 at single dose for COVID-19 immunisation. The patient's and concomitant medications were not reported. After she got the first dose of vaccine on 04Mar2021, on an unknown date in Mar2021, patient developed a swollen face, flushing, she felt like a brain fog like when someone slaps you, had 102 degree F fever, non-stop severe loss of bowel that is diarrhea, felt burning hot and cold, loss of appetite, and headache. The patient ( 41-year-old paramedic) wanted to report side effects experienced from the first dose of Pfizer's COVID-19 vaccine. She went for the second dose on the day of report, they were hesitant to vaccine her but did administer it. The patient questioned that, having being so sick with the first dose, would the patient will have many side effects with the second dose. The clinical outcome of events was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Pyrexia, Swelling face
Clinical narrative: swollen face; flushing; 102°F fever; non-stop severe loss of bowel; felt burning hot and cold; loss of appetite; headache; she felt "like a brain fog"; This is a spontaneous report from a contactable other health care professional. A 41-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Mar2021 at single dose for COVID-19 immunisation. The patient's and concomitant medications were not reported. After she got the first dose of vaccine on 04Mar2021, on an unknown date in Mar2021, patient developed a swollen face, flushing, she felt like a brain fog like when someone slaps you, had 102 degree F fever, non-stop severe loss of bowel that is diarrhea, felt burning hot and cold, loss of appetite, and headache. The patient ( 41-year-old paramedic) wanted to report side effects experienced from the first dose of Pfizer's COVID-19 vaccine. She went for the second dose on the day of report, they were hesitant to vaccine her but did administer it. The patient questioned that, having being so sick with the first dose, would the patient will have many side effects with the second dose. The clinical outcome of events was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash on the right side of her body/It was underneath arm and side middle body of arm she had shot.; This is a spontaneous report from a contactable consumer or other non hcp.   A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EN6199, Expiry date: unknown) via an unspecified route of administration, administered in right arm on 08Mar2021 at 11:15, as DOSE 1, SINGLE for COVID-19 immunization. Medical history included localized infection from an unknown date and unknown if ongoing. Concomitant medication included sulfamethoxazole, trimethoprim (SMX/TMP) taken for localised infection from 06Mar2021 to an unspecified stop date. On an unspecified date in Mar2021, the patient experienced itchy rash on the right side of her body/it was underneath arm and side middle body of arm she had shot. The rash was better, but it was not around the shot area. It was reported that sometime around the 1st shot, patient developed itchy rash on the right side of her body for 12 days - On that night she went to ER care unit due to infected finger on the same arm where she had the 1st shot. Patient clarified that she first went into the ER and 2 days after that had the Pfizer COVID vaccine shot. She cannot say for sure if it was an allergic reaction to the vaccine. The rash was bad for 15 days and the last 2 days has been better. She provided name of the antibiotic as generic and stated it was shown on the bottle as SMX/TMP 800mg-160mg and she was taking one tablet twice daily. It is in a pharmacy vial with no lot or expiration. Patient wanted to know if her rashes were brought by the vaccine or antibiotic and get advice about getting second shot. She did not remember if the rash started out 08Mar2021 or 09Mar2021, or somewhere around there. She thought it was an insect bite and then it spread. Then she thought it was a heat rash. Her second dose was on due this Monday. Patient did not think her other medications were relevant. The patient had not received any other vaccine within 4 weeks neither on the same day of vaccination. Patient received no treatment for the event. The outcome of event was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscular weakness
Clinical narrative: After finishing 2nd dose of the Covid vaccine, patient had lymph swelling(two spots) in the left neck area where is the same side of the vaccination (L arm); Constantly feel weak in left upper limb; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Jan2021 at 15:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as not applicable (as per source doc). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patients known allergies to medications, food or other products was reported as not applicable (as per source doc). The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 06Jan2021 at 15:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 12Feb2021, the patient experienced lymph swelling (two spots) in the left neck area on the same side of the vaccination (L arm) and also constantly felt weak in left upper limb. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymph swelling (two spots) in the left neck area and felt weak in left upper limb was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Musculoskeletal stiffness
Clinical narrative: My limbs didnt work for 7hrs. I couldnt move anything on my body.; My limbs didnt work for 7hrs. I couldnt move anything on my body.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 11:00 (at the age of 46-year-old), as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis and allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ocrelizumab (OCREVUS), levothyroxine sodium (SYNTHROID), citalopram hydrobromide (CELEXA), gabapentin (MANUFACTURER UNKNOWN) and baclofen (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received cefaclor (CECLOR), amoxicillin (MANUFACTURER UNKNOWN and vancomycin (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and experienced drug allergy. On 20Mar2021 at 03:00, the patient experienced that patient's limbs did not work for 7 hours. The patient could not move anything on her body. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events limbs did not work and could not move anything on body was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Caller added her pneumonia shot was much worse as far as pain in her arm.; This is a spontaneous report from a contactable consumer (patient).   A 52-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration in Sep2020 (Batch/Lot number was not reported) as dose number unknown, single for pneumococcal pneumonia vaccination.  The patient's medical history and concomitant medications was not reported. The patient experienced her arm is sore, but nothing that she hasn't experienced with other vaccines she has received. The pneumonia shot of patient was much worse as far as pain in her arm. The outcome of event was unknown.  Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis
Clinical narrative: dermatitis; This is a spontaneous report from a contactable consumer (patient, reported for self). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration in Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were reported as none. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine two weeks ago, five days later he started experiencing a rash from his face to his neck. He consulted his doctor, and he was diagnosed with dermatitis. Patient would like to know if this has been reported. The outcome of events was unknown.  No follow up attempts were possible. Information about lot/batch number could not be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Rash erythematous
Clinical narrative: across her abdomen is a rash- red and itchy; across her abdomen is a rash- red and itchy/red splotches; a slight headache; fever; chills; fatigue,tired; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207; expiry date: 31Jul2021) via an unspecified route of administration on 24Mar2021 (age at vaccination 70 years) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization and the patient experienced soreness around the area of the arm, that was kind of rough. On 24Mar2021, at night of vaccination, the patient experienced a slight headache, fever, chills, fatigue, tired. On 26Mar2021, the patient experienced across her abdomen was a rash- red and itchy/ red splotches. The patient stated that on Wednesday, 24Mar2021, she got her last dose of the Pfizer vaccine and next day morning, she might have had it yesterday but she did not notice it yesterday, this morning she noticed red splotches across her stomach and it is a little itchy, she did not scratch but it is a little itchy. She put Benadryl cream (Lot number: LLCT288CTZ/1 and expiry date: Sep2022) on it for the itching, she can look under the light and see if it was still there, she says yes it was still ongoing. She said it has persisted about the same since this morning. The outcome of the event across her abdomen was a rash- red and itchy/ red splotches was reported as not recovered and the outcome of rest of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: across her abdomen is a rash- red and itchy; across her abdomen is a rash- red and itchy/red splotches; a slight headache; fever; chills; fatigue,tired; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207; expiry date: 31Jul2021) via an unspecified route of administration on 24Mar2021 (age at vaccination 70 years) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization and the patient experienced soreness around the area of the arm, that was kind of rough. On 24Mar2021, at night of vaccination, the patient experienced a slight headache, fever, chills, fatigue, tired. On 26Mar2021, the patient experienced across her abdomen was a rash- red and itchy/ red splotches. The patient stated that on Wednesday, 24Mar2021, she got her last dose of the Pfizer vaccine and next day morning, she might have had it yesterday but she did not notice it yesterday, this morning she noticed red splotches across her stomach and it is a little itchy, she did not scratch but it is a little itchy. She put Benadryl cream (Lot number: LLCT288CTZ/1 and expiry date: Sep2022) on it for the itching, she can look under the light and see if it was still there, she says yes it was still ongoing. She said it has persisted about the same since this morning. The outcome of the event across her abdomen was a rash- red and itchy/ red splotches was reported as not recovered and the outcome of rest of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity, Peripheral swelling, Walking disability
Clinical narrative: can't walk on one of my legs; swollen; muscle pain; joint pain; having pain her legs; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date were not reported) via an unspecified route of administration on 02Mar2021 as dose 2, single (age at vaccination: 71-year-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date were not reported) via an unspecified route of administration on an unspecified day as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced can't walk on one of her legs, swollen, muscle pain, joint pain, having pain her legs. The patient had taken Tylenol and Advil, but they aren't helping. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: have bruising in the inside of the not at the site of my shot arm since last night; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 23Mar2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 25Mar2021, the patient experienced have bruising in the inside of the not at the site of my shot arm since last night. Patient asked is it is a side effect and could not find anything online about it. The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Rash erythematous, Vaccination site rash, Wheelchair user
Clinical narrative: wheelchair; it is a square rash that is mottled red and purple; rash below injection site; bruise; sore arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Left arm on 19Mar2021 13:15 (at the age of 79 year old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported as none. After vaccine dose, on an unspecified date in Mar2021, patient experienced sore arm and on 25Mar2021, she developed a rash about 2.25 inches below injection site, stated that at first she thought it was a bruise, and she googled, could see photos of rashes that looks like of hers, those were mottled red and purple. It was reported that she was confined to a wheelchair, has to get transportation through the county. Patient wanted to know if she should get the second dose of the vaccine. The outcome of the event vaccination site rash was not recovered and of other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Cystitis, Dizziness, Malaise
Clinical narrative: caller is not feeling well; feeling dizzy; cough; a bladder infection; This is a spontaneous report from a contactable consumer (patient) received from a program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Mar2021, patient was feeling not well, dizzy, and had cough. She hopes it would not be COIVD-19. For the last few days, she noticed that she had a bladder infection. It feels like it, though not sure and had not been confirmed by an health care proffessional. She had been drinking cranberry juice for bladder infection and at the time of report, she feels a lot better. Her second dose of the vaccine was scheduled on Monday (29Mar2021). She wanted to know that if she still doesn't feel good by Monday, should she still take the vaccine. The outcome of the event bladder infection was recovering and of other events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth.  Began immediately Monday within minutes, still ongoing today, Friday.; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 22Mar2021 at 14:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included SYNTHROID from unknown date for unknown indication and unknown if ongoing. On 22Mar2021 at 14:30, the patient experienced metallic taste in mouth, began immediately monday within minutes, still ongoing today, friday. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste in mouth was not recovered at the time of this report.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hyperhidrosis, Muscle spasms, Nausea
Clinical narrative: she felt real bad; feverish; hot and sweaty; body ache; really tired; leg cramps; nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8730; Expiration Date: 31Jul2021), via an unspecified route of administration on 25Mar2021 08:45 as dose 1, single for COVID-19 immunisation. Medical history included ongoing COPD, Diabetes, Fibromyalgia, and High Blood Pressure. The patient's concomitant medications were not reported. On 25Mar2021 at 8:45, patient received her first vaccine and about an hour and a half later she experienced leg cramps in the back of her legs. Her friend rubbed her legs and they were fine after that. On the same day, at night, 8:00PM she felt real bad and started feeling feverish, being hot and sweaty. On 26Mar2021 she got up and everything seemed ok, so she went out to have breakfast with friends and then a half hour after she got to work, she was having body aches, feverish, felt really tired, and had the hot, sweaty feeling again with mild leg cramps. The leg cramps were better than previous day. She mentioned that it was not really a fever where her forehead was not hot, but was difficult to describe. She felt like the sun was beating on her, the skin was on fire, and felt hot and sweaty like she just worked out. She also mentioned that she would have a really weird feeling of nausea that would last about 1 minute every, now and then. She has started taking Emergency, which is a regimen of 1000mg Vitamin C with Zinc. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: she felt real bad; feverish; hot and sweaty; body ache; really tired; leg cramps; nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8730; Expiration Date: 31Jul2021), via an unspecified route of administration on 25Mar2021 08:45 as dose 1, single for COVID-19 immunisation. Medical history included ongoing COPD, Diabetes, Fibromyalgia, and High Blood Pressure. The patient's concomitant medications were not reported. On 25Mar2021 at 8:45, patient received her first vaccine and about an hour and a half later she experienced leg cramps in the back of her legs. Her friend rubbed her legs and they were fine after that. On the same day, at night, 8:00PM she felt real bad and started feeling feverish, being hot and sweaty. On 26Mar2021 she got up and everything seemed ok, so she went out to have breakfast with friends and then a half hour after she got to work, she was having body aches, feverish, felt really tired, and had the hot, sweaty feeling again with mild leg cramps. The leg cramps were better than previous day. She mentioned that it was not really a fever where her forehead was not hot, but was difficult to describe. She felt like the sun was beating on her, the skin was on fire, and felt hot and sweaty like she just worked out. She also mentioned that she would have a really weird feeling of nausea that would last about 1 minute every, now and then. She has started taking Emergency, which is a regimen of 1000mg Vitamin C with Zinc. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: one day after vaccine, I experienced blurring of eyes. It stayed for about 25 minutes before it became normal; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included losartan potassium (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 03Mar2021 at 15:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 13:00, one day after vaccine, the patient experienced blurring of eyes. It stayed for about 25 minutes before it became normal. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blurring of eyes was recovered on 25Mar2021 at 13:25, after the duration of 25 minutes.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Nausea
Clinical narrative: Chills; Weakness; Headache; Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 24Mar2021 at 10:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 18:00, the patient experienced chills, weakness, headache, dizziness, and nausea. The patient reported that the most severe lasted from 12 to 26 hours after dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, weakness, headache, dizziness, and nausea were resolved on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.