chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: numbness and tingling in both hands and fingers; numbness and tingling in both hands and fingers; Tiredness; Aches; This is a spontaneous report from a contactable nurse, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 05Apr2021 at 14:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included undifferentiated connective tissue disease, rosacea, thyroid cancer and status post (S/P) thyroidectomy. The patient had no allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), hydroxychloroquine sulfate (PLAQUENIL), doxycycline (MANUFACTURER UNKNOWN), colecalciferol (D3 VITAMIIN) and meloxicam (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 16:00, an hour or so after the vaccine, the patient had numbness and tingling in both hands and fingers. The events had persisted with slight improvement. On the same day and time, the patient also had the expected tiredness and aches. 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. The clinical outcome of the events numbness and tingling in both hands and fingers were resolving and the events of tiredness and aches were not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event description of 'numbness in both hands and fingers' updated as numbness and tingling in both hands and fingers'.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Entire left side of body went numb on side of injection face, arm, abdomen, leg.; This is a spontaneous report from a contactable consumer (patient herself). A 19-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 07Apr2021 14:45 (Lot number and Expiry date was not reported) (age at vaccination 19 years) as dose 1, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included polycystic ovarian syndrome, high blood pressure and asthma. The patient was allergic to pineapple. Concomitant medications included bupropion (BUPROPION), montelukast (MONTELUKAST), spironolactone (SPIRONOLACTONE) and topiramate (TOPIRAMATE). All concomitant medications received within 2 weeks of vaccination. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient experienced entire left side of body went numb on side of injection face, arm, abdomen, leg on 07Apr2021 15:00. It was reported that since the vaccination, the patient didn't test for COVID-19. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for events. The outcome of events reported as not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis atopic, Pruritus
Clinical narrative: Atopic dermatitis; Pruritis; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 05Apr2021 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic asthma, rhinitis and COVID-19. The patient did not have any allergies to food, medications, or other products. Concomitant medications included levocetirizine dihydrochloride (XYZAL) 5mg once daily (QD) and montelukast sodium (SINGULAIR) 10 mg once daily (QD), both taken from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced atopic dermatitis and pruritis. Therapeutic measures were taken as a result of the events and included treatment with benadryl. The clinical outcome of the events atopic dermatitis and pruritis was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A forty-two-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 left arm on 02Apr2021 at 10:00 (at the age of forty-two-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications. The patient was allergic to anti diarrheal medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced armpit hurts and sometimes her muscle by clavicle hurts a little. The adverse event did not result in a visit to the doctors 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. The clinical outcome of the events armpit pain and muscle pain was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Influenza like illness, Myalgia, Nausea
Clinical narrative: Diarrhea; Achy muscles; Achy muscles and joints; Low grade fever; Flu like symptoms; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Mar2021 at 13:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and glucosamine (MANUFACTURER UNKNOWN), all taken from unknown dates for unknown indications. The patient previously took morphine and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 20:00, the patient experienced diarrhea, achy muscles and joints, low grade fever, flu like symptoms and nausea. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events diarrhea, achy muscles and joints, low grade fever, flu like symptoms and nausea were resolved on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea; Achy muscles; Achy muscles and joints; Low grade fever; Flu like symptoms; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Mar2021 at 13:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and glucosamine (MANUFACTURER UNKNOWN), all taken from unknown dates for unknown indications. The patient previously took morphine and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 20:00, the patient experienced diarrhea, achy muscles and joints, low grade fever, flu like symptoms and nausea. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events diarrhea, achy muscles and joints, low grade fever, flu like symptoms and nausea were resolved on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 07Apr2021 at 13:30 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have allergies to medications, food or other products. 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 07Apr2021 at 20:00, the patient experienced severe diarrhea. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe diarrhea was not resolved at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Parosmia, SARS-CoV-2 test
Clinical narrative: Headache mostly around my left eye; One week after 2nd Pfizer vaccine I smell smoke along with a headache mostly around my left eye. There is no smoke in my home but I smell it 24/7; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER ZU 13) via an unspecified route of administration in the left arm on 21Mar2021 at 10:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes2. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2U13) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 09:00, one week after second dose of vaccination, the patient experienced smelled smoke along with a headache mostly around the left eye. There was no smoke in the patient's home but the patient smelled it 24/7. On 07Apr2021, the patient underwent nasal swab test and the result was unknown. 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 events. The clinical outcome of the events smelled smoke along with a headache mostly around the left eye was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: Restless Sleep on the first night; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 17:15(at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 17Mar2021 at 22:00, the patient experienced restless sleep on the first night. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event restless sleep was recovered on an unknown  date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pyrexia, Vaccination site pruritus
Clinical narrative: Headache; Right arm, itchy / in the right arm, site of the vaccination, it's itchy.; Fever; Weakness; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in right arm on 05Apr2021 (at the age of 61 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. Vaccination facility type was military base. Prior vaccination (within 4 weeks) and adverse event following prior vaccination was none. No other vaccines were received within four weeks prior to the administration of bnt162b2. On 05Apr2021, the patient experienced fever and weakness, on 06Apr2021, the patient experienced headache and right arm, itchy / in the right arm, site of the vaccination, it's itchy. Additional context received as, the patient states she had the vaccine on 05Apr2021 afternoon, the patient doesn't see an expiry date also states she can't read NDC or LOT because of it being so small. The patient does verify information is handwritten on card. The patient does locate LOT and provides it. Overnight she has had fever, still has a headache and she woke up today with headache, her headache is not serious because she has Tylenol and her headache was persisting, even with taking Tylenol. The patient states she can't read the LOT of Tylenol. Patient states LAD16, FLA, she doesn't know if its a 0 or 15. Caller states expiry date is JUL 2022. UPC: The patient states they are really small, she can't read it, she can't see them because it is too small. Caller states bottle has 400 tablets. Dosage on each tablet is 500mg. The patient took one, 500mg tablet, and she takes it every four hours. Tylenol strength and count size dispensed: 400 tablets, 500mg tablets, she takes one, 500mg, every four hours. The patient was weak after the vaccine and weakness was started after three hours of the vaccine. The patient also states in the right arm, site of the vaccination, it's itchy, this started this morning when she woke up. No relevant tests. The report was non serious. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Gait inability, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen lymph nodes/worsened; Cannot really walk, hard to get up/ worsened; Rash; Hard to breathe; Internal fever; Joint pain/worsened; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: WM5429) dose 1 via an unspecified route of administration on 31Mar2021 07:20 (at the age of 45 years old) as dose 1, single for COVID-19 immunisation. Medical history included surgery from 1997 and ongoing for had metal rods in her left femur and left cheek, Chicken pox. The patient concomitant medication was not reported. On 31Mar2021 the patient experienced internal fever, hard to breathe. On 01Apr2021 the patient experienced rash. On 06Apr2021 the patient experienced swollen lymph nodes/worsened, cannot really walk hard to get up/ worsened. On an unspecified date patient experienced joint pain/worsened. She mentioned in the beginning she had an internal fever. She was not sure if she had an actual fever but had an internal fever. She also had a rash. Her body got hot. In the very beginning the Pharmacist increased the amount of time she had to wait and was watched for 30 minutes instead. Her head got hot, and it was hard to breathe. She also got rashes, they were on her face, leg, and arm. She just scheduled an appointment with the doctor because she had bad swollen lymph nodes and will see the doctor if they do not get better. She also had joint pain. She was not able to walk because it hurts so bad. She confirmed she does not have an email address to provide for the doctor. The internal fever happened while waiting in the pharmacy. It lurked around for about two days. She confirmed she had recovered completely and feels fine now. The swollen lymph nodes are bad. She officially noticed it last night. The joint pain started last week; she does not remember the exact day it started. It had been around her knees. Her knees have been hurting and her legs are hurting. Now she had swollen lymph nodes. She commented she wonders if her lymph nodes were swollen at the time of joint pain last week but was not noticeable then. She did not notice the swollen lymph nodes until last night. Caller not being able to really walk and hard to get up like out of bed started last night. History of all previous immunizations with the Pfizer vaccine considered as suspect: None, this was the First dose. While capturing details for Vaccine Supplemental Form caller commented she needed to disconnect as she must get back to work. The adverse events not resulted in an emergency room visit and physician office visit. The clinical outcome of the event hard to breathe was recovered on 31Mar2021, internal fever was recovered on an unspecified date of 2021. The clinical outcome of the events rash, swollen lymph nodes/worsened, joint pain/worsened, cannot really walk, hard to get up/ worsened was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Swollen lymph nodes/worsened; Cannot really walk, hard to get up/ worsened; Rash; Hard to breathe; Internal fever; Joint pain/worsened; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: WM5429) dose 1 via an unspecified route of administration on 31Mar2021 07:20 (at the age of 45 years old) as dose 1, single for COVID-19 immunisation. Medical history included surgery from 1997 and ongoing for had metal rods in her left femur and left cheek, Chicken pox. The patient concomitant medication was not reported. On 31Mar2021 the patient experienced internal fever, hard to breathe. On 01Apr2021 the patient experienced rash. On 06Apr2021 the patient experienced swollen lymph nodes/worsened, cannot really walk hard to get up/ worsened. On an unspecified date patient experienced joint pain/worsened. She mentioned in the beginning she had an internal fever. She was not sure if she had an actual fever but had an internal fever. She also had a rash. Her body got hot. In the very beginning the Pharmacist increased the amount of time she had to wait and was watched for 30 minutes instead. Her head got hot, and it was hard to breathe. She also got rashes, they were on her face, leg, and arm. She just scheduled an appointment with the doctor because she had bad swollen lymph nodes and will see the doctor if they do not get better. She also had joint pain. She was not able to walk because it hurts so bad. She confirmed she does not have an email address to provide for the doctor. The internal fever happened while waiting in the pharmacy. It lurked around for about two days. She confirmed she had recovered completely and feels fine now. The swollen lymph nodes are bad. She officially noticed it last night. The joint pain started last week; she does not remember the exact day it started. It had been around her knees. Her knees have been hurting and her legs are hurting. Now she had swollen lymph nodes. She commented she wonders if her lymph nodes were swollen at the time of joint pain last week but was not noticeable then. She did not notice the swollen lymph nodes until last night. Caller not being able to really walk and hard to get up like out of bed started last night. History of all previous immunizations with the Pfizer vaccine considered as suspect: None, this was the First dose. While capturing details for Vaccine Supplemental Form caller commented she needed to disconnect as she must get back to work. The adverse events not resulted in an emergency room visit and physician office visit. The clinical outcome of the event hard to breathe was recovered on 31Mar2021, internal fever was recovered on an unspecified date of 2021. The clinical outcome of the events rash, swollen lymph nodes/worsened, joint pain/worsened, cannot really walk, hard to get up/ worsened was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia, Somnolence
Clinical narrative: fever; really tired; He has slept through the day/sleeping constantly; his whole body is sore; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 29-year-old male patient received bnt162b2 (BNT162B2, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 11:00 (Batch/Lot Number: ER8734; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for COVID-19 immunisation (at the age of 29-year-old). No additional vaccines administered on same date. The patient did not have any medical history. The patient had not received any other vaccine within 4 weeks. Family Medical History Relevant to AE was None. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (dose number 1, lot number; EP7534, Expiry date: 31Jul2021 on 16Mar2021 at 10.00) for Covid 19 Immunization. The subject did not receive other product. The patient was fine after his first dose of the COVID vaccine. The patient had a fever, took a Motrin at 1:02PM, because he needed to bring his fever down. Since taking the Motrin, his fever has improved. He was really tired: He had slept through the day. Last night he had dinner and drank coffee. He could feel his body come to a fever. Since then he had maybe been awake for two hours. He had been sleeping constantly. He felt like he got hit by a truck: Clarifies that his whole body was sore. He attributed to feeling like that to his fever. He felt better after taking Motrin. He did not have chills with his fever. He was not in too much pain. The patient underwent lab tests and procedures which included body temperature: 102 on 06Apr2021. The patient did not visit emergency room or physician Office. Therapeutic measures were taken as a result of fever and is whole body is sore. The outcome of events fever and his whole body is sore was recovering and for other events it was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Maternal exposure during pregnancy, Parosmia, Taste disorder
Clinical narrative: is_pregnant:Yes/gestational_period:35; Certain foods have Foul and slightly sweet taste. Cant pinpoint a particular ingredient that is causing it. Smell the exact same way; Certain foods have Foul and slightly sweet taste. Cant pinpoint a particular ingredient that is causing it. Smell the exact same way; Certain foods have Foul and slightly sweet taste. Cant pinpoint a particular ingredient that is causing it. Smell the exact same way; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 14:00 (at the age of 27-years-old) (maternal exposure during pregnancy- third trimester) as a single dose for COVID-19 immunisation. The patients gestation period was 35 weeks. Medical history included COVID-19. Concomitant medications taken within two weeks prior to the vaccination included sertraline hydrochloride (ZOLOFT), promethazine (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. The patient did receive other vaccines within four weeks prior to the vaccination, which included tetanus vaccine toxoid, diphtheria vaccine toxoid, pertussis vaccine acellular (TDAP) on 24Feb2021 for an unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021 the patient experienced certain foods had foul and slightly sweet taste (the same taste). The patient could not pinpoint a particular ingredient that was causing it. Things also smelled the exact same way (foul and slightly sweet). Toothpaste, mouthwash, soda, peanut butter, tea, chocolate, mint, all tasted this way. All deodorant, soap, shampoo, etc had this smell. Feces also smelled the exact same way. 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 events. The clinical outcome of the events certain foods had foul and slightly sweet taste (the same taste), things also smelled the exact same way (foul and slightly sweet), toothpaste, mouthwash, soda, peanut butter, tea, chocolate, mint, all tasted this way, all deodorant, soap, shampoo, etc had this smell, faeces also smelled the exact same way was not resolved at the time of this report.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: the consumer stated she was been on her period for almost 3 weeks now which was incredibly unusual; This is a spontaneous report from a contactable consumer (the patient's friend). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the consumer stated she was been on her period for almost 3 weeks now which was incredibly unusual, my friend (the patient) also mentioned the same thing happened to her after receiving the Pfizer vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377384 same reporter/product/event , different patient.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Nausea, Pain, Paraesthesia
Clinical narrative: First COVID-19 vaccine: right side of her body go numb- it had like that tingling feeling like pins and needles; First COVID-19 vaccine: very sore; First COVID-19 vaccine: nausea; First COVID-19 vaccine: stiffness in her neck and back, on her right side; First COVID-19 vaccine: right side of her body go numb- it had like that tingling feeling like pins and needles; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER6207, patient was 30-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 15Mar2021 at 03:40 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety and depression from 2016 diagnosed probably about 5 years, Chronic migraines from 2019 diagnosed about 2 years, lactose intolerance for 9 years, allergy to latex for as long as she can remember. Probably since birth, anytime someone touches her with latex, she breaks out into hives, ichy after getting a vaccine which was family history, sensitivity to cow milk. There were no concomitant medications. Historical vaccine included flu shot for immunization and experienced chills, mild fever, nausea, feels icky. Most of the other vaccines, she had not really had since she was a child, but she usually gets a mild fever, achy, that is what she remembers. She guesses usually when she gets any vaccine, she feels "icky". Caller states she does have her vaccination card that is from California where she received these vaccinations. All of the childhood vaccinations on her card show when she received it but does not give what type of vaccine or any additional information. Caller confirmed she was not a healthcare provider such as a doctor, pharmacist or nurse at the beginning of the call, although caller later states when probed for indication of the vaccine, she is healthcare worker at a childcare facility. No previous immunization with the Pfizer vaccine considered as suspect. No other vaccinations received within four weeks prior to the first administration date of the suspect vaccine(s). On 15Mar2021, the patient experienced first covid-19 vaccine: right side of her body go numb- it had like that tingling feeling like pins and needles, first covid-19 vaccine: very sore, first covid-19 vaccine: nausea, first covid-19 vaccine: stiffness in her neck and back, on her right side. AE does not require to visit physician office and emergency Room. Reporter that she had not taken anything yet as treatment. She adds she had probably going to take Tylenol since she read on the paper it was safe to take. The outcomes of events were recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypomenorrhoea, Menstruation irregular, Pregnancy test
Clinical narrative: My period came a week early. After my first vaccine, My period started one week earlier than expected (22Mar2021) and was lighter/didn't last as long.; Period was lighter; Fatigue; Headache; This is a spontaneous report from a contactable other healthcare professional (Patient). A 32-years-old non-pregnant female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 32-years-old) as dose 1, single for Covid-19 immunisation. Medical history included eczema. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not have any known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for Covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 the patient experienced irregular periods and it was reported that period came a week early and was not on birth control and have had a regular period for lifetime. After first vaccine, period started one week earlier than expected (22Mar2021) and period was lighter and did not last as long. After two hours of vaccination (06Mar2021) the patient experienced fatigue and headache. On 07Apr2021, patient underwent lab tests and procedures, which included pregnancy test and tested negative. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took second dose on 31Mar2021 and had no symptoms. The clinical outcome of the event irregular periods, fatigue, period was lighter, and headache were unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: feels slight numbness; tingling in lower-left jaw; muscle pain in upper neck and shoulders coming from spine days later; This is a spontaneous report from contactable consumer via Pfizer Sales Representative. The consumer reported for himself that:  A male patient of unspecified age (38-Unit Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took cortisone. (Patient had received a cortisone injection in his left arm's elbow one month prior to getting this vaccine in the same (left) arm.). On an unspecified date, 4 hours after first COVID vaccine shot, the patient had left-hand side of face (primarily lower-left jaw) and upper neck muscles felt tingling and as if they were going numb. Sensation grew more extreme for 15 minutes, then diminished. Less-extreme recurrence of said symptoms happened twice several days later, both for a half an hour long. Still feels slight numbness and tingling in lower-left jaw, even more days later and reported muscle pain in upper neck and shoulders coming from spine days later. At the time of this report event outcome was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell count, Red blood cell count decreased
Clinical narrative: red blood cell count is very low; This is a spontaneous report from a contactable female consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 17Mar2021 as dose 1, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported as red blood cell count is very low on an unspecified date in Mar2021. It was reported that, patient received her 1st dose on 17Mar2021 and due to have her 2nd dose on 07Apr2021. She was taking Prednisone after the 1st dose because her red blood cell count was very low. Patient enquired if she should put off her 2nd dose or she could continue taking her 2nd dose and medication at the same time. The patient underwent lab tests and procedures which included red blood cell count: low on an unspecified date. The patient received treatment with prednisone after the 1st dose because her red blood cell count is very low. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: persistent fever; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 61-year-old male patient received patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via unknown route of administration at arm left on 31Mar2021 13:30 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not taken vaccinations within 4 weeks prior to take Pfizer vaccine. On 01Apr2021, the patient experienced persistent fever which goes up to 102F, until being the 9th day post-vaccination. The patient asked if his symptom was normal or abnormal because on most material, he reads they should last a couple of days. Patient has been taking Tylenol and Ibuprofen, every 6 hours. The patient confirms the fever began 24 hours exactly from when he received the shot. The fever has not improved. Therapeutic measures were taken as a result of persistent fever. The outcome of event was not recovered.     No follow-up attempts are possible; Information about lot/batch number cannot be obtained.  .
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: received his first shot/dose of Pfizer Covid 19 vaccine and had numbness in his left foot (outer side); This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was healthy. No other concomitant issues and known allergies reported. The patient received his first shot/dose of Pfizer Covid 19 vaccine and had numbness in his left foot (outer side). He stated that 24 hours later, the numbness was not as substantial, but the numbness was still present. Event took place after use of product. Outcome of the event was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: severe headache; fatigue; joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 59-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 left arm on 10Mar2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus (type 2 diabetic). Concomitant medications included metformin (MANUFACTURER UNKNOWN) and thyroid (ARMOUR THYROID), both for unknown indications on unknown dates. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021, the patient experienced severe headache, fatigue and joint pain. 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 for the reported events. The clinical outcomes of the events severe headache, fatigue and joint pain were recovering at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Mar2021(at the age of 59-years-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: woke up with a fever; chill; body ache after covid vaccine; This is a spontaneous report from a Pfizer. A contactable consumer (Parent) reported that a male patient (Son) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as Dose Number Unknown, Single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, Son woke up with a fever, chill and body ache after covid vaccine. No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. There were not any unaddressed medical questions referred or forwarded to Medical Information. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches; Fever; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiry date were not reported) via an unspecified route of administration on an unknown date in 2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. This report was not related to a study or programme. The patient experienced fever and body aches on an unknown date in 2021. She asked if it was normal to have side effects from the first vaccine dose 5-7 days after having the vaccine. She also asked if she should just stay home and wait it out or get tested for covid. She wanted to know in clinical trials how high fever did participants get after a dose of the covid vaccine. She asked If hypothetically she go to her doctor and get tested for covid, and she tested positive, so how long would she have to wait to get her second dose. She asked how long it takes to get side effects from the vaccine, if it was common to get side effects 5 to 7 days after the first Pfizer BioNTech covid-19 vaccine dose.  She was advised that she would be transferred for further assistance. Investigation assessment was not reported. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Diarrhoea, Fatigue, Headache
Clinical narrative: Muscle joint pain; Muscle joint pain; Headache; Fatigue; Nausea; Diarrhea; Fever of 99.00; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 15:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, supraventricular tachycardia (SVT) and COVID-19 on 30Sep2020. The patient has no known allergies to food, medications or other products. Concomitant medications included acyclovir (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 08:30, 17 hours after vaccination, the patient experienced fever of 99.00 (unspecified units). On 08Apr2021 at 10:00, the patient experienced muscle joint pain, headache, fatigue, nausea and diarrhea. On 08Apr2021 the patient underwent body temperature measurement and the result was 99:00 (units unspecified). The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events muscle joint pain, headache, fatigue, nausea, diarrhea and fever of 99.00 was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle joint pain; Muscle joint pain; Headache; Fatigue; Nausea; Diarrhea; Fever of 99.00; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 15:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, supraventricular tachycardia (SVT) and COVID-19 on 30Sep2020. The patient has no known allergies to food, medications or other products. Concomitant medications included acyclovir (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 08:30, 17 hours after vaccination, the patient experienced fever of 99.00 (unspecified units). On 08Apr2021 at 10:00, the patient experienced muscle joint pain, headache, fatigue, nausea and diarrhea. On 08Apr2021 the patient underwent body temperature measurement and the result was 99:00 (units unspecified). The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events muscle joint pain, headache, fatigue, nausea, diarrhea and fever of 99.00 was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.