chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, Disturbance in attention, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: Headaches; Swollen under left arm; Hot and cold feeling; Menstrual cycle came back on after going off just before the injection; Pain/ Throbbing pain under my arm;  fatigued; I couldn't concentrate; I was moving in slow motion, and tripping over my feet; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) in the left arm on 31Mar2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Concomitant medications included unspecified multivitamins for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Apr2021, the patient experienced headaches, swollen under left arm, hot and cold feeling, menstrual cycle came back on after going off just before the injection. Every evening around 02:00, she also experienced pain, such as headache and throbbing pain under arm, gary fatigued and really could not concentrate and seemed like she was moving in slow motion and tripping over her feet. The events resulted in emergency room/department visit 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 headaches, swollen under left arm, hot and cold feeling, menstrual cycle came back, throbbing pain under arm, gary fatigued, could not concentrate, seemed like she was moving in slow motion and tripping over her feet was resolving at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) in the left arm on 28Apr2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Pain, Peripheral swelling
Clinical narrative: Headaches; Swollen under left arm; Hot and cold feeling; Menstrual cycle came back on after going off just before the injection; Pain/ Throbbing pain under my arm;  fatigued; I couldn't concentrate; I was moving in slow motion, and tripping over my feet; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) in the left arm on 31Mar2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Concomitant medications included unspecified multivitamins for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Apr2021, the patient experienced headaches, swollen under left arm, hot and cold feeling, menstrual cycle came back on after going off just before the injection. Every evening around 02:00, she also experienced pain, such as headache and throbbing pain under arm, gary fatigued and really could not concentrate and seemed like she was moving in slow motion and tripping over her feet. The events resulted in emergency room/department visit 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 headaches, swollen under left arm, hot and cold feeling, menstrual cycle came back, throbbing pain under arm, gary fatigued, could not concentrate, seemed like she was moving in slow motion and tripping over her feet was resolving at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) in the left arm on 28Apr2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Warm sensation in right hip / Feels like someone pressing very warm iron to right buttock.; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 22Apr2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse, sickle cell disease and iodine allergy. 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. The patient previously took codeine phosphate (CODEIN) and sulfur (MANUFACTURER UNKNOWN); both for unknown indication on an unknown date and experienced drug allergy. On 22Apr2021 at 11:30, the patient experienced warm sensation in right hip that began half an hour after vaccination. The sensation was intermittent throughout day, worse at night and felt like someone pressing very warm iron to the right buttock. The event 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 event warm sensation in right hip was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: left side of the chest between the left arm and under the armpit really swollen and it hurts; left side of the chest between the left arm and under the armpit really swollen and it hurts; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male adult patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration, administered in left arm on 01May2021 at 04:30 PM (at the age of 35-years-old) as dose 2, single for COVID-19 immunisation at other facility. Medical history included high triglycerides from an unknown date and unknown if ongoing. Concomitant medications were not reported. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. He did not receive any other vaccine in 4 weeks. The patient previously took first dose of BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot Number was not reported) via unspecified route of administration in arm left on 10Apr2021 at 01:00 PM (at the age of 35-years-old) as dose 1, single for COVID-19 immunisation at other facility. On 02May2021 at 08:30 PM, the patient experienced left side of the chest between the left arm and under the armpit really swollen and it hurts, left side of the chest between the left arm and under the armpit really swollen and it hurts. Still the patient do not know what to do, and asking for visit emergency room. No therapeutic measures were taken as a result of adverse events. Outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oropharyngeal pain
Clinical narrative: Heavy menstrual bleeding, lasting over 6 days. I have Mirena IUD. Sore throat.; Sore throat; This is a spontaneous report from a contactable consumer, the patient. An adult non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Apr2021 as a single dose for COVID-19 immunisation. Medical history included embedded intra uterine device (Mirena IUD). The patient had no medical history. 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. On 27Apr2021, the patient experienced heavy menstrual bleeding, lasting over 6 days and also experienced sore throat. Therapeutic measures included treatment with ibuprofen, taken as a result of the events, heavy menstrual bleeding and sore throat. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore throat and heavy menstrual bleeding were 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: Allergy to vaccine, Swelling
Clinical narrative: swell up all over her body; Allergic reactions to pneumonia vaccine; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 60-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date (lot number and expiry date were not reported) as dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swell up all over her body and allergic reactions to pneumonia vaccine on an unspecified date. It was reported that the patient had allergic reactions to pneumonia vaccine in the past, made her swell up all over her body. The outcome of all events was unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria 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-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Hyperhidrosis, Throat irritation
Clinical narrative: Woke up last night sheets wet (sweats)/awakening both symptoms very pronounced; Hoarse voice/awakening both symptoms verypronounced; Hoarse voice (throat irritatation); This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 29Apr2021 at 09:45 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included mild hypertension at times. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sildenafil citrate (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 09:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 03May2021 at 02:00, the patient woke up with night sheets wet (sweats) and hoarse voice (throat irritation) and that morning upon awakening both symptoms were very pronounced. 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, woke up with night sheets wet (sweats) and hoarse voice (throat irritation) that morning upon awakening both symptoms very pronounced was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Tenderness
Clinical narrative: Swollen left armpit; tender left armpit; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the arm left on 30Apr2021 at 11:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid and known allergy to yellowjackets (allergy to arthropod bite).  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 levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 09Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 07:00, the patient experienced swollen and tender left armpit. The events did not result in doctor or other health care professional office/clinic visit, and 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 swollen and tender left armpit was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 29Apr2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history includes auto-immune disease and hypercoagulation. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN) and hydrochloride; all from an unknown date for an unknown indication and unknown if ongoing. On 29Apr2021, the patient experienced full body rash. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of full body rash which included treatment with diphenhydramine hydrochloride (BENADRYL) and cortisone cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event full body rash was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site pain
Clinical narrative: she came out with a rash in the upper chest, on the collar bone area near neck and and on her back; it was itching; pain in right arm at injection site; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 40-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE mRNA, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, administered in right arm on 29Apr2021 at 11:30 (at the age of 40-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history reported as none. Family medical history was none. The patient's concomitant medications were not reported. She did not receive any prior vaccine (within 4 weeks) and not received any other vaccinations within four weeks prior to the first administration date of the suspect. On 29Apr2021, there was pain in right arm at injection site. She had the first shot of Pfizer Covid-19 vaccine on Thursday morning and yesterday at mid-afternoon on 02May2021, she came out with a rash in the upper chest, on the collar bone area near neck and on her back, it was a small rash at night it was itching. The events did not result in emergency room or physician office. Outcome of the event pain in right arm at injection site was recovered on 30Apr2021, for itching it was unknown and for a small rash in the front near her neck and on the back, it was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives worsened; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on 29Apr2021 (at the age of 63-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated she received the first dose of the Pfizer covid 19 vaccine 29Apr2021 in the late evening (as reported on Thursday). Caller stated that after the shot she noticed different things going on. Caller reiterated that after the shot things started happening and things started intensifying. Caller stated she has hives on 29Apr2021. She mentioned she started to get the hives right after getting the shot and she let the nurse know when she got it while sitting there. She was given Benadryl, but she still experienced the hives for some reason. She was looked at and was informed she would be fine. However, a couple of days have gone by, and things were progressively worse. Her whole back, back of her neck and face have broken out. It does not look right. She felt the hives, but it was intensifying now. Caller did not have full HCP details to provide. While capturing HCP Details caller mentioned her son was calling and asked for us to hold. Caller stated she did yard work earlier in the week. Caller stated this shot was given by the state. Caller asked who was going to pay for the adverse reactions, as she was unemployed and wanted to know how a person that was unemployed and had side effects how was that handled. Caller asked if she was to go see her doctor. Therapeutic measures were taken as a result of hives with Benadryl. At the time of this report, the outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Influenza like illness, Palpitations
Clinical narrative: Flu like symptoms; Heart palpitations; This is a spontaneous report from a Pfizer sponsored program. A contactable other-Health Care Professional and a non-contactable consumer (patient) reported. This case is a spontaneous report received on 23Apr2021, from a consumer via specialty pharmacy. Initial Reporter Also Sent Report to FDA- UNK.  A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 20Apr2021 (at the age of 60 years old) as dose 1, single for covid-19 immunisation; treprostinil sodium (REMODULIN), via an unspecified route of administration from 15Aug2019 to an unspecified date, at 5.0 mg/ml, daily (UNK, continuing, (Continued)), subcutaneous from an unspecified date (Batch/Lot Number: 2101734; Expiration Date: 30Nov2021) to an unspecified date, at 0.068 micro g/kg, continuing for secondary pulmonary arterial hypertension; macitentan (OPSUMIT), via an unspecified route of administration from 20Apr2021 to an unspecified date, at unspecified dose for an unspecified indication . Medical history included secondary pulmonary arterial hypertension from an unknown date and unknown if ongoing. Concomitant medication included riociguat (ADEMPAS). It was reported that the patient might took a double dose of Opsumit but she was not sure. The patient also reported having flu like symptoms after COVID vaccination on Tuesday (on 20Apr2021) as well as heart palpitations. On an unreported date in Apr 2021, the patient experienced the events of heart palpitations [Palpitations], flu like symptoms after COVID vaccination. The action taken in response to the events for treprostinil sodium was unknown, for macitentan was unknown. The outcome of event palpitations and influenza like illness was unknown at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Joint swelling, Lymphadenopathy
Clinical narrative: Lymph nodes under her armpit and neck are swollen; Swollen arm; Muscles being tight it could affect the nerves and be causing her pain; Shoulder is swollen and she could feel it was warmer on the left side; It was warmer on the left side; the next day, were very sore and tight/pain radiated down to her elbow and wrist; the next day, were very sore and tight/pain radiated down to her elbow and wrist; her arm started to get "stiff and sore; intense throbbing pain, from her shoulder through her back; felt very fatigued and tired, and she stayed in bed and slept the whole day; felt very fatigued and tired, and she stayed in bed and slept the whole day; Arm started to get "stiff and sore"/her arm and shoulder on the left, the next day, were very sore and tight/pain radiated down to her elbow and wrist; her left arm, where she received the vaccine, "started to get sore; Pain from her left shoulder drop back down into her back and the back of shoulder scapula; neck stiffness; This is a spontaneous report received from a contactable consumer(patient). A 47-year-old female patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 20Apr2021 at17:05 (Lot number: EW0150) into left arm as single dose for COVID-19 immunization. The patient medical history and concomitant were not reported. On 21Apr2021, the patient had experienced that her arm started to get "stiff and sore" and that is was "throbbing" and she was "exhausted. She stayed in bed for a day, went back to work cleaning houses on Thursday 22Apr2021. She reported that the pain radiates from her left shoulder, around to the scapula on her back, then down to her elbow and wrist, and feels like its "pulling" and she "feels like I need to continue to flex my wrist".  Symptoms worsen when she walks, stands, or sits, the only relief she gets is when laying on her back in bed, or in a very specific way on her left side. She reported that symptoms worsened 27Apr2021 and that she's "been in bed since Wednesday" (28Apr2021). On 30Apr2021 the patient had experienced shoulder was swollen and she could feel it was warmer on the left side. On 03May2021, the patient had experienced swollen arm, and the lymph nodes under her armpit and neck are swollen and also experienced with the muscles being tight it could affect the nerves and be causing her pain. Therapeutic measures were taken for the AE and treatment included were Ibuprofen, Acetaminophen, Massage, ice, and heat. The outcome of the events felt very fatigued and tired, and she stayed in bed and slept the whole day was recovered, on unknown date. The outcome of other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Peripheral swelling, Skin warm
Clinical narrative: Lymph nodes under her armpit and neck are swollen; Swollen arm; Muscles being tight it could affect the nerves and be causing her pain; Shoulder is swollen and she could feel it was warmer on the left side; It was warmer on the left side; the next day, were very sore and tight/pain radiated down to her elbow and wrist; the next day, were very sore and tight/pain radiated down to her elbow and wrist; her arm started to get "stiff and sore; intense throbbing pain, from her shoulder through her back; felt very fatigued and tired, and she stayed in bed and slept the whole day; felt very fatigued and tired, and she stayed in bed and slept the whole day; Arm started to get "stiff and sore"/her arm and shoulder on the left, the next day, were very sore and tight/pain radiated down to her elbow and wrist; her left arm, where she received the vaccine, "started to get sore; Pain from her left shoulder drop back down into her back and the back of shoulder scapula; neck stiffness; This is a spontaneous report received from a contactable consumer(patient). A 47-year-old female patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 20Apr2021 at17:05 (Lot number: EW0150) into left arm as single dose for COVID-19 immunization. The patient medical history and concomitant were not reported. On 21Apr2021, the patient had experienced that her arm started to get "stiff and sore" and that is was "throbbing" and she was "exhausted. She stayed in bed for a day, went back to work cleaning houses on Thursday 22Apr2021. She reported that the pain radiates from her left shoulder, around to the scapula on her back, then down to her elbow and wrist, and feels like its "pulling" and she "feels like I need to continue to flex my wrist".  Symptoms worsen when she walks, stands, or sits, the only relief she gets is when laying on her back in bed, or in a very specific way on her left side. She reported that symptoms worsened 27Apr2021 and that she's "been in bed since Wednesday" (28Apr2021). On 30Apr2021 the patient had experienced shoulder was swollen and she could feel it was warmer on the left side. On 03May2021, the patient had experienced swollen arm, and the lymph nodes under her armpit and neck are swollen and also experienced with the muscles being tight it could affect the nerves and be causing her pain. Therapeutic measures were taken for the AE and treatment included were Ibuprofen, Acetaminophen, Massage, ice, and heat. The outcome of the events felt very fatigued and tired, and she stayed in bed and slept the whole day was recovered, on unknown date. The outcome of other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: Lymph nodes under her armpit and neck are swollen; Swollen arm; Muscles being tight it could affect the nerves and be causing her pain; Shoulder is swollen and she could feel it was warmer on the left side; It was warmer on the left side; the next day, were very sore and tight/pain radiated down to her elbow and wrist; the next day, were very sore and tight/pain radiated down to her elbow and wrist; her arm started to get "stiff and sore; intense throbbing pain, from her shoulder through her back; felt very fatigued and tired, and she stayed in bed and slept the whole day; felt very fatigued and tired, and she stayed in bed and slept the whole day; Arm started to get "stiff and sore"/her arm and shoulder on the left, the next day, were very sore and tight/pain radiated down to her elbow and wrist; her left arm, where she received the vaccine, "started to get sore; Pain from her left shoulder drop back down into her back and the back of shoulder scapula; neck stiffness; This is a spontaneous report received from a contactable consumer(patient). A 47-year-old female patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 20Apr2021 at17:05 (Lot number: EW0150) into left arm as single dose for COVID-19 immunization. The patient medical history and concomitant were not reported. On 21Apr2021, the patient had experienced that her arm started to get "stiff and sore" and that is was "throbbing" and she was "exhausted. She stayed in bed for a day, went back to work cleaning houses on Thursday 22Apr2021. She reported that the pain radiates from her left shoulder, around to the scapula on her back, then down to her elbow and wrist, and feels like its "pulling" and she "feels like I need to continue to flex my wrist".  Symptoms worsen when she walks, stands, or sits, the only relief she gets is when laying on her back in bed, or in a very specific way on her left side. She reported that symptoms worsened 27Apr2021 and that she's "been in bed since Wednesday" (28Apr2021). On 30Apr2021 the patient had experienced shoulder was swollen and she could feel it was warmer on the left side. On 03May2021, the patient had experienced swollen arm, and the lymph nodes under her armpit and neck are swollen and also experienced with the muscles being tight it could affect the nerves and be causing her pain. Therapeutic measures were taken for the AE and treatment included were Ibuprofen, Acetaminophen, Massage, ice, and heat. The outcome of the events felt very fatigued and tired, and she stayed in bed and slept the whole day was recovered, on unknown date. The outcome of other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Internal shaking; Chest pain; Chest pain that made her out of breath; Anxiety; Lack of sleep; Headache; Fatigue; Muscle pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8735, Expiry Date: Unknown) via an unspecified route of administration in right arm (reported as injection to upper right arm) on 26Apr2021 at 08:00 (at the age of 53 years-old) as dose 1, single for COVID-19 immunization. Patient medical history reported as none. The concomitant medications (other products) were not reported. The vaccine was not administered at (Privacy) facility. No Family medical history relevant to adverse events was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. No additional administered vaccines and prior vaccinations (within 4 weeks) reported. Adverse events following prior vaccinations once, it was the flu shot, her arm got the flu, if that, it sounds weird, her arm became feverish, swollen, she became somewhat sick, tired, it was a really nasty reaction to that shot, the injection area. Flu shot, lot, expiry unknown. On Apr2021 patient experienced headache, fatigue, muscle pain, chest pain that made her out of breath, these side effects causing her anxiety and lack of sleep and shivering of internal muscle (it is outside the norm, she is having kind of, she does not know how to describe it, it was like cold and shiver, it is kind of an internal shaking and is still having that) on 26Apr2021. Internal shaking was started the same day as the vaccine, but later that night, it is not going away. Patient first shot symptoms were more noticeable. Patient didn't visited emergency room and physician office. The relevant tests and  investigation assessment were not reported. The outcome of internal shaking was not recovered (ongoing) while that of remaining was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Sleep deficit, Tremor
Clinical narrative: Internal shaking; Chest pain; Chest pain that made her out of breath; Anxiety; Lack of sleep; Headache; Fatigue; Muscle pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8735, Expiry Date: Unknown) via an unspecified route of administration in right arm (reported as injection to upper right arm) on 26Apr2021 at 08:00 (at the age of 53 years-old) as dose 1, single for COVID-19 immunization. Patient medical history reported as none. The concomitant medications (other products) were not reported. The vaccine was not administered at (Privacy) facility. No Family medical history relevant to adverse events was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. No additional administered vaccines and prior vaccinations (within 4 weeks) reported. Adverse events following prior vaccinations once, it was the flu shot, her arm got the flu, if that, it sounds weird, her arm became feverish, swollen, she became somewhat sick, tired, it was a really nasty reaction to that shot, the injection area. Flu shot, lot, expiry unknown. On Apr2021 patient experienced headache, fatigue, muscle pain, chest pain that made her out of breath, these side effects causing her anxiety and lack of sleep and shivering of internal muscle (it is outside the norm, she is having kind of, she does not know how to describe it, it was like cold and shiver, it is kind of an internal shaking and is still having that) on 26Apr2021. Internal shaking was started the same day as the vaccine, but later that night, it is not going away. Patient first shot symptoms were more noticeable. Patient didn't visited emergency room and physician office. The relevant tests and  investigation assessment were not reported. The outcome of internal shaking was not recovered (ongoing) while that of remaining was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: started coughing and coughing and coughing ever since.; This is a spontaneous report from a contactable consumer (Patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number:ER8737 and Expiry date was not reported), via an unspecified route of administration on 29Apr2021 at 13:00 (at the age of 39-years-old) in right arm as dose 2, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: ER2613 and Expiry date was not reported), via an unspecified route of administration on 08Apr2021 in right arm as dose 1, single for COVID-19 immunization. Time the Vaccination was given between 13:00-13:30 both the first and second dose. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. Patient's Medical History including any illness at time of vaccination was none. No Family Medical History Relevant to AE(s). Relevant Tests was none. The patient had not received other products. Caller would like to know if a cough is a common side effect after receiving the second dose of the Pfizer COVID vaccine. Caller states she did an online report and regarding her side effect. Call then is taken over by the patient's mother. Consumer who states her daughter is coughing so bad she cannot talk to the Agent. The caller reports her daughter received the second dose Pfizer Covid Vaccine on 29Apr2021 and had no side effects until a couple days ago, on 01May2021, the patient started coughing and coughing and coughing ever since. Caller states she would be a health care provider since she's a mom. Caller clarified she is a consumer and not an HCP. Caller states her daughter does not have a primary care physician. Caller states her daughter is concerned about the coughing, wants to make sure her daughter is not dying or anything right now. The patient was not visited to emergency room and physician office. The outcome for the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Illness, Macule, Papule
Clinical narrative: A Pharmacist told her the injection may have been given too low on the arm; Caller experienced side effects (unnamed); Red, Raised, Warm, Burning Spot on Left Arm; Red, Raised, Warm, Burning Spot on Left Arm; Red, Raised, Warm, Burning Spot on Left Arm; Red, Raised, Warm, Burning Spot on Left Arm; Red, Raised, Warm, Burning Spot on Left Arm; This is a spontaneous report from a contactable consumer (Patient herself) via medical information team. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Er8737), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 13:30 (at the age of 56 years old) as dose 2, single for covid-19 immunisation. Medical history included breast cancer from 2020 to an unknown date Verbatim: Breast Cancer. Additional Information for Other Conditions: Diagnosed 4-5 years ago, ongoing rheumatoid arthritis Verbatim: Rheumatoid arthritis. The Patient Medical continuing: Yes. Concomitant medications included methotrexate sodium (METHOTREXATE [METHOTREXATE SODIUM]) from Feb2021 and ongoing, prednisone (PREDNISONE) and tamoxifen (TAMOXIFEN) taken for breast cancer, aromatase inhibition therapy from Feb2021 to an unspecified stop date. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8727), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 as dose 1, single for covid-19 immunisation. It was reported No related to a study or programme, Investigation Assessment, Vaccine Administered at emergency room and Physician Office. On an unspecified date, the patient experienced caller experienced side effects (unnamed), A Pharmacist told her the injection may have been given too low on the arm. On 30Apr2021, the patient experienced red, raised, warm, burning spot on left arm. The outcome of the event Red, Raised, Warm, Burning Spot on Left Arm was not recovered and other was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth, Wrong technique in product usage process
Clinical narrative: A Pharmacist told her the injection may have been given too low on the arm; Caller experienced side effects (unnamed); Red, Raised, Warm, Burning Spot on Left Arm; Red, Raised, Warm, Burning Spot on Left Arm; Red, Raised, Warm, Burning Spot on Left Arm; Red, Raised, Warm, Burning Spot on Left Arm; Red, Raised, Warm, Burning Spot on Left Arm; This is a spontaneous report from a contactable consumer (Patient herself) via medical information team. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Er8737), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 13:30 (at the age of 56 years old) as dose 2, single for covid-19 immunisation. Medical history included breast cancer from 2020 to an unknown date Verbatim: Breast Cancer. Additional Information for Other Conditions: Diagnosed 4-5 years ago, ongoing rheumatoid arthritis Verbatim: Rheumatoid arthritis. The Patient Medical continuing: Yes. Concomitant medications included methotrexate sodium (METHOTREXATE [METHOTREXATE SODIUM]) from Feb2021 and ongoing, prednisone (PREDNISONE) and tamoxifen (TAMOXIFEN) taken for breast cancer, aromatase inhibition therapy from Feb2021 to an unspecified stop date. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8727), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 as dose 1, single for covid-19 immunisation. It was reported No related to a study or programme, Investigation Assessment, Vaccine Administered at emergency room and Physician Office. On an unspecified date, the patient experienced caller experienced side effects (unnamed), A Pharmacist told her the injection may have been given too low on the arm. On 30Apr2021, the patient experienced red, raised, warm, burning spot on left arm. The outcome of the event Red, Raised, Warm, Burning Spot on Left Arm was not recovered and other was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood blister, Oral disorder
Clinical narrative: Blood Blister on her cheek on the left side; I felt a little bump in my mouth then when I looked, it was this dark, like their was blood in it.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0165), via an unspecified route of administration, administered in Arm Left on 30Apr2021 (age at the time of vaccination was 47 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03May2021 at 03:00, the patient experienced blood blister on her cheek on the left side and i felt a little bump in my mouth then when i looked, it was this dark, like their was blood in it. It was reported that, the patient received first dose of the vaccine Pfizer covid vaccine on Friday. The patient stated that this morning, at 3am she felt a little bump in her mouth then when she looked, it was this dark, like there was blood in it, a blood blister. She enquired was that something that had been reported as a reaction to the vaccine. She read it could be tied to the rare blood disorder. She asked does she need to go to the ER and if it was a platelet issue. The patient stated that she received her first vaccination on Friday, 30Apr2021. The patient stated that last night, at 03:00a.m. she got a thing in her mouth, a blood blister. She said she have never had any blood blisters before and she had nothing going on with her mouth. She asked if this was a possible side effect and does she need to go to the ER. She enquired was there a possibility of it being the rare blood disorder people were getting. She stated she had no bruises and she wasn't doing anything. She clarified it started today at 03:00a.m, she was finishing up something before she went to bed. She stated it felt like it was getting smaller. She said she wants to know if she should go to the ER to make sure there is no platelet issue or was that something Pfizer heard a lot. Treatment was reported as none. Reporter seriousness for Blood Blister on her cheek on the left side was reported as unspecified. It was reported that this report was not related to a study or programme. Investigation Assessment was reported as no. The outcome of the events was recovering.  No follow-up attempts needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: has had other allergies and has broken out in hives before; she developed hives; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0176, Expiry date: not reported), via intramuscular route of administration in right arm on 29Apr2021 15:00 (at age of 51-years-old) as dose 1, single for covid-19 immunization. Medical history included covid-19 from Mar2021 to an unknown date. No patient medical history (including any illness at time of vaccination) was reported. The patient's concomitant medications were not reported. History of all previous immunization with the bnt162b2 vaccine considered as suspect were none. No additional vaccines administered on same date of the bnt162b2 suspect. It was unknown if the patient had received any other vaccine within 4 weeks. The patient was taking bnt162b2 vaccine to protect self and others. On 29Apr2021 at 17:30, the patient experienced she developed hives and had other allergies and has broken out in hives before on an unspecified date. Further reported that patient had a little on her forehead on Friday 30Apr2021. Definitely Saturday everything was gone. Patient has asked that should or shouldn't she get the second shot scheduled for 20May2021. The patient did not require visit to emergency room or physician office due to the adverse events. No relevant tests were performed. The outcome of the event has had other allergies and has broken out in hives before was unknown while the event hives recovered on 01May2021 (at 18:30).  No follow-up attempts are possible. No further information is expected.