chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Rash, Skin discolouration, Skin exfoliation, Urticaria
Clinical narrative: hives; rash; swirly snake redness; discoloration; skin peeling; This is a spontaneous report from contactable consumer (patient's mother).  A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7984), via an unspecified route of administration, administered in left arm on 20Jul2021 (at the age of 39-years-old) at 16:30-17:00 as dose 1, single for COVID-19 immunisation. Medical history included difficult pregnancy (baby was born at the end of May2021). Family history included diabetes (some diabetes in grandparents). There were no concomitant medications.  The patient experienced hives on 21Jul2021 17:00. On 21Jul2021 (unspecified time) the patient experienced rash, "swirly snake redness" (as reported), discoloration and skin peeling. It was reported that it was exactly almost 24 hours after vaccination that patient developed a rash which she called "odd". The reporter described it as "swirly snake redness" on her arm to shoulder and in the back with some discoloration. She also added that her daughter had large hives on her arm and on her back. Reporter said that her daughter already took Benadryl and Benadryl cream on the hives and it calmed down but they were quite large when they came out. The patient still had discoloration and it was dark with skin peeling. She was at her house and she noticed getting huge hives on upper arms, shoulder and like near her back.  It was literally almost 24 hours, then right away, she called (Available) and they said to take Benadryl and if you have trouble breathing, to get to the ER, but she had no trouble breathing.  She then had a swirly snake redness on her arm to shoulder and is left with discoloration or darkness of skin and a little peeling. She was due to get second shot on Thursday and was really concerned this works out ok. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Fatigue, Loss of personal independence in daily activities, SARS-CoV-2 test
Clinical narrative: I felt out of body like I could not focus for the first day; increasingly more and more dizzy and put off it; I was also exhausted and could barely do anything; havent been able to work since I got the vaccine; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: En6203), via an unspecified route of administration in the left arm on 26Apr2021 at 13:30 (at the age of 37-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient stated that on 26apr2021 14:00, she felt out of body like she could not focus for the first day and then increasingly more and more dizzy and put off it. She was also exhausted and could barely do anything, ended up in urgent care and then the ER. She had not been able to work since she got the vaccine and still struggle everyday with her energy and cognitive levels. The events were assessed to be serious (Disabling/Incapacitating). The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent sars-cov-2 test: negative on 06May2021. The patient received treatment for the events. The clinical outcome for events was recovering.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Computerised tomogram, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: lymph nodes in left  side of neck, total 6 big and small nodes.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0188) via an unspecified route of administration in the left arm on 21May2021 at 14:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0171) via an unspecified route of administration in the right arm on 30Apr2021 at 14:30 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 30Jun2021, the patient underwent test with COVID-19 test (nasal swab) and the result was negative. On 13Jul2021 at 18:15, the patient experienced lymph nodes in left side of neck, total 6 big and small nodes. The event resulted in doctor or other healthcare professional office/clinic visit ,emergency room/department or urgent care . On an unknown date in 2021 patient underwent biopsy, unspecified blood test, (CT) examination and results were unknown. The clinical outcome of the event enlargement of lymph nodes was not recovered.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory disorder, Supraventricular tachycardia
Clinical narrative: SVT; Respiratory problems; This is a spontaneous report from a contactable consumer (patient himself). A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Er2613), via an unspecified route of administration, administered in left arm on 24Mar2021 (age at vaccination: 71 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included diabetes mellitus. The patient did not take concomitant medications (patient did not take any other medications within 2 weeks of vaccination). The patient's historical vaccine included bnt162b2 on an unknown date at 14:00 in left arm as DOSE 1, SINGLE for covid-19 immunisation. The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 12:00, the patient experienced svt (supraventricular tachycardia) and respiratory problems. Onset of SVT within 5 days on second shot also respriatory problems. All the events were considered to be disabling. The event of svt was treated with medications. The adverse events led to Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. It was serios and seriousness criteria not resulted in death, life threatening, caused/prolonged hospitalization, congenital anomaly/birth defect but Seriousness criteria resulted in Disabling/Incapacitating. Prior to vaccination, the patient was diagnosed with COVID-19 nor the patient has been tested for COVID-19 since the vaccination. The outcome of the events was not recovered. The device date was 07Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lupus nephritis, Renal failure, SARS-CoV-2 test
Clinical narrative: Kidney failure; Lupus Nephritis; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself that the 61-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer Covid19) at the age of 61-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 14:00 (Batch/Lot Number: ER8737) as dose 2, single for covid-19 immunisation. Medical history included Diabetis from an unknown date and unknown if ongoing, High blood pressure from an unknown date and unknown if ongoing. She is not pregnant or not pregnant at the time of vaccination. No known allergies. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer Covid19) at the age of 61-year-old in Arm Left on 20Mar2021 14:00 (Batch/Lot Number: EP7534) for covid-19 immunization. The patient experienced kidney failure on 06Jun2021 15:00 with outcome of not recovered , lupus nephritis on 06Jun2021 15:00 with outcome of not recovered.  Seriousness criteria of the events was hospitalization, disability, medically significant, life threatening. The patient was hospitalized for kidney failure and lupus nephritis for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab): unknown results on 2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. It is unknown if the treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Electric shock sensation, Feeling abnormal, Muscle twitching, Nerve injury
Clinical narrative: I got muscle twitches in the left arm where it was injected/it has progressed to twitching over my whole body; severe pain pins and needles electric shocks; severe pain pins and needles electric shocks; severe pain pins and needles electric shocks; feeling like I am wearing Gloves and socks in my arms and legs; My balance is affected; 20% of my nerves are damaged; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration (at the age of 52-years), administered in arm left on 02Apr2021 at 11:00 as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism and high blood pressure, and had allergies to penicillin. Concomitant medications included atenolol, received within 2 weeks of vaccination. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6z06), via an unspecified route of administration (at the age of 52-years), administered in arm left on 15Mar2021 at 09:30 as dose 1, single for COVID-19 immunization and experienced no reaction on previous exposure to drug. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at time of vaccination. On 04Apr2021, It was reported that after the second dose I got muscle twitches in the left arm where it was injected. Now it has progressed to twitching over her whole body. now have severe pain pins and needles electric shocks and feeling like she was wearing, gloves and socks in her arms and legs. Her balance was affected. Her neurologist did a nerve test which was showing 20% of my nerves were damaged. The events were considered as serious (Disabling/Incapacitating) as per reporter. The treatment was not received for all the events. The adverse event result in physician office visit and emergency room visit. The facility where the most recent COVID-19 vaccine was administered was reported as other. The clinical outcome for all the events was reported as not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological examination, Pain, Paraesthesia
Clinical narrative: I got muscle twitches in the left arm where it was injected/it has progressed to twitching over my whole body; severe pain pins and needles electric shocks; severe pain pins and needles electric shocks; severe pain pins and needles electric shocks; feeling like I am wearing Gloves and socks in my arms and legs; My balance is affected; 20% of my nerves are damaged; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration (at the age of 52-years), administered in arm left on 02Apr2021 at 11:00 as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism and high blood pressure, and had allergies to penicillin. Concomitant medications included atenolol, received within 2 weeks of vaccination. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6z06), via an unspecified route of administration (at the age of 52-years), administered in arm left on 15Mar2021 at 09:30 as dose 1, single for COVID-19 immunization and experienced no reaction on previous exposure to drug. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at time of vaccination. On 04Apr2021, It was reported that after the second dose I got muscle twitches in the left arm where it was injected. Now it has progressed to twitching over her whole body. now have severe pain pins and needles electric shocks and feeling like she was wearing, gloves and socks in her arms and legs. Her balance was affected. Her neurologist did a nerve test which was showing 20% of my nerves were damaged. The events were considered as serious (Disabling/Incapacitating) as per reporter. The treatment was not received for all the events. The adverse event result in physician office visit and emergency room visit. The facility where the most recent COVID-19 vaccine was administered was reported as other. The clinical outcome for all the events was reported as not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: Diagnosed with vitiligo in a small area in back, two spots developed within 2 days of second dose.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 10Mar2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, within 2 days of second dose, the patient developed two spots and was diagnosed with vitiligo in a small area in the back. The patient had no family history nor any other prior indications. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with steroid and topical medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diagnosed with vitiligo in a small area in back was not recovered at the time of this report.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Feeding disorder, Muscle atrophy, Vomiting
Clinical narrative: Vomiting when eating pain in stomach.; Vomiting when eating pain in stomach.; Ive lost over 40 pounds since this began; Still unable to eat and keep Food down; Muscle loss; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) reported for himself that.  A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 16Apr2021 09:00 (at the age of 51-years-old) as dose 2, single for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included vitamins nos (VITAMINS NOS) taken for migraine, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727) via an intramuscular route of administration, administered in right arm on 26Mar2021 09:00 (at the age of 51-years-old) as dose 1, single for COVID-19 immunization. On 22Apr2021 07:00 patient experienced, vomiting when eating pain in stomach. Cannot keep anything down can only manage to hold down hard pretzels and cheese. Patient had lost over 40 pounds since this began. No medication can help with the pain in his stomach or help alleviate any of the pain. Still unable to eat and keep food down. Patient had lost over 40 pounds since this began. (Withheld) was worried now about muscle loss. The events assessed as serious (medically significant). Patient received treatment medication for vomiting and pain in stomach. Patient visited doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood test: unknown result (nothing shows wrong with my insides) in 2021. The outcome of the events was reported as not recovered.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Vomiting when eating pain in stomach.; Vomiting when eating pain in stomach.; Ive lost over 40 pounds since this began; Still unable to eat and keep Food down; Muscle loss; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) reported for himself that.  A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 16Apr2021 09:00 (at the age of 51-years-old) as dose 2, single for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included vitamins nos (VITAMINS NOS) taken for migraine, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727) via an intramuscular route of administration, administered in right arm on 26Mar2021 09:00 (at the age of 51-years-old) as dose 1, single for COVID-19 immunization. On 22Apr2021 07:00 patient experienced, vomiting when eating pain in stomach. Cannot keep anything down can only manage to hold down hard pretzels and cheese. Patient had lost over 40 pounds since this began. No medication can help with the pain in his stomach or help alleviate any of the pain. Still unable to eat and keep food down. Patient had lost over 40 pounds since this began. (Withheld) was worried now about muscle loss. The events assessed as serious (medically significant). Patient received treatment medication for vomiting and pain in stomach. Patient visited doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood test: unknown result (nothing shows wrong with my insides) in 2021. The outcome of the events was reported as not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dyspnoea, Lung disorder, Swelling face
Clinical narrative: my face began to swell; my BP went to 198/120 plus 110/196/110 plus still at 110; I was unable to breath and chocking on my own fluids in my lungs; My lungs were chocking me; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in left arm on 30Jul2021 at 14:15 (Batch/Lot Number: FA7485) as a single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD), chronic myeloid leukaemia (CML) in remission and heart condition. Concomitant medications included topiramate, metoprolol and lisinopril; all taken for an unspecified indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. About thirty minutes after the injection at 16:00, the patient face began to swell, and her BP went to 198/120 plus 110. Then 2 hours later she was rushed to hospital and was unable to breath and chocking on her own fluids in her lungs. She arrived at hospital unable to breathe nor catch her breath. Her lungs were chocking her, and her BP was 196/110 plus still at 110. After entering emergency room (ER) they had no clue what to do and treated her as a covid patient. She needed a nebulizer and was told the ER doctor couldn't give it to her there and no beds were available. The doctor gave her pills without explaining and then kept treating her like she came in for covid. She had the worst reaction of her life and was treated horribly. The doctor did not give her discharge paperwork, nor did hospital follow up. It was not until she went yesterday to her GP and he even said the notes were missing information, also the doctor supposedly sent me with prescriptions which she never got. She encountered, all side effects of the shot. The adverse events resulted in emergency room/department or urgent care. The outcome of the events was recovered with sequel.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose-event temporal relationship likely hypersensitivity post-vaccination  the causal role of  bnt162b2 vaccine cannot be excluded for reported events. Underlying CMLL and chronic onstructive pulmonary disease are significant risk factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Pain, Pain in extremity
Clinical narrative: Some pain right from the arm where there shot was administered coming right up to the area of collar bone on right/ There seems to be some sort of crumb forming around collar bone and very painful; There seems to be some sort of crumb forming around collar bone; Some pain right from the arm where there shot was administered; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old, male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO198) via an unspecified route of administration in the right arm on 03Aug2021 at 13:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history and known allergies were reported as not available. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date 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: EWO186) via an unspecified route of administration in the right arm on 13Jul2021 at 11:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 05Aug2021 at 04:30, the patient experienced some pain right from the arm where the shot was administered and came right up to the area of collar bone on right, there seemed to be some sort of crumb forming around collar bone and was very painful. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events some pain right from the arm where there shot was administered and came right up to the area of collar bone on right, there seemed to be some sort of crumb forming around collar bone and very painful were not recovered at the time of this report.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Influenza like illness, Loss of personal independence in daily activities, Pain
Clinical narrative: body aches/ Body continues to feel very achy; slight fever/occasional low fever; chest pain; difficulty taking a deep breath; inability to exercise; sleep disturbances; Body continues to feel very achy like the flu; shooting pains in limbs; occasional tremor in hands and feet; This is a spontaneous report from a contactable consumer (reported for himself).   A 20-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0178/Batch number was not reported), dose 2 via an unspecified route of administration on 25May2021 (at the age of 20-years-old) as dose 2, single for covid-19 immunisation at Pharmacy. Medical history included pectus excavatum from an unknown date and unknown if ongoing (Other medical history: Medical history includes Nuss procedure to correct pectus excavatum), mite allergy from an unknown date and unknown if ongoing (Known allergies: only dust mites). The patient's concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0176/Batch number was not reported), dose 1 via an unspecified route of administration on 04May2021 (at the age of 20-years-old) as dose 1, single for covid-19 immunisation at Pharmacy. On 26May2021 at 10:00, the patient experienced body aches/ body continues to feel very achy, slight fever/occasional low fever, chest pain, difficulty taking a deep breath, inability to exercise, sleep disturbances, body continues to feel very achy like the flu, shooting pains in limbs and occasional tremor in hands and feet. The case assessed as serious disability. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date in Jun2021 (Nasal Swab). Therapeutic measures were taken as a result of events included treatment with Diagnostic tests and trial of medicines. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test, Sleep disorder, Tremor
Clinical narrative: body aches/ Body continues to feel very achy; slight fever/occasional low fever; chest pain; difficulty taking a deep breath; inability to exercise; sleep disturbances; Body continues to feel very achy like the flu; shooting pains in limbs; occasional tremor in hands and feet; This is a spontaneous report from a contactable consumer (reported for himself).   A 20-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0178/Batch number was not reported), dose 2 via an unspecified route of administration on 25May2021 (at the age of 20-years-old) as dose 2, single for covid-19 immunisation at Pharmacy. Medical history included pectus excavatum from an unknown date and unknown if ongoing (Other medical history: Medical history includes Nuss procedure to correct pectus excavatum), mite allergy from an unknown date and unknown if ongoing (Known allergies: only dust mites). The patient's concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0176/Batch number was not reported), dose 1 via an unspecified route of administration on 04May2021 (at the age of 20-years-old) as dose 1, single for covid-19 immunisation at Pharmacy. On 26May2021 at 10:00, the patient experienced body aches/ body continues to feel very achy, slight fever/occasional low fever, chest pain, difficulty taking a deep breath, inability to exercise, sleep disturbances, body continues to feel very achy like the flu, shooting pains in limbs and occasional tremor in hands and feet. The case assessed as serious disability. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date in Jun2021 (Nasal Swab). Therapeutic measures were taken as a result of events included treatment with Diagnostic tests and trial of medicines. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary fibrosis, SARS-CoV-2 test
Clinical narrative: Pulmonary fibrosis; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in right arm on 18Apr2021 12:30 (age at vaccination was 58 years) (Batch/Lot Number: EW0161) as dose 1, single for covid-19 immunization. Medical history included cardiac failure congestive from an unknown date. Concomitant medication included valsartan (VALSARTAN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had tested negative for COVID-19 since the vaccination. On 21Apr2021, at 12:00am after receiving the vaccine the patient experienced pulmonary fibrosis resulted in emergency room visit, Disability or permanent damage. The patient stayed 7 days in the hospital. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 30Apr2021 Post vaccination. The patient received treatment for the events. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Head injury, Loss of consciousness
Clinical narrative: I must have blacked out for a second; Woke up cold the following morning; I then felt light headed. I couldn't hold my head up; I couldn't hold my head up; feeling weak; I hit my head when I fell.; arm was sore where I got the shot.; This is a spontaneous report from a contactable consumer (reported himself). A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0183), via an unspecified route of administration, administered in arm right on 06Aug2021 17:30 (age at vaccination 15-year-old) as dose 1, single for COVID-19 immunisation and school or student health clinic. The patient medical history was not reported. The patient concomitant medication was vitamin C (unspecified) received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient stated that on 07Aug2021 09:00, he woke up cold the following morning. Patient sat down to eat breakfast at the kitchen table. Patient stated that "I then felt lightheaded. I couldn't hold my head up". Patient stated that his body just went limp. Patient was feeling weak, then patient went sideways. Patient stated that "I must have blacked out for a second" because the next thing patient know, her mother was picking me up from the floor. Patient stated that "I hit my head when I fell". The rest of the day patient felt weak, his head hurt, and patient stated that "arm was sore where I got the shot". The patient received acetaminophen as the treatment for the events. The patient was not hospitalization. Since the vaccination, the patient had not tested for COVID-19. The outcome of the events was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Vaccination site pain
Clinical narrative: I must have blacked out for a second; Woke up cold the following morning; I then felt light headed. I couldn't hold my head up; I couldn't hold my head up; feeling weak; I hit my head when I fell.; arm was sore where I got the shot.; This is a spontaneous report from a contactable consumer (reported himself). A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0183), via an unspecified route of administration, administered in arm right on 06Aug2021 17:30 (age at vaccination 15-year-old) as dose 1, single for COVID-19 immunisation and school or student health clinic. The patient medical history was not reported. The patient concomitant medication was vitamin C (unspecified) received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient stated that on 07Aug2021 09:00, he woke up cold the following morning. Patient sat down to eat breakfast at the kitchen table. Patient stated that "I then felt lightheaded. I couldn't hold my head up". Patient stated that his body just went limp. Patient was feeling weak, then patient went sideways. Patient stated that "I must have blacked out for a second" because the next thing patient know, her mother was picking me up from the floor. Patient stated that "I hit my head when I fell". The rest of the day patient felt weak, his head hurt, and patient stated that "arm was sore where I got the shot". The patient received acetaminophen as the treatment for the events. The patient was not hospitalization. Since the vaccination, the patient had not tested for COVID-19. The outcome of the events was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Condition aggravated, Influenza like illness, Pain, SARS-CoV-2 test
Clinical narrative: Severe chest tightness and severe pain; Severe chest tightness and severe pain; flu like symptoms; chest pains have gotten worse; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 28-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EW0185), via an unspecified route of administration, administered in Arm Left on 28Jul2021 15:00 (at the age of 28-Years-old) as dose 1, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as other. Medical history was reported as none. There were no concomitant medications. No known allergies were reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). No other medications the patient received within 2 weeks of vaccination. The patient experienced severe chest tightness and severe pain, flu like symptoms and chest pains have gotten worse on 29Jul2021. The patient was hospitalized for severe chest tightness and severe pain, flu like symptoms and chest pains have gotten worse for 1 day. The adverse event resulted in visiting of emergency room/ department or urgent care. The adverse events were considered as serious with seriousness criteria of hospitalization. Patient went to the emergency room for pain and chest pain was worse over 9 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07Aug2021. No treatment was received for the reported events. The outcome of the events was reported as not recovered.
Age: 90.0
Sex: U
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Gait disturbance, Head injury, Neuropathy peripheral
Clinical narrative: I had a seizure before, I got down and head hit on the wall.; I had a seizure before, I got down and head hit on the wall.; I had a seizure before, I got down and head hit on the wall.; I have neuropathy in my head so bad. It's very hard for me to write.; I can barely walk.; I am suffering so bad; This is a spontaneous report from a contactable consumer (patient). A 90-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 02Aug2021 (at the age of 90 years old) as dose 1, single for COVID-19 immunization. Medical history included menstrual seizure, iritis. Concomitant medication included "lot of medications" as reported by the patient. No other vaccine was administered prior to COVID vaccine. The patient experienced "i had a seizure before, i got down and head hit on the wall" on 06Aug2021, "i have neuropathy in my head so bad, it's very hard for me to write, i am suffering so bad, i can barely walk" on an unspecified date on Aug2021. Patient have lot of medical problems, and lot of health issues but well. Patient wouldn't feeling that bad, just the few weeks before, patient was diagnosed with iritis and have history of having menstrual seizures. Patient took the vaccination this past Monday (02Aug2021) and patient was going on well. This Friday (06Aug2021) after patient took it, When patient was walked into the room that, patient go to wait. Patient had a seizure before, patient got down and head hit on the wall. Patient took the first one on Monday and due to take second which the 23rd of this month. What to do. Patient was suffering so bad. Patient don't feel up to, have neuropathy in head so bad It's very hard for patient to write. Outcome of all the events were unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 90.0
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: I had a seizure before, I got down and head hit on the wall.; I had a seizure before, I got down and head hit on the wall.; I had a seizure before, I got down and head hit on the wall.; I have neuropathy in my head so bad. It's very hard for me to write.; I can barely walk.; I am suffering so bad; This is a spontaneous report from a contactable consumer (patient). A 90-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 02Aug2021 (at the age of 90 years old) as dose 1, single for COVID-19 immunization. Medical history included menstrual seizure, iritis. Concomitant medication included "lot of medications" as reported by the patient. No other vaccine was administered prior to COVID vaccine. The patient experienced "i had a seizure before, i got down and head hit on the wall" on 06Aug2021, "i have neuropathy in my head so bad, it's very hard for me to write, i am suffering so bad, i can barely walk" on an unspecified date on Aug2021. Patient have lot of medical problems, and lot of health issues but well. Patient wouldn't feeling that bad, just the few weeks before, patient was diagnosed with iritis and have history of having menstrual seizures. Patient took the vaccination this past Monday (02Aug2021) and patient was going on well. This Friday (06Aug2021) after patient took it, When patient was walked into the room that, patient go to wait. Patient had a seizure before, patient got down and head hit on the wall. Patient took the first one on Monday and due to take second which the 23rd of this month. What to do. Patient was suffering so bad. Patient don't feel up to, have neuropathy in head so bad It's very hard for patient to write. Outcome of all the events were unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dry throat, Muscular weakness, Nausea, Pyrexia
Clinical narrative: fever/the fever started to skyrocket to 104 or 105.; Dry throat; feeling a bit nauseous; lower body feels weak; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 14-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 03Aug2021 16:00 (Batch/Lot Number: SC3180) as dose 1, single for COVID-19 immunization at a pharmacy. The patient has no medical history and concomitant medications. No history of previous immunization with the Pfizer vaccine. No additional vaccines administered on same date. No vaccinations 4 weeks prior. No relevant tests. On 04Aug2021 03:00, the patient experienced fever/the fever started to skyrocket to 104 or 105, dry throat, feeling a bit nauseous, and lower body feels weak. The patient got the fever of 104 in the morning after the vaccine, now it has lowered to 102 but stayed consistently at 102. He has been taking ibuprofen 600mg for the fever. He took them every eight hour, one each eight hours. It has been breaking up his fever since it lowered it from 104 to 102. The patient underwent lab tests and procedures which included body temperature: 104 or 105 (fever) on 04Aug2021 at 03:00, body temperature: 104 (fever) on 04Aug2021 morning after vaccination, and body temperature: 102 on 06Aug2021. The outcome of the event fever and dry throat was not recovered, for the event nauseous was recovered on an unspecified date, for lower body feels weak was recovered on 04Aug2021.   Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tinnitus
Clinical narrative: Ringing in Left ear; Low nausea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 03Aug2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Aug2021, the patient experienced ringing in left ear and low nausea. 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 ringing in left ear and low nausea was not recovered at the time of this report.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Musculoskeletal stiffness
Clinical narrative: Arthritis pain in finger of dominant hand on a daily basis, started to occur 2 months after receiving 2nd dose. I wake up with my ring finger folded and all fingers feeling very stiff. I need to stretch my hand to get relief.; Arthritis pain in finger of dominant hand on a daily basis, started to occur 2 months after receiving 2nd dose. I wake up with my ring finger folded and all fingers feeling very stiff. I need to stretch my hand to get relief.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 17Apr2021 at 09:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously had shellfish and experienced shellfish allergy. Concomitant medications taken within two weeks of vaccination included low dose acetylsalicylic acid (ASPIRIN). The patient previously took ciprofloxacin (CIPRO) for unknown indication on unknown date and experienced drug allergy. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 28Mar2021 at 09:00 (at the age of 50-years-old) 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 not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arthritis pain in finger of dominant hand on a daily basis, started to occur from 01Jun2021 at 06:30, two months after receiving second dose. The patient woke up with his ring finger folded and all fingers feeling very stiff. The patient needed to stretch his hand to get relief. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event arthritis pain in finger of dominant hand on a daily basis, started to occur from 01Jun2021 at 06:30, two months after receiving second dose; the patient woke up with his ring finger folded and all fingers feeling very stiff; the patient needed to stretch his hand to get relief was not resolved at the time of this report.