chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: fever of 102; feeling unwell; This is a spontaneous report received from a non-contactable consumer via Pfizer Colleague. This consumer reported for a male patient (boyfriend) that.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of vaccine BNT162B2 (formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. During a group discussion, an acquaintance mentioned that after receiving the 2nd injection of Pfizer BioNTech COVID-19 vaccine, her boyfriend (Name) had a fever of 102 for a number of hours and was feeling unwell during that time. Once the fever was gone, (Name) felt fine again. The patient experienced fever of 102 and feeling unwell both on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 102 on unspecified date. The clinical outcome of the events was unknown.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Slight throat swelling; This is a spontaneous report from a contactable Nurse (patient). A 34-years-old female patient received BNT162 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on an unspecified date in May2021 (age at vaccination: 34years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in May2021, slight throat swelling. It was reported that patient had received her first dose of Pfizer covid vaccine 2 weeks ago and experienced slight throat swelling within 5 mins of taking vaccine. It lasted for about 20-25 mins and then went away. she was wondering if she should get the second dose. The outcome of the event was recovered on an unspecified date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: swollen arm and itching; swollen arm and itching; This is a spontaneous report from a contactable consumer (patient) via medical information team. An 83-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported. The patient wants to know if there is any content on the Pfizer COVID 19 vaccine that is similar to the pneumonia vaccine before taking the vaccine. She had the pneumonia shot few years ago can't remember exactly the brand was, she had swollen arm and itching on unspecified date. The outcome of the events was unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate 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 conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itching rash on  both arms and legs.; This is a spontaneous report received from a contactable consumer (patient reported for himself). A 54-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EF8736, Expiration date: Unknown), via an unspecified route of administration, administered in Arm right on 07May2021 (age at vaccination: 54 years) as dose number unknown, single for COVID-19 immunisation. The patient medical history was none. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The patient received most recent COVID-19 vaccine facility in pharmacy or drug store. 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 has not been tested for COVID-19. On 19May2021 the patient experienced itching rash on both arms and legs. Patient was no prolonged hospitalization. Patient visits emergency room, department or urgent care. Treatment was received for the event as steroid shot and hydrolyzed prescription as a treatment for itching rash on both arms and legs. The outcome of the events was reported as unknown.  Follow-Up (16Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: had a little rash; experienced much severe pain; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiration date: unknown), via an unspecified route of administration on 18May2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were unknown. Historical vaccine included, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 05Apr2021 as dose 1, single for COVID-19 immunisation and experienced heart attack (13May2021) and shingles (16May2021). The patient had the second dose on 18May2021, the patient was not aware he had a shingles outbreak on 16May2021. Stated that he had internal shingles, which was different from what he previously had. On an unknown date, the patient only had a little rash, which was not that bad on the outside, but experienced much severe pain. The patient asked shingles may affect the second dose of the vaccine. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Mass, Pruritus, Scar
Clinical narrative: 1st dose: 24Mar2021; 2nd dose: 24Mar2021; Mysterious bumps ("bite like") bumps forming; Extremely itchy; form in a row (arms, torso, crusted, leaving dark scars; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: EW0153), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 15:00 (at the age of 54-years-old) as DOSE 2, SINGLE for covid-19 immunization at pharmacy or drug store. The patient medical history was not reported. Concomitant medication(s) included venlafaxine 37.5 mg, taken for an unspecified indication, start and stop date were not reported. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection, batch/lot number: ER8732), via an unspecified route of administration, administered in arm left on 24Mar2021 at 15:00 as dose 1, single for covid-19 immunization and after 4 days experienced bumps, extremely itchy, crusted and left dark scars. The patient previously took, septra and experienced allergy. The patient did not receive any other vaccines within 4 weeks. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient received both the doses on 24Mar2021. On an unspecified date, patient developed mysterious bumps (bite like) bumps forming, extremely itchy, form in a row (arms, torso, crusted, leaving dark scars for which patient had to visit doctor or other healthcare professional office/clinic visit. The patient did not received any treatment for the events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: aches and pains; This is a spontaneous report received from contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria CRM 197 Protein) (PREVNAR 13), via an unspecified route of administration in 2015 (batch/lot number was not reported) as single dose for immunization.  The patient's medical history and concomitant medications were not reported. The patient informed that six years ago (unspecified date), she got the pneumonia shot and had aches and pains but it went away for 3 days (revcovered).   No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Nausea, Neck pain
Clinical narrative: Burning where injected and through chest and neck for 4 days strong; hurts to move left arm or my neck; hurts to move left arm or my neck; nausea; tiredness; fever; chills; sweats; This is a spontaneous report from a contactable consumer (Patient, self-reported).  A 36-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8736 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 19May2021 at 03:45 PM, as DOSE 1, SINGLE for COVID-19 immunization (age at vaccination: 36 year). The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included gabapentin (GABAPENTIN). The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 19May2021 at 20:00, the patient experienced burning where injected and through chest and neck for 4 days strong now hurts to move left arm or my neck, nausea, tiredness, fever, chills, sweats. The AE did not result in emergency room or physician office visit. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Burning where injected and through chest and neck for 4 days strong; hurts to move left arm or my neck; hurts to move left arm or my neck; nausea; tiredness; fever; chills; sweats; This is a spontaneous report from a contactable consumer (Patient, self-reported).  A 36-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8736 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 19May2021 at 03:45 PM, as DOSE 1, SINGLE for COVID-19 immunization (age at vaccination: 36 year). The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included gabapentin (GABAPENTIN). The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 19May2021 at 20:00, the patient experienced burning where injected and through chest and neck for 4 days strong now hurts to move left arm or my neck, nausea, tiredness, fever, chills, sweats. The AE did not result in emergency room or physician office visit. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Rash, Urticaria
Clinical narrative: Fever; Muscle aches; Fatigue; Rash/hives at injection site and on arms; Rash/hives at injection site and on arms; Rash/hives at injection site and on arms; Rash/hives at injection site and on arms; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports. A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0168, expiration date was not reported), via an unspecified route of administration, administered in left arm on 19May2021 at 01:00 (at the age of 32-years-old) as dose 2, single for covid-19 immunization. The patient medical history included blood pressure high. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC), loratadine, pseudoephedrine sulfate (CLARITIN-D) both taken for unknown indications from an unknown date. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0176, expiration date was not reported), via an unspecified route of administration, administered in left arm on 28Apr2021 at 14:45 (at the age of 32-years-old) as dose 1, single for covid-19 immunization and experienced rash/hives at injection site and on arms. The patient previously received vancomycin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021 the patient experienced rash/hives at injection site and on arms. On 20May2021 at 07:00, the patient experienced fever, muscle aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events rash/hives at injection site and on arms, fever, muscle aches and fatigue were recovered on an unknown date in May2021.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site urticaria
Clinical narrative: Fever; Muscle aches; Fatigue; Rash/hives at injection site and on arms; Rash/hives at injection site and on arms; Rash/hives at injection site and on arms; Rash/hives at injection site and on arms; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports. A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0168, expiration date was not reported), via an unspecified route of administration, administered in left arm on 19May2021 at 01:00 (at the age of 32-years-old) as dose 2, single for covid-19 immunization. The patient medical history included blood pressure high. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC), loratadine, pseudoephedrine sulfate (CLARITIN-D) both taken for unknown indications from an unknown date. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0176, expiration date was not reported), via an unspecified route of administration, administered in left arm on 28Apr2021 at 14:45 (at the age of 32-years-old) as dose 1, single for covid-19 immunization and experienced rash/hives at injection site and on arms. The patient previously received vancomycin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021 the patient experienced rash/hives at injection site and on arms. On 20May2021 at 07:00, the patient experienced fever, muscle aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events rash/hives at injection site and on arms, fever, muscle aches and fatigue were recovered on an unknown date in May2021.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Debilitating elbow pain/ joint pain In left elbow that has not subsided/elbow pain/ Following covid vax in left arm arthritis type pain developed in 24 hrs and has been persistant; Debilitating elbow pain/ joint pain In left elbow that has not subsided/elbow pain/ Following covid vax in left arm arthritis type pain developed in 24 hrs and has been persistant; This is a spontaneous report from a contactable other Health Care Professional (patient). A 42-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ep6955), via an unspecified route of administration in left arm on 27Mar2021 12:00 as (at the age of 42 years old, not pregnant at the time of vaccination) dose 1, single for covid-19 immunisation. Medical history included covid prior vaccination. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 28Mar2021 patient experienced debilitating elbow pain/ joint pain In left elbow that has not subsided. Following covid vaccine in left arm arthritis type pain developed in 24 hours and has been persistent. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731), via an unspecified route of administration in left arm on 17Apr2021 at 12:00 for covid-19 immunization. No relevant tests were performed. The patient did not received treatment due to the events. No hospitalization required. Reporter considered events as non-serious. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain in extremity, Rash
Clinical narrative: Rash; Muscle pain; It is red and sore; like somebody punched me in the arm; Muscle pain; It is red and sore; like somebody punched me in the arm; Muscle pain; It is red and sore; like somebody punched me in the arm; This is a spontaneous report received from a contactable consumer (patient's boyfriend) or other non-healthcare professional. A 57-year-old female patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0183, Expiry Date: un-known), via an unspecified route of administration on 20May2021 (at the age of 57-year-old), as a single dose for COVID-19 immunization. Medical history included hypertension, hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included Lisinopril taken for hypertension, start and stop date were not reported, alendronate taken for hypothyroidism, start and stop date were not reported. On 20May2021 the patient experienced rash, muscle pain it is red and sore like somebody punched me in the arm. Patient had first shot yesterday (20May2021). 5 hours after patient got the shot (20May2021) had Muscle pain; It is red and sore; like somebody punched me in the arm, stated that It started last night little bit this morning patient's arm is sore and red." It was like somebody punched me in the arm. So, he soreness. That is what it felt like. Patient had some muscle pain and some rash on it. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Parosmia, Rhinorrhoea, Sneezing
Clinical narrative: itchy eyes; Sensitivity to strong odors; unstoppable sneezing; continuous runny nose; This is a spontaneous report from a non-contactable consumer (patient). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 04Apr2021 at 12:00 (at the age of 41-years-old) as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. There were no known allergies. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 08:45 as dose 1, single for COVID-19 immunization. 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 not been tested for COVID-19. The patient experienced itchy eyes, sensitivity to strong odors, unstoppable sneezing and continuous runny nose on 14Apr2021 12:00. The patient did not receive any treatment for the events. The clinical outcome for the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dyspnoea, Headache, Lymph node pain, Mood altered
Clinical narrative: I start having lymph nodes under my armpits painful like to small balls; I can feel something like soreness and pain; change the mood; having headache; You have you hit your arm; that you cannot even breath; I start having lymph nodes under my armpits painful like to small balls; I can feel something like soreness and pain; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that,  A 62-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0171; Expiration Date: 31Aug2021) (at the age of 62 years old), dose 1 via an unspecified route of administration, administered in arm left on 01May2021 as dose 1, single for covid-19 immunisation. Medical history included blood pressure measurement from an unknown date and unknown if ongoing Verbatim: Blood pressure. There were no concomitant medications. It was reported that patient took her first vaccine dose on 01May 2021, on 03May2021 she had lymph nodes under her armpits painful like to small balls, she could feel something like soreness and pain which was coming to her side of her toothbrush and since she was still having the same thing but it was not like constant it went and came back but when it came like the soreness it felt like sometimes it was like, she even had to change the mood, having headache, she hit her arm and started pressing on that arm were she felt that she could not even breath, right like a lump, her second vaccine shot was next day. She took Tylenol and gabapentin as a treatment. The outcome for the events was not recovered.  Follow-up (02Jul2021): Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I start having lymph nodes under my armpits painful like to small balls; I can feel something like soreness and pain; change the mood; having headache; You have you hit your arm; that you cannot even breath; I start having lymph nodes under my armpits painful like to small balls; I can feel something like soreness and pain; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that,  A 62-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0171; Expiration Date: 31Aug2021) (at the age of 62 years old), dose 1 via an unspecified route of administration, administered in arm left on 01May2021 as dose 1, single for covid-19 immunisation. Medical history included blood pressure measurement from an unknown date and unknown if ongoing Verbatim: Blood pressure. There were no concomitant medications. It was reported that patient took her first vaccine dose on 01May 2021, on 03May2021 she had lymph nodes under her armpits painful like to small balls, she could feel something like soreness and pain which was coming to her side of her toothbrush and since she was still having the same thing but it was not like constant it went and came back but when it came like the soreness it felt like sometimes it was like, she even had to change the mood, having headache, she hit her arm and started pressing on that arm were she felt that she could not even breath, right like a lump, her second vaccine shot was next day. She took Tylenol and gabapentin as a treatment. The outcome for the events was not recovered.  Follow-up (02Jul2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood glucose, Pain, Somnolence
Clinical narrative: so sore everywhere; could not stay awake; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Eisai (manufacturer control number: EC-2021-092984). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 12May2021 as dose 2, single for covid-19 immunisation and lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 11May2021 (Batch/Lot number was not reported) to an unspecified date, at 20 mg, daily for thyroid cancer. Medical history included Malignant neoplasm of thyroid gland (diagnosis/ lCD code: C73 (ICD-IO-CM)). The concomitant medications were not reported. The patient received first dose of bnt162b2 on an unknown date for covid-19 immunization. On 12May2021 the patient experienced so sore everywhere and could not stay awake. It was reported that the patient had been tried to get his blood sugar under control prior to starting Lenvima and patient was on Lantus. Patient reported that he was really tired, no energy, fatigue. Cause thought to be related to Lenvima and occurred while on Lenvima. Patient reported he received his second Pfizer COVID shot on 12May2021 and on same day the patient reported he was so sore everywhere and could not stay awake after the shot. Patient said those symptoms from the shot lasted for about 24 hours. Cause was not thought to be related to Lenvima but occurred while on Lenvima. Patient reported his tongue felt like it was burned, it hurts. Cause thought to be related to Lenvima and occurred while on Lenvima. Patient reported blurred vision up close but thought that might be from his Lantus he was took. Patient was unsured if it began prior to Lenvima, or after started Lenvima. Cause unknown but occurred while on Lenvima. Patient reported he was still tried to get his blood sugar under control, & this began prior to Lenvima. Patient reported his Blood Sugar has been in the high hundreds recently and it was 140 this morning (18May2021). Patient was taking Lantus to tried to control his Blood sugar. Cause was not stated to be from Lenvima but had continued to occur while on Lenvima. Action taken with Lenvima was unknown. The patient underwent lab tests and procedures which included blood glucose: high hundreds on an unknown date and blood glucose: 140 on 18May2021. The outcome of the events was resolved on an unknown date in May2021.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Scab
Clinical narrative: Rash from my hips up to my neck and back of ears covering my entire back, arms, torso, breasts, neck. Very very itchy, dots and kind of scabby.; Very very itchy, dots and kind of scabby.; Rash from my hips up to my neck and back of ears covering my entire back, arms, torso, breasts, neck. Very very itchy, dots and kind of scabby.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) reported for herself. A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0167), dose 1 via an unspecified route of administration, administered in left arm on 05May2021 at 20:45 (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation at pharmacy or drug store. The patient's medical history and concomitant medications were not reported. No other medical history was reported. The patient previously took amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced rash from my hips up to my neck and back of ears covering my entire back, arms, torso, breasts, neck. very very itchy, dots and kind of scabby on 16May2021 at 18:30. The event had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. No treatment was received for the events. The outcome of the events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed strange hive-like rash on injection arm top from about elbow down and top of right hand on same arm.; Incredibly itchy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 45-years-old non pregnant female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 14Apr2021 14:30 (Batch/Lot number was not reported) (at the age of 45-years-old) as dose 1, single for covid-19 immunisation. Medical history included high blood pressure, obesity, asthma, mitral-valve prolapse, Known allergies:  Polyester allergy, Bee allergy from an unknown date and unknown if ongoing. The patient concomitant medication included VITAMIN D [ERGOCALCIFEROL], zinc, ascorbic acid (VITAMIN C CITRUS); all taken for an unspecified indication, start and stop date were not reported. The patient had known allergies for polyester allergy and bee allergy. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient diagnosis for COVID-19 prior to vaccination was unknown and had not been tested since the vaccination. On 05May2021 13:00, the patient developed strange hive-like rash on injection arm top from about elbow down and top of right hand on same arm and incredibly itchy. Almost unbearable for patient at times. Cortisone 10 clear salve helped patient eventually. The patient received treatment for itchy and for the remaining event not received. The outcome of the events was not recovered at the time of report.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Rash, Skin burning sensation, Skin erosion
Clinical narrative: Started from my hand on the top of my hand gets really red,; the heels of my feet has like a red rash and it just feels raw; COVID toes; really red, so raw; have a couple of toes and each foot that are red around the cuticle and then the heels of my feet has like a red rash and it just feels raw; COVID toes; Felt like a raw burning in my hand; This is a spontaneous report from a contactable consumer. A 62 year patient of unspecified gender had received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-EW0179 ) via an unspecified route of administration on 10May2021 (Age at vaccination 62-years-old) into arm left as DOSE  2 SINGLE for COVID-19 immunization.The patient medical history and concomitant were not reported. The patient previously took BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on unspecified date as DOSE1,SINGLE for COVID-19 immunization. On 19May2021 the patient had experienced rash and felt like a raw burning in my hand and now noticing that patient have like red round the couple of toes and a rash on top of foot and heels of feet. They feel raw and looked it up it said COVID toes. Therapeutic measures were taken for the AE and treatment was included with putting Aloe Vera gel on it so to sooth like a little bit. It's not itchy but it is some sort of a rash. Really don't know what. The clinical outcome of the events were unknown.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Inflammation
Clinical narrative: Slight kind of dizziness kind of feeling; I got the inflammations all the different symptoms after I got the vaccine not before; This is a spontaneous report from a contactable consume reported that. 75-years-old patient of an unspecified gender received BNT162B2 (- BioNTech/Pfizer vaccine solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 20May2021 (Batch/Lot Number: EW0185; Expiration Date: 31Jul2021) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination 75 years). The patient past medical history included blood cholesterol from an unknown date and unknown if ongoing and blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication(s) included atorvastatin (ATORVASTATIN) taken for blood cholesterol, start and stop date were not reported; hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for blood pressure measurement, start and stop date were not reported. The patient reported after the COVID-19 Vaccine on last Thursday on unspecified date in May2021 the patient experienced have been having just slight dizziness kind of, I am trying to get an idea along this from last, there was another problem that I had is that I got the inflammations you know all the different symptoms after I got the vaccine not before, that's one problem And I am trying to understand along this here, my last everything else is alright, but I am just since like a very slight kind of dizziness kind of feeling. The event outcome was unknown.  Consumer schedule for second shot will be on 10Jun2021(left shoulder). When confirmed if consumer wanted information about having slight dizziness, consumer stated, "Yes, very slight, nothing serious. Consumer was provided the number of Pfizer Medical Information Department.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (mentioned as 20th) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Clinical course reported as when probed if patient wants to report adverse event (rash), patient stated, Yes, not sure of what it was but was curious. The patient experienced rash on an unspecified date. Outcome of the event was unknown at the time of reporting.   Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Pyrexia
Clinical narrative: She is really achy; She has got a 101.3 fever; Nausea; Headache; This is a spontaneous report received from a contactable consumer or other non-healthcare professional. A 43-years-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 22May2021 (age at vaccination 43-years-old) as dose 2, single for COVID-19 immunisation. Medical history included was not included. Concomitant medications included Methadone for an unspecified indication. Patient previously took novocain and experienced drug hypersensitivity and lidocaine and experienced drug hypersensitivity. The patient previously 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 an unspecified date as dose 1, single for COVID-19 immunisation. Reporter stated, Me and my wife both got the Pfizer Covid 19 second the second shot on yesterday and I am not experiencing any side effects but she is really achy, she has got a 101.3 fever, nausea, headache and its been going on over 24 hours on 22May2021. No treatment was received for the events. The patient underwent lab tests and medical procedures which included body Temperature: 101.3 on 22May2021 and body Temperature: 101.3 on 23May2021. The outcome of the events was reported as not recovered.  Information on lot/ batch number has been requested.  Follow-up (29Jun2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling, Urticaria
Clinical narrative: The caller states the rash is persisting, nothing beats the first time the caller witnessed the rash. The rash was swollen like a new tattoo; The caller states the rash is persisting, nothing beats the first time the caller witnessed the rash. The rash was swollen like a new tattoo; Skin reaction was hives; The caller basically has been itching all over since Saturday evening; This is a spontaneous report from a contactable consumer (Patient). A 26-years-old male patient received bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Batch/Lot Number: ER8736), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 on Thursday of last week as DOSE 2, SINGLE for covid-19 immunisation (at the age of 26 Years). Medical history and concomitant medications were not reported. The patient previously took bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Batch/Lot Number: ER8736), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 as DOSE 1, SINGLE for covid-19 immunisation at the age 26 years. No investigation assessment. The patient experienced on 22May2021 the reaction started happening about two days after the caller received the second dose Pfizer Covid 19 Vaccine. The caller reports the skin reaction was hives. The caller basically has been itching all over since Saturday evening, 22May2021. The caller stated on an unspecified date the hives are ongoing and persisting to keep it short. The caller stated the rash is persisting, nothing beats the first time the caller witnessed the rash. The rash was swollen like a new tattoo. The caller stated he had no reactions after receiving the first dose Pfizer Covid 19 Vaccine. Skin reaction was hives with outcome of not recovered, the caller basically has been itching all over since Saturday evening and the caller states the rash is persisting, nothing beats the first time the caller witnessed the rash. the rash was swollen like a new tattoo with outcome of unknown.   Follow-up (29Jun2021): Follow-up attempts completed. No further information expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: swelling in lips; This is a spontaneous report from a contactable Other-HCP (Nurse).   A 12-years-old male patient received first dose of bnt162b2 (Solution for injection, Batch/Lot Number: EL0176) via an unspecified route of administration, administered in Arm Right on 21May2021 12:40 (Age at Vaccination 12-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing asthma the patient was very early on diagnosed with asthma when he was 1-2 years old. Concomitant medications were not reported.  The patient experienced swelling in lips on 22May2021 with outcome of not recovered.  Therapeutic measures were taken as a result of swelling in lips. It was reported that Per Caller, My son, age 12 developed swelling in lips after the first dose of the Pfizer covid vaccine. Patient was administered Benadryl and Zyrtec for swollen lips following the Pfizer Covid-19 vaccine.  Caller reported that the Benadryl and Zyrtec were ineffective for the patients lip swelling. Caller reported that the patient's second dose of the Covid-19 vaccine was scheduled for 11Jun2021.The outcome of the event was not recovered.  Follow-up (05Jul2021): Follow-up attempts completed. No further information expected
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: ACHY ARM AFTER COVID VACCINE; Vaccination site pain; This is a spontaneous report from a contactable consumer or other non health care professional based on information received by Pfizer from [Mfr. Control No. :21K-163-3907125-00]. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via Intramuscular on an unspecified date as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via Intramuscular on an unspecified date as dose 2, single for covid-19 immunization. The patient also received adalimumab (HUMIRA, Batch/Lot number was not reported) via subcutaneous from an unspecified date and ongoing, at unspecified dose for ankylosing spondylitis. The patient medical history included ankylosing spondylitis. Concomitant medications were not reported. It was reported that on an unknown date, the patient experienced achy arm after covid vaccine, vaccination site pain. Social Media report by a consumer of a person with an event of non-serious achy arm after covid vaccine with humira (adalimumab). COVID-19 VACCINE was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On unknown date, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. Primary reporter contact for lot number information was not available. The reporters causality for the event of achy arm after covid vaccine was not provided. The reporters causality for the event of vaccination site pain was not reported. The action taken in response to the event for adalimumab was dose not changed. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: shortness of breath; chest tightness; lightheaded and dizzy; This is a spontaneous report from a contactable consumer. This Consumer reported for a 16-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient received her first dose of the COVID vaccine. A few minutes after receiving her shot, on an unspecified date she began to feel lightheaded and dizzy. She sat down and continued to complain of chest tightness and shortness of breath. The pharmacist that administered the vaccine called 911 and medics arrived. By this point, she started to feel better and her symptoms went away. She did not receive any treatment and she was doing fine. The outcome of all events was recovered on an unspecified date.  Follow-up (25Jun2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vomiting
Clinical narrative: 15 hours after vaccine, nausea for several hours & vomited x1.; 15 hours after vaccine, nausea for several hours & vomited x1.; Temp 101.4 (forehead), Tylenol 1,000mg taken, fever gone about 5 hours later.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient) and other healthcare professional in response to HCP letter via follow-up letter.  A 17-years-old non-pregnant female patient received bnt162b2 (PFIZER BIONTEC COVID-19 VACCINE, solution for injection, batch no: not reported; Lot Number: EW0182) via an unspecified route of administration, administered in left arm on 07May2021 14:30 (Age at vaccination 17 years old) as dose 2, single for covid-19 immunization at Pharmacy or Drug Store. Medical history included and concomitant medications were none. Known allergies were reported as none. Historical vaccine included patient received bnt162b2 (PFIZER BIONTEC COVID-19 VACCINE, solution for injection, batch no: not reported/Lot Number: EW0151) via an unspecified route of administration, administered in left arm on 07Apr2021 13:30 (Age at vaccination 17 years old) as dose 1, single for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination and other medications received within 2 weeks were none. On 08May2021 05:15, 15 hours after vaccine the patient experienced, nausea for several hours & vomited per day and experienced fever (temperature 101.4 (forehead). Seriousness of the case reported as no. The patient underwent lab tests and procedures which included body temperature (forehead) of 101.4 Fahrenheit on 08May2021. Therapeutic measures were taken as a result of temp 101.4 (forehead) was Tylenol 1,000mg, fever gone about 5 hours later. No treatment received for other events reported. The outcome of the events nausea, vomited was recovered on an unspecified date in May2021 and fever (temperature 101.4) was recovered on 08May2021.  Follow-up attempts completed. No further information expected.