chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: Intense chills and sweats; Multiple body aches including joint pain and headache; Multiple body aches including joint pain and headache; Multiple body aches including joint pain and headache; Restless sleep; Frequent urination; Intense chills and sweats; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:1686 (as reported)), via an unspecified route of administration on 05Jan2021 at 13:00 at single dose in left arm for COVID-19 immunisation. Age at vaccination was 54 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. On 05Jan2021 at 21:00 the patient experienced intense chills and sweats, multiple body aches including joint pain and headache, restless sleep and frequent urination. These symptoms started approximately 12 hours after injection (clarification requested) and lasted for approximately 14-16 hours. The events were non serious. No treatment was received for the events. The events resolved in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Poor quality sleep
Clinical narrative: Intense chills and sweats; Multiple body aches including joint pain and headache; Multiple body aches including joint pain and headache; Multiple body aches including joint pain and headache; Restless sleep; Frequent urination; Intense chills and sweats; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:1686 (as reported)), via an unspecified route of administration on 05Jan2021 at 13:00 at single dose in left arm for COVID-19 immunisation. Age at vaccination was 54 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. On 05Jan2021 at 21:00 the patient experienced intense chills and sweats, multiple body aches including joint pain and headache, restless sleep and frequent urination. These symptoms started approximately 12 hours after injection (clarification requested) and lasted for approximately 14-16 hours. The events were non serious. No treatment was received for the events. The events resolved in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Migraine, Nausea, Tremor
Clinical narrative: migraines; blood glucose dropped below 80; severe shakes; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 14:30 at single dose at left arm for covid-19 immunization. Medical history included fibromyalgia, chronic migraines, degeneraive disc disease, spinal spinosis, celiac, arthritis, and type 2 diabetic, known allergies. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks included prescribed medications. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Patient was a type 2 diabetic and the next day after the injection, on 05Jan2021 08:00 patient blood glucose dropped below 80 and patient usually run 128 and above. It was hard getting BG level up over 100 for over two weeks and patient had severe shakes, nausea, and migraines as an adverse effect from very low BG levels. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events was not recovered. Patient lowered insulin units as treatment.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Facial numbness and pain at injection site
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Mobility decreased, Pyrexia, Respiratory tract congestion
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient).  A 70-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration in right shoulder on 15Jan2021 08:40 at single dose for covid-19 immunisation.  Medical history included ongoing hypertension, family history of hypertension, blood cholesterol, drug intolerance (can't take statins for cholesterol), sleep disorder, back pain. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), zolpidem (unknown manufacturer), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN). The patient had the first symptoms of congestion in the chest on 21Jan2021, fever of 101.2 degrees fahrenheit on 22Jan2021, has a little sinus issue and did not want to get up in Jan2021. He was tested positive for covid-19 on 23Jan2021. The outcome of the event was recovering. The patient was taking Tylenol due to the event. The event did not require visit to emergency room nor to physician office
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sinus disorder
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient).  A 70-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration in right shoulder on 15Jan2021 08:40 at single dose for covid-19 immunisation.  Medical history included ongoing hypertension, family history of hypertension, blood cholesterol, drug intolerance (can't take statins for cholesterol), sleep disorder, back pain. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), zolpidem (unknown manufacturer), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN). The patient had the first symptoms of congestion in the chest on 21Jan2021, fever of 101.2 degrees fahrenheit on 22Jan2021, has a little sinus issue and did not want to get up in Jan2021. He was tested positive for covid-19 on 23Jan2021. The outcome of the event was recovering. The patient was taking Tylenol due to the event. The event did not require visit to emergency room nor to physician office
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Malaise
Clinical narrative: I had a fever, chills, headache, and fatigue. A week later, I'm still not feeling 100%. The scariest reaction was a rash that broke out all over my chest. I also had one on my forehead. It looked like lacerations and I still have marks left behind. The rash on my chest was very hot and I had trouble breathing at night. I took pictures.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Skin warm
Clinical narrative: I had a fever, chills, headache, and fatigue. A week later, I'm still not feeling 100%. The scariest reaction was a rash that broke out all over my chest. I also had one on my forehead. It looked like lacerations and I still have marks left behind. The rash on my chest was very hot and I had trouble breathing at night. I took pictures.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Fatigue, Feeling hot, Nausea
Clinical narrative: her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper chest, the medial aspect of her left arm and down her upper arm initially pain/fingers ached; down her upper arm initially pain; About 15 minutes later her wrist and fingers ached/joint pain; a gradual increase of body aches; nausea; feeling 'hot'; Big time tired, fatigue the patient would go to bed early; This is a spontaneous report from a contactable Nurse (patient).  A 57-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at Arm Left on 25Jan2021 14:15 at the 57 years old at single dose for COVID-19 immunization.  The medical history included FAP (Familial adenomatous polyposis), hernia repair, ankylosing spondylitis, bipolar disorder II, chronic depression, PTSD(Post-traumatic stress disorder), anxiety, GERD, Penicillin allergy, Adhesive tape allergy, Antiemetics allergy. The concomitant medications were amlodipine, ASA, HCTZ, lamotrigine (LAMICTAL), losartan, naproxen. The patient previously took Ciprofloxacin and experienced allergy, Ativan and experienced allergy. Right after the patient received the shot on 25Jan2021 14:30, her left side of her upper chest, the medial aspect of her left arm and down her upper arm initially pain. About 15 minutes later her wrist and fingers ached. From then on 25Jan2021 14:30, a gradual increase of body aches and joint pain, some nausea feeling 'hot' but not 'hot flashes' no sweats, Big time tired, fatigue the patient would go to bed early. She was keeping very hydrated. There was no other vaccine in four weeks. There was no treatment for the adverse events. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was recovering.    Information about lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper chest, the medial aspect of her left arm and down her upper arm initially pain/fingers ached; down her upper arm initially pain; About 15 minutes later her wrist and fingers ached/joint pain; a gradual increase of body aches; nausea; feeling 'hot'; Big time tired, fatigue the patient would go to bed early; This is a spontaneous report from a contactable Nurse (patient).  A 57-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at Arm Left on 25Jan2021 14:15 at the 57 years old at single dose for COVID-19 immunization.  The medical history included FAP (Familial adenomatous polyposis), hernia repair, ankylosing spondylitis, bipolar disorder II, chronic depression, PTSD(Post-traumatic stress disorder), anxiety, GERD, Penicillin allergy, Adhesive tape allergy, Antiemetics allergy. The concomitant medications were amlodipine, ASA, HCTZ, lamotrigine (LAMICTAL), losartan, naproxen. The patient previously took Ciprofloxacin and experienced allergy, Ativan and experienced allergy. Right after the patient received the shot on 25Jan2021 14:30, her left side of her upper chest, the medial aspect of her left arm and down her upper arm initially pain. About 15 minutes later her wrist and fingers ached. From then on 25Jan2021 14:30, a gradual increase of body aches and joint pain, some nausea feeling 'hot' but not 'hot flashes' no sweats, Big time tired, fatigue the patient would go to bed early. She was keeping very hydrated. There was no other vaccine in four weeks. There was no treatment for the adverse events. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was recovering.    Information about lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Facial/body itching, redness of skin; itching decreased after Benadryl 50 mg was given. Went to ED.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure measurement, Dizziness, Hypertension, Laboratory test
Clinical narrative: high blood pressure/blood pressure was sky high; she didn't feel well/not being well; dizzy; nausea; sharp pain in stomach; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 19Jan2021 at 14:00 into left arm at single dose so she wouldn't die from COVID-19, she is 88. Medical history included cancer survivor, patient had one kidney, that kidney was stage 4 kidney disease and was not on dialysis, the one kidney was kidney cancer in 2010; high blood pressure; had blood clots from 2017; heart disorder; iron was low; having problems with memory. Concomitant medications included amlodipine started taking it years ago and hydralazine both for high blood pressure, bupropion, iron started a year and a half before (in 2019) for iron was low, all ongoing; donepezil started taking it in 2011 or 2012 as memory medication, apixaban (ELIQUIS) started taking two years before (in 2019) for blood clots, isosorbide started it so many years for heart, quetiapine from 2011 for having problems with memory. The patient previously took another medicine for blood clots. The patient went to hospital for the following side effects: dizzy and nausea on 23Jan2021, sharp pain in stomach in Jan2021, high blood pressure on 24Jan2021. Reporter would like to know if this side effects were reported or what should she do for her mom. Patient had just not being well in Jan2021 after received bnt162b2. Reporter had to take her mother to the ER 24Jan2021, and right now patient was dizzy, had nausea, and reporter took her to the ER yesterday and they couldn't find anything, and reporter was trying to find: was this due to the vaccine. Patient said she didn't feel well, since Saturday (23Jan2021). Patient now had a lot of stomach pain, so reporter took patient to the ER on 24Jan2021, and did a lot of tests, and her blood pressure was sky high, reporter wondering did the vaccine affect blood pressure. Patient was just not herself, and reporter knew the patient, patient had been doing pretty good, but was not herself. Reporter stated they let patient came home from the hospital on 24Jan2021, clarified she was in the ER on 24Jan2021, was not admitted to hospital. The outcome of event nausea was not recovered, outcome of the other events was unknown.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: high blood pressure/blood pressure was sky high; she didn't feel well/not being well; dizzy; nausea; sharp pain in stomach; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 19Jan2021 at 14:00 into left arm at single dose so she wouldn't die from COVID-19, she is 88. Medical history included cancer survivor, patient had one kidney, that kidney was stage 4 kidney disease and was not on dialysis, the one kidney was kidney cancer in 2010; high blood pressure; had blood clots from 2017; heart disorder; iron was low; having problems with memory. Concomitant medications included amlodipine started taking it years ago and hydralazine both for high blood pressure, bupropion, iron started a year and a half before (in 2019) for iron was low, all ongoing; donepezil started taking it in 2011 or 2012 as memory medication, apixaban (ELIQUIS) started taking two years before (in 2019) for blood clots, isosorbide started it so many years for heart, quetiapine from 2011 for having problems with memory. The patient previously took another medicine for blood clots. The patient went to hospital for the following side effects: dizzy and nausea on 23Jan2021, sharp pain in stomach in Jan2021, high blood pressure on 24Jan2021. Reporter would like to know if this side effects were reported or what should she do for her mom. Patient had just not being well in Jan2021 after received bnt162b2. Reporter had to take her mother to the ER 24Jan2021, and right now patient was dizzy, had nausea, and reporter took her to the ER yesterday and they couldn't find anything, and reporter was trying to find: was this due to the vaccine. Patient said she didn't feel well, since Saturday (23Jan2021). Patient now had a lot of stomach pain, so reporter took patient to the ER on 24Jan2021, and did a lot of tests, and her blood pressure was sky high, reporter wondering did the vaccine affect blood pressure. Patient was just not herself, and reporter knew the patient, patient had been doing pretty good, but was not herself. Reporter stated they let patient came home from the hospital on 24Jan2021, clarified she was in the ER on 24Jan2021, was not admitted to hospital. The outcome of event nausea was not recovered, outcome of the other events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash erythematous, Rash pruritic
Clinical narrative: Mild itching night of the injection then 8 days later I developed a red, itchy rash that is about 2 inches in diameter. Mild-moderate itching.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Injection site erythema, Lymphadenopathy, Vaccination site swelling
Clinical narrative: dizziness; swelling at injection site; redness at injection site; lymphadenopathy swelling of lymph nodes; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 21; unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated he previously received the first dose and experienced a few adverse reactions and wanted to know if it was ok to get the second dose. He reported dizziness within 10 minutes of receiving it, a very hard case of it, swelling at injection site accompanied by redness at injection site, lymphadenopathy swelling of lymph nodes (one of them). He was going to get his second dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis, Induration
Clinical narrative: A hard raised area  became red, hot, and tender to touch. This area grew from size of a nickel to size of a baseball within 24 hours. It became hard and hot. I had chills and sweats two days, felt fatigued with general muscle aches and pain for about four days. And I had little to no appetite.  Symptoms have improved but redness and tenderness over the left deltoid persists.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Pain, Skin warm
Clinical narrative: A hard raised area  became red, hot, and tender to touch. This area grew from size of a nickel to size of a baseball within 24 hours. It became hard and hot. I had chills and sweats two days, felt fatigued with general muscle aches and pain for about four days. And I had little to no appetite.  Symptoms have improved but redness and tenderness over the left deltoid persists.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the site of injection lasting 2 days; This is a spontaneous report from a non-contactable consumer reported for herself. A 50-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL8982, via an unspecified route of administration on 22Jan2021 at single dose in right arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced pain in the site of injection lasting 2 days on 23Jan2021. The patient had not been tested for COVID-19 since the vaccination. No treatment was received for the event. The outcome of the event was recovered on 25Jan2021. Serious criteria was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: ?Covid arm?  Painful red area that was swollen and hard on injection site 7 days after injection.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: ?Covid arm?  Painful red area that was swollen and hard on injection site 7 days after injection.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness and marked swelling at injection site 1 week after receiving the vaccine. Patient has a history of delayed allergic reactions.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Redness and marked swelling at injection site 1 week after receiving the vaccine. Patient has a history of delayed allergic reactions.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Sore arm; This is a spontaneous report from a non-contactable consumer (patient).   A 34 years old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 22Jan2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 23Jan2021, the patient experiencing headache and sore arm. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Severe chills, fever, headache, muscle ache in arms and back, fatigue
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Loss of smell and taste; Loss of smell and taste; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 08:30 at single dose, second dose of bnt162b2 via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included Sulfa allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included phentermine hydrochloride, topiramate (QSYMIA), rizatriptan benzoate (MAXALT). The patient experienced loss of smell and taste on an unspecified date. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Feeling abnormal, Heart rate, Heart rate increased, Hypopnoea
Clinical narrative: my system felt ramped up; my voice sounded worked up; I had slightly shallow breathing; My heart rate went up, not extremely high but and EMT said it felt "racy".; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: RL3249) at left arm on 21Jan2021 12:15 AM at single dose for COVID-19 immunization. Medical history included asthma, allergies to sulfa, dairy, egg, peanuts. Patient is not pregnant. Other medications in two weeks included low dose naltrexone and salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) and Herbals. No other vaccine in four weeks. Patient previously took erythromycin and epinephrine and had allergy to them. Within 5 minutes (21Jan2021 12:15 AM), her system felt ramped up. Her heart rate went up, not extremely high but and EMT said it felt "racy". She was told that her voice sounded worked up. she had slightly shallow breathing. It lasted about 30 minutes then began to subside. The next day she felt it somewhat. she was totally normal after 12 hours. She had a sensitivity to epinephrine and the Pfizer dose reaction reminded her of a milder version of the epinephrine reaction. No Covid prior vaccination, no covid tested post vaccination. No treatment received for the events; patient was recovered from the events in 22Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Migraine, Pain, Pruritus
Clinical narrative: rash, from her butt down to the back part of her legs; headaches; body aches; fever; bad migraines; itching; This is a spontaneous report from a contactable nurse (reported for herself). A female patient of an unspecified age (age: 33; Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included preexisting condition: lupus. The patient's concomitant medications were not reported. The patient reported that on Friday she received her first dose and just now this morning (25Jan2021), she woke up with a rash, from her butt down to the back part of her legs. This morning it was bad, warts. She worked at a dialysis center and they gave her Benadryl, and Benadryl cream. She wanted to make sure because she had a preexisting condition: lupus. They had the patient wait for 30 minutes after the vaccine. The patient had bad headaches, body aches, fever, bad migraines and this itching had been incredible on 22Jan2021. Caller wanted to know if there was any information regarding this and what to do about the second dose. The events were non-serious per the reporter. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: rash, from her butt down to the back part of her legs; headaches; body aches; fever; bad migraines; itching; This is a spontaneous report from a contactable nurse (reported for herself). A female patient of an unspecified age (age: 33; Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included preexisting condition: lupus. The patient's concomitant medications were not reported. The patient reported that on Friday she received her first dose and just now this morning (25Jan2021), she woke up with a rash, from her butt down to the back part of her legs. This morning it was bad, warts. She worked at a dialysis center and they gave her Benadryl, and Benadryl cream. She wanted to make sure because she had a preexisting condition: lupus. They had the patient wait for 30 minutes after the vaccine. The patient had bad headaches, body aches, fever, bad migraines and this itching had been incredible on 22Jan2021. Caller wanted to know if there was any information regarding this and what to do about the second dose. The events were non-serious per the reporter. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, pain, and small amount of swelling.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: Headache; Muscle pain for 36 hours; Fever over 100; chills; joint pain for 36 hours; This is a spontaneous report from a contactable consumer reporting for himself. A 50-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 21Jan2021 11:30 AM at single dose in Left arm for COVID-19 immunisation. Medical history included ulcerative colitis and lactose intolerance, both from an unknown date. Concomitant medication included minerals nos, vitamins nos (CENTRUM) daily vitamin received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), on 31Ded2020 10:30 AM in Left arm for COVID-19 immunisation. 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. The patient experienced Fever over 100, chills, muscle and joint pain for 36 hours after second dose on 21Jan2021 10:00 PM. Headache has persisted and not subsided since second dose on 21Jan2021 10:00 PM. The patient underwent lab tests and procedures which included body temperature: over 100 on 21Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The treatment was not received for the adverse event. The outcome of the events was recovering. The case was reported as non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Muscle pain for 36 hours; Fever over 100; chills; joint pain for 36 hours; This is a spontaneous report from a contactable consumer reporting for himself. A 50-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 21Jan2021 11:30 AM at single dose in Left arm for COVID-19 immunisation. Medical history included ulcerative colitis and lactose intolerance, both from an unknown date. Concomitant medication included minerals nos, vitamins nos (CENTRUM) daily vitamin received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), on 31Ded2020 10:30 AM in Left arm for COVID-19 immunisation. 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. The patient experienced Fever over 100, chills, muscle and joint pain for 36 hours after second dose on 21Jan2021 10:00 PM. Headache has persisted and not subsided since second dose on 21Jan2021 10:00 PM. The patient underwent lab tests and procedures which included body temperature: over 100 on 21Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The treatment was not received for the adverse event. The outcome of the events was recovering. The case was reported as non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, SARS-CoV-2 test
Clinical narrative: Joint pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1283), via an unspecified route of administration at Left arm on 22Jan2021 11:45 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported.  Concomitant medication included duloxetine. The patient was not pregnant. No known allergies. The patient experienced joint pain and nausea on 24Jan2021 10:00. No treatment received for the events. No COVID prior vaccination. Nasal Swab performed on 25Jan2021, but result was pending. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Body temperature, Chills, Fatigue, Headache
Clinical narrative: injection site pain; tiredness; headache; nausea; bad chills; fever; muscle pain; no motivation; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she and her mother took the Pfizer covid vaccine on Saturday. Patient's mother (94-year-old female) did not experienced any side effects but the patient experienced tiredness, headache, nausea, bad chills, fever, muscle pain, no motivation, injection site pain on an unspecified date in Jan2021. She took Tylenol, Aleve, feeling better tonight but still have few chills. The patient wanted to know if it is safe to take the second dose, if the second dose is worse and if is it the same medication. Chills had not resolved, while the remaining events were resolving.  Information on Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: injection site pain; tiredness; headache; nausea; bad chills; fever; muscle pain; no motivation; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she and her mother took the Pfizer covid vaccine on Saturday. Patient's mother (94-year-old female) did not experienced any side effects but the patient experienced tiredness, headache, nausea, bad chills, fever, muscle pain, no motivation, injection site pain on an unspecified date in Jan2021. She took Tylenol, Aleve, feeling better tonight but still have few chills. The patient wanted to know if it is safe to take the second dose, if the second dose is worse and if is it the same medication. Chills had not resolved, while the remaining events were resolving.  Information on Lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Muscle fatigue, Nausea, Pyrexia
Clinical narrative: Extremely muscle fatigue, low grade fever, nausea, shaking, headache, stomach discomfort.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Extremely muscle fatigue, low grade fever, nausea, shaking, headache, stomach discomfort.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, Chills, Headache, Nausea, Pain
Clinical narrative: extreme nausea; body aches; headache; chills; I did not have antibodies; This is a spontaneous report from a contactable consumer reported for herself.   A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# 3246 on 12Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm in the hospital. Relevant medical history was not reported. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) for birth control. The patient had received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, on 24Dec2020 02:00 PM from Lot number#5730 at single dose for immunization, via intramuscular route at the left arm. The patient is not pregnant. No COVID prior vaccination. On 06Jan2021 the patient done a SARS coronavirus 2-VITALAXIS test (Nasal Swab) with negative result. On 13Jan2021 the patient experienced extreme nausea, body aches, headache, chills. The outcome of the events was reported as recovered on unspecified date in Jan2021. No treatment received. The patient received an antibody test two weeks after second dose and it indicated that she did not have antibodies.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: extreme nausea; body aches; headache; chills; I did not have antibodies; This is a spontaneous report from a contactable consumer reported for herself.   A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# 3246 on 12Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm in the hospital. Relevant medical history was not reported. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) for birth control. The patient had received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, on 24Dec2020 02:00 PM from Lot number#5730 at single dose for immunization, via intramuscular route at the left arm. The patient is not pregnant. No COVID prior vaccination. On 06Jan2021 the patient done a SARS coronavirus 2-VITALAXIS test (Nasal Swab) with negative result. On 13Jan2021 the patient experienced extreme nausea, body aches, headache, chills. The outcome of the events was reported as recovered on unspecified date in Jan2021. No treatment received. The patient received an antibody test two weeks after second dose and it indicated that she did not have antibodies.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Headache, Myalgia, Nausea
Clinical narrative: Headache; extreme muscle aches; joint pain; nausea; burning sensation all over body; This is a spontaneous report from a contactable consumer (patient). This 25-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL1283) at single dose in left arm on 22Jan2021 at 07:30 A.M. for COVID-19 immunization. Medical history included fibromyalgia; GERD (gastrooesophageal reflux disease); known allergies to wheat and coconut oil. Patient had known allergies to cefprozil (CEFZIL), amoxicillin, acetylsalicylic acid (ASPIRINE), aripiprazole (ABILIFY). Concomitant medications in two weeks included escitalopram oxalate (LEXAPRO), venlafaxine, omeprazole, diphenhydramine hydrochloride (UNISOM), ibuprofen (ADVIL). There was no other vaccine in four weeks. There was no COVID prior vaccination, no COVID tested post vaccination. Patient experienced headache, extreme muscle aches, joint pain, nausea, burning sensation all over body on 22Jan2021 at 07:00 P.M. There was no treatment received for the adverse events. The outcome of events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Breast pain, Chest pain, Muscle spasms
Clinical narrative: Upon awakening the next day, I began to have extremely painful deep chest spasms starting in outer right side ribs and quickly radiating under breast and up into nipple. Happened in a succession of maybe 2-3 spasms then stopped. Occurred maybe 6 times over the course of about 5 hours, then totally stopped around the 24 hour mark of the injection.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Nausea, Pain
Clinical narrative: Pain at injection site; swelling at injection site; fever; chills; body aches; muscle pain; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via an unspecified route of administration in the left arm, on 23Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history was unknown. Patient is not pregnant. Patient did not have COVID prior vaccination. Patient did not have other vaccine in four weeks. Concomitant medications included Ibuprofen and Acetaminophen. Patient previously received first dose of BNT162B2 (Lot number: EK9231) via an unspecified route of administration in the left arm on 02Jan2021 11:15 at the age of 32 years for COVID-19 immunisation. Patient experienced pain at injection site, swelling at injection site, fever, chills, body aches, muscle pain, nausea on 24Jan2021 03:00. The patient did not receive treatment for the events. Patient tested COVID post vaccination through nasal swab which revealed negative on 08Jan2021. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain at injection site; swelling at injection site; fever; chills; body aches; muscle pain; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via an unspecified route of administration in the left arm, on 23Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history was unknown. Patient is not pregnant. Patient did not have COVID prior vaccination. Patient did not have other vaccine in four weeks. Concomitant medications included Ibuprofen and Acetaminophen. Patient previously received first dose of BNT162B2 (Lot number: EK9231) via an unspecified route of administration in the left arm on 02Jan2021 11:15 at the age of 32 years for COVID-19 immunisation. Patient experienced pain at injection site, swelling at injection site, fever, chills, body aches, muscle pain, nausea on 24Jan2021 03:00. The patient did not receive treatment for the events. Patient tested COVID post vaccination through nasal swab which revealed negative on 08Jan2021. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Feeling hot
Clinical narrative: Loose stools; stomach ache; body became hot up to her head then red haze seen in room/Body became hot like a hot flash again; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at Left arm on 21Jan2021 15:45 at SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. Medical history included high blood pressure, arthritis, known allergies: sulfa drugs, dust, mold. Concomitant medication included atenolol, atorvastatin, lactobacillus nos (CULTURELLE), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon dioxide, sodium metavanadate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc (CENTRUM SILVER ADULTS 50+). No other vaccine in four weeks. The patient's body became hot up to her head then red haze seen in room on first day 21Jan2021 07:00 PM. Body became hot like a hot flash again, no color haze on the second day (22Jan2021). Loose stools and stomach ache on third day (23Jan2021). No treatment received for the events. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the events was recovered in Jan2021.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, body aches, low grade fever and chills.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable physician and consumers reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not reported), via an unspecified route of administration on 09Jan2021 at a single dose for Covid-19 immunization. The vaccine was administered at a nursing home. Medical history included dementia, hyperlipidemia, hypothyroid, and drug allergy to penicillin; all from an unknown date. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took iodine and experienced drug allergy. The patient experienced bell's palsy on 15Jan2021. The reported event was resulted in Emergency room/department or urgent care. No treatment was provided for the event. The outcome of the event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: fatigue; myalgias; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm, on an unspecified date in Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. Patient has no known allergies. Patient is not pregnant. Patient did not have Covid prior vaccination. Patient did not have other vaccine in four weeks. Patient had fatigue and myalgias for 3 days after the 1st dose in Dec2020. No treatment received for the events. Patient did not test Covid post vaccination. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her arms and legs; This is a spontaneous report from a contactable consumer. An elderly non-pregnant female patient (reporter's mother) received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported.  The patient received the 1st dose of the vaccine on 18Jan2021. 4 days later she experienced pain in her arms and legs on 22Jan2021. This resolved 24 hours later. No treatment was received. The outcome of the event was recovered on 23Jan2021. Since the vaccination, the patient had not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: sudden dizziness
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash pruritic
Clinical narrative: has a big ol round spot on her arm; really sore for a day or two; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 second dose at SINGLE DOSE  for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient "has a big ol round spot on her arm"  on Jan2021 with outcome of unknown and "really sore for a day or two" on Jan2021 with outcome of unknown. The action taken was not applicable. The reported stated "my sister actually, she took it. She took her second one about two days ago and she is been going through it with it. You know nothing terrible but you can tell she took it. You can tell her immune system is really working. She has a big ol round spot on her arm and she was really sore for a day or two". Information on the lot/ batch number has been requested.