chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Palmar erythema, Plantar erythema, Pruritus, Rash
Clinical narrative: Body rash starting with bright red palms and soles of feet, then spreading over entire body; This is a spontaneous report from a contactable consumer reporting for herself. A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9269/expiration date: not provided), via an unspecified route of administration, on 02Feb2021 at 11:45 as a single dose in the right arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 12Jan2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient has a known allergies to iodine. The patient was not pregnant at the time of vaccination. Prior to the 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. On 07Feb2021 at 12:00, the patient experienced body rash starting with bright red palms and soles of feet, then spreading over entire body. The patient did not receive any treatment for these events. The outcome of the event body rash starting with bright red palms and soles of feet, then spreading over entire body was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Body rash starting with bright red palms and soles of feet, then spreading over entire body; This is a spontaneous report from a contactable consumer reporting for herself. A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9269/expiration date: not provided), via an unspecified route of administration, on 02Feb2021 at 11:45 as a single dose in the right arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 12Jan2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient has a known allergies to iodine. The patient was not pregnant at the time of vaccination. Prior to the 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. On 07Feb2021 at 12:00, the patient experienced body rash starting with bright red palms and soles of feet, then spreading over entire body. The patient did not receive any treatment for these events. The outcome of the event body rash starting with bright red palms and soles of feet, then spreading over entire body was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: neck problems; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as 73, unknown unit) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of on an unspecified date at a single dose for COVID-19 immunization. The first dose was given on an unspecified date. The patient's medical history and concomitant medications were not reported. The patient was having neck problems on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Hypersensitivity
Clinical narrative: severe asthma attack; allergic reaction; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age (reported as 40, unit not reported) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he was directed by his doctor's office to call in and report a potential side effect following the administration of his second dose. The patient asked if a severe asthma attack normal as an allergic reaction (onset dates unspecified). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Myalgia, Pain
Clinical narrative: Sever chills; body/muscle aches; body/muscle aches; This is a spontaneous report from a contactable other Health Professional (the patient). This 36-year-old  male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9263), via an unspecified route of administration, in the left arm on 29Jan2021 at 15:30 PM (at the age of 36-years) as a single dose for COVID-19 immunization. Medical history reported as none.  The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021 at 10:45 PM, the patient experienced severe chills, body/muscle aches all over for 2 days. No treatment was given. The clinical outcome of severe chills, body/muscle aches was recovering. It was also reported that since the vaccination, the patient had been tested for COVID-19, via Nasal Swab on 05Feb2021, the test result was negative.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain
Clinical narrative: Brief, intermittent sharp pain on R side of mouth; This is a spontaneous report from a non-contactable consumer. This 54-year-old female consumer (patient) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK5730/expiration date: unknown), via unknown route of administration, on 06Jan2021 as a single dose for COVID-19 immunization at a hospital. Relevant medical history included Hypertension, allergic rhinitis. Relevant concomitant medications included fexofenadine hydrochloride (ALLEGRA), famotidine (PEPCID), HCTZ, magnesium oxide (MAG OXIDE), multivitamins. The patient was not diagnosed with COVID-19 prior to the vaccination or if patient received any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date in Jan2021 about a week after vaccine injection, the patient experienced brief, intermittent sharp pain on R side of mouth, lasted 2 days. The outcome of the event was recovered. The patient did not receive any treatment for the event. It was not known that since the vaccination, the patient had been tested for COVID-19.      No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Vaccination site hypoaesthesia
Clinical narrative: shot in her left arm/Her left arm and face went numb; face went numb; headache; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A female patient of an unspecified age (61, age unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on left arm on 05Feb2021 (between 11:00 and 12:00) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the shot in her left arm. Her left arm and face went numb and she has a terrible headache, all in Feb2021. She stated this were still occurring. The patient asked if these were normal side effects and if there was anything she could take for it. The patient considered the events as non-serious. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: on the same arm and lymph node, under my arm pit, there is a swelling the size of a lemon; This is a spontaneous report from a contactable healthcare professional (patient) via medical information team. A female patient of an unspecified age (reported as 59, no unit) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, on the arm, on 03Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation on an unspecified date. The patient received the second dose of the Pfizer vaccine last 03Feb2021 and reported that "today (07Feb2021) on the same arm and lymph node, under my arm pit, there is a swelling the size of a lemon." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza virus test, Pyrexia, SARS-CoV-2 test, Streptococcus test
Clinical narrative: Low grade fever  for 12 days; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EL9263, expiration date May2021, via an unspecified route of administration from 25Jan2021 18:00 (at the age of 43 years old) as a SINGLE DOSE in the left arm for COVID-19 immunization.  Medical history included none.  Patient had no known allergies.Concomitant medication included lamotrigine (LAMICTAL), bupropion hydrochloride (WELLBUTRIN), alprazolam (XANAX), drospirenone, ethinylestradiol betadex clathrate (YAZ). The patient experienced fever the next day around early evening, on 26Jan2021 around 06:00PM. Initially her temperature stayed between 99-100 degrees Fahrenheit, that has been where it stayed but not continuous for the first couple of days. She says she would wake up with no fever, then it would be low in the evening. Last weekend, a week after getting the vaccine, every day she had a fever and it was going above 100 degrees Fahrenheit, to like 100.5 degrees Fahrenheit. The patient experienced low grade fever for 12 days.Treatment included taking generic Ibuprofen. She says she took two tablets as needed every 6 hours, and the strength for two tablets together is 400mg, LOT: 9BE2588A, Expiration date she just realized that this expired last month, Dec 2020. She says that the medication seems to be working just fine. The patient underwent lab tests and procedures which included body temperature: stayed between 99-100 fahrenheit on  unknown date, body temperature: above 100 fahrenheit on unknown date, body temperature: above 100 fahrenheit it was going above 100 degrees Fahrenheit, to like 100.5 degrees Fahrenheit on  unknown date, flu test: negative on 04Feb2021, covid test type post vaccination- nasal swab: negative on 03Feb2021, Covid-19 virus test: negative on 04Feb2021, strep test: negative on 04Feb2021.   Outcome of the event was not recovered
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Large swollen spot in my right armpit; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2 (brand= Pfizer Biontech), lot no. EL3248, via an unspecified route of administration (right arm) on 05Feb2021 15:00 at a single dose for COVID-19 immunization at a pharmacy or drug store. The patient had no relevant medical history. No known allergies. No COVID prior to vaccination. Concomitant medications included levothyroxine sodium and escitalopram. No other vaccine in four weeks. The patient experienced large swollen spot in her right armpit on 06Feb2021 16:00. No treatment received for the event. No COVID test post vaccination. The outcome of the event was not recovered.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; joint pain; body aches; throwing up; headache; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EC3246),  dose  1, single dose via an unspecified route of administration in the left arm on 22Jan2021 at 14:30 (at the age of 51 years-old) for COVID-19 vaccination. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. Concomitant medications included zolpidem (AMBIEN) and lisinopril. On 22Jan2021 at 16:45, the patient experienced fever, joint pain, body aches, throwing up and headache. The events resulted in a physician's office visit. Treatment was not received for the events. The clinical outcome of fever, joint pain, body aches, throwing up and headache was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 on 27Jan2021: polymerase chain reaction (PCR) nasal swab and was negative.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever; joint pain; body aches; throwing up; headache; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EC3246),  dose  1, single dose via an unspecified route of administration in the left arm on 22Jan2021 at 14:30 (at the age of 51 years-old) for COVID-19 vaccination. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. Concomitant medications included zolpidem (AMBIEN) and lisinopril. On 22Jan2021 at 16:45, the patient experienced fever, joint pain, body aches, throwing up and headache. The events resulted in a physician's office visit. Treatment was not received for the events. The clinical outcome of fever, joint pain, body aches, throwing up and headache was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 on 27Jan2021: polymerase chain reaction (PCR) nasal swab and was negative.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site bruising, Vaccination site pruritus, Vaccination site rash, Vaccination site urticaria
Clinical narrative: rash/Rash is about 6 " below injection site; Large hot itchy welts; Large hot itchy welts; Large hot itchy welts/warmth; injection site has small bruise; arm is very sore; This is a spontaneous report from a contactable consumer (patient). A 55-years-oldnon-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL9263, via an unspecified route of administration from 06Feb2021 12:00 (at the age of 55 years old) as a SINGLE DOSE in the left arm for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing, supraventricular tachycardia (SVT) from an unknown date and unknown if ongoing.  The patient did not have allergies. Concomitant medication included metoprolol, ibuprofen, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]). The patient did not receive other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Feb2021 12:00, the patient experienced large hot itchy welts. Turned into one large spot. Approximately 4 inches around. Rash began appearing about 2 hours after injection (06Feb2021 14:00). Rash is about 6 " below injection site. Actual injection site has small bruise from 06Feb2021 12:00, and arm is very sore from 06Feb2021 12:00. Rash and warmth still present after 24 hours. No treatment was received for the events. Outcome of large hot itchy welts, injection site has small bruise, Large hot itchy welts/warmth, arm is very sore, rash/Rash is about 6 " below injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: rash/Rash is about 6 " below injection site; Large hot itchy welts; Large hot itchy welts; Large hot itchy welts/warmth; injection site has small bruise; arm is very sore; This is a spontaneous report from a contactable consumer (patient). A 55-years-oldnon-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL9263, via an unspecified route of administration from 06Feb2021 12:00 (at the age of 55 years old) as a SINGLE DOSE in the left arm for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing, supraventricular tachycardia (SVT) from an unknown date and unknown if ongoing.  The patient did not have allergies. Concomitant medication included metoprolol, ibuprofen, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]). The patient did not receive other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Feb2021 12:00, the patient experienced large hot itchy welts. Turned into one large spot. Approximately 4 inches around. Rash began appearing about 2 hours after injection (06Feb2021 14:00). Rash is about 6 " below injection site. Actual injection site has small bruise from 06Feb2021 12:00, and arm is very sore from 06Feb2021 12:00. Rash and warmth still present after 24 hours. No treatment was received for the events. Outcome of large hot itchy welts, injection site has small bruise, Large hot itchy welts/warmth, arm is very sore, rash/Rash is about 6 " below injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient said she had sinus and went to her primary doctor and provided her steroids. The patient was scheduled to get the second dose this coming Sunday. The patient wants to know if she can take the second dose. Therapeutic measures were taken as a result of sinus included steroids (unspecified). The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Respiratory rate decreased, Therapeutic response unexpected
Clinical narrative: Affected my metabolism; I felt-a big surge of energy; Breathing less rapid from normal; This is a spontaneous report from a contactable consumer, the patient.  An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 05Feb2021 at 15:00 (at an unknown age) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. The patient has no allergies. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medications included atorvastatin (LIPITOR) and acetaminophen (TYLENOL). The vaccine was administered to the patient in a hospital. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient reported that he did not experience anything adverse but that what he did experience was "Very Positive!" He continued to say that less than 24 hours after the shot, he went to his usual workout-swimming laps. After a couple of laps, he was shocked at how strong he felt-a big surge of energy and he was breathing less rapidly from normal. He stated that he has been swimming like this for 15 years and doing other exercise- nothing like this every happened before. He also stated that "at 83 usually the opposite happens!"  He added that it "had to be something in the vaccine that affected my metabolism no other explanation!!"  No treatment was received and clinical outcomes were not reported. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Productive cough, SARS-CoV-2 test
Clinical narrative: dry cough; productive cough; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration at the right arm on 12Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medication included ascorbic acid (VIT C). Historical vaccine included first dose of bnt162b2 (lot number: EF5730, expiry date not reported) in the left arm on 22Dec2020 08:00 at single dose for COVID-19 immunization. The patient experienced dry cough that turned into a productive cough on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 01Feb2021. Therapeutic measures were taken as a result of the events that included dexamethasone injection and Zithromax. Clinical outcome of the events was recovered with sequelae on an unspecified date.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Productive cough, SARS-CoV-2 test
Clinical narrative: dry cough; productive cough; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration at the right arm on 12Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medication included ascorbic acid (VIT C). Historical vaccine included first dose of bnt162b2 (lot number: EF5730, expiry date not reported) in the left arm on 22Dec2020 08:00 at single dose for COVID-19 immunization. The patient experienced dry cough that turned into a productive cough on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 01Feb2021. Therapeutic measures were taken as a result of the events that included dexamethasone injection and Zithromax. Clinical outcome of the events was recovered with sequelae on an unspecified date.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Fatigue, Pruritus
Clinical narrative: no appetite for 2 weeks; extreme itching in hands, feet, scalp; Severe fatigue; This is a spontaneous report from a contactable other hcp (reporting for herself) A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose left arm on 18Jan2021 for covid-19 immunisation. First dose was administered intramuscular on left arm on 28Dec2020 17:15. Medical history was none. The patient's concomitant medications were not reported. The patient experienced severe fatigue on 25Jan2021, no appetite for 2 weeks on an unspecified date, extreme itching in hands, feet, scalp on an unspecified date. It was reported to be unbearable, and she was treated with Medrol dose pack, now Atarax, and prednisone (higher dose) and still have uncontrollable itching with only relief at night. The events outcome was not recovered.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Pruritus
Clinical narrative: no appetite for 2 weeks; extreme itching in hands, feet, scalp; Severe fatigue; This is a spontaneous report from a contactable other hcp (reporting for herself) A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose left arm on 18Jan2021 for covid-19 immunisation. First dose was administered intramuscular on left arm on 28Dec2020 17:15. Medical history was none. The patient's concomitant medications were not reported. The patient experienced severe fatigue on 25Jan2021, no appetite for 2 weeks on an unspecified date, extreme itching in hands, feet, scalp on an unspecified date. It was reported to be unbearable, and she was treated with Medrol dose pack, now Atarax, and prednisone (higher dose) and still have uncontrollable itching with only relief at night. The events outcome was not recovered.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Sensation of foreign body, Vaccination site reaction
Clinical narrative: sensation that something was stuck in her throat (similar to when a tonsil stone is present); Stiffness at injection site; Itching; Sore muscle; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL6269), via an unspecified route of administration in the right arm on 06Feb2021 08:15 at a single dose for COVID-19 immunization. The patient's medical history included sulfa allergy. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced sore muscle on 06Feb2021 23:15, stiffness at injection site on 07Feb2021 04:15, itching on 07Feb2021 04:15, and sensation that something was stuck in her throat (similar to when a tonsil stone is present) on 07Feb2021 08:15. No treatment was received for the adverse events. Outcome of the events was recovering.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: swollen lymph node in his neck, left side, above the collar bone.; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN5318), via an unspecified route of administration in left arm on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient did not have Covid prior vaccination. Concomitant medications included anthrax vaccine (ANTHRAX) in Dec2020. The patient previously received the first dose of BNT162B2 (Lot number EL1284) on 06Jan2021 in left arm. The patient experienced swollen lymph node in his neck, left side, above the collar bone on 30Jan2021 06:00. The patient underwent lab tests and procedures which included Covid-19 RT-PCR test (Nasal Swab): negative on 06Feb2021 post vaccination. No treatment was received for the event. The outcome of the event was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This is a spontaneous report from a contactable consumer reporting on behalf of her mother. A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL 8982), via an unspecified route of administration on 16Jan2021 at 16:30 (at the age of 90-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included Bronchiectasis, osteoporosis, anemia, Pre- Diabetes, Sjogren's, sleep apnea, GERD and SIBO. The patient has known allergies but these were not specified. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a nursing home/senior living facility. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included zolpidem (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), pyridoxine hydrochloride (B6 MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), biotin (BIOTIN MANUFACTURER UNKNOWN), colecalciferol (D3 MANUFACTURER UNKNOWN) and cyanocobalamin (B12 MANUFACTURER UNKNOWN), all from unknown dates and for unspecified indications. On 17Jan2021 at 12:00 (also referred to  as "two days after the vaccine"), and for five days, the patient was very dizzy. She says it wasn't vertigo. It was not spinning. just dizzy like she thought she was going to faint and fall on the floor. She tried to be "sure footed" when she walked and did not walk much other than in her Condo. The patient did not receive any treatment for the event. The clinical outcomes of the event dizziness was reported as recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Feeling hot, Flushing, Hyperhidrosis, Pain in extremity
Clinical narrative: her face flushed out; she got hot and sweaty; she got hot and sweaty; for three days following getting the vaccine, she felt like she had been punched in the arm; she is losing her voice; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL1283 and expiry date was unknown) via an unspecified route of administration, into left arm on 15Jan2021, as single dose for COVID Prevention. Medical history and concomitant medications were not reported. Patient stated that quickly after getting the vaccine, her face flushed out, and she got hot and sweaty. For three days following getting the vaccine, she felt like she had been punched in the arm, she was not just sore, but it felt like she had been punched. Stated that she was losing her voice. Patient received no other vaccines on the same day as the COVID vaccine. Patient wondering if other people are having the problem with the face flushing from the vaccine. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Dizziness, Insomnia, Pain in extremity
Clinical narrative: aching in her bones and joints of her shoulder and elbow; unable to sleep because her left arm was very painful; unable to sleep because her left arm was very painful; aching in her bones and joints of her shoulder and elbow; Dizziness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Covid-19 vaccine, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC number: unknown, Lot number: unknown, UDI number: EJ1686, Expiry date: unknown), via an unspecified route of administration on 27Jan2021 16:00 at single dose for covid-19 immunization. Covid-19 vaccine was a Pfizer product. Covid-19 vaccine manufacturer was unspecified. The patient medical history and concomitant medications were not provided. Caller (patient) received the Covid-19 yesterday (27Jan2021) at 4:00 pm. On 27Jan2021, she had a short period of dizziness. Two to three hours later her arm started aching in her bones and joints of her shoulder and elbow. She was unable to sleep because her left arm was very painful. She was scheduled for the next dose on 17Feb2021. Investigation Assessment was not Provided. The outcome of event dizziness was recovered on Jan2021 while unknown for events "her arm started aching in her bones and joints of her shoulder and elbow" and "She was unable to sleep because her left arm was very painful".  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Extreme pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 14:00 at single dose for COVID-19 immunization. Medical history included atrial fibrillation. Concomitant medication included apixaban (ELIQUIS). The patient previously took iodine and experienced allergies to Iodine.  The patient experienced extreme pain at the injection site on 05Feb2021 14:00. No Treatment received for the event. The patient was not pregnant. The patient had no COVID prior vaccination. She had no COVID tested post vaccination. There was no other vaccine received in four weeks. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Feeling abnormal, Muscle tightness, Pain in extremity, Throat tightness
Clinical narrative: little tight around my neck and throat, like a tightness; Tightening in my neck and around my mouth area; As soon as I got the shot I felt a little strange; My arms hurting a little; I did not eat anything; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via an unspecified route of administration on 25Jan2021 (at the age of 77-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing low thyroid and mostly it's food allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) 125 ug, daily for low thyroid. The consumer stated, I took the vaccine on Monday (25Jan2021), three days ago and as soon as I got the shot I felt a little strange and I came prepared because I do have some reactions sometimes. Mostly it's food allergies but I guess was being prepared, so I took Benadryl with me and I took it out of the packet. When probed for the treatment, consumer stated, "I just took Benadryl as soon as I got the shot I felt a little strange and I was prepared and I took my Benadryl with me and we stayed there I guess about 45 minutes until I felt better it would have been 12:15 and I was fine." The consumer stated, "I have been trying for two days, that was in my arms hurting a little on an unspecified date in Jan2021 and then today (28Jan2021) around noon I was feeling a reaction again. I had the tightening in my neck and around my mouth area that's where I usually get the reactions from, but for two days I have been fine and I did not eat anything on an unspecified date in Jan2021 out of the way to give me a reaction to it. Now I took 2 Benadryl and it subsided but it's still tight around my neck and a little tight around my neck and throat, like a tightness. What am I supposed to do? After I took this shot on Monday today is Thursday and I am having the same reactions that I had when I took (incomplete sentence) (pending clarification). The outcome of the events as soon as I got the shot I felt a little strange was recovered on 25Jan2021, little tight around my neck and throat, like a tightness and tightening in my neck and around my mouth area was not recovered and other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Dyspnoea, Headache, Illness
Clinical narrative: It started off with sort of standard like severe pain in the arm and some aches and pain; Then it progressed into headaches, dizziness and a bit of confusion off and on; Then it progressed into headaches, dizziness and a bit of confusion off and on; Then it progressed into headaches, dizziness and a bit of confusion off and on; Some breathing difficulties not continuous on occasion during this period in time; she was sick for at least a week in each case.; it started off with sort of standard like severe pain in the arm and some aches and pain; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (BNT162B2, lot number: EK9231), intramuscular in left arm on an unspecified date at SINGLE DOSE for covid-19 immunisation. Medical history included Multiple Chemical sensitivity syndrome, thyroid hormone support. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid hormone support. The patient experienced  it started off with sort of standard like severe pain in the arm and some aches and pain, then it progressed into headaches, dizziness and a bit of confusion off and on, some breathing difficulties not continuous on occasion during this period in time , she was sick for at least a week in each case,  She tends to react by taking Advil so she shouldn't take anymore and she didn't take Tylenol because she reacts more to Tylenol, It makes her very tired. Reporter stated, "I am calling for my wife (name), my wife is, will be getting her or scheduled to have her 2nd Covid 19 vaccine, Pfizer Vaccine next Friday the 12th. She is been having the prolonged well it appears to be prolonged side effects from the first injection. It started off with sort of standard like severe pain in the arm and some aches and pain. Then it progressed into headaches, dizziness and a bit of confusion off and on and she said some breathing difficulties not continuous on occasion during this period in time and we are concerned that she had two bouts of Covid 19 we believe back in one in Feb and one in Apr that were not diagnosed, with a proper diagnose because of that time the health partners, (name), wasn't doing any tests.  So, we couldn't get it tested but she was sick for at least a week in each case. So we are concerned about the fact that she had those bouts of Covid and that she might be getting her first injection something that is more kin to the second injection response. So, we are trying to decide whether or not she ought to be doing the second shot?" Regarding treatment, Reporter stated, "She did take two Advils on 30Jan but that's all she took she tends to react by taking Advil so she shouldn't take anymore and she didn't take Tylenol because she reacts more to Tylenol." Reporter further stated, "She does in generally reacts with Tylenol and Advil she has, it makes her very tired so she doesn't like to have it very often so she stopped after that one day." The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: It started off with sort of standard like severe pain in the arm and some aches and pain; Then it progressed into headaches, dizziness and a bit of confusion off and on; Then it progressed into headaches, dizziness and a bit of confusion off and on; Then it progressed into headaches, dizziness and a bit of confusion off and on; Some breathing difficulties not continuous on occasion during this period in time; she was sick for at least a week in each case.; it started off with sort of standard like severe pain in the arm and some aches and pain; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (BNT162B2, lot number: EK9231), intramuscular in left arm on an unspecified date at SINGLE DOSE for covid-19 immunisation. Medical history included Multiple Chemical sensitivity syndrome, thyroid hormone support. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid hormone support. The patient experienced  it started off with sort of standard like severe pain in the arm and some aches and pain, then it progressed into headaches, dizziness and a bit of confusion off and on, some breathing difficulties not continuous on occasion during this period in time , she was sick for at least a week in each case,  She tends to react by taking Advil so she shouldn't take anymore and she didn't take Tylenol because she reacts more to Tylenol, It makes her very tired. Reporter stated, "I am calling for my wife (name), my wife is, will be getting her or scheduled to have her 2nd Covid 19 vaccine, Pfizer Vaccine next Friday the 12th. She is been having the prolonged well it appears to be prolonged side effects from the first injection. It started off with sort of standard like severe pain in the arm and some aches and pain. Then it progressed into headaches, dizziness and a bit of confusion off and on and she said some breathing difficulties not continuous on occasion during this period in time and we are concerned that she had two bouts of Covid 19 we believe back in one in Feb and one in Apr that were not diagnosed, with a proper diagnose because of that time the health partners, (name), wasn't doing any tests.  So, we couldn't get it tested but she was sick for at least a week in each case. So we are concerned about the fact that she had those bouts of Covid and that she might be getting her first injection something that is more kin to the second injection response. So, we are trying to decide whether or not she ought to be doing the second shot?" Regarding treatment, Reporter stated, "She did take two Advils on 30Jan but that's all she took she tends to react by taking Advil so she shouldn't take anymore and she didn't take Tylenol because she reacts more to Tylenol." Reporter further stated, "She does in generally reacts with Tylenol and Advil she has, it makes her very tired so she doesn't like to have it very often so she stopped after that one day." The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pruritus, Headache, Pain, Pruritus
Clinical narrative: Body aches; itching eyes & body; itching eyes & body; chills; headache; This is a spontaneous report from a contactable other health professional (Patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810), via an unspecified route of administration, Right arm on 05Feb2021 at single dose for covid-19 immunisation (Age at vaccination 44 years) at hospital. Patient was not pregnant at the time of vaccination. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received other medications received within 2 weeks of vaccination. Medical history included ehlers-danlos syndrome (EDS), mast cell activation syndrome (MCAS), postural orthostatic tachycardia syndrome (POTS). Allergies to medications, food, or other products included Latex allergy. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COVID 19, Pfizer, PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249), via an unspecified route of administration, Right arm on 15Jan2021 at single dose for covid-19 immunization (Age at vaccination 44 years). On 06Feb2021, the patient experienced body aches, chills, headache, itching eyes & body. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. No treatment was received for the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Drug ineffective; SARS-CoV-2 test positive; This is a spontaneous report from a non-contactable consumer reported for herself.  An adult female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 05Jan2021 for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient was not pregnant. No COVID prior vaccination. On 06Feb2021 the patient tested positive for Covid 19 via nasal swab.  The outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Laboratory test, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Shoulder was a little sore; Arm soreness; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports.  A 69-year-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number reported as "ELI283 or EL1283"), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure (abnormal) and cholesterol (abnormal). Concomitant medications included blood pressure medication and cholesterol. The consumer was reporting on behalf of his 69 year old wife. She received the first dose of the BNT162B2 vaccine on 30Jan2021. On 06Feb2021, she started to experience itchiness, a rash, and a big area of redness on her left arm which was the injection arm. He stated he heard that the second dose can cause more side effects and he stated they both experienced arm soreness after the first dose on an unspecified date. Consumer stated, first of all thank you guys for making this vaccine. He and his wife received the vaccine (unspecified vaccine) their first dose last Saturday, a week ago yesterday and had no reaction to it at all, their shoulder was a little sore but that's it. Yesterday night, last night his wife noticed that the arm where she had the vaccination it has like a rash and he knows this online that Moderna has something called COVID arm but it doesn't say anything about Pfizer. He meant it's not to bother it itches a little bit you put some anti-itch cream on it wasn't a big deal. He was kind of concerned about the next you know they got the next one coming on the 18th, so, does she should change arm, do it on the other arm. Consumer added that that would be fine, he knows you guys want to know if there was any reaction so that you can log it in and that was basically why he called. They were going for their next shot they were going to the hospital and there were professionals there so pretty much ask them what they should do. Should they change arm or nothing to worry about if they do it again that was not the problem he just wanted to let you guys know that there was some kind of reaction a rash. Consumer stated he just put Cortaid cream on it and itch went away. The patient underwent lab tests and procedures which included lab work on 27Jan2021: doctor did for cholesterol, blood pressure reasons and everything was fine. The outcome was recovered for the event itchiness; and unknown for the rest of the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021170691 same reporter and drug, similar events, different patient